SET-C Versus Fluoxetine in the Treatment

of Childhood Social Phobia

DEBORAH C. BEIDEL, PH.D., SAMUEL M. TURNER, PH.D.,y FLOYD R. SALLEE, M.D., PH.D.,
ROBERT T. AMMERMAN, PH.D., LORI A. CROSBY, PSY.D., AND SANJEEV PATHAK, M.D.

ABSTRACT
Objective: To determine the efficacy of fluoxetine, pill placebo, and Social Effectiveness Therapy for Children (SET-C) for
children and adolescents with social phobia. Method: Youths ages 7 to 17 were randomly assigned to one of the treatment
conditions. Outcome was evaluated using self-reports, parent ratings, independent evaluator ratings, and behavioral
assessment. Results: Both fluoxetine and SET-C were more efficacious than placebo in reducing social distress and
behavioral avoidance and increasing general functioning. SET-C was superior to fluoxetine on each of these measures
and was the only treatment superior to placebo in terms of improving social skills, decreasing anxiety in specific social
interactions, and enhancing ratings of social competence. Furthermore, whereas fluoxetine appears to exert maximum
effect by 8 weeks, SET-C provides continued improvement through week 12. Conclusions: Both fluoxetine and SET-C
are efficacious for social phobia, although SET-C appears to provide added benefit by enhancing social skills. J. Am. Acad.
Child Adolesc. Psychiatry, 2007;46(12):1622Y1632. Key Words: fluoxetine, Social Effectiveness Therapy for Children,
cognitive-behavioral therapy, social phobia, pharmacological treatment.

Approximately 5% of youths suffer from social
phobia (American Psychiatric Association, 2000),
the third most common psychiatric disorder in the
United States (Beidel and Turner, 2007). In addition
to social fear, these youths describe general anxiety,
depression, and loneliness (Beidel et al., 1999; Perrin
Accepted July 9, 2007.
Dr. Beidel is with the Department of Psychology, University of Central
Florida; Dr. Sallee is with the Department of Psychiatry, University of
Cincinnati College of Medicine; and Drs. Ammerman and Crosby are with
Children_s Hospital Medical Center, University of Cincinnati College of
Medicine. At the time this research was conducted, Dr. Pathak was also with
Children_s Hospital Medical Center, University of Cincinnati and is now
employed by AstraZeneca.
yDeceased.
This research was supported in part by NIMH grant R01MH53703 to the
first three authors. Lilly Corporation supplied the fluoxetine and matching
placebo capsules. The authors acknowledge the efforts of Patricia Rao, Ph.D.,
Project Coordinator Richard Gross, M.D., and Stephen Kwass, M.D.,
psychiatrists, and David Strong, Ph.D., statistical consultant for this project.
Clinical trial registration informationVURL: http://www.clinicaltrials.gov.
Unique identifier: NCT00043537.
Correspondence to Dr. Deborah C. Beidel, Department of Psychology,
University of Central Florida, 4000 Central Florida Blvd., Orlando, FL 32816;
e-mail: dbeidel@mail.ucf.edu.
0890-8567/07/4612-1622Ó2007 by the American Academy of Child
and Adolescent Psychiatry.
DOI: 10.1097/chi.0b013e318154bb57
and Last, 1993), impaired peer acceptance (Greco and
Morris, 2005), poor social skills (Beidel et al., 1999;
Spence et al., 1999), and among adolescents,
increased likelihood of conduct problems and truancy
(Clark, 1993). There are long-term consequences as
well. Early onset predicts a more severe and chronic
course (Davidson et al., 1993; Kessler, 2003) and is
associated with occupational and social impairment in
adulthood (Merikangas et al., 2002). Despite its
prevalence, only 39% of adults receive treatment
(Merikangas et al., 2002) and the rate is likely even
lower for youths. This is unfortunate because, as
illustrated below, both pharmacological and psycho-
logical treatments are efficacious.
PHARMACOLOGICAL TREATMENT
Selective serotonin reuptake inhibitors (SSRIs) are
the pharmacological treatment of choice for youths
with anxiety disorders, including social phobia. Among
youths with a primary or secondary diagnosis of social
phobia, 76% responded positively to fluvoxamine
(maximum dose, 300 mg/day) compared to 29%
treated with placebo (Research Units in Pediatric
Pharmacology, 2001), but it was unclear how many

1622 J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46 :12, DECEMBER 2007

Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.

