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Journal of Child Psychology and Psychiatry **:* (2019), pp **–** doi:10.1111/jcpp.13162

Randomized controlled trial of family-focused

treatment for child depression compared to individual
psychotherapy: one-year outcomes
Joan Rosenbaum Asarnow,1 Martha C. Tompson,2 Alexandra M. Klomhaus,1
Kalina Babeva,1 David A. Langer,3 and Catherine A. Sugar1
1
University of California, Los Angeles, Los Angeles, CA; 2Boston University, Boston, MA, USA; 3Suffolk University,
Suffolk, UK

Objective: Childhood-onset depression is associated with increased risk of recurrent depression and high morbidity
extending into adolescence and adulthood. This multisite randomized controlled trial evaluated two active
psychosocial treatments for childhood depression: family-focused treatment for childhood depression (FFT-CD)
and individual supportive psychotherapy (IP). Aims were to describe effects through 52 weeks postrandomization on
measures of depression, functioning, nondepressive symptoms, and harm events. Methods: Children meeting
criteria for depressive disorders (N = 134) were randomly assigned to 15 sessions of FFT-CD or IP and evaluated at
mid-treatment for depressive symptoms and fully at roughly 16 weeks (after acute treatment), 32 weeks, and 52
weeks/one year. See clinicaltrials.gov: NCT01159041. Results: Analyses using generalized linear mixed models
confirmed the previously reported FFT-CD advantage on rates of acute depression response (≥50% Children’s
Depression Rating Scale reduction). Improvements in depression and other outcomes were most rapid during the
acute treatment period, and leveled off between weeks 16 and 52, with a corresponding attenuation of observed group
differences, although both groups showed improved depression and functioning over 52 weeks. Survival analyses
indicated that most children recovered from their index depressive episodes by week 52: estimated 76% FFT-CD, 77%
IP. However, by the week 52 assessment, one FFT-CD child and six IP children had suffered recurrent depressive
episodes. Four children attempted suicide, all in the IP group. Other indicators of possible harm were relatively evenly
distributed across groups. Conclusions: Results indicate a quicker depression response in FFT-CD and hint at
greater protection from recurrence and suicide attempts. However, outcomes were similar for both active treatments
by week 52/one year. Although community care received after acute treatment may have influenced results, findings
suggest the value of a more extended/chronic disease model that includes monitoring and guidance regarding
optimal interventions when signs of depression-risk emerge. Keywords: Depression; treatment trials;
psychotherapy; outcome; family therapy.

treatments for childhood depressive disorders (Luby

Introduction
et al., 2018). There are some promising treatments for
Depression is common, estimated to affect 350,000,000
children with depressive disorders evaluated only in
people and to be the leading cause of total years lost to
open trials (Kovacs et al., 2016), and randomized
disability worldwide (WHO, 2012). Although relatively
controlled trials (RCTs) evaluating psychosocial inter-
rare in childhood, depressive disorders become more
ventions for children selected for elevated depressive
prevalent during adolescence and are associated with
symptoms (for review, Weisz, McCarty, & Valeri, 2006).
disruptions in development and impaired functioning
However, results from subclinical samples may not
(Avenevoli, Swendsen, He, Burstein, & Merikangas,
generalize to samples with depressive disorders.
2015; Luby, Barch, Whalen, Tillman, & Freedland,
Four RCTs examined treatments for depressive dis-
2018). The limited data on depression in children
orders in school-age children. One small treatment-
indicate that most recover over time, but recurrence
development RCT found significant reductions in
after recovery is common and estimated to occur in up
depressive symptoms and higher remission rates at
to 72% of children over 15 years of follow-up (Kovacs,
post-treatment with family-based interpersonal psy-
Obrosky, & George, 2016). Adult outcomes of chil-
chotherapy, relative to child-centered supportive ther-
dren with depressive disorders tend to be poor, with
apy (Dietz, Weinberg, Brent, & Mufson, 2015). Another
elevated rates of suicide attempts, substance abuse,
found that children with depression or bipolar disor-
and conduct problems (Kovacs et al., 2016; Weiss-
ders receiving multifamily psychoeducation groups
man et al., 1999).
plus usual care (UC) had reduced mood symptoms
Despite the general preference for psychosocial
compared to waitlist controls plus usual care over 12
treatment over medications for children (Tarnowski,
months (Fristad, Verducci, Walters, & Young, 2009). A
Simonian, Bekeny, & Park, 1992), few studies have
third found an advantage of brief behavioral therapy,
examined the comparative efficacy of psychosocial
compared to assisted referral, among children and
adolescents with depressive or anxiety disorders
Conflict of interest statement: No conflicts declared. (Weersing, Brent, et al., 2017). A pilot trial with a mixed

