Journal of Consulting and Clinical Psychology © 2010 American Psychological Association

2010, Vol. 78, No. 4, 498 –510 0022-006X/10/$12.00 DOI: 10.1037/a0019055

Cognitive Behavioral Therapy for 4- to 7-Year-Old Children

With Anxiety Disorders: A Randomized Clinical Trial
Dina R. Hirshfeld-Becker, Bruce Masek, and Lauren Raezer Blakely
Aude Henin Massachusetts General Hospital
Massachusetts General Hospital and Harvard Medical School

Rachel A. Pollock-Wurman Julia McQuade, Lillian DePetrillo, and

Massachusetts General Hospital and Harvard Medical School Jacquelyn Briesch
Massachusetts General Hospital

Thomas H. Ollendick Jerrold F. Rosenbaum and Joseph Biederman

Virginia Polytechnic Institute and State University Massachusetts General Hospital and Harvard Medical School

Objective: To examine the efficacy of a developmentally appropriate parent– child cognitive behavioral
therapy (CBT) protocol for anxiety disorders in children ages 4 –7 years. Method: Design: Randomized
wait-list controlled trial. Conduct: Sixty-four children (53% female, mean age 5.4 years, 80% European
American) with anxiety disorders were randomized to a parent– child CBT intervention (n ⫽ 34) or a 6-month
wait-list condition (n ⫽ 30). Children were assessed by interviewers blind to treatment assignment, using
structured diagnostic interviews with parents, laboratory assessments of behavioral inhibition, and parent
questionnaires. Analysis: Chi-square analyses of outcome rates and linear and ordinal regression of repeated
measures, examining time by intervention interactions. Results: The response rate (much or very much
improved on the Clinical Global Impression Scale for Anxiety) among 57 completers was 69% versus 32%
(CBT vs. controls), p ⬍ .01; intent-to-treat: 59% vs. 30%, p ⫽ .016. Treated children showed a significantly
greater decrease in anxiety disorders (effect size [ES] ⫽ .55) and increase in parent-rated coping (ES ⫽ .69)
than controls, as well as significantly better CGI improvement on social phobia/avoidant disorder (ES ⫽ .95),
separation anxiety disorder (ES ⫽ .82), and specific phobia (ES ⫽ .78), but not on generalized anxiety
disorder. Results on the Child Behavior Checklist Internalizing scale were not significant and were limited by
low return rates. Treatment response was unrelated to age or parental anxiety but was negatively predicted by
behavioral inhibition. Gains were maintained at 1-year follow-up. Conclusions: Results suggest that devel-
opmentally modified parent– child CBT may show promise in 4- to 7-year-old children.

Keywords: childhood anxiety disorders, cognitive behavioral therapy, preschoolers, behavioral inhibition,
randomized clinical trial

Dina R. Hirshfeld-Becker, Bruce Masek, Aude Henin, Rachel A.
Pollock-Wurman, Jerrold F. Rosenbaum, and Joseph Biederman, Depart-
ment of Psychiatry, Massachusetts General Hospital, and Department of
Psychiatry, Harvard Medical School; Lauren Raezer Blakely, Julia
McQuade, Lillian DePetrillo, and Jacquelyn Briesch, Department of Psy-
chiatry, Massachusetts General Hospital; Thomas H. Ollendick, Depart-
ment of Psychology, Virginia Polytechnic Institute and State University.
Lauren Raezer Blakely is now at the Guidance Department, Needham
Public School System, Needham, MA; Julia McQuade is now at the Depart-
ment of Psychology, University of Vermont; Lillian DePetrillo is now at the
Department of Psychology, Catholic University; and Jacquelyn Briesch is now
at the Department of School Psychology, Northeastern University.
This work was supported by National Institutes of Health Grant K08
MH001538, awarded to Dina R. Hirshfeld-Becker. The Brandon Shedd
Fund at the Massachusetts General Hospital funded early development of
the treatment manual. We gratefully acknowledge Jerome Kagan, Nancy
Snidman, Michael Otto, and Michael Monuteaux for their contributions to
this project, as well as Lynette Dufton and Natasha Segool, who assisted
with coordination and coding.
Dina R. Hirshfeld-Becker and Aude Henin have received honoraria from
Reed Medical Education (a company working as a logistics collaborator for
the MGH Psychiatry Academy). The education programs conducted by the
MGH Psychiatry Academy were supported, in part, through independent
medical education grants from pharmaceutical companies, including
AstraZeneca, Lilly, McNeil Pediatrics, Janssen, Bristol-Myers Squibb,
Shire, Forest Laboratories, Inc., Sanori Advents, and Pfizer. Aude Henin
has received honoraria from Shire, Abbott Laboratories, and the American
Academy of Child and Adolescent Psychiatry. She receives royalties from
Oxford University Press. Jerrold F. Rosenbaum served on the advisory
board of Medavante in 2009, on the advisory boards of Boheringer In-
gelheim and Lilly in 2008, and on the advisory board of Organon in 2007.
Joseph Biederman is currently receiving research support from the follow-
ing sources: Alza, AstraZeneca, Bristol Myers Squibb, Eli Lilly and Co.,
Janssen Pharmaceuticals, Inc., McNeil, Merck, Organon, Otsuka, Shire, the
National Institute of Mental Health, and the National Institute of Child
Health and Human Development. In 2009, he received speaker’s fees from
the following sources: Fundacion Areces, Medice Pharmaceuticals, and the
Spanish Child Psychiatry Association. In previous years, he received
research support, consultation fees, or speaker’s fees for or from the
following additional sources: Abbott, AstraZeneca, Celltech, Cephalon, Eli
Lilly and Co., Esai, Forest, Glaxo, Gliatech, Janssen, McNeil, the National
Alliance for Research on Schizophrenia and Depression, the National
Institute on Drug Abuse, New River, Novartis, Noven, Neurosearch,
Pfizer, Pharmacia, the Prechter Foundation, Shire, the Stanley Foundation,
UCB Pharma, Inc., and Wyeth.
Correspondence concerning this article should be addressed to Dina R.
Hirshfeld-Becker, Massachusetts General Hospital, 185 Alewife Brook Parkway,
Suite 2000, Cambridge, MA 02138. E-mail: dhirshfeld@partners.org