had received a primary diagnosis of social phobia. In
contrast, a recent randomized, double-blind, placebo-
controlled trial for youths with primary social phobia
(Wagner et al., 2004) found a 77.6% treatment
responder rate (defined as much or very much
improved) for paroxetine (mean dose 32.6 mg/day)
and 38.4% for placebo; 34.6% of those treated
paroxetine were without a diagnosis at posttreatment
as were 8% of placebo patients. In an open trial of
sertraline (mean dose 123 mg/day), 36% of youths with
a diagnosis of social phobia were judged by indepen-
dent evaluators as treatment responders (much or very
much improved; Compton et al., 2001). Ratings by
psychiatrists were lower, with only a 21% sertraline
response rate.
Response rates for fluoxetine (mean dose, 24 mg for
children and 40 mg for adolescents) reflect similar
variability in treatment response. In an open trial, 80%
of youths with social phobia were judged as clinically
improved, although 62.5% still met diagnostic criteria
at posttreatment (Fairbanks et al., 1997). In a
randomized, placebo-controlled trial including various
childhood anxiety disorders (Birmaher et al., 2003),
76% of youths with primary social phobia treated with
fluoxetine (mean dose, 20 mg/day) were judged as
much or very much improved compared to 21% treated
with placebo. Those treated with fluoxetine also had
significantly better overall functioning than placebo
(45.5% versus 10.5%). In summary, social phobia
response rates for SSRIs range from 36% to 77%,
although remission rates are typically lower and some
youths are still symptomatic at posttreatment.
COGNITIVE-BEHAVIORAL THERAPY
Initial investigations examining the efficacy of
cognitive-behavioral therapy (CBT) for youths with
various anxiety disorders, including social phobia
(Barrett et al., 1996; Kendall, 1994; Kendall et al.,
1997; Silverman et al., 1999a,b) were encouraging, but
few youths with primary social phobia were included in
the samples, making interpretation difficult (Beidel and
Turner, 2005). More recent research has focused
specifically on efficacy for youths with a primary
diagnosis of social phobia. Cognitive-behavioral group
treatment for adolescents (Albano et al., 1995)
combined skill building with exposure. In a rando-
mized, controlled trial, cognitive-behavioral group
treatment for adolescents with or without family
J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46:12, DECEMBER 2007
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
SET-C VS. FLUOXETINE
involvement was superior to waitlist, and 70% did
not meet diagnostic criteria at posttreatment (Tracey
et al., 1998). In another investigation (Hayward et al.,
2000), significantly more adolescent females treated
with cognitive-behavioral group treatment for adoles-
cents no longer met diagnostic criteria compared with
waitlist (45% versus 4%, respectively). However, at 1-
year follow-up, there were no group differences.
Using a sample of children and young adolescents, a
comprehensive CBT program (social skills training
[SST], relaxation, social problem solving, cognitive
interventions, and exposure) with or without parental
involvement was significantly superior to waitlist
(87.5% versus 58% versus 7%, respectively; Spence
et al., 2000). In another investigation, 9 hours of group
CBT (education, identification and replacement of
negative self-talk, and exposure) decreased general
anxiety and depression but not social anxiety or social
competence when compared to waitlist (Gallagher
et al., 2004). At posttreatment, 37% in CBT and 0% in
the control group were without a diagnosis, a
statistically significant difference. In summary,
although efficacious, CBT (with or without family
involvement) has been compared primarily to waitlist;
its efficacy in comparison to active placebo or other
active interventions is unclear.
BEHAVIORAL THERAPY
A behavioral approach for preadolescent children,
Social Effectiveness Therapy for Children (SET-C;
Beidel et al., 2000) includes group SST, peer
generalization sessions, and individualized in vivo
exposure. In comparison to an active, nonspecific
control (an intervention for test anxiety), SET-C
enhanced social skills, reduced social anxiety, and
increased overall social functioning. At posttreatment
67% treated with SET-C no longer had social phobia,
compared to 5% in the active control. Treatment
gains were maintained 5 years later (Beidel et al.,
2006). An adaptation of SET-C for school settings
reduced social anxiety and avoidance and improved
overall social functioning among adolescents with
social phobia when compared to waitlist (Masia-
Warner et al., 2005), and outcomes were maintained
9 months later. Finally, in a small comparative,
randomized trial of SST and exposure, 36% of treated
youths no longer met diagnostic criteria compared
with 0% for waitlist (Baer and Garland, 2005).
1623
BEIDEL ET AL.
COMBINATION TREATMENT
To date, the only comparative/combination trial (n =
12; Chavira and Stein, 2002) combined citalopram
(maximum dose 40 mg/day) with psychoeducation
(education, instruction in hierarchy construction,
graduated exposure, basic social skills, cognitive
challenging, and relapse prevention). At posttreatment,
83.3% were rated as improved, although symptoms of
social phobia remained. These promising results suggest
that randomized, controlled trials are warranted.
In summary, pharmacological and psychological
interventions are efficacious for youths with social
phobia; however, numerous issues remain. First, there
are few randomized, controlled trials of pharmacologi-
cal interventions; only one trial (Wagner et al., 2004)
had more than 20 subjects per group. Second, although
the literature on behavioral and cognitive-behavioral
treatments is slightly larger, most studies have com-
pared active intervention to waitlist. Only two trials
(Beidel et al., 2000; Silverman et al., 1999b) used an
attention-placebo or active, nonspecific comparison
group. Third, active treatment comparisons consist of
CBT to which is added a second condition termed family
treatment/support. There are no comparisons of different,
active interventions, particularly a comparison of pharma-
cological and psychological interventions. To address these
limitations, this two-site trial compared SET-C, fluox-
etine, and pill placebo in youths with a primary diagnosis
of social phobia. It was hypothesized that both active
interventions would be more efficacious than placebo on
measures of social anxiety. It was further hypothesized that
the SST component of SET-C would result in greater
efficacy on measures of social competence.
METHOD
Participants
The protocol was approved by the institutional review boards at
both universities. Parents gave informed consent and youths gave
informed assent. All of the youths were between the ages of 7 and 17
and had a primary diagnosis of social phobia. To be considered
primary, social phobia symptoms were of at least moderate severity
(4 or higher on an 8-point scale) and created functional impairment.
Coexisting disorders could not have higher severity ratings or cause
more substantial impairment. To ensure generalization of study
findings, secondary comorbid diagnoses were allowed, with the
exception of bipolar disorder, psychosis, conduct disorder, autism
spectrum disorders, and mental retardation. Youths with moderate
to severe depression who expressed active suicidal ideation or who
1624
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
had a previous unsuccessful trial of fluoxetine or behavior therapy
were excluded. All of the children had at least average IQ based on
the WAIS. Demographic characteristics and rates of comorbid
diagnoses are presented in Table 1.
Participants were recruited from the Maryland Center for
Anxiety Disorders at the University of Maryland, College Park
and the Department of Pediatrics, Cincinnati Children_s Hospital
Medical Center from September 2001 through September 2004. At
each site, recruitment occurred through media announcements
(newspaper, radio, television, flyers at schools and libraries) or
through referrals from mental health clinicians.
Between the two sites, 807 families contacted the project; 397
completed a telephone screen and 250 followed with an on-site
diagnostic assessment. Among that group, 40 youths were excluded
for failure to meet diagnostic criteria and 71 families declined
participation due to factors such as inability to make time
commitment, transportation issues, and reluctance toward medica-
tion (see Young et al., 2006).
Using a computer-generated program, the remaining 139
subjects, ages 7 to 17, were randomized to one of three treatment
groups: SET-C, fluoxetine, or pill placebo. Fifteen subjects (11%)
dropped out after randomization but before the first treatment
session, including five children randomized to placebo and eight to
fluoxetine. In each case, parents refused medication and withdrew
once informed of random assignment. Two subjects dropped out
after randomization to SET-C. One parent did not want the child to
discontinue taking an SSRI, and one child developed depression
while waiting for SET-C treatment to begin. These 15 subjects
were classified as pretreatment dropouts and excluded from the
analysis. An additional two subjects were administratively removed
from the protocol due to treatment noncompliance (both children
were assigned to the medication group but refused to swallow pills).
Of those randomized, 122 (88%) completed at least one
treatment session and were classified as intent-to-treat patients.
Among this group, 16 subjects (3 randomized to fluoxetine, 3 to
placebo, and 10 to SET-C) dropped out during treatment. Reasons
for discontinuation included difficulty keeping appointments,
transportation problems, and adolescent opposition to treatment.
Data were analyzed for the 122 children in the intent-to-treat
group: 57 youths who received SET-C, 33 received fluoxetine, and
32 received pill placebo. The uneven random assignment resulted
partly from the larger pretreatment attrition for the medication
groups (n = 13 versus n = 2). Two additional children assigned to
the pill condition had to be removed because they would not take
the medication. In an additional six cases, slower recruitment
periods resulted in a child being specifically placed in SET-C to
complete group formation and initiate treatment. In these cases, it
was predetermined that the next child in the correct age range who
completed pretreatment assessment would go to the SET-C
condition. Finally, this study was conducted during the issuance
of the black box warning by the U.S. Food and Drug Adminis-
tration, which effectively stopped parental agreement to participate
in the protocol. Therefore, the study was terminated prematurely,
which would have resulted in more even cell sizes.
There were no significant site differences for age or sex, but there
were significantly fewer racial and ethnic minority subjects in
Cincinnati than Maryland (12% versus 39%; x2 = 19.336, p < .01).
The groups were equal in terms of socioeconomic status, with the
majority of families classified as middle class using the Hollingshead
Classification System. Forty-seven youths (61.5%) had at least one
secondary diagnosis (Table 1). There were no site differences on any
demographic or clinical characteristics. In addition, there were no
J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46 :12, DECEMBER 2007
 SET-C VS. FLUOXETINE