© 2019 Association for Child and Adolescent Mental Health

Published by John Wiley & Sons Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main St, Malden, MA 02148, USA
2 Joan Rosenbaum Asarnow et al.
child/adolescent sample found that individual family-
education, as a monotherapy or combined with omega-
3 fatty acids, had similar impacts on depressive severity
trajectories to placebo alone over 12 weeks (Fristad
et al., 2015).
This paper reports on the first large multisite
randomized controlled trial comparing two active
psychosocial treatments for depressive disorders in
children (ages 7–14). We compared a developmen-
tally informed family-focused treatment targeting
childhood depression (FFT-CD) to individual sup-
portive psychotherapy (IP). Rooted in family and
cognitive-behavioral models of change, FFT-CD
aimed to strengthen family processes to support
recovery. Building on our previously published find-
ings indicating that FFT-CD children showed signif-
icantly higher depression response rates than IP
children after acute treatment (primary RCT out-
come), this secondary report examines longer-term
outcomes over 52 weeks/one year. Specific aims are
to describe: patterns of depression response, recov-
ery, and recurrence; functioning and nonaffective
symptom outcomes; and harm events. Based on
evidence from adolescent depression trials that
change occurs in a piecewise fashion with the most
rapid improvement observed by treatment end-point,
followed by stabilization and/or recurrence during
follow-up (Asarnow et al., 2009; Goodyer et al.,
2017; Vitiello et al., 2011), we predicted a significant
time effect, with a stronger FFT-CD advantage on
depression response following acute treatment, and
lower recurrence risk among FFT-CD children.
Method
Previous reports on this single-blind RCT describe the design,
methods, and acute treatment results (Tompson, Langer,
Hughes, & Asarnow, 2017; Tompson, Sugar, Langer, &
Asarnow, 2017); an overview is provided below. Institutional
Review Boards at both sites and a Data Safety and Monitoring
Board approved and oversaw study procedures. Informed
consent/assent was obtained for all participants. See clinical-
trials.gov: NCT01159041.
Participants
Children were recruited (N = 134) between February 2011 and
January 2014 from two sites in large metropolitan areas in the
western and northeastern United States. Inclusion criteria
were as follows: current diagnosis of major depression (MDD),
dysthymic disorder (DD), or depressive disorder-not otherwise
specified (DD-Nos); age 7–14; if taking medication, stable dose
(≥3 months); and living with participating parent. Exclusion
criteria were as follows: symptoms/problems that would
interfere with participation in treatment or assessments (e.g.,
psychotic disorder). These criteria represent expansions of the
original age range (7–12) and diagnosis (MDD/DD) to enhance
recruitment/feasibility.
Trial design
Eligible participants were randomly assigned to FFT-CD or IP
(1:1 ratio) using a computerized algorithm with a random mix
of blocks lengths (2 and 4). Children were stratified by site,
gender, baseline depression diagnosis (MDD/DD vs. DD-Nos),
and the presence/absence of antidepressant medication treat-
ment. Treatment allocation was concealed from assessment
and enrollment staff. Both intervention conditions offered
comparable treatment exposure: 15 sessions over ≤22 weeks;
the same therapists; and up to three booster sessions of the
randomized intervention (FFT-CD or IP) following the end of
acute treatment.
FFT-CD. FFT-CD aimed to enhance developmentally appro-
priate family interpersonal processes that can promote recov-
ery, buffer children from the adverse impacts of stress and
distress, and enhance protective processes (Tompson, Langer,
et al., 2017). Sessions emphasized: (a) strengthening family
relationships and fostering supportive parent–child interac-
tions (e.g., ‘family thanks notes’ to increase supportive com-
munication, active listening, communication, and pleasant
activities); and (b) boosting skills for effective coping and
emotion regulation (e.g., problem-solving, helpful thoughts,
and behavioral activation). Through psychoeducation, role-
plays, and practice/homework, families were assisted in
identifying helpful/upward interaction spirals and unhelp-
ful/downward spirals and using skills to improve mood.
IP. The study IP used a manualized supportive approach
(adapted from Cohen & Mannarino, 1996). This individual
treatment focused on helping children better understand their
feelings through empathic listening and a safe supportive
relationship. An initial parent session and brief monthly
supportive meetings were allowed.
Therapist adherence and competence were monitored on
randomly selected sessions, using a 7-point scale (7 = highest
adherence/competence). Results indicated high competence
(FFT-CD: mean 6.43, SD 1.10; IP: mean 7.00, SD 0.00) and
adherence (FFT: mean 6.34, SD 1.44; IP: mean 6.57, SD 1.38),
with strong differentiation between treatments (low IP adher-
ence ratings for FFT-CD sessions, mean 1.03, SD 0.25; low
FFT-CD adherence for IP sessions, mean 1.07, SD 0.26). High
IP competence ratings for FFT-CD sessions (mean 6.95, SD
0.17) indicated strong therapist warmth and genuineness
across conditions.
Assessments/outcomes
Full assessments were scheduled at baseline, at the end of
acute treatment/week 16, week 32, and week 52 (February
2011-January 2015). Assessors had graduate education in a
mental health field, were naive to intervention assignment, and
received regular supervision. Inter-rater reliability was strong
for all interviewer measures: intraclass correlation coefficients
0.77–0.94; kappa depression diagnosis 0.91 (Tompson, Sugar
et al., 2017).
Depression. As reported previously (Tompson, Langer
et al., 2017), the primary study outcome was depression
response at post-treatment, defined as ≥50% reduction from
the baseline score on the interviewer-rated Children’s Depres-
sion Severity-Revised Scale (CDRS-R; Poznanski, Hartmut,
Grossman, & Freeman, 1985), based on combined child and
parent report. Other depression outcomes included the follow-
ing: depression remission, defined as CDRS-R ≤ 28; depres-
sion severity measured by the total CDRS-R Score; and
self-reported depressive symptoms on the Children’s Depres-
sion Inventory (CDI; Kovacs, 1992) completed by children
(CDI-C) and parents (CDI-P) mid-treatment at weeks 5 and 10.
Depression recovery and recurrence after recovery were
assessed with the Schedule for Affective Disorders and
Schizophrenia for School-Aged Children (K-SADS-PL, Kaufman
et al., 1997) administered to children and parents. A life chart
© 2019 Association for Child and Adolescent Mental Health