498
 CBT FOR 4- TO 7-YEAR-OLD CHILDREN WITH ANXIETY
Anxiety disorders represent one of the most common categories
of childhood disorders (Costello et al., 1996; Costello, Mustillo,
Erkanli, Keeler, & Angold, 2003). Studies suggest that childhood
anxiety disorders are associated with social, familial, and academic
impairment (Essau, Conradt, & Petermann, 2000; Ezpeleta, Kee-
ler, Erkanli, Costello, & Angold, 2001; Ialongo, Edelsohn,
Werthamer-Larsson, Crockett, & Kellam, 1995; Strauss, Frame, &
Forehand, 1987), are likely to persist if untreated, and tend to
predispose children to develop anxiety disorders later in adoles-
cence and adulthood (Costello et al., 2003; Hirshfeld, Micco,
Simoes, & Henin, 2008; Newman et al., 1996; Weissman, 1999).
Clearly, the ability to intervene early to treat these disorders would
be beneficial.
Over the last two decades, promising cognitive behavioral ther-
apies (CBT) have been developed to treat childhood anxiety dis-
orders, including social phobia, separation anxiety disorder, and
generalized anxiety disorder (GAD; James, Soler, & Weatherall,
2005; Ollendick & King, 1998; Silverman, Pina, & Viswesvaran,
2008). Such studies have suggested that CBT can be efficacious
for these disorders when offered individually or as a family treat-
ment (Kendall, Hudson, Gosch, Flannery-Schroeder, & Suveg,
2008) and when offered alone or in combination with sertraline
(Walkup et al., 2008). However, despite at least eight early studies
showing the efficacy of approaches such as in vivo desensitization;
filmed, live, and participant modeling; graded exposure; reinforced
practice; and verbal self-instruction to treat fears or specific pho-
bias in preschool- and kindergarten-age children (see Ollendick &
King, 1998), the protocols addressing the other major childhood
anxiety disorders have been evaluated mainly among school-age
children and adolescents. Although some studies extended their
inclusion age downward to age 5 or 61⁄2 (e.g., King et al., 1998;
Shortt, Barrett, & Fox, 2001), they generally included relatively
small numbers of the youngest children (with mean sample ages of
11.03 and 7.8 years, respectively) and did not examine results
separately for the youngest age group.
The underrepresentation of younger children in studies of CBT
protocols for major childhood anxiety disorders may have derived
from beliefs about the transience of anxiety disorders in this age
group or from the assumption that younger children were not
developmentally mature enough to benefit from cognitive behav-
ioral interventions. However, recent studies have challenged these
assumptions. First, studies have demonstrated that preschoolers
present with persistent anxiety disorders at rates almost as high as
older children (Egger & Angold, 2006; Lavigne et al., 1998), and
factor-analytic studies have shown that the symptom presentations
in preschoolers closely parallel those found in older children (Eley
et al., 2003; Spence, Rapee, McDonald, & Ingram, 2001). In
addition, several groups have recently begun testing the use of
CBT protocols for a variety of anxiety disorders in younger chil-
dren.
For example, Freeman et al. (2008) developed and tested a
family-based CBT protocol for 5- to 8-year-old children with
obsessive-compulsive disorder (OCD) with promising results, sug-
gesting that young children can benefit from CBT tailored to their
developmental needs. Scheeringa et al. (2007) piloted a CBT
protocol for posttraumatic stress disorder in preschoolers. With
regard to anxiety disorders in general, Rapee, Kennedy, Ingram,
Edwards, and Sweeney (2005) demonstrated that a six-session
group intervention training parents to apply CBT strategies with
499
their behaviorally inhibited 3- to 4-year-olds significantly reduced
the rates of anxiety symptoms and disorders among the children,
compared with children who were monitored only. However,
although the effect of assignment to the intervention on the number
of anxiety disorders at 12-month follow-up was significant, a
substantial portion of the treated children continued to meet crite-
ria for anxiety disorders, with 50% of treated compared with 64%
of untreated children still affected (90% had been affected at
baseline).
Two research groups have implemented CBT directly with
young children with mixed anxiety disorders. First, in an open trial
with nine children, our group piloted a CBT intervention geared to
4- to 7-year-olds. The treatment was offered to families individu-
ally; it included six parent-only sessions and up to 14 parent– child
sessions, which focused on coping skills training and graduated
exposure (Hirshfeld-Becker et al., 2008). It incorporated puppet
play, games, and specific anxiety management strategies found
efficacious in treating fears and phobias in preschool-age children
(Hirshfeld-Becker & Biederman, 2002). Using the Clinical Global
Improvement (CGI) Anxiety scale, we judged eight of the nine
children (89%) to be much or very much improved at postinter-
vention. Although all but one had at least one anxiety disorder at
baseline, according to criteria in the Diagnostic and Statistical
Manual of Mental Disorders (4th ed.; DSM–IV; American Psychi-
atric Association, 1994), six (67%) were free from anxiety disor-
ders at follow-up (Hirshfeld-Becker et al., 2008). Similarly,
Monga, Young, and Owens (2009) openly piloted a CBT group
treatment geared toward 5- to 7-year-olds, which offered parallel
child and parent groups. In their study, 48% of children no longer
met criteria for any anxiety disorders at posttreatment, and 72%
had at least one anxiety disorder remit.
Given these new results suggesting that anxiety disorders other
than specific phobias in preschoolers and young elementary school
children may be amenable to direct CBT approaches, there could
be significant advantages to treating anxiety disorders earlier in
development. Beginning intervention earlier could afford the op-
portunity to teach children and parents skills for managing anxiety
before symptoms begin to impair the child’s self-concept, social-
ization, and learning (Hirshfeld-Becker & Biederman, 2002). Ear-
lier intervention might also be able to help modify some of the
factors hypothesized to maintain anxiety, including parenting fac-
tors (Hudson, Comer, & Kendall, 2008; Rapee, Schniering, &
Hudson, 2009). However, randomized clinical trials are needed to
better evaluate the efficacy of direct CBT intervention in this age
group.
Therefore, in the present study we tested a CBT protocol
adapted for young children and their families in a randomized
clinical trial of 64 children, ages 4 –7 years, with anxiety disorders.
Similar to many first trials of new CBT protocols for anxiety
(James et al., 2005; Kendall, 1994), we conducted this initial trial
versus a monitoring-only (wait-list) control condition. This ap-
proach provides preliminary evidence that the outcome of the
proposed intervention is better than the natural course of the
condition; if successful, the intervention could be further evaluated
against other interventions in subsequent trials. We hypothesized
that the treated children would show significantly more improve-
ment in anxiety and ability to cope with feared situations at
posttreatment than controls and that gains would be maintained at
1-year follow-up.
500 HIRSHFELD-BECKER ET AL.
Method
Participants
Children ages 4 –7 years were recruited from the outpatient child
psychiatry clinic at a general hospital, as well as through print ads
in local newspapers and parent magazines, e-mail advertisements
to hospital employees, and posters at local pediatrics practices
calling for children this age who were “extremely shy, fearful, or
worried.” The study was conducted in our research clinic at a
general hospital. We designed the study to detect a large effect
size for the difference in improvement rates between groups
(measured via blind clinician ratings of CGI; see Data Analytic
section). For chi-square analyses, with 60 subjects (30 per
group) the power to detect a large effect size would be in excess
of .95, using a critical value of .05. To allow for attrition, we set
the recruitment goal at 64.
To be included, children had to meet criteria for a current
DSM–IV anxiety disorder. Children were excluded on the basis of
(a) active psychosis, suicidality, or substance abuse in a parent; (b)
mental retardation in the child; or (c) current psychiatric treatment
or past CBT. Children were also excluded if a consensus of two
senior clinicians judged the child to be (d) too uncooperative or
distractible to take part in the trial; or (e) too severely symptomatic
to wait 6 months to receive treatment, based on suicidal ideation,
serious impairment in eating or sleeping habits, severe social
isolation, severe impairment in school function or attendance, or
severe OCD. Because of our interest in risk factors for anxiety and
in their potential to moderate treatment outcome, we also assessed
the families for anxiety disorders in the parents (Hirshfeld et al.,
2008) and for behavioral inhibition in the children (Hirshfeld-
Becker et al., 2007; Hirshfeld-Becker, Biederman, & Rosenbaum,
2004).
The study was approved by the institutional review board. After
meeting with a clinician who explained the study procedures, risks,
and benefits and answered any questions, parents signed informed