TABLE 1
Demographic and Clinical Characteristics
Pretreatment Dropouts Treatment Completers
2
(n = 17) (n = 122) t x
Mean age 11.18 (2.6) 11.61 (2.6) 0.64
Sex 1.93
Male 6 (35.37%) 65 (53.3%)
Female 11 (64.7%) 57 (46.7%)
Race/ethnicity 10.34
African American 6 (35.3%) 15 (12.3%)
American Indian 0 (0%) 1 (0.8%)
Asian 0 (0%) 4 (3.3%)
White 8 (47.1%) 95 (77.9%)
Latino 1 (5.9%) 2 (1.6%)
Other 0 (2.1%) 4 (3.3%)
No endorsement 2 (11.8%) 1 (0.8%)
Comorbidity
No secondary disorder 7 (46.7%) 47 (38.5%) 0.30
Generalized anxiety disorder 3 (20%) 38 (31%) 0.80
Specific phobia 3 (20%) 17 (14%) 0.06
Separation anxiety disorder V 13 (11%) 1.83
Dysthymic disorder 1 (6.7%) 5 (4.1%) 0.03
Selective mutism V 12 (10%) 0.06
ADHD 2 (13%) 15 (12%) 2.17
Language/reading disorder 1 (6.7%) 1 (0.8%) 2.70
Learning disorder NOS V 1 (0.8%) 0.14

Note: ADHD = attention-deficit/hyperactivity disorder; NOS = not otherwise specified.

differences between the 17 pretreatment dropouts/administrative Independent Evaluator Ratings

removals and the 122 participants in the intent-to-treat sample
(Table 1).
Diagnostic Interview
Interviews were conducted by psychiatrists, clinical psychologists,
or doctoral students in clinical psychology using the Anxiety
Disorders Interview Schedule for Children and Parents (Silverman
and Albano, 1996). Parents were interviewed first, then the same
clinician interviewed the child. Diagnoses were based on informa-
tion provided by both informants. The interviewer also assigned a
severity rating for each disorder using the 8-point Clinical Severity
Rating Scale that is part of the Anxiety Disorders Interview Schedule
for Children and Parents. Twenty percent of the interviews were
audiotaped and scored by a second interviewer to determine
interrater agreement (10% of the tapes from Cincinnati were sent to
Maryland to ensure intersite reliability). Interrater reliability for the
diagnosis of social phobia was 0 = .78, with only one case of
disagreement. Other diagnoses were not assessed with sufficient
frequency to allow ratings of interrater agreement. Interrater
reliability for social phobia on the Clinical Severity Rating Scale
was r = 0.82.
It should be noted that if children completed pretreatment
assessment and waited longer than 6 weeks for a SET-C group to
form, the entire pretreatment assessment was redone. This
happened in only four cases.
Rating scales were completed by the diagnostic interviewer at pre-
treatment and by an independent evaluator blinded to group status
at all subsequent evaluations (after 4 and 8 weeks of treatment, at
posttreatment [12 weeks] and at 3-, 6-, and 12-month follow-up).
Ratings included the Clinical Global Impressions (CGI) Severity of
Illness and Improvement Scale (Guy, 1976), the Children_s Global
Assessment Scale (CGAS; Shaffer et al., 1983) and a 7-point
Behavioral Avoidance Rating Scale to assess social avoidance.
Interrater reliabilities, conducted for 20% of the sample were as
follows: CGI (r = .86), Behavioral Avoidance (r = 0.87), and the
CGAS (r = 0.80).
Self-Report Inventories
The following inventories were administered at pre- and
posttreatment, and at 3-, 6-, and 12-month follow-up: the Social
Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al.,
1995), the Multidimensional Anxiety Scale for Children (MASC;
March, 1997; only the total score was included in this
investigation), the Children_s Depression Inventory (CDI;
Kovacs, 1985), the Loneliness Scale (Asher and Wheeler, 1985),
and the Eysenck Personality Questionnaire-Junior (Eysenck and
Eysenck, 1975; only the extraversion and neuroticism scales were
included). The psychometric properties for all of these scales are
well established.