was used to define dates of recovery and recurrent depressive
episodes following recovery from the index episode. Recovery
was defined based on the date when children no longer met
depressive disorder criteria and recurrence as the time when
children met criteria for a new depressive episode (MDD or DD)
following recovery. When the exact date was uncertain, we
identified the time interval when symptoms emerged and dated
recovery/recurrence at the midpoint (Kovacs et al., 2016).
Functioning. The interviewer-rated Children’s Global
Adjustment Scale (C-GAS; Shaffer et al., 1983) and child-
reported Social Adjustment Scale for Children – Self-Report
(Weissman, Orvaschel, & Padian, 1980) measured functioning.
Nondepressive symptoms. Child-reported anxiety
symptoms were assessed using the Multidimensional Anxiety
Scale for Children (MASC; March, Parker, Sullivan, Stallings, &
Conners, 1997). Parent-reported internalizing, externalizing,
and total problems were assessed on the Child Behavior
Checklist (CBCL; Achenbach, 1991).
Possible harm events. Possible harm events were
assessed using IRB adverse and clinical incident reports plus
the K-SADS-PL supplemented by CDRS-R and our versions of
the Columbia Suicide Severity Rating Scale (C-SSRS) and the
Suicide and Self-Harm History Interview (SSI), which provided
information on dates and self-harm classification (suicide
attempt or nonsuicidal self-injury (NSSI), Asarnow, Hughes,
Babeva, & Sugar, 2017).
Nonstudy services. The parent-reported Child and Ado-
lescent Services Assessment (CASA; Ascher, Farmer, Burns, &
Angold, 1994) assessed ED visits, hospitalizations, and non-
study services. Medication treatment rates from CASA parent
report are used for consistency across study time points and
are slightly lower than those based on multiple data sources
used for randomization reported previously (Tompson et al.,
2017).
Statistical analysis
This report describes preplanned analyses of outcomes over
the 52-week study observation period, supplementing our
prior publication describing acute treatment effects. The goal
of this secondary exploratory report is description of the
outcome trajectory patterns over the 52-week follow-up. We
used generalized linear mixed models (GLMMs) (logistic link for
binary outcomes; identity link for continuous outcomes) with
subject level random effects to account for correlations
induced by the repeated measures data structure. For binary
outcomes that were defined postbaseline (depression response,
remission), there were three repeated measurements corre-
sponding to planned visits at 16, 32, and 52 weeks. For
continuous outcomes, baseline was included as a time point,
yielding four repeated measurements (6 for the CDI-C/CDI-P).
Models used actual time from entry (continuous measure)
rather than treating the planned visit times as categorical.
They allowed for a change in slope at the end of acute
treatment and included the interactions of treatment with
each of these two time components. This resulted in a
piecewise linear fit within each of the treatment arms. For
each of the continuous outcomes, we first performed an
omnibus two degree of freedom test for an overall difference
in the treatment trajectories (i.e., we tested jointly whether the
two groups by time interaction terms were significant). To
further characterize the longitudinal pattern of treatment
effects, when the omnibus test reached p < .05, post hoc
contrasts examined each component of the trajectory sepa-
rately within and between groups. Specifically, we assessed
change within each of the acute and follow-up periods, along
© 2019 Association for Child and Adolescent Mental Health
Randomized trial of family treatment for child depression 3
with change in slope from the acute to follow-up period. We
present estimated slope coefficients (parameterized as weekly
rates of change) for each treatment arm, along with effect sizes
using Cohen’s f2, the standard metric for regression and
related modeling types, with f2 = 0.02, 0.15, and 0.35 corre-
sponding to small, medium, and large effects, respectively
(Cohen, 1988).
Analyses that consider the full longitudinal outcome trajec-
tories have embedded in them the original acute treatment
comparisons. However, because the models are using addi-
tional time points, the standard error estimates of the key
parameters may be slightly different and imposing the piece-
wise linear structure may affect the fit at the end of acute
treatment. We, therefore, felt it was worthwhile to affirm that
the model augmentation did not in any way affect the major
findings from the previously published report of acute out-
comes (Tompson et al., 2017).
To assess whether longer-term trajectory patterns could
have been affected by postintervention treatment-seeking or
individual provider characteristics, we conducted sensitivity
analyses including therapist effects (both main effects and
interactions with treatment group) and treatment usage vari-
ables (receipt of study treatment booster sessions, medica-
tions, nonstudy therapy after acute treatment as time-varying
covariates) in the longitudinal models. As this did not change
the observed pattern of treatment effects and usage of non-
study adjunctive treatments was similar in the FFT-CD and IP
groups (see Table S1), we restrict the manuscript presentation
to the primary analyses.
Survival analyses examined between-group differences in