consent for themselves and their children. All children were given
age-appropriate explanations; 7-year-old children assented in writ-
ing to study procedures.
Study Procedures
Children were assessed at baseline, were blocked on presence or
absence of parental anxiety disorder, and were randomized to the
intervention (up to 20 sessions over 6 months) or control (6-month
wait-list) condition. The allocation sequences were generated in
advance for the two cells (presence or absence of parental anxiety
disorders) by the study coordinator and concealed in a computer
file from all other staff (including the clinicians who enrolled the
patients, the assessors and clinicians who conducted the assess-
ments, and the clinicians who determined the eligibility of each
child). Parents of children in the control condition repeated ques-
tionnaire measures at Week 7 and were instructed to contact our
office if the child’s symptoms worsened. Children from both
conditions were reassessed at posttreatment, and families in the
control condition were offered the CBT intervention. At 1-year
follow-up, children who had been assigned to CBT were reas-
sessed with the Schedule for Affective Disorder and Schizophrenia
for School-Age Children, Epidemiologic Version (K-SADS—E;
Orvaschel, 1994), clinician interview, and Kendall’s (1994) Cop-
ing Questionnaire (CQ). Although participants and clinicians de-
livering the treatment could not be blinded to treatment assign-
ment, assessors and clinicians conducting outcome assessments
were blinded. In addition, participants were instructed at their
follow-up assessment interviews not to reveal their treatment as-
signment.
Baseline Assessments
Children were assessed at baseline using structured diagnostic
research interviews administered to mothers, clinical interviews
by clinicians who met with the child and mother, standardized
behavioral observations, and questionnaire measures. The re-
search interviews used the child version of the Schedule for
Affective Disorders and Schizophrenia, Epidemiologic Version
(K-SADS-E) for DSM–IV (Orvaschel, 1994), a widely used
diagnostic instrument with established test–retest reliability and
acceptable concurrent and predictive diagnostic validity
(Ambrosini, 2000). We supplemented the K-SADS-E with the
DSM–III–R avoidant disorder module from the Diagnostic Inter-
view for Children and Adolescents, Parent Version (Herjanic &
Reich, 1982). We included this module in this and previous studies
of anxious children (Biederman et al., 2001; Hirshfeld-Becker et
al., 2007) because we have found that it captures symptoms that do
not entirely overlap with those measured by the K-SADS-E social
phobia module in this age group but still characterize debilitating
social anxiety among young children. Although there were very
few children who met criteria for avoidant disorder but not social
phobia (one at baseline and two at posttreatment), they were still
judged by clinicians to have impairing social anxiety. No child was
included in the study on the basis of avoidant disorder alone, and
avoidant disorder was not counted as a separate diagnosis in
calculating the number of anxiety disorders for which the child met
criteria or determining the presence of “any anxiety disorder.”
However, it was used in the separate analysis of the effects of CBT
on social anxiety. To determine the parents’ diagnoses, both par-
ents were interviewed directly at baseline with the Structured
Clinical Interview for DSM–IV (SCID), a well-validated instru-
ment in wide use in research settings (First, Spitzer, Gibbon, &
Williams, 1995).
All diagnostic interviews were conducted under the supervision
of senior psychiatrists and psychologists by raters with bachelor’s
or master’s degrees in psychology, and final diagnoses were as-
signed by consensus of two senior clinicians. We computed kappa
coefficients of agreement by having experienced board-certified
psychiatrists and licensed psychologists diagnose subjects from
audiotaped interviews by assessment staff. Based on 20 modules
per diagnosis, kappa coefficients were 1.0 for separation anxiety
disorder, 1.0 for social phobia, 0.95 for GAD, 1.0 for agoraphobia,
0.95 for specific phobia, 0.95 for panic disorder, 1.0 for OCD, and
1.0 for major depressive disorder. In addition, to estimate the
reliability of the diagnostic review process, we computed kappa
coefficients of agreement between clinician reviewers. The kappa
coefficients between individual clinicians and the diagnoses as-
signed by the review committee were 0.89 for separation anxiety
disorder, 0.90 for social phobia, 0.90 for GAD, 0.80 for agorapho-
bia, and 0.85 for specific phobia, 0.77 for panic disorder, 0.73 for
OCD, and 1.0 for major depressive disorder.
 CBT FOR 4- TO 7-YEAR-OLD CHILDREN WITH ANXIETY
All K-SADS-E modules about lifetime and current diagnoses were
administered to generate tentative research diagnoses that were veri-
fied in the clinical interview. Clinician evaluators who were licensed
psychologists or advanced postdoctoral clinical psychology fellows
conducted an evaluation with the family that included an interview to
evaluate parental concerns about the child and a play interview with
the child. The clinicians administered a DSM–IV symptom checklist
to the parents to verify all positive K-SADS-E diagnoses. On the basis
of a review of the K-SADS-E and the clinical interviews, the
clinician evaluator assigned ratings for the presence or absence and
the severity of each anxiety disorder in the child, using a CGI-
Anxiety 7-point rating.
Children were assessed for behavioral inhibition (BI) with stan-
dardized age-specific observational laboratory protocols at base-
line and at posttreatment. The BI protocols were closely adapted,
after consultation with Jerome Kagan and Nancy Snidman, from
those used in our longitudinal study of high-risk children (Rosen-
baum et al., 2000). In these assessments, the child, accompanied by
the mother, was brought into the laboratory, and his or her reac-
tions to unfamiliar people, rooms, objects, and cognitive tasks
were videotaped and coded for indicators of BI, including low
number of spontaneous comments, and global ratings of inhibition
or shyness. To estimate the child’s intellectual functioning, we
included the Kaufman Brief Intelligence Test (K-BIT) Vocabulary
and Matrices subtests (Kaufman & Kaufman, 1990). Videotapes
were coded by a single rater who had been trained to acceptable
reliability on videotaped assessments coded by Jerome Kagan
(all ␬s ⬎ 0.70). Children were considered inhibited if they
achieved a global rating score of 3 (more inhibited than not) or
4 (extremely inhibited). As a reliability check, 15 tapes were
recoded by a second trained rater, with perfect agreement on the
dichotomous classification of BI (␬ ⫽ 1.0) and excellent agree-
ment on the number of spontaneous comments (intraclass cor-
relation [ICC] ⫽ .85).
Laboratory ratings of BI were supplemented by two parent-
report measures. The Retrospective Self-Report of Inhibition is a
30-item questionnaire about inhibited behaviors in childhood
(Reznick, Hegeman, Kaufman, Woods, & Jacobs, 1992). Reznick
et al. (1992) found that the parent version had excellent internal
consistency (Cronbach’s ␣ ⫽ .86) and strong agreement between
parent and adolescent informants reporting retrospectively (r ⫽
.63). We modified the wording so that parents reported on their
child’s current behavior. The Emotionality-Activity-Sociability
Temperament Survey (EAS) is a widely used inventory that in-
cludes both a shyness and a sociability scale (Buss & Plomin,
1984). We used the five-item shyness scale as a measure of
inhibition. Studies of the measure in American and English sam-
ples did not report separate psychometric properties for the shy-
ness and sociability scales; however, a validation study of 737
Norwegian children (age 50 months) found that all of the shyness
items loaded primarily on a separate factor, with an internal
consistency (Cronbach’s ␣) of .79 and moderate stability from
18 –30 months (r ⫽ .57) and 30 –50 months (r ⫽ .59) of age
(Mathiesen & Tambs, 1999).
In addition, parents completed the Child Behavior Checklist
(CBCL/4 –18), a widely used, well-normed measure with estab-
lished psychometric properties (Achenbach, 1991) that records the
behavioral problems and competencies of children ages 4 to 18, as
reported by their parents. The scales were constructed from anal-
501
yses of parent ratings of 2,300 clinically referred children and
normed on 1,300 nonreferred children. On the Internalizing and
Externalizing subscales, scores over 63 are considered in the
clinical range, and those from 60 to 63 are considered borderline.
The reported 1-week test–retest reliability for its use among 4- to
11-year-olds (N ⫽ 80) is .89 for the Internalizing subscale and .93
for the Externalizing subscale (Achenbach, 1991), with internal
consistencies of .89 and .93 for boys and .90 and .93 for girls,
respectively. Finally, we used an adaptation of Kendall’s (1994)
CQ. In this questionnaire, clinicians asked parents to list their
child’s most feared situations and to rate the child’s ability to cope
with each of them on a 7-point Likert scale (1 ⫽ completely unable
to help him/herself feel less upset, 4 ⫽ somewhat able, and 7 ⫽