J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46:12, DECEMBER 2007 1625

Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
BEIDEL ET AL.
Parent Report
The Child Behavior Checklist (CBCL; Achenbach, 1991) was
administered to the parent pre- and posttreatment and at 3-, 6-, and
12-month follow-up. The Internalizing, Externalizing, and Social
Competence Scales were used in the analysis.
Behavioral Assessment
To assess social competence, youths participated in five brief role-
play interactions (Beidel et al., 1999) with a same-age peer trained
to respond in a friendly but nonleading manner. Scene content
included starting a conversation, offering help, giving a compli-
ment, receiving a compliment, and responding assertively to
inappropriate behavior. Raters blind to group assignment rated
skill and anxiety using 4-point Likert scales. Skill ratings ranged
from 1 = not effective at all (Bno response or one-word response,
does not ask questions, mumbling, barely audible speech[) to 4 =
effective (Bno awkwardness, carries part of the conversation, may
self-disclose, voice strong and clear[). Anxiety ratings ranged from
1 = not at all anxious (Bno overt signs of anxiety, smiles, appears
interested, and/or enjoys the interaction[) to 4 = severely anxious
(Bconsistent, gross motor signs of anxiety; also could be manifested as
extreme inhibition[). The assessment occurred at pre- and posttreat-
ment, and at 3-, 6-, and 12-month follow-up. To determine interrater
reliability, 25% of the assessments were rated by a second blind rater (r =
0.84 for social skill/effectiveness and r = 0.91 for anxiety). Assessments
were conducted at both sites and videotapes from Cincinnati were
shipped to Maryland, where ratings were conducted. After the task,
participants rated their anxiety using a 5-point pictorial rating scale
ranging from 1 = very relaxed to 5 = very anxious or distressed.
Treatment Responder Criteria
A priori and consistent with other pharmacological trials
(Birmaher et al., 2003; Wagner et al., 2004), the CGI-Improvement
Scale was designated as the primary treatment outcome variable.
Ratings of 1 (very much improved) or 2 (much improved) denoted a
treatment responder. In addition, using the Anxiety Disorders
Interview Schedule for Children and Parents, the number of youths
who did not meet diagnostic criteria for social phobia at
posttreatment was calculated. Finally, to assess overall functioning
as well as emotional status, an end-state functioning measure used
previously (Beidel et al., 2000, 2006) was calculated. Children were
designated to have high end-state functioning if they had both a
score of less than 18 on the SPAI-C (a cutoff score previously
documented as characteristic of youths without social phobia) and a
rating of 8 or 9 on the CGAS, indicating no more than mild
impairment on overall functioning.
Adverse Events
In the medication groups a psychiatrist completed an adverse
events checklist at each weekly visit. Each of 34 symptoms was
assessed systematically. Symptom categories included cardiovascular,
gastrointestinal, central nervous, psychological, ocular, respiratory,
genitourinary, dermatological, and musculoskeletal complaints. If
present, symptoms were rated for number of days present as well as
severity (mild, moderate, or severe). For the placebo group, no
symptoms were rated as more than mild in severity. In the fluoxetine
group, no symptoms were rated as severe; eight symptoms (diarrhea,
heartburn, facial pallor, fatigue, weakness, lethargy, anger outbursts,
and difficulty concentrating) were rated as moderate. However, none
of these symptoms were reported by more than 11% of the entire
1626 J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46 :12, DECEMBER 2007
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
sample, and no complaint lasted longer than 3 days. Finally, only one
symptom, nausea, significantly differentiated the two groups, with
greater ratings of severity among those taking fluoxetine than placebo
(1.6 versus 1.0, t(df = 9) = 2.48, p < .05). Although rated as more
severe for fluoxetine, complaints of nausea were rated as mild by the
majority of all of the children who reported it.
Treatment
Medication Conditions. Fluoxetine was chosen based on its safety
and efficacy profile. Identically appearing fluoxetine or placebo
capsules were dispensed using the following titration schedule:
weeks 1 and 2, one capsule (10 mg) per day; weeks 3 and 4, two
capsules (20 mg) per day; and weeks 5 and 6, three capsules (30 mg)
per day. At week 7, dose was increased to 40 mg (four capsules) and
held constant throughout treatment (through week 12). Dose
reduction/discontinuation was allowed in the case of moderate or
severe side effects, but no adjustments were necessary. There were
no reports of suicidal ideation or parasuicidal behaviors. Children
continued to be seen weekly throughout the 12-week program. In
addition to medication management, the psychiatrist offered general
encouragement and support, but no specific exposure instructions
during each 60-minute session.
SET-C (Beidel et al., 2000) includes SST, peer generalization
experiences, and in vivo exposure. (The SET-C treatment manual is
available from Multi-Health Systems, Inc.) Social skills training/
peer generalization is conducted in small groups (four to five
youths), whereas in vivo exposure is conducted individually.
Treatment consisted of one individual and one group session per
week for 12 weeks. Group sessions are 150 minutes in length (60
minutes of SST and 90 minutes of peer generalization) and were
constituted with no more than a 3-year age span (e.g., 8Y11, 9Y12)
and individual sessions averaged 60 minutes.
SST. SST targeted seven major topic areas: greeting skills, initiating
and maintaining conversations, listening skills, joining groups of peers,
friendship establishment and maintenance, positive and negative
assertion, and telephone skills. Content of the treatment sessions and
role-play scenarios were always modified to be age appropriate. Non-
verbal skills (eye contact, voice volume, vocal tone) were also addressed.
Peer generalization experiences directly followed SST and allowed
practice of social skills outside the clinic. Activities varied depending
on group age but typically included roller skating, bowling, video
arcades, pizza parlors, picnics, flying kites, and children_s museums.
Same-age nonanxious peers, recruited from the community, were
trained as facilitators and participated in generalization sessions.
In vivo exposure targeted unique fear patterns. Commonly used
tasks included reading in front of others, writing on the blackboard,
conversing with same-age peers, and asking questions of adults.
Discontinued when self-reported anxiety returned to baseline (see
Beidel et al., 2000), individual exposure sessions averaged 60
minutes but did not exceed 90 minutes.
After 12 weeks, all of the youths completed the posttreatment
assessment. For the pill conditions, dose was reduced by two
capsules (20 mg) every 7 days. Thus, 2 weeks after treatment, all of
the medication was discontinued.
Treatment Integrity
All group and individual sessions (for all conditions) were
reviewed by the investigators on a weekly basis. To ensure integrity
across sites, biweekly telephone conference calls reviewed the status
of each participant and quarterly on-site visits further calibrated
activities. In addition, 20% of the sessions were audio- or
 SET-C VS. FLUOXETINE