time to recovery and recurrence postrecovery. Based on our
prediction that treatment effects would be strongest acutely,
we employed Wilcoxon tests which are more sensitive than the
traditional log-rank procedure when the ratio of hazards is
higher earlier in the follow-up window. GLMMs and survival
analyses automatically account for missing data and censor-
ing, respectively, producing unbiased estimates assuming
observations are missing at random or the censoring mecha-
nism is noninformative.
Our basic analytic approach called for considering as
covariates variables that (a) were used for stratification or (b)
were significantly associated with loss to follow-up. (The latter
was necessary as our GLMM approach will produce biased
parameter estimates unless observations are missing at ran-
dom.) There were four stratification variables used in this
study: site, gender, baseline depression diagnosis (MDD or DD
vs. DD-NOS), and the presence/absence of antidepression
medication treatment. We included as covariates baseline
factors associated with incomplete longitudinal data, as deter-
mined by logistic regression. These were as follows: single
versus dual parent status; baseline antidepressant medica-
tion; and DD-NOS versus MDD or DD. Following current
standards, no other covariates were included in the primary
models (Kraemer, 2015).
Statistical analyses were conducted using SAS 9.4 (SAS
Institute Inc., 2017). We note that the primary RCT outcome
was 16-week depression response and the study was designed
to have 80% power to detect differential acute treatment effects
(Tompson et al., 2017); the trajectory analyses in this report,
describing changes in outcome over the full 52 weeks, were
considered exploratory. Additionally, the initial omnibus tests
in the GLMMs provide some protection against multiple
comparisons for the post hoc contrasts; thus, we report
unadjusted p-values, although we note that some of the
observed effects would survive a formal correction for multiple
comparisons.
Results
Among the 134 children enrolled, 119 (88.8%) had
at least one postbaseline evaluation: 116 (86.6%)
4 Joan Rosenbaum Asarnow et al.
post-treatment/16 week; 97 (72.4%) 32 week; and
100 (74.6%) 52 week (Figure 1). The baseline sam-
ple had a mean age of 10.84 (SD 2.09), was 56%
female, and racially and ethnically diverse (49%
endorsed minority race or Hispanic/Latino ethnicity;
Table S2). At baseline, 89 children (66%) met MDD
criteria, 24 (18%) met DD criteria, 7 (5%) met double
depression (MDD plus DD) criteria, and 14 (11%)
met DD-NOS criteria. Comorbidity was common:
disruptive behavior disorders, n = 56 (42%); anxiety
disorders, n = 50 (37%). Treatment groups did not
differ on acute treatment dose (Mean #acute treat-
ment sessions FFT-CD, 11.25, SD 4.97; IP 11.78, SD
4.64, t(132) = 0.59, p = .55). Booster sessions
delivered in the child’s randomized arm were
received by 28 children (20.9%): 10 FFT-CD 14.9%;
18 IP 26.9%, v2 = 2.89, p = .09 (Table S1 for detail
by visit).
Ancillary/nonstudy treatment
Based on CASA parent report, during the trial,
25.6% of children received medication treatment
(22.4%, 15/67 FFT-CD; 28.8%, 19/66 IP) and
12.0% received antidepressant treatment (10.45%,
7/67 FFT-CD; 13.6%, 9/66 IP). After acute treat-
ment, 29.0% (31/107) received nonstudy psy-
chotherapy (26.5% (13/49) FFT-CD, 31% (18/58)
IP, v2(1) = 0.26, p = .61, Table S1 for detail by visit).
443 Screened
187 Consented/Assessment
134 Randomized
67 Family-Focused Treatment ITT
48 (72%) Completed Treatment*
13 (19%) Had Booster Sessions**
Assessments Completed
54 Post-treatment/Week 16
45 Week 32
46 Week 52 Assessment
Figure 1 Participant flow. *Defined as ≥11 sessions; **range 1–3
Depression outcomes
Table 1 and Tables S3 and S4 show raw frequencies
for binary outcomes and means for continuous
outcomes, respectively. Table 2 provides results of
GLMMs. Although we show the best estimates of the
(weekly) rates of change in the outcomes for each
treatment arm and study phase for descriptive
purposes, inferential comparisons between groups
are only valid in the presence of a significant
differential trajectory finding (group by time interac-
tion, weeks 16–52, for binary outcomes; omnibus
test for continuous outcomes). Figure 2 illustrates
these model estimates of trajectories over time for the
CDRS-R and CDI-C as representative examples. Note
that in each case, the FFT-CD group appears to
improve more rapidly than the IP group over the
acute treatment period; post-treatment rates of
change are less rapid in both arms, although the
leveling off is more pronounced in the FFT-CD group,
leading to an attenuation of the estimated treatment
effects over follow-up.
Consistent with our previous report (Tompson
et al., 2017), mixed effects logistic regression anal-
yses confirmed a significant intervention effect on
the primary binary outcome, depression response at
post-treatment (week 16 group difference contrast:
F1,192 = 7.09, p = .009). There was a statistically
significant treatment by time interaction over the
256 Excluded:
122 Ineligible
63 No Interest
71 Lost contact
53 Excluded:
45 Ineligible
8 Withdrawn
67 Individual Psychotherapy ITT
51 (76%) Completed Treatment*
15 (22%) Had Booster Sessions**
Assessments Completed
62 Post-treatment/Week 16
52 Week 32
54 Week 52
© 2019 Association for Child and Adolescent Mental Health