completely able to help him/herself feel less upset). Analyses have
demonstrated adequate internal consistency and test–retest reliabil-
ity and have documented the measure’s utility as a measure of
change with treatment (Kendall et al., 2008).
Posttreatment and Follow-Up Assessments
At posttreatment, mothers were interviewed about each child’s
current diagnoses using the K-SADS-E administered by a research
interviewer; children were assessed again for BI via a laboratory
observation conducted in a novel site (on another campus of the
hospital) by a novel examiner blind to the child’s treatment con-
dition and rated by a rater blind to the child’s treatment assign-
ment. On the basis of reviewing the BI assessment and the post-
treatment K-SADS–E, interviewing the mother using a DSM–IV
symptom checklist, and comparing the results with the record of
the baseline clinician evaluation, the blind clinician rater assigned
ratings for the presence or absence and improvement of each
disorder, as well as an overall CGI-Anxiety Improvement rating
(reliability based upon 19 children rated independently by two
raters, ICC ⫽ .87). In addition, parents completed all of the
questionnaire measures.
At 1-year follow-up, mothers of children who had been assigned
to the intervention were interviewed about the child’s current
diagnoses using the K-SADS-E administered by a research inter-
viewer blind to the child’s treatment condition. The BI assessment
was not repeated because many children had aged out of the range
that can be assessed using age-specific protocols developed by
Kagan, Reznick, and Snidman (1988). Based on reviewing the
posttreatment K-SADS–E, interviewing the mother using a
DSM–IV symptom checklist, and comparing the results with the
record of the baseline clinician evaluation, the blind clinician
evaluator assigned ratings for the presence or absence and im-
provement of each disorder, as well as an overall CGI-Anxiety
Improvement rating (from baseline to follow-up). In addition,
parents repeated the CQ.
Description of Intervention
The intervention was administered by licensed psychologists
and one advanced postdoctoral psychology fellow. The manual-
ized intervention, called Being Brave: A Program for Coping with
Anxiety for Young Children and Their Parents, was loosely mod-
eled after the manualized Coping Cat program (Kendall, Kane,
Howard, & Siqueland, 1992) and was adapted with Kendall’s
502 HIRSHFELD-BECKER ET AL.
permission.1 This program includes skill building (relaxation train-
ing, cognitive restructuring) and in vivo exposure. The protocol
needed to be modified in several ways for use with younger
children (Hirshfeld-Becker et al., 2008), including (a) use of tech-
niques developmentally appropriate for younger children, with
age-appropriate self instructive strategies to control and/or cope
with anxiety and exposure exercises modified to include games
and immediate positive reinforcement; (b) greater parental in-
volvement in modeling and reinforcing coping techniques; (c)
inclusion of parental anxiety management strategies; and (d) in-
clusion of parent skills training. Therefore, the intervention con-
sisted of a combination of parent-only and child-and-parent ses-
sions (see Table 1 for the session content).
The conceptual model for this protocol has been previously
described in detail (Hirshfeld-Becker & Biederman, 2002).
Briefly, we followed a CBT model of anxiety in positing that
graded exposure is the primary means of reduction in child anxiety
symptoms; however, in order for the child to participate in expo-
sure exercises, the child needs to understand the rationale for
treatment (presented through age-appropriate stories), to rehearse
some basic coping strategies to facilitate exposure (e.g., recogniz-
ing anxious feelings and implementing a coping plan), and to
achieve motivation to practice exposure exercises through contin-
gent reinforcement. In this regard, the model parallels the Coping
Cat protocol, which comprises 16 sessions. Because of the young
age of the children, however, we added six initial parent-only
sessions that included psychoeducation on anxiety management
strategies, instruction on parenting skills useful in parenting an
anxious child, and instruction on planning, implementing, and
reinforcing exposure hierarchies. We developed a six-session
parent-only protocol and then allowed for as many parent– child
sessions as needed to complete exposure exercises to several
feared situations, setting minimum and maximum limits of eight to
13 child sessions. In our pilot trial the mean total number of
sessions was 17.1 (SD ⫽ 2.4; Hirshfeld-Becker et al., 2008).
Although the protocol’s main aim is symptom reduction, it also
seeks to modify some of the parenting factors hypothesized to
maintain child anxiety—for example, by teaching parents to model
optimal coping, to praise the child’s efforts at adaptive coping, and
to refrain from criticizing or reinforcing anxious behavior. In this
way its goals are similar to those of treatment models that have
included parents as co-clients in CBT work with older youths to
facilitate generalization and persistence of treatment gains
(Barmish & Kendall, 2005). To counter any tendencies to over-
protect or micromanage, we assign a play exercise, where parents
work on allowing the child space, and discuss guidelines for
protecting the child from dangers, not from anxiety. To address a
well-meaning parent’s tendency to enable avoidance or inadver-
tently reinforce anxious behaviors, we encourage parents to foster
exposure and contingently to reinforce exposure practice and use
of coping plans. Therefore, we hypothesized that the intervention
might also have longer term effects.
Data Analytic Strategy
We used several different outcome measures. Our primary out-
come measure was the rate of clinical improvement, defined as the
proportion of children who were rated as very much improved or
much improved on the CGI-Anxiety by clinicians blind to treat-
ment status at posttreatment (6 months from baseline). A second
primary clinical outcome measure was the rate of children who no
longer met criteria for an anxiety disorder. Secondary measures
included the number of anxiety disorders, scores on the CQ,
CGI-improvement ratings for each of the individual anxiety dis-
orders, and temperament and CBCL ratings.
Data analyses were conducted using Stata statistical software
(2003, 2005). To determine whether randomization was success-
ful, baseline variables were compared between groups using con-
tingency tables for categorical variables (chi-squares or Fisher’s
exact test, where cell values were 5 or less) and Student’s t tests (or
Mann-Whitney tests, where sample sizes were small) for contin-
uous variables. Posttreatment categorical measures (e.g., rates of
improvement, rates of any anxiety disorder) were compared be-
tween groups using contingency tables (chi-square analysis). Post-
treatment continuous measures that were not repeated (e.g., CGI
improvement ratings for individual disorders) were compared us-
ing Student’s t test. Change scores (for number of anxiety disor-
ders and CQ means) were compared using Mann-Whitney tests.
Repeated measures were tested using regression analyses includ-
ing terms for intervention status (i.e., treatment vs. control), time
(i.e., baseline to posttreatment) and Time ⫻ Intervention Status
interaction. We used linear and ordinal regression for continuous
(e.g., mean coping scale scores, temperament scale scores) and
ordinal (e.g., number of anxiety disorders) outcome measures. In
these analyses, because we had multiple measurements per subject,
the assumption of independence of observations was violated;
therefore, to account for correlation within individuals, we used
robust estimates of variance so that p values would not be under-
estimated (Liang & Zeger, 1986). In reporting these analyses,
mean values are presented and significances are reported as the t or
z values for the Time ⫻ Intervention Status term.
For ease of comparison with other treatment studies, we calcu-
lated the between and within group Hedge’s (bias-corrected) effect
sizes for each of the significantly different continuous outcome
measures. For significantly different rate measures, we calculated
measures of excess risk, using the formula 兩% in Treated ⫺ % in
Controls兩/% in Treated.
Results
Participant Flow and Characteristics
Study recruitment occurred between February 2001 and January
2004. Children were reassessed at posttreatment (6-month follow-
up) and at 1-year follow-up (mean 1.27 years from posttreatment,
SD 0.45). Figure 1 shows the flow of participants through each
phase of the study. Of the 103 children screened for the study, 15
were found ineligible. Four did not meet the inclusion criteria, one
had active substance abuse in a parent, two were too uncooperative
or inattentive to participate, and eight were judged too severely
symptomatic to be randomized, based upon mood disorders (n ⫽
4) or OCD, school refusal, severe social isolation, or severe strain
in parent– child relationship (n ⫽ 1 each). An additional 13 with-
1
We gratefully acknowledge Philip Kendall for his input in making
available Coping Cat materials and in reviewing the initial draft of the
adapted manual.
 CBT FOR 4- TO 7-YEAR-OLD CHILDREN WITH ANXIETY 503