TABLE 2
Mean Scores for Three Treatment Conditions (SET-C, Fluoxetine, and Placebo)
SET-C, % or Fluoxetine, % Placebo, % or
Measure Mean (SD) or Mean (SD) Mean (SD)
Primary outcome measures
CGI-Improvement 79.0%a 36.4%b 6.3%c
Absence of SAD diagnosis 53.0%a 21.2%b 3.1%c
High-end state functioning 46.0%a 21.2%b 3.1%c
Secondary outcome measures
SPAI-C 17.2 (9.8)a 15.6 (11.0)a 19.5 (11.0)b
EPQ-J Extraversion 14.0 (5.0) 13.8 (5.4) 13.4 (5.2)
Behavioral avoidance rating 2.2 (1.1)a 2.8 (1.3)b 3.4 (1.3)c
CGAS 7.3 (1.0)a 6.8 (0.8)b 6.2 (0.7)c
CGI-Severity 2.8 (1.2)a 3.7 (1.1)b 4.1 (0.9)c
CDI 9.5 (8.0) 8.8 (7.6) 10.9 (11.0)
Loneliness scale 34.5 (10.6)a,b 31.2 (11.1)a 36.1 (11.0)b
EPQ-J Neuroticism 8.6 (5.0) 8.9 (5.1) 8.0 (4.8)
MASC total score 47.4 (19.4) 43.5 (21.4) 45.1 (19.1)
CBCL Internalizing 59.3 (10.9)a 58.1 (7.1)a 64.8 (13.2)b
CBCL Externalizing 42.9 (11.1)a 44.8 (9.9)a,b 47.5 (11.9)b
Social skills effectiveness 2.5 (0.8)a 2.1 (0.6)b 2.2 (0.6)b
Social skills anxiety 2.6 (0.8) 2.3 (0.8) 2.3 (0.7)
SAM rating 1.9 (0.9)a 2.1 (1.1)a,b 2.5 (1.2)b
CBCL Social Competence 43.9 (10.6)a 42.0 (9.6)a,b 40.1 (11.3)b
Note: Values not sharing superscripts are significantly different at p < .05. SET-C = social
effectiveness therapy for children; CGI = Clinical Global Impressions; SAD = social anxiety disorder;
SPAI-C = Social Phobia and Anxiety Inventory for Children; EPQ-J = Eysenck Personality
Questionnaire-Junior; CGAS = Children_s Global Assessment Scale; CDI = Children_s Depression
Inventory; MASC = Multidimensional Anxiety Scale for Children; CBCL = Child Behavior Checklist;
SAM = Self-Assessment Mannikin.

videotaped and formally reviewed in Maryland for treatment
integrity. There were no protocol deviations.
SET-C compliance was determined by attendance at treatment
sessions. Medication compliance was determined by pill count and
blood level. Medicine bottles contained a random number of pills
(between 7 and 10), and parents returned unused medication at the
next visit. Pill counts confirmed medication compliance, and less
than 9% of the doses were missed. Second, one visit was randomly
predetermined for a medication compliance blood draw. In each
case, compliance was confirmed.
Follow-up
Treatment responders (rated as much or very much improved) as
well as those who were nonresponders but whose parents opted to
forgo further treatment participated in 3-, 6-, and 12-month follow-
up assessments that were identical to the pre- and posttreatment
assessment.
RESULTS
Site Differences
There were no differences in outcome between the
two sites, allowing their combination for purposes of
outcome analysis. All of the data were analyzed using an
intent-to-treat strategy with the last observation carried
forward in the case of missing data. For all of the
analyses, age and site were included as covariates. Data
for all of the outcome measures are presented in Table 2.
Primary Outcome Variables
Treatment Responders. On the CGI Improvement
Scale, there were significant group differences (x2[df =
2] = 45.98; p < .001). Significantly more of the SET-C
group were judged as treatment responders (79%) than
either fluoxetine (36.4%; x2[df = 1] = 16.32; p < .001)
or placebo (6.3%; x2[df = 1] = 43.46; p < .001). Further-
more, there were significantly more treatment responders
for fluoxetine than placebo (x2[df = 1] = 8.72; p < .005).
Presence/Absence of Social Phobia. There were sig-
nificant group differences at posttreatment (x2[df = 2] =
25.50; p < .001); 53% of the SET-C group no longer
met diagnostic criteria, significantly higher than
fluoxetine (21.2%; x2[df = 1] = 8.52; p < .005) or