Table 1 Binary depression outcomes (raw counts)
Week 16 Week 32 Week 52
N Freq (%) N Freq (%) N Freq (%)
Response: CDRS-R ≥ 50% reduction
FFT 54 43 (79.63) 45 37 (82.22) 46 31 (67.39)
IP 62 37 (59.68) 52 36 (69.23) 54 41 (75.93)
Remission: CDRS-R ≤ 28
FFT 54 29 (53.70) 45 21 (46.67) 46 24 (52.17)
IP 62 22 (35.48) 52 22 (42.31) 54 33 (61.11)
CDRS-R, Children’s Depression Severity-Revised Scale.
follow-up (difference in slopes 0.046, F1,192 = 6.58,
p = .012), corresponding to an attenuation of the
acute treatment effect, whereby the IP group contin-
ued to improve slightly (slope 0.025, F1,192 = 4.26,
p = .041) while the FFT-CD group if anything showed
slight (nonsignificant) deterioration (slope 0.021,
F1,192 = 2.56, p = .112). A similar but weaker pattern
emerged for CDRS-R-remission (slopes FFT-CD
0.0003, IP 0.028, difference 0.027). Note that for
the binary outcomes, the slopes correspond to
(weekly) changes in log-odds of response or remis-
sion and can be exponentiated to obtain the corre-
sponding odds ratios. For depression response, we
have an odds ratio of 0.979 in the FFT-CD group and
1.025 in the IP group, meaning the odds of depres-
sion response go down by 2.1% per week in the
former and up by 2.5% in the latter.
For the CDRS total score, there was a bigger
estimated initial improvement in the FFT-CD group
than the IP group (depression scores decreased by
1.41 vs. 1.17 points per week, respectively, over the
acute period), followed by an attenuation of that
effect as the IP group continues to improve, albeit
more slowly, while the FFT-CD group levels off
(slopes 0.029 vs. 0.140 over weeks 16–52). How-
ever, the omnibus test for differential trajectories is
not significant (see Table 2 and Figure 2). The
pattern of findings was similar for the CDI-C and
CDI-P.
Thus, on all three of the continuous depression
measures, we saw highly significant improvements
in both study arms over the acute treatment period
(block 1 of Table 2 results; all p-values <.0001).
There was evidence for an acute differential treat-
ment effect favoring FFT-CD on depression response
and parallel though nonsignificant patterns of esti-
mates for the other binary and continuous out-
comes. For all continuous depression measures, the
rate of improvement leveled off significantly in both
treatment arms (block 3 of Table 2 results; all p-
values <.0009). In all depression measures, there
was a suggestion that the IP group continued to
improve significantly over follow-up, while the FFT-
CD group did not (block 2 of Table 2 results). We note
that the cross-group improvements over the acute
period and leveling off over follow-up were so signif-
icant that they would survive a correction for the full
© 2019 Association for Child and Adolescent Mental Health
Randomized trial of family treatment for child depression 5
number of component tests provided in Table 2,
clearly indicating that both treatments per-
formed well at reducing youth depression and that
effects did not continue at the same rate postinter-
vention.
Analyses limited to children aged 7–12, and those
limited to children with MDD and/or DD, indicated
the same pattern and magnitude of effects for the
CDRS-R and CDI-C variables, with somewhat
higher p-values due to the smaller sample size
(Table S5a,b).
Survival analyses showed similar rates of recovery
over time for FFT-CD and IP groups (Wilcoxon v2
(1) = 0.083, p = .77). Based on the survival curves,
we estimate one-year rates of recovery from the index
episode of 76% for FFT-CD and 77% for IP children,
with median times to recovery of 81 and 88 days in
FFT-CD and IP, respectively. Among children who
recovered, survival analyses examining time to
recurrence suggest a possible FFT-CD advantage
(Wilcoxon v2 (1) = 3.34, p = .068). One FFT-CD and 6
IP children suffered recurrences with estimated rates
of 3% and 14%, respectively.
Functioning and nondepressive symptoms
The omnibus tests for differential treatment effects
were nonsignificant for secondary functioning
(CGAS, SAS-SR) and nondepressive symptom mea-
sures (CBCL internalizing, externalizing, and total
problems). However, most of these measures showed
the same basic pattern of effects as the depression
measures, with significant initial improvements in
both groups (estimates slightly larger but not signif-
icantly so in the FFT-CD group), followed by leveling
off over the follow-up period (estimates slightly but
not significantly favoring the IP group). The excep-
tion was the MASC which did show evidence of an
overall differential treatment effect, but did not have
the same leveling off pattern as the other measures
and the group differences for the individual study
phases were not significant (Table 2, Table S3).
Harm events
There were no reported deaths. Five suicide attempts
(SAs, including interrupted attempts) were identified
in four children (1 hanging, 2 overdose, 1 cutting,
and 1 method unknown), all in the IP group (1 during
treatment, 4 during weeks 16–52). NSSI was
reported in 15 children: 7 FFT-CD (15 episodes in 6
children during treatment, 1 episode in 1 child
during weeks 16–52); 8 IP (12 episodes in 6 children
during treatment; 9 episodes in 5 children during
weeks 16–52). Mental health-related ED visits and
hospitalizations were similar across treatment arms:
4 FFT-CD children with 7 total ED visits (2 children
with 3 total visits during treatment, 2 children with 4
total visits weeks 16–52); 4 IP children with 5 total
ED visits (2 children, 2 total visits, during treatment
6 Joan Rosenbaum Asarnow et al.