Table 1
“Being Brave” Intervention: Content of Sessions

Session Description

Parent-only sessions: Learning about anxiety management

1 Psychoeducation about cognitive behavioral model of anxiety (including physical, cognitive, and emotional components); learning to
observe child’s anxiety response and its antecedents and consequences.
2 Understanding and recognizing cognitive errors that contribute to anxiety or overprotection; cognitive restructuring (for parent).
3 Modeling coping skills; distinguishing helpful and unhelpful parental responses to child’s anxiety.

Parent-only sessions: Coaching the child in anxiety management

4 Psychoeducation about factors that maintain child anxiety; nondirective play exercise (learning to play with the child in a relaxed way).
5 Distinguishing protection from overprotection; learning to contingently reinforce good coping.
6 Planning and beginning to implement graduated exposure exercises for the child.

Parent–child sessions: Child anxiety management

7 Introducing the approach to working on “being brave”; teaching relaxation.
8 Teaching the idea of coping plans; beginning to plan or implement exposure.
9–17 Planning, rehearsing, and implementing graduated exposure with reinforcement.
18 Child makes final project (short video or book) reflecting a strategy for learning to be brave.
19 Final party or graduation celebrating the child’s gains.

Parent-only session: Relapse prevention

20 Maintaining gains, anticipating difficulties (e.g. transitions, developmental changes), addressing symptoms that may reemerge, knowing
when to seek further help.

drew from participation prior to completing their baseline assess-
ments, and 11 families who began but did not complete the
assessment process were lost to follow-up.
Of the 64 children, 53% were female, with a mean age of 5.4
years (SD ⫽ 1.0). Of the children, 80% were European American,
3% were of Latino origin, 8% were of Asian origin, and 9%
belonged to more than one group or had unknown ethnicity.
Children had a mean of 1.02 (SD ⫽ 0.79) siblings (range 0 – 4),
and 87.5% lived with both parents. Children tended to be from
middle-class households (Hollingshead Four Factor Class range
I–III, M ⫽ 1.38, SD ⫽ 0.63; Hollingshead, 1975). Of the mothers,
6.3% were high school graduates, 14.1% had attended some col-
lege, 42.2% had completed college, and 37.5% had attended grad-
uate school. Of the fathers, 6.8% were high school graduates,
16.9% had attended some college, 30.5% had completed college,
and 45.8% had attended graduate school. With regard to occupa-
tion, 3.4% of fathers were machine operators or semiskilled work-
ers; 6.8% were skilled manual workers; 3.4% were small business
owners; 45.8% were managers, administrators, or semiprofession-
als; and 40.7% were professionals. Of the mothers, 35.9% did not
have paid employment, 10.9% were employed part-time, and
53.1% were employed full-time (70.6% as technicians, managers,
administrators or semiprofessionals, and 29.4% as executives or
professionals). Children’s standard scores on the K-BIT Vocabu-
lary subtest ranged from 78 to 146 (M ⫽ 113.93, SD ⫽ 13.62) and
on the Matrices subtest ranged from 74 to 146 (M ⫽ 106.57, SD ⫽
13.70).
Seventy-seven percent of the children had more than one
DSM–IV anxiety disorder, with rates of disorders as follows:
separation anxiety disorder, 44%; social anxiety disorder, 67%
(including one with avoidant disorder); GAD, 44%; agoraphobia,
36%; and specific phobia, 48% (only one child had specific phobia
with no other anxiety disorders). With regard to risk factors for
anxiety, 59% of children had BI, 73% had at least one parent with
a lifetime history of major anxiety disorder (presence of panic
disorder, agoraphobia, social phobia, GAD and/or OCD), and 44%
had at least one parent with a current major anxiety disorder.
As seen in Table 2, children assigned to the CBT and control
conditions did not differ significantly on any demographic vari-
ables. The children also did not differ significantly on rates of
multiple or individual anxiety disorders, comorbid diagnoses, or
on their CBCL scores (means and standard deviations for 32 CBT
versus 27 control children: Internalizing: 64.94, 7.85 vs. 64.22,
8.62, t ⫽ 0.33, p ⫽ .74; Externalizing: 52.88, 11.05 vs. 52.33, 11.5,
t ⫽ 0.18, p ⫽ .86). Children in the intervention and control groups
had similar rates of BI, 59% versus 57%, ␹2(1, N ⫽ 62) ⫽ 0.0178,
p ⫽ .89 (two assessments could not be scored due to equipment
failure); and similar mean and SD for verbal (114.12, 14.36 vs.
113.70, 12.94) and nonverbal (108.63, 14.69 vs. 104.14, 12.24)
functioning on the K-BITS. The two groups had similar rates of
lifetime maternal anxiety disorder, 53% versus 50%, ␹2(1, N ⫽
64) ⫽ 0.55, p ⫽ .81; current maternal anxiety disorder, 32% versus
30%, ␹2(1, N ⫽ 64) ⫽ 0.041, p ⫽ .84; lifetime paternal anxiety
disorder, 47% versus 38%, ␹2(1, N ⫽ 56) ⫽ 0.38, p ⫽ .54; and
current paternal anxiety disorder, 20% versus 27%, ␹2(1, N ⫽
56) ⫽ 0.37, p ⫽ .54.
Of the 64 children enrolled, five dropped out and two were lost
to follow-up before completing the posttreatment assessment, re-
sulting in 57 completers. Drop-out rates did not differ significantly
between groups (see Table 2). Among the treated children, one
dropped out (after Session 1) because the child had improved from
baseline, two dropped out (after Sessions 1 and 6) because of
difficulty commuting to the clinic, one dropped out (after Session
8) to seek medication for preexisting conduct disorder, and one
completed the treatment but was lost to follow-up before complet-
ing the posttreatment assessment. Among the controls, one
dropped out to seek alternative treatment upon assignment to the
control condition, and one was lost to follow-up. Noncompleters
504 HIRSHFELD-BECKER ET AL.

Assessed for eligibility

(n = 103)

Excluded (n = 39)

Not meeting criteria (n = 15)

Refused participation (n = 13)
Eligible Lost to follow-up (n = 11)

Randomized (n = 64)
Block randomized: with parental anxiety
(n = 34), without (n = 30).

Allocated to intervention (n = 34) Allocated to control group (n = 30)

Remained in intervention (n = 34) Allocation Remained in control group (n = 29)
Did not remain: n = 1
Dropped out to seek alternative
treatment.

Completed intervention (n = 29)

Did not complete (n = 5) Completed control condition (n = 28)
1 improved from baseline Did not complete (n = 1)
2 had difficulty commuting Lost to follow-up
1 sought treatment for Posttrial
conduct disorder
1 was lost to follow-up

Analyzed (n = 29, n = 34 in Analyzed (n = 28, n = 30

intent to treat analysis) Analysis in intent to treat analysis)

Included (n = 29) 1 Year Follow-Up N/A

Lost to follow-up (n = 0)

Figure 1. Flow of participants through the study.

did not differ significantly from completers in age, socioeconomic
class, gender, ethnicity, family intactness, number of siblings, or
nonverbal ability, but noncompleters had higher K-BIT Vocabu-
lary scores (M, SD: 121.5, 5.5 vs. 113.09, 14.02, z ⫽ –1.97, p ⫽
.049). Noncompleters did not differ significantly from completers
on BI or on any anxiety disorders or symptoms but did have a
higher rate of oppositional defiant disorder (57% vs. 16%, p ⫽
.027 by Fisher’s exact test) and higher CBCL externalizing scores
(M, SD: 60.57, 14.11 vs. 51.56, 10.44, z ⫽ –1.99, p ⫽ .046 by
Mann Whitney test).
Posttreatment Results
The proportion of children completing each condition who were
rated by the clinician evaluator as much improved or very much
improved (on the CGI-Anxiety) was 69% (20/29) for the CBT
children and 32% (9/28) for the controls, ␹2(1, N ⫽ 57) ⫽ 8.31,
p ⬍ .01. In an intent-to-treat analysis, the response rate was 59%
(20/34) versus 30% (9/30) in CBT vs. control children, ␹2(1, N ⫽
64) ⫽ 5.85, p ⫽ .016. Among completers, 59% of the CBT
children (17/29) were rated as free of anxiety disorders at post-
treatment, compared with 18% (5/28) of control children, ␹2(1,
N ⫽ 57) ⫽ 9.99, p ⬍ .01. In an intent-to-treat analysis, 50%
(17/34) of children assigned to the CBT condition compared with
16.7% (5/30) of those assigned to the control condition were free
of anxiety disorders, ␹2(1, N ⫽ 64) ⫽ 7.85, p ⬍ .01.
As seen in Table 3, although children completing the control
condition showed some improvement on number of anxiety
disorders and coping ability, children completing the CBT
condition showed significantly greater gains. When we calcu-
lated change scores, we found that treated children had a mean
decrease in number of anxiety diagnoses of 1.72 (SD ⫽
1.53), compared with a decrease of 0.93 (SD ⫽ 1.30) in control
children (z ⫽ –2.21, p ⫽ .027 by Mann Whitney). Treated
children had a mean increase in CQ score of 2.07 (SD ⫽ 1.18),
compared with 1.26 (SD ⫽ 1.13) in control children (z ⫽ 2.56,
p ⫽ .011). Full evaluation of the effects of the intervention on
CBCL Internalizing scores was hampered by an incomplete
posttreatment response rate: Mothers of only 36/57 completers
(63%: 20 treated and 16 controls) returned the CBCL forms at
posttreatment. The posttreatment response rate for fathers was
even lower (13 treated and seven controls), making analysis of
father reports unfeasible. As seen in Table 3, the Time ⫻
 CBT FOR 4- TO 7-YEAR-OLD CHILDREN WITH ANXIETY 505