J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46:12, DECEMBER 2007 1627

Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
BEIDEL ET AL.
placebo (3.1%; x2[df = 1] = 22.13; p < .001). The dif-
ference between the fluoxetine and placebo groups was
also significantly different (x2[df = 1] = 4.92); p < .05).
End-State Functioning. There were significant group
differences for the percentage of youths achieving high
end-state functioning (x2[df = 2] = 19.40; p < .001).
The 46% outcome achieved for SET-C was signifi-
cantly higher than the 21% for fluoxetine (x2[df = 1] =
5.36; p < .025) and the 3.1% for placebo (x2[df = 1] =
17.51; p < .001). The percentage for the fluoxetine
group was significantly higher than placebo (x2[df = 1] =
4.92; p < .05).
Secondary Outcome Variables
A series of pre- to postlinear regression analyses
(where age and pretreatment score served as covariates)
was conducted for variables assessing social phobia
severity, other aspects of psychopathology, and social
skills/competence. Regression models were evaluated
for overall group differences and planned contrasts
using t tests for contrast coded terms were conducted to
compare active treatments to placebo. Follow-up t tests
compared active treatments.
Social Phobia Severity. The overall regression model
was significant for the SPAI-C (F[df = 4,116] = 13.08;
p < .001). When compared to placebo, youths treated
with either SET-C or fluoxetine had significantly
lower scores (t[df = 88] = 2.01 and t[df = 64] = 2.10,
respectively; p < .05; Table 2). The two active
treatments were not significantly different. In addi-
tion, both active treatments had mean SPAI-C scores
that were below 18, a cutoff previously validated as
indicative of a possible diagnosis of social phobia
(Beidel et al., 1999). The score for the placebo group
was above 18. In contrast, there were no posttreat-
ment group differences on the Eysenck Personality
Questionnaire-Junior Extraversion scale (p 9.10).
On the behavioral avoidance rating scale, the overall
model was significant (F [df = 4,117] = 10.90; p < .001).
Youths treated with SET-C or fluoxetine had signifi-
cantly less avoidance than placebo (t[df = 88] = 5.38; p <
.001 and (t[df = 64] = 2.31; p < .025, respectively).
Furthermore, scores for SET-C were significantly lower
than fluoxetine (t[df = 88] = 2.37; p < .025). The overall
model was significant for CGI Severity (F[df = 4,117] =
15.59; p < .001). Youths treated with SET-C had
significantly lower scores than placebo (t[df = 117] =
5.49; p < .001) or fluoxetine (t[df = 88] = 3.49;
1628
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
p < .001). The difference between the two pill conditions
was not significant. On the CGAS, the overall model
was significant (F [df = 5,116] = 11.93; p < .001).
Youths in both SET-C and fluoxetine had significantly
higher scores than placebo (t[df = 88] = 2.6; p < .001
and t[df = 87] = 2.6; p < .01). Furthermore, those
treated with SET-C had scores significantly higher than
fluoxetine (t[df = 77.8] = 2.62; p < .01).
Other Aspects of Psychopathology. On the CBCL
Internalizing scale, the overall model was significant
(F[df = 5,115] = 5.06; p < .001). Both SET-C and
fluoxetine had significantly lower scores than placebo
(t[df = 88] = 2.34 and t[df = 87] = 2.21, respectively;
p < .05 for both). The two active treatments were not
significantly different. The overall model was signifi-
cant for the CBCL Externalizing scale (F [df = 4,115] =
12.26; p < .001). Youths treated with SET-C had
significantly lower scores than placebo (t[df = 88] =
2.09; p < .05). Scores for fluoxetine fell between, but
were not significantly different from, the others.
On the Loneliness Scale, the overall model was
significant (F[df = 4,11] = 24.92; p < .001). Youths
treated with fluoxetine had significantly lower scores
than placebo (t[df = 87] = 2.51; p < .025). Scores for the
SET-C group were not significantly different from the
others. There were no group differences at posttreat-
ment on the Eysenck Personality Questionnaire-Junior
Neuroticism scale, the CDI, or the MASC total score
( p 9 .10).
Social Skills/Competence. For social skills effective-
ness, the overall model was significant (F[df = 4,106] =
8.11; p < .001). Youths treated with SET-C had
significantly higher ratings of social skill than fluoxetine
(t[df = 89] = 2.05; p < .05) or placebo (t[df = 88] = 2.47;
p < .025), which were not significantly different. There
were no group differences on observer rating of anxiety.
For self-report of anxiety, the overall model was
significant (F[df = 3,118] = 14.64; p < .001). Youths
treated with SET-C reported significantly less anxiety
than those treated with placebo (t[df = 88] = 6.4; p <
.01), whereas fluoxetine was not different from the
others. Finally, with respect to the CBCL Social
Competence scale, the overall model was significant
(F[(df = 4,110] = 27.19; p < .001). Youths treated with
SET-C had scores that were significantly lower than
placebo (t[df = 110] = 2.38; p < .025). Those treated
with fluoxetine were not significantly different from the
others.
J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46 :12, DECEMBER 2007