Table 2 Rates of change in the FFT and IP groups over each study period and corresponding group differences, adjusted for site,
gender, baseline diagnostic status, baseline medication, and family composition

Acute treatment period Follow-up period16– Change from acute to

Baseline to week 16 52 weeks follow-up

Slope F p-value f2 Slope F p-value f2 D Slope F p-value f2

CDRS-R response
FFT 0.021 2.56 .112 0.013
IP 0.025 4.26 .041 0.022
FFT-IP 0.046 6.58 .012 0.034
CDRS-R remission
FFT 0.0003 0.00 .982 0.000
IP 0.028 7.11 .009 0.037
FFT-IP 0.027 3.28 .072 0.017
CDRS-R
Trajectory test F = 2.30, p-value = .103, f 2 = 0.015
FFT 1.41 208.95 <.0001 0.676 0.029 0.49 .485 0.002 1.38 117.61 <.0001 0.381
IP 1.17 164.88 <.0001 0.534 0.140 14.93 .0001 0.048 1.03 79.07 <.0001 0.256
CDI-C
Trajectory test F = 2.28, p-value = .104, f 2 = 0.009
FFT 0.482 64.53 <.0001 0.128 0.020 0.70 .404 0.001 0.462 37.26 <.0001 0.074
IP 0.311 29.71 <.0001 0.059 0.070 9.19 .003 0.018 0.241 11.25 .0009 0.022
CDI-P
Trajectory test F = 2.44, p-value = .089, f 2 = 0.010
FFT 0.557 114.63 <.0001 0.226 0.027 1.62 .205 0.003 0.530 65.60 <.0001 0.129
IP 0.498 100.78 <.0001 0.199 0.090 19.39 <.0001 0.038 0.408 42.13 <.0001 0.083
CGAS
Trajectory test F = 0.18, p-value = .836, f 2 = 0.001
FFT 0.670 53.78 <.0001 0.183 0.121 9.11 .003 0.031 0.549 21.04 <.0001 0.072
IP 0.658 55.87 <.0001 0.190 0.098 6.47 .012 0.023 0.560 23.60 <.0001 0.080
SAS-SR
Trajectory test F = 2.36, p-value = .096, f 2 = 0.016
FFT .372 21.89 <.0001 0.075 0.019 0.33 .568 0.001 0.391 14.40 .0002 0.050
IP .220 8.35 .005 0.029 0.082 6.18 .014 0.021 0.139 1.94 .165 0.007
MASC
Trajectory test F = 3.21, p-value = .042, f 2 = 0.022
FFT 0.101 0.59 .444 0.002 0.131 5.50 .020 0.019 0.030 0.01 .859 0.00003
IP 0.297 5.62 .019 0.018 0.223 17.24 <.0001 0.059 0.074 0.20 .652 0.001
FFT-IP 0.196 1.17 .280 0.004 0.092 1.42 .235 0.005 0.104 0.19 .660 0.001
CBCL internalizing
Trajectory test F = 1.56, p-value = .212, f 2 = 0.011
FFT 0.642 74.97 <.0001 0.267 0.047 2.22 .138 0.008 0.594 37.50 <.0001 0.133
IP 0.485 46.76 <.0001 0.166 0.119 15.20 .0001 0.054 0.366 15.48 .0001 0.055
CBCL externalizing
Trajectory test F = 2.32, p-value = .101, f 2 = 0.017
FFT 0.434 37.15 <.0001 0.132 0.021 0.47 .492 0.002 0.413 19.62 <.0001 0.070
IP 0.224 10.80 .002 0.038 0.082 7.89 .006 0.028 0.142 2.51 .115 0.009
CBCL total problems
Trajectory test F = 2.80, p-value = .063, f 2 = 0.020
FFT 0.580 63.02 <.0001 0.224 0.036 1.31 .254 0.005 0.544 32.35 <.0001 0.115
IP 0.358 26.11 <.0001 0.093 0.123 16.78 <.0001 0.060 0.234 6.51 .012 0.023

Binary outcomes were evaluable only postbaseline. Slopes represent change in log-odds (binary) or number of points increased (+) or
decreased ( ) (continuous) per week. Between-group differences (computed as FFT-CD – IP) were included for continuous measures
only if the omnibus tests for differential trajectories were significant; negative slope differences indicate an FFT-CD advantage,
except for C-GAS where higher scores reflect better functioning. Slope differences between acute and follow-up periods were
computed as (follow-up – acute); positive values correspond to a leveling off of change during the follow-up period. Effect sizes are
shown as Cohen’s f 2, the standard metric for regression/related models; f 2 = 0.02, 0.15, and 0.35 correspond to small, medium,
and large effects, respectively. Degrees of freedom: numerator = 2 for trajectory tests and 1 for all other tests; denominator differed
due to missing data (CDRS-R Binary 192; Total 309; MASC 295; SAS 290; C-GAS 294; CBCL 282; and larger number of assessment
points for the CDI-C 506; and CDI-P 507).