Table 2
Demographic Characteristics

CBT (N ⫽ 34) Controls (N ⫽ 30)

Fisher’s
Characteristic n % n % exact p

Sex of child (female) 17 50% 17 57% .63

Age of child
4 years 7 21% 5 17% .97
5 years 12 35% 12 40%
6 years 9 26% 8 27%
7 years 6 18% 5 17%
Ethnicity
European American 27 79% 24 80% 1.0
Latino origin 1 3% 1 3%
Asian origin 3 9% 2 7%
Biracial or othera 3 9% 3 10%
Family intact 31 91% 25 83% .46
Completers 29 85% 28 93% .43
M SD M SD t ( p)
Socioeconomic status 1.35 0.65 1.40 0.62 ⫺.30 (.77)
a
Biracial or other children included two European and African American children, two European and Asian
American children, and two unreported.

Treatment interaction was not a significant predictor of the
CBCL Internalizing scale. The change scores (using mother
reports) for the CBCL Internalizing score (initial t score minus
final t score, for treated vs. control children, respectively) were
M ⫽ 7.25, SD ⫽ 8.72, versus M ⫽ 2.0, SD ⫽ 9.57 (z ⫽ –1.53,
p ⫽ .12 by Mann Whitney). At baseline, 70% of treated
children and 68% of controls had CBCL Internalizing scores in
the borderline or clinical range. At posttreatment, 65% of the
treated children and 44% of the control children had scores in
the normal range (z ⫽ 1.27, p ⫽ .20). Of the 36 children (69%)
who were in the borderline or clinical range on the CBCL
Internalizing scale at baseline, 22 (61%) returned the posttreat-
ment CBCL. Of these, 6/12 of the treated children compared
with 3/10 of the control children had normalized scores by
posttreatment (ns).
Table 4 shows the mean CGI improvement scores rated sepa-
rately for each disorder among the children who had that disorder
at baseline. Treated children showed significantly greater improve-
ment on social anxiety disorder, separation anxiety disorder, and
social phobia.
To allow comparisons with other treatment studies, we calcu-
lated the between-group effect sizes on significant continuous
outcome measures (change in number of anxiety disorders, change
in CQ score), and measures of excess risk (for treated compared
with controls) on rate measures (i.e., response rate, anxiety-free
rate). As seen in Table 5, the intervention led to a 49%– 69%
increase in improvement, relative to control children. Similarly,
effect sizes on both secondary outcome measures were medium to
large in size. The number needed to treat (based upon the primary
outcome measure, the proportion of children rated as 1 or 2 on the

Table 3
Clinical and Temperamental Characteristics of Completers at Baseline and Posttreatment

Baseline Posttreatment
Significance of
CBT (N ⫽ 29) Control (N ⫽ 28) CBT (N ⫽ 29) Control (N ⫽ 28) interaction term
Time ⫻ Treatment
Measure M SD M SD M SD M SD Status

# Anxiety disorders 2.34 1.23 2.50 1.04 0.62 0.94 1.57 1.32 z ⫽ 2.32, p ⫽ .020
Coping score (range 1–7) 2.41 0.55 2.21 0.66 4.48 1.15 3.45 0.85 t ⫽ ⫺2.69, p ⫽ .009
CBCL Internalizing 65.92 7.71 63.32 8.02 58.90 10.10 60.69 8.11 t ⫽ 1.44, p ⫽ .157
Number of spontaneous comments 20.86 23.76 14.42 16.54 26.63 22.63 8.40 9.76 t ⫽ ⫺2.13, p ⫽ .038
EAS Shyness 3.80 0.86 3.82 0.92 3.52 0.91 3.23 1.09 t ⫽ 0.31, p ⫽ .76
RSRI Inhibition 2.85 0.38 2.89 0.33 2.47 0.34 2.57 0.31 t ⫽ 0.73, p ⫽ .73

Note. Number of anxiety disorders includes separation anxiety disorder, social anxiety disorder, general anxiety disorder, agoraphobia, and specific phobia
and ranged from 0 –5. Coping mean at posttreatment, n controls ⫽ 27. Child Behavior Checklist (CBCL) ns at baseline ⫽ 28 in treatment, 25 controls;
ns at posttreatment ⫽ 21 in treatment, 16 controls. Number of spontaneous comments was rated during laboratory assessments of behavioral inhibition
(higher numbers indicate lower inhibition); ns ⫽ 28, 26 at baseline and 24, 20 at posttreatment for the treatment and control groups, respectively. Ns for
the treatment and control groups for the Emotionality-Activity-Sociability Temperament Survey (EAS) were 29, 27 at baseline and 21, 16 at posttreatment;
for the RSRI they were 29, 26 at baseline and 21, 17 at posttreatment.
506 HIRSHFELD-BECKER ET AL.

Table 4
Mean CGI Improvement Scores for Individual Anxiety Disorders

CBT Controls Significance

Disorder n M SD n M SD Student’s t test

Social anxiety 19 2.42 0.96 20 3.40 1.05 t ⫽ ⫺3.04, p ⬍ .01

Separation 12 1.67 0.98 13 2.46 0.88 t ⫽ ⫺2.12, p ⫽ .045
GAD 12 2.17 0.83 12 2.58 1.38 t ⫽ ⫺0.90, p ⫽ .38
Specific phobia 15 1.87 1.30 15 2.87 1.19 t ⫽ ⫺2.20, p ⫽ .037
Agoraphobia 9 2.22 0.83 11 2.55 1.45 t ⫽ ⫺0.57, p ⫽ .58

Note. 1 ⫽ very much improved; 2 ⫽ much improved; 3 ⫽ minimally improved; 4 ⫽ unchanged. Rates of disorders at posttreatment were as follows (in
cognitive behavioral therapy [CBT] vs. control groups, respectively): social anxiety, 21% versus 46%; separation, 10% versus 25%; general anxiety disorder
(GAD), 7% versus 29%; specific phobia, 17% versus 39%; agoraphobia, 7% versus 25%.