Fig. 1 Change in Clinical Global Impressions-Severity across treatment
time. SET-C = social effectiveness therapy for children.
Time Course of Treatment
Independent evaluator ratings (CGI-Severity, CGAS,
and behavioral avoidance) were completed after
4 and 8 weeks of treatment and at posttreatment
(12 weeks). All of the treatment dropouts occurred by
week 8. Consistent with intent-to-treat analysis, if 12-
week data were not available, the last available
assessment point was used. To determine change
across time, a repeated-measures analysis using linear
mixed models was conducted, allowing comparisons
of change in the active treatment groups relative to
observed changes in the placebo condition. Consistent
with the intent-to-treat analysis, all 122 subjects were
included. Results suggested that the effect of active
treatment became stronger in the latter stage of
treatment. For CGI severity, there was a significant
time
group interaction. From week 8 to week 12,
severity ratings for youths in SET-C decreased
significantly when compared to placebo (t[df = 241] =
4.45; p < .001; Fig. 1). This effect was not found for
fluoxetine. For behavioral avoidance, there was a similar
significant interaction. At week 12, youths treated with
Fig. 2 Change in behavioral avoidance across treatment time. SET-C =
social effectiveness therapy for children.
J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46:12, DECEMBER 2007
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
SET-C VS. FLUOXETINE
Fig. 3 Change in Clinical Global Impressions across treatment time. SET-
C = social effectiveness therapy for children.
SET-C had significantly less avoidance than placebo
(t[df = 240] = 3.47; p < .001; Fig. 2). This effect was not
found for fluoxetine. For the CGAS, there were
significant time
group interactions for both active
treatments when compared to placebo. Ratings for youths
in SET-C increased significantly through week 12
(t[df = 241] = 5.29; p < .001) as did ratings for youths
treated with fluoxetine (t[df = 241] = 2.30; p < .025;
Fig. 3).
Comparison of Fluoxetine and SET-C Responders
at 1-Year Follow-up
Parents of all 35 youths randomized to placebo and
parents of 15 youths treated with fluoxetine chose to
participate in a trial of SET-C following posttreatment,
leaving 18 youths treated with fluoxetine to participate
in follow-up. Nine were treatment responders and nine
had shown some degree of improvement, leading their
parents to forgo further treatment. These 18 youths were
matched by age (within 2 years) and sex to 18 youths
treated with SET-C who also completed follow-up.
Because most nonresponders self-selected out of follow-
up, this selection bias negates the use of last observation
carried forward as an appropriate analysis. Therefore, a
series of 2 (group)
4 (time; posttreatment, 3-month
follow-up, 6-month follow-up, 12-month follow-up)
repeated-measures analyses determined whether treat-
ment gains were maintained 1 year later. Analyses were
conducted on the same set of variables described above.
Across all of the variables except the SPAI-C, there
were no main effects for time or for time
group
interactions. Thus, all treatment gains were maintained
1 year later. For the SPAI-C, youths treated with either
fluoxetine or SET-C had significantly lower scores 1
year later than at posttreatment (Hotelling_s Trace,
1629
BEIDEL ET AL.
F [df = 3,54] = 4.60; p < .01), indicating further
improvement during follow-up.
For fluoxetine, 11 children and adolescents (61%)
qualified as treatment responders at 1-year follow-up.
One participant relapsed. In contrast, three youths (33%)
who were not treatment responders at posttreatment met
responder criteria 1 year later. Eleven youths (61%) did
not have a diagnosis at 1-year follow-up. Again, one child
relapsed. Finally, 10 youths (55.6%) met criteria for high
end-state functioning at 1-year follow-up. One child
relapsed, whereas four children (36%) who did not meet
criteria at posttreatment did so 1 year later.
For SET-C, all 18 youths (100%) maintained
treatment responder status and were without a diag-
nosis at 1-year follow-up. Seventeen of the youths
(94%) retained their high end-state status 1-year later,
whereas one child (6%) relapsed.
DISCUSSION
In this first randomized, comparative trial, both
fluoxetine and SET-C were superior to pill placebo
across all outcome measuresV decreasing social anxiety
and behavioral avoidance and increasing overall
functioning. For fluoxetine, these results are consistent
with other investigations examining the efficacy of
SSRIs (Compton et al., 2001; Research Unit for the
Pediatric Psychopharmacology Anxiety Study Group,
2001; Wagner et al., 2004), and particularly fluoxetine
(Birmaher et al., 2003; Fairbanks et al., 1997).
Similarly, SET-C was significantly superior to pill
placebo on primary outcome measures as well as
specific symptom measures (social anxiety, behavioral
avoidance, and overall functioning). Previously, SET-C
was demonstrated to be superior to an active,
nonspecific psychological treatment (Beidel et al.,
2000). These data indicate that SET-C is efficacious
in comparison to pill placebo.
With respect to comparative treatment effects, there
was no difference between SET-C and fluoxetine on the
SPAI-C, suggesting that both groups benefited equally
in terms of decreased social distress. On other variables,
SET-C was superior to fluoxetine, including rate of
treatment responders, lack of posttreatment diagnosis,
and achievement of high end-state functioning. In
addition, youths treated with SET-C had less beha-
vioral avoidance, lower symptom severity, and higher
overall general functioning.
1630
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
Differential treatment effects were particularly
apparent in the area of social skill/competence. At
posttreatment, youths in SET-C were rated by
independent evaluators as more socially skilled than
youths treated with placebo or fluoxetine. Furthermore,
when compared to placebo, only SET-C had signifi-
cantly lower self-ratings of social anxiety and higher
parental ratings of social competence. Thus, whereas
fluoxetine and SET-C decrease social anxiety, only
SET-C appears to exert a specific effect on social
competence. In turn, acquisition of social skills and
positive reinforcement may function to further decrease
social distress, allowing SET-C to demonstrate a
superior outcome across a range of variables.
Fluoxetine may exert its maximum treatment effect
by week 8, whereas the full effect of SET-C may not be
evident for an additional 4 weeks (12 weeks total). If
replicated, nonresponse to fluoxetine after 8 weeks may
indicate the need for a different medication or an
alternative type of treatment. Would a larger dose of
fluoxetine have enhanced treatment outcome? Although
a definitive answer is not possible, a maximum dose
of 20 mg/day (Birmaher et al., 2003), half the dose
used in this investigation, resulted in higher response
rates than in this study. This would not suggest a linear
relationship between improvement and fluoxetine
dose.
At 1-year follow-up, all of the treatment gains were
maintained and on the SPAI-C, both groups had
continued improvement. One-year relapse rates were
17% for fluoxetine and 10.3% for SET-C. For SET-C,
this rate is consistent with other studies of behavioral
(Beidel et al., 2006) or cognitive-behavioral (Spence
et al., 2000) treatment. For fluoxetine, although fewer
youths initially responded, the majority maintained
their treatment gains. Perhaps fluoxetine relieves
symptoms of subjective distress, allowing youths to
approach social situations, and exposure occurs natu-
rally over time. A challenge for future research will be to
identify any subgroup likely to respond to the
medication.
Limitations
This study has several limitations. First is the issue of
pretreatment attrition, particularly parents who allowed
their children to complete the assessment but then
refused the randomization assignment. This may have
resulted in a sample more accepting of medication, but
J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46 :12, DECEMBER 2007