period; 2 children with 3 total visits weeks 16–52); Discussion

3 FFT-CD children with 5 total hospitalizations
(2 children with 2 total hospitalizations during
treatment; 1 child with 3 total hospitalizations
during weeks 16–52); and 2 IP children with 2 total
hospitalizations (1 during treatment, 1 weeks
16–52).
This study reports results of the first large multi-
site RCT to our knowledge to evaluate two active
psychosocial treatment strategies for children with
depressive disorders. Expanding on our prior
report (Tompson et al., 2017) of an initial advan-
tage for FFT-CD on depression response, we found

© 2019 Association for Child and Adolescent Mental Health

 Randomized trial of family treatment for child depression 7

Figure 2 Mixed model analyses: CDRS-R and CDI-C from baseline to week 52. Plots show the estimated marginal means for each treatment
group over time, based on the mixed models adjusted for site, gender, baseline diagnostic status, baseline medication usage, and family
composition

that, after acute treatment, as children returned to
usual care, symptom trajectories leveled off in both
groups and treatment effects attenuated, resulting
in similar depression levels by 52 weeks/one year.
Because the study did not evaluate extended FFT-
CD versus IP treatment over 52 weeks, with families
free to pursue treatments as needed after acute
treatment, the early FFT-CD advantage may have
been weakened by the lack of clinical control after
week 16. Consistent with the possibility that differ-
ential treatment use after acute treatment may have
contributed to the trajectory toward equivalence
across treatment arms over follow-up, IP children
were somewhat more likely to receive booster
sessions of their study treatment during the follow-
up period; although patterns of ancillary nonstudy
medication and psychosocial treatments were similar
in both groups. While sensitivity analyses adjusting
for use of study booster sessions and ancillary non-
study treatments did not alter the longitudinal find-
ings, we cannot rule out the possibility that
differences in nonstudy care impacted results. Nev-
ertheless, our full trial results support the need for
conservative interpretation of the early FFT-CD
advantage, and readers should note the potential for
slippage of differential treatment benefits over time.
Most children recovered within a year (estimated
rates 76%–77%), and both treatments had large

© 2019 Association for Child and Adolescent Mental Health

8 Joan Rosenbaum Asarnow et al.
effect sizes on the CDRS-R at week 16. These rates
are high and comparable to those reported for
clinically referred samples in observational studies
(Kovacs et al., 2016) and in adolescent depression
treatment trials (Birmaher et al., 2000; Curry et al.,
2011; Goodyer et al., 2008, 2017; March et al.,
2009; Vitiello et al., 2011). However, with time some
children suffered recurrent episodes, all but one in
the IP group.
Supporting the safety of both treatments, there were
no deaths and relatively few harm events. We observed
five SAs, all in IP children. Consistent with our
hypothesis that a family-focused approach could
mobilize protective strengths, and similar to research
showing benefits of treatments with strong family
components for reducing SA-risk (Asarnow, Hughes,
et al., 2017; Ougrin, Tranah, Stahl, Moran, & Asarnow,
2015), the greater family involvement in FFT-CD may
have had an advantage for SA prevention.
The emergence of recurrent episodes over time
suggests the need for a more extended/chronic
treatment model. These results are consistent with
those from the largest longitudinal evaluation of
depression in childhood which indicated that up to
72% of children who recovered from their first major
depressive episodes suffered recurrent episodes (me-
dian between-episode interval 3–5 years, (Kovacs
et al., 2016). This suggests the importance of more
extensive prevention efforts, perhaps with interven-
tions designed specifically for relapse/recurrence
prevention (Kennard et al., 2008) or with monitoring
strategies such as check-ups and ‘caring contacts’
that remind parents and children that treatment is
attainable and can help them to address emerging
symptoms and stress. Incorporating monitoring and
outreach strategies within primary care or school
services could improve access and reach.
Our results point to the limitations of examining
only single time points or simple acute treatment
interaction effects and the importance of examining
trajectories over time. Focusing on the acute period
missed the observation that the initial treatment
advantage did not last, whereas focusing on 52-week
outcomes would neglect the earlier FFT-CD benefits.
Examination of trajectories, as done here, allows
discovery of potential group differences in pathways
to longer-term outcomes. Knowing the change tra-
jectories with one treatment versus another allows
an evidence-based approach to the timing of treat-
ments including acute and postacute treatment
strategies.
One potential explanation for the equivalence of FFT-
CD and IP outcomes at 52 weeks is that both are
effective treatments, particularly when delivered by the
same therapists rated as high in nonspecific factors
such as therapist warmth and genuineness. Further,
while IP youths had depression improvements similar
to FFT-CD youths at 52 weeks, this is also the furthest
point from original randomization and the likelihood of
nonstudy influences is greatest, and our results do
indicate that FFT-CD children showed a more rapid
depression response as indicated by the significant
FFT-CD advantage at 16 weeks.
The absence of a no-treatment condition was a
study limitation, leaving uncertainty regarding
whether both treatments were effective or whether
time alone would yield similar healing. For ethical
and scientific reasons, we used an active treatment
comparator modeled after UC and matched to FFT-
CD for key features (e.g., # sessions offered). Other
limitations were as follows: the exclusive focus on
psychosocial treatment; the short follow-up; and the
absence of differential treatment effects on measures
of functioning and other symptoms. Because the trial
was powered for acute treatment effects, we were
likely underpowered for some trajectory analyses.
Nevertheless, our findings of a leveling off between
weeks 16–52 and an attenuation of the acute treat-
ment effect for depression call for caution in inter-
preting the initial FFT-CD advantage. Longer follow-
up might have revealed stronger benefits (consistent
with results on FFT for bipolar illness, Miklowitz
et al., 2014) and is needed for evaluation of longer-
term risks including depression-recurrence, SAs,
and health-risk behaviors (Bai et al., 2018; Kovacs
et al., 2016; Weissman et al., 1999). Study treat-
ments were delivered within a rigorous efficacy trial
with extensive therapist training and clinical moni-
toring, likely strengthening both safety and benefits.
Future research is needed to evaluate effectiveness
under less controlled practice conditions.
In conclusion, our full trial results indicate an
earlier depression response with FFT-CD, with a hint
of possible protection from recurrence and SAs.
However, our data suggest general equivalence of
these two active treatments at 52 weeks. While this
trajectory toward equivalence may have been affected
by differential treatment use and other factors after
the end of acute treatment, our results are consistent
with findings from large adolescent depression trials
that have found initial differential effects of psy-
chosocial treatments but similar outcomes at longer
follow-ups (Weisz et al., 2006). Multiple treatments
lead to recovery, as do time and natural healing for
many children. Attention to mechanisms contribut-
ing to recovery, identifying which children are most
likely to benefit from treatments targeting different
mechanisms, considering both psychosocial and
medication treatment options, and understanding
trajectories of improvement may help us to person-
alize and sequence treatments to provide optimal
acute and longer-term care. While most children in
FFT-CD and IP recovered, with time recurrent
episodes emerged, and the literature suggests that
depressive disorders will have longer-term adverse
impact for many children. The challenge is to develop
the science to optimize clinical decision-making, a
critical challenge given links between early depres-
sion and suicide and increasing rates of suicide
deaths in the United States and other nations.
© 2019 Association for Child and Adolescent Mental Health
 Randomized trial of family treatment for child depression 9