CGI Anxiety scale) was 2.7 (3.5 based upon intent-to-treat anal-
ysis).
We also explored the effects of the intervention on measures of
inhibition. As seen in Table 3, treated children showed a differ-
ential increase in the number of spontaneous comments they made
during the BI assessment. Among the 60% of children who had
shown BI at baseline (26/33 or 79% were reassessed), 8/16 or 50%
of treated children but only 1/10 or 10% of controls lost their
inhibited status ( p ⫽ .087 by two-sided Fisher’s exact test, ns).
Sixty-six percent of parents returned their posttreatment tempera-
ment questionnaires. No significant effects for parent-report mea-
sures of temperament were observed.
1-Year Follow-Up
Data were collected at 1 year posttreatment (M interval ⫽ 1.28
years, SD ⫽ 0.46 years) from all 29 completers of the CBT
condition (100%). Twenty-four of 29 (83%) were rated as very
much or much improved from their baseline presentation, and none
were rated unchanged or worse. Seventeen of 29 (59%) were free
of all anxiety diagnoses. At 1 year posttreatment, the children met
criteria for a mean of 0.55 (SD ⫽ 0.78) anxiety diagnoses and had
a mean coping score on their original feared situations of 4.74
(SD ⫽ 1.24). Seven children (24%) had sought subsequent treat-
ment for anxiety or mood disorders (two with medication only, two
with therapy only, and three with both medication and therapy).
Among those who did not seek further treatment, 19/22 (86%)
were much or very much improved from baseline, none were
unchanged or worse, and 15/22 (68%) were free of anxiety disor-
ders, with a mean of 0.36 (SD ⫽ 0.58) anxiety disorders and mean
coping score of 5.01 (SD ⫽ 1.17).
Exploration of Predictors of Response
We explored several individual and parental diagnostic predic-
tors of response among all children who received the CBT treat-
ment (N ⫽ 46; 29 originally assigned to CBT and 17 controls who
subsequently completed CBT), using logistic regression analyses.
We found no effect on rate of improvement or on rates of anxiety
for age or gender of child, for whether the child had been assigned
to treatment originally or after a waiting period, or for lifetime or
current parental anxiety disorder. However, laboratory-rated child
BI at baseline did emerge as a significant negative predictor of
both CGI-rated global improvement (N ⫽ 44; odds ratio [OR] ⫽
0.11, 95% CI [0.012, 0.93], z ⫽ –2.03, p ⫽ .042) and loss of
anxiety disorder (N ⫽ 44; OR ⫽ 6.50, [1.64, 25.76]; p ⬍ .01).
Children without BI had a global improvement rate of 16/17
(94%), whereas those with BI had an improvement rate of 17/27
(63%). Of those without BI, 13/17 (76.4%) were free of anxiety
disorders after CBT, compared with only 18/27 (33%) of those
with BI.
Discussion
Results of this randomized clinical trial suggest that parent–
child CBT, developmentally modified to meet the needs of 4- to
7-year old children, may show promise for reducing anxiety and
improving coping skills in this age range. The reduction in anxiety

Table 5
Measures of Excess Risk and Within Group Effect Sizes

Measures of excess risk (兩%T-%C兩/%T)

Response rate (very much or much improved on CGI-Anxiety, completers) .54
Response rate, intent-to-treat .49
Rate free of anxiety disorders .69
Rate free of anxiety disorders, intent-to-treat .67
Between-group Hedge’s effect sizes with 95% confidence intervals
Change in number of anxiety disorders .55 [0.02, 1.08]
Change in coping score .69 [0.15, 1.22]
Mean CGI improvement in social anxiety disorder .95 [0.29, 1.62]
Mean CGI improvement in separation anxiety disorder .82 [0.01, 1.64]
Mean CGI improvement in specific phobia .78 [0.04, 1.52]

Note. CGI ⫽ Clinical Global Impression.