it decreased the final sample sizes. Second, youths (and
parents) assigned to SET-C knew that they were
receiving an active intervention, whereas the pill
condition was a true double blind. One may hypothe-
size that the superiority of SET-C stemmed from this
knowledge. However, independent evaluators and
blinded behavioral raters were unaware of treatment
assignment, and those data confirmed the overall
efficacy of SET-C. Thus, outcome data were not
based solely on unblinded sources. Furthermore, the
psychiatrist who completed weekly side effects check-
lists did not conduct independent evaluator ratings;
these response ratings were not influenced by reported
side effects, a concern raised in other investigations
(e.g., Research Unit for the Pediatric Psychopharma-
cology Anxiety Study Group, 2001). Third, although
cell sizes for primary social phobia are among the largest
reported, they are still insufficient to determine factors
that may predict treatment response. This study
recruited youths prior to the issuance of the Bblack
box[ warning for SSRIs by the U.S. Food and Drug
Administration. The original goal was to recruit a larger
sample, but the decision of the U.S. Food and Drug
Administration significantly affected recruitment, sub-
stantially increasing parent reluctance for medication
assignment. Given these parameters, future studies may
require multiple centers to collect a suitable sample to
examine potential predictive factors. Fourth, due to the
differential nature of the interventions, there were
differences in therapist time, although one may also
argue that children had access to their intervention
(medication) everyday, whereas those in SET-C only
had treatment twice per week. Fifth, although the
sample size at follow-up was quite small, the data are
important because they demonstrate treatment stabi-
lity. Only one other study (Clark et al., 2005) reported
a 1-year medication-free follow-up interval for fluox-
etine (with a sample size of 10). Finally, SET-C, with its
twice-per-week sessions and its peer generalization
component, may present special challenges when
implemented in fee-for-service clinical settings. We
are investigating ways to streamline its implementation
without reducing its efficacy.
Clinical Implications
Both SET-C and fluoxetine decrease symptoms of
social phobia in comparison to pill placebo, although
the percentage who benefit varies by the particular
J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 46:12, DECEMBER 2007
Copyright @ 2007 American Academy of Child and Adolescent Psychiatry. Unauthorized reproduction of this article is prohibited.
SET-C VS. FLUOXETINE
intervention. The absolute response rate of fluoxetine in
this study (36.4%) is lower than some (Birmaher et al.,
2003; Wagner et al., 2004) but not all (Compton et al.,
2001) investigations. Several factors may account for
this difference, including variations in defining a rating
of Bimproved[ or Bmuch improved[ and variations in
sample compositions. Including youths with various
anxiety disorders in the same trial has advantages (larger
samples, many youths have comorbid diagnoses), but it
confounds understanding treatment response for any
singular diagnosis. All anxiety disorders may not respond
equally to a specific medication (e.g., Storch et al., 2006).
The same caveat applies to placebo response. For ex-
ample, in the Research Unit for the Pediatric Psycho-
pharmacology Anxiety Study Group (2001) trial, the
overall placebo response rate was 40% but decreased to
24% when only youths with primary or secondary social
phobia were examined. Thus, social phobia may be less
responsive to SSRIs or placebo than generalized anxiety
disorder or separation anxiety disorder.
Another consideration is that across available trials,
some youths remain symptomatic at posttreatment. For
example, the remission rate (not improvement rate)
for SSRIs appears to range from 34.6% to 37.5%
(Fairbanks et al., 1997; Wagner et al., 2004) and 21.2%
in this study. For SET-C (and behavior therapy/CBT in
general), rates of remission are higher (e.g., 53% in this
investigation). Thus, it is important to distinguish be-
tween improvement and remission when determining
treatment outcome and to seek alternative interventions
in a timely and appropriate fashion.
In summary, both fluoxetine and SET-C appear
superior to placebo in reducing social distress in youths
with social phobia. SET-C appears to provide addi-
tional efficacy over fluoxetine alone, perhaps resulting
from its additive approach to enhancing social compe-
tence through SST. For those who respond positively,
effects appear to be maintained 1 year later, without
additional intervention. Future studies designed to
identify factors that may predict those most likely to
benefit from these interventions are needed.
Disclosure: Drs. Beidel and Turner are the authors of the Social Phobia
and Anxiety Inventory for Children and the Social Effectiveness
Therapy for Children Treatment Manual and receive royalties from
Multi-Health Systems, Inc. for the sale of these items. Dr. Sallee receives
grant support from Shire and Bristol-Myers Squibb pharmaceutical
companies; is a paid consultant to Shire and Abbott Laboratories and a
speaker for Pfizer and Takeda Pharmaceuticals; and is on the board of
1631
BEIDEL ET AL.
directors of P2Dinc and Satiety Solutions LLC. Dr. Pathak is employed
by AstraZeneca and has received royalties from Forest Laboratories. The
other authors have no financial relationships to disclose.
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