Services Administration, American Foundation for Sui-

Supporting information
Additional supporting information may be found online
in the Supporting Information section at the end of the
article:
Table S1. Use of booster sessions and nonstudy med-
ication and psychotherapy treatments during the trial.
Table S2. Sample characteristics at baseline.
Table S3. Means and standard deviations for continu-
ous outcomes baseline to 52-weeks for each treatment
group.
Table S4. Mean and standard deviations for Child
Depression Inventory Child (CDI-C) and Parent (CDI-P)
from baseline to 52-weeks for each treatment group.
Table S5a. Rates of change in the FFT and IP groups
over each of the study periods and corresponding group
differences for Age ≤12, adjusted for site, gender,
baseline-diagnostic-status, baseline-medication, and
family-composition.
Table S5b. Rates of change in the FFT and IP groups
over each of the study periods and corresponding group
differences for Syndromal Only, adjusted for site, gen-
der, baseline-medication, and family-composition.
Acknowledgements
This work was supported by National Institute of
Mental Health (NIMH) grants MH082856 and
MH082861. The content is solely the responsibility of
the authors and does not necessarily represent the
official views of the National Institutes of Health or other
funding agencies. J.R.A. received grant/other support
from NIMH, Substance Abuse and Mental Health
cide Prevention, American Psychological Association,
Society of Clinical Child and Adolescent Psychology,
Association for Child and Adolescent Mental Health,
and Klingenstein Third Generation Foundation. She
consulted/presented on depression and suicidal/self-
harm behavior, served on Data Safety and Monitoring
and noncommercial Advisory Boards/Expert Panels.
C.S. received research support from NIH through mul-
tiple divisions; Health Resources and Services Admin-
istration; and the Veterans Administration; served on
technical expert panels for the Centers for Medicare and
Medicaid Services, and Data Safety and Monitoring
Boards for academic institutions and Kaiser Perma-
nente. M.T. received research support from the NIMH,
the Patient Centered Outcomes Research Institute, and
the Smith Family Foundation; book royalties from
Guilford Press and BVT Publishing; and honoraria from
the American Psychological Association. The authors
thank the children, families, and many colleagues who
made this project possible including Judith Cohen who
provided the IP training, Thomas Belin who provided
statistical consultation, and the project DSMB: Donald
Guthrie, Gabrielle Carlson, and Sherryl Goodman. The
authors have declared that they have no competing or
potential conflicts of interest.
Correspondence
Joan Rosenbaum Asarnow, Department of Psychiatry
and Behavioral Sciences, University of California, Los
Angeles, 300 Medical Plaza, Los Angeles, CA 90095-
6968, USA; Email: Jasarnow@mednet.ucla.edu

Key points

 Childhood-onset depressive disorders are associated with substantial morbidity and mortality.
 This is the first large multisite RCT to evaluate two active psychosocial treatment strategies for children ages
7–14 with depressive disorders.
 Results indicate a quicker depression response in family-focused treatment, compared to individual
psychotherapy after roughly 16 weeks of acute treatment, and a hint of greater protection from recurrence
and suicide attempts. However, outcomes were similar for both treatments by week 52/one year.
 Although community care received after acute treatment may have influenced results, findings suggest the
value of an extended/chronic disease model that includes monitoring and clinical guidance regarding
optimal interventions when signs of depression-risk emerge.

Ascher, B.H., Farmer, E.M.Z., Burns, B.J., & Angold, A. (1994).

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Accepted for publication: 10 October 2019
© 2019 Association for Child and Adolescent Mental Health