 CBT FOR 4- TO 7-YEAR-OLD CHILDREN WITH ANXIETY
diagnoses at posttreatment (59% of CBT children compared with
18% of controls free of anxiety disorders) were within range of
those reported in CBT trials of older children (e.g., proportion of
completers free of anxiety disorders in CBT vs. waitlist control
groups: 64% vs. 5% [Kendall, 1994]; 69.8% vs. 26% [Barrett,
Rapee, & Dadds, 1996]; 64% vs. 0% [Flannery-Schroeder &
Kendall, 2000]; 55% for CBT [Ollendick et al., 2009]). The rate of
those free of anxiety disorders was also similar to the rates of
children who recovered from their principal diagnoses in a recent
study comparing individual (57%) and family CBT (55%) for 7- to
14-year olds with anxiety disorders (Kendall et al., 2008).
Similarly, the CGI-based response rate (60% vs. 30% in intent-
to-treat analysis) was very close to that observed for CBT versus
pill placebo in a recent large-scale study of children ages 7–17
years with social phobia, GAD, or separation anxiety disorder
(59.7% vs. 23.7%; Walkup et al., 2008). The improvement in
coping ability was comparable to that reported in studies by
Kendall and colleagues of older children treated in both individual
(Kendall et al., 1997) and family modalities (Kendall et al., 2008).
All of these findings underscore the potential efficacy of a parent–
child CBT intervention in this younger age group.
As with many CBT trials with older children, our study included
children with a spectrum of anxiety disorders, including social
anxiety disorder, separation anxiety disorder, GAD, agoraphobia,
and specific phobia. Although we had limited power to test the
differences in reduction in rates of each of these disorders sepa-
rately, we were able to compare blindly rated CGI improvement
scores on each of the disorders and found significantly greater
clinical improvement of social anxiety disorder, separation anxiety
disorder, and specific phobia.
Despite these clinical indicators of improvement and the in-
ferred improved functioning accompanying the loss of all anxiety
diagnoses (not just the principal diagnosis) in the majority of
children, our study could not demonstrate normalization of func-
tioning in the treated children. Although we attempted to collect
the CBCL from both parents in each family at baseline and
follow-up, we were limited by a low return rate of the question-
naires at follow-up. Therefore, the study was not adequately pow-
ered to compare the normalization of CBCL Internalizing scale
scores between groups.
Our intervention was not designed to modify temperament,
because we conceptualize BI as a behavioral style that, although it
can elevate risk for disabling social anxiety, need not be impairing
of itself. Based on our pilot data (Hirshfeld-Becker et al., 2008)
and on another study attempting to reduce BI in preschoolers
(Rapee et al., 2005), we expected that whereas the intervention
might succeed in reducing the intense social anxiety and avoidance
exhibited by some inhibited children, it was unlikely to modify BI
itself. Unexpectedly, however, the treated BI children showed a
significantly greater increase in spontaneous comments during the
laboratory assessment at posttreatment than the controls. Whereas
50% of the inhibited children treated with CBT lost their BI status,
compared with only 10% of control children, this change did not
reach significance (i.e., the study was not powered to detect
whether it was due to sampling error) and was not borne out by
parent temperament ratings. However, the finding that CBT may
be able to reduce some manifestations of BI (avoiding chatting
spontaneously with an unfamiliar person) should be explored
further in larger samples, because it is consistent with experiments
507
with primates suggesting that BI can be modified through parent-
ing behaviors early in development (Suomi, 1997).
Follow-up results revealed that the treated children’s clinical
improvement was maintained at 1-year follow-up with similar
outcomes to those at posttreatment: 83% of children were rated as
much or very much improved from baseline, and 59% of children
no longer met criteria for an anxiety diagnosis. These rates were
similar to those reported in CBT interventions with older children
(Barrett, Duffy, Dadds, & Rapee, 2001; Kendall et al., 2008;
Kendall, Safford, Flannery-Schroeder, & Webb, 2004; Kendall &
Southam-Gerow, 1996). Not all follow-up studies of CBT with
older school-age children in the literature reported the rate of
seeking further treatment during the follow-up period, but several
did afford a basis for comparison. The rate in our sample (23%)
was higher than that in one study (Barrett et al., 2001) but lower
than that reported by Kendall et al. (2004) at longer term follow-
up. In the latter study, 52.4% of children had sought further
treatment at 7.4-year follow-up, including 5.5% hospitalized,
39.7% treated with outpatient therapy, and 31.5% treated with
medication. The 23% rate of seeking further treatment in the
present study may reflect an increased readiness on the part of
parents to recognize and seek help for their children’s symptoms,
or it may reflect the extremely high risk profiles of the children
enrolled, many of whom presented with multiple risk factors and
disorders at a very young age. Although we did not have an
untreated comparison group for the 1-year follow-up, 71% of the
children assigned to the wait-list control condition in our study
sought subsequent treatment, with 20/28 opting to receive the CBT
intervention (and 17 completing it). Further studies are needed to
examine whether CBT at an early age can mitigate the course of
anxiety disorders or new onset of disorders later in childhood or
adolescence. In addition, future studies might explore whether the
addition of booster sessions could improve long-term outcome.
The study was conducted at a research center of a general
hospital. Although the ethnic makeup of the sample roughly ap-
proximated that of the county in which our research center was
situated (Middlesex County, MA), which includes 80.3% Euro-
pean Americans, 4.3% African Americans, 8.6% Asian Ameri-
cans, 5.8% people of Latino origin, and 1.4% people of two or
more races, the sample included fewer African Americans, more
biracial children, and participants with higher parental education
and socioeconomic status than the general Middlesex County
community. Further studies are needed to examine the protocol’s
efficacy in samples with greater socioeconomic and ethnic diver-
sity, as well its effectiveness in community mental health settings.
In addition, our criteria allowed for the exclusion of children
judged too uncooperative or distractible to take part in the treat-
ment (two children) or children deemed too clinically severe to
wait 6 months to receive treatment, based on severe mood disor-
der, severe social isolation, severe impairment in school function
or attendance, or severe OCD (a total of seven children). These
criteria generally excluded children who clinically would not be
administered CBT for anxiety disorders as their first treatment
(i.e., they might be offered such treatment after their other symp-
toms were addressed). CBT for anxiety would have been appro-
priate for two of the seven children, but they were excluded solely
because of the risk of being randomized to the control condition.
Therefore, study results can be generalized only to children whose
anxiety disorders are not so severe as to cause school refusal or
508 HIRSHFELD-BECKER ET AL.
severe social isolation. In other regards, however, the sample
appeared representative of clinical samples, with high comorbidity
of anxiety disorders and with 69% in the borderline or clinical
range on the CBCL Internalizing scale. In addition, our extensive
intake assessment battery, which required a total of four parent
and/or child visits prior to randomization, deterred as many as 1 in
4 potential participants and may have selected for families who
were especially motivated to take part in treatment.
Although all of the children in the study had anxiety diagnoses,
the majority also carried additional risk factors for anxiety, namely
BI and/or parental anxiety disorder. In exploratory analyses, we
examined whether these risk factors or other demographic factors
influenced treatment outcome. We found no effect on response rate
or freedom from anxiety disorders for child age or gender or for
current or lifetime history of anxiety disorders in parents, but we
did find that baseline BI was a negative predictor of response.
Although children with BI still responded at a reasonable rate
(63%), those without BI had a significantly higher overall response
rate. In addition, in spite of this high rate of showing much or very
much improvement, the BI children were much less likely to lose
all of their anxiety diagnoses. This interesting and novel finding, if
confirmed, suggests that children with BI may require longer or
more intensive treatment approaches to address their anxiety di-
agnoses.
Whereas most of the children in the study presented with dis-
orders that are relatively common in early childhood (e.g., sepa-
ration anxiety disorder, social phobia, and specific phobias, one or
more of which were found in 91% of participants), a significant
number also had comorbid GAD (44%) or comorbid (33%) or
noncomorbid (3%) agoraphobia. Emerging evidence suggests that
these disorders may not be as uncommon in early childhood as
previously thought. Age of onset estimates from a prospective–
longitudinal community study of 3,021 German adolescents and
adults suggest that nearly 20% of individuals diagnosed with
agoraphobia without panic disorder by adulthood and nearly 10%
of those diagnosed with GAD by adulthood had developed these
disorders by age 8 or younger (Beesdo, Pine, Lieb, & Wittchen,
2010). Using a diagnostic interview designed to assess DSM–IV
disorders in preschoolers, Egger and Angold (2006) found that the
rate of GAD among preschoolers from a large primary-care pedi-
atric practice was 6.5%. Similarly, a study of 2- to 5-year-olds
from primary pediatric practices that used clinician best-estimate
diagnoses found that GAD was equally as prevalent as separation
anxiety disorder (Lavigne et al., 1996). Biederman et al. (1997)
found that among 91 children (ages 4 –17) presenting with agora-
phobia to a general pediatric psychopharmacology clinic, the mean
age of onset was 4 –5 years. When GAD and agoraphobia present
at a developmentally earlier stage, they may be characterized by
age-appropriate symptoms and fear content. For example, com-
pared with adults, children with GAD show fewer physical symp-
toms and are likely to focus on excessive concerns with perfec-
tionism, punctuality, and their own performance, in addition to
worries about future or catastrophic events (American Psychiatric
Association, 2000). They may also be more likely to exhibit
excessive reassurance seeking than to ruminate about worries
(Masi et al., 2004). Similarly, because young children with ago-
raphobia are not as free as adults are to avoid feared situations they
may be more likely to endure them with intense distress or require
a companion (Biederman et al., 1997). Because they do not go out
alone, travel unaccompanied, or drive in bridges or tunnels, they
more commonly display fears of being in crowded places, riding in
cars or buses, or going alone to developmentally appropriate places
(e.g., another floor or room of the house). In such cases, agora-
phobia is distinguishable from separation anxiety disorder if the
child’s required companion need not be a major attachment figure.
Clearly, more research is needed to characterize these disorders in
young children and to validate their homotypic continuity across
childhood or adolescence.
This study should be considered in light of its methodological
limitations. First, as with many first trials of new or newly adapted
protocols, the trial used a monitoring-only (wait-list) control con-
dition. Although a wait-list control group has generally been the
first step in studies of CBT protocols for anxiety in youth (and has
been the control condition in the majority of CBT protocols for
older youths and parents of preschoolers tested to date), such a
condition cannot control for the nonspecific effects of attention
provided in the course of CBT. Therefore, further studies are
needed to test the protocol versus an attention-control therapy
condition.
Second, the assessments of these young children relied heavily
on input from parents. However, in clinical work with children in
this age range, parents typically serve as the primary informants.
Parents are relied upon in this way because young children often
lack the verbal and comprehension abilities to report on their own
symptoms or to understand the importance of being accurate in
their reports and because other informants (e.g., teachers) who are
aware of the child’s anxiety symptoms are not always available. In
addition, although some recent instruments have been developed to
assess fears by self-report in preschool and early elementary
school children, they were not available at the time this study was
designed. Where possible (e.g., in the coping ratings), we com-
bined data from both parents to get a more comprehensive view of
the child. On the other hand, the assessment of BI used standard-
ized laboratory assessments. In addition, we also lacked good
continuous outcome measures that assess anxiety symptoms for
use in this age range. Although recent parent-report questionnaires
have been developed for the assessment of anxiety in young
children (e.g., the Preschool Anxiety Scale), only the CBCL (4/18)
was available for this age range at the time this study was de-
signed, and it was not ideal as a change measure because of its lack
(in this early version) of an anxiety-only scale and its 6-month
reporting interval. Another limitation was the length of the inter-
vention, which might need to be shortened for use in future
controlled trials as well as for practical clinical use. A 14-week
adapted version has been piloted in our center with promising
results. Further attention-controlled studies of shortened protocols
in larger samples, incorporating state-of-the-art self-report assess-
ments developed for preschool and early elementary school chil-
dren, are needed to confirm these results. Finally, our analyses of
both effects for specific anxiety disorders and predictors of treat-
ment response were limited by the small number of children with
each disorder treated, the overall sample size and the resulting
limited power to detect significant effects. Therefore, negative
findings should be viewed with caution. Effects on specific disor-
ders and predictors of treatment response should be further eval-
uated in larger samples.
Despite these limitations, our results suggest that a developmen-
tally modified parent– child CBT protocol shows promise as an
 CBT FOR 4- TO 7-YEAR-OLD CHILDREN WITH ANXIETY
intervention for anxiety in children ages 4 –7. Future studies are
needed to continue to evaluate the efficacy and effectiveness of
this intervention, as well as to test its potential as a preventive
intervention.
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Received April 6, 2009
Revision received January 11, 2010
Accepted January 13, 2010 䡲