Cognitive Behavioral Treatments for Anxiety
in Children With Autism Spectrum Disorder
A Randomized Clinical Trial
Jeffrey J. Wood, PhD; Philip C. Kendall, PhD; Karen S. Wood, PhD; Connor M. Kerns, PhD;
Michael Seltzer, PhD; Brent J. Small, PhD; Adam B. Lewin, PhD; Eric A. Storch, PhD
IMPORTANCE Anxiety is common among youth with autism spectrum disorder (ASD), often
interfering with adaptive functioning. Psychological therapies are commonly used to treat
school-aged youth with ASD; their efficacy has not been established.
OBJECTIVE To compare the relative efficacy of 2 cognitive behavioral therapy (CBT) programs
and treatment as usual (TAU) to assess treatment outcomes on maladaptive and interfering
anxiety in children with ASD. The secondary objectives were to assess treatment outcomes
on positive response, ASD symptom severity, and anxiety-associated adaptive functioning.
DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial began recruitment in
April 2014 at 3 universities in US cities. A volunteer sample of children (7-13 years) with ASD
and maladaptive and interfering anxiety was randomized to standard-of-practice CBT,
CBT adapted for ASD, or TAU. Independent evaluators were blinded to groupings. Data
were collected through January 2017 and analyzed from December 2018 to February 2019.
INTERVENTIONS The main features of standard-of-practice CBT were affect recognition,
reappraisal, modeling/rehearsal, in vivo exposure tasks, and reinforcement. The CBT
intervention adapted for ASD was similar but also addressed social communication and
self-regulation challenges with perspective-taking training and behavior-analytic techniques.
MAIN OUTCOMES AND MEASURES The primary outcome measure per a priori hypotheses was
the Pediatric Anxiety Rating Scale. Secondary outcomes included treatment response on the
Clinical Global Impressions–Improvement scale and checklist measures.
RESULTS Of 214 children initially enrolled, 167 were randomized, 145 completed treatment,
and 22 discontinued participation. Those who were not randomized failed to meet eligibility
criteria (eg, confirmed ASD). There was no significant difference in discontinuation rates
across conditions. Randomized children had a mean (SD) age of 9.9 (1.8) years; 34 were
female (20.5%). The CBT program adapted for ASD outperformed standard-of-practice CBT
(mean [SD] Pediatric Anxiety Rating Scale score, 2.13 [0.91] [95% CI, 1.91-2.36] vs 2.43 [0.70]
[95% CI, 2.25-2.62]; P = .04) and TAU (2.93 [0.59] [95% CI, 2.63-3.22]; P < .001). The CBT adapted for ASD also outperformed standard-of-practice CBT and TAU on parent-reported scales of internalizing symptoms (estimated group mean differences: adapted vs standard-of-practice CBT, −0.097 [95% CI, −0.172 to −0.023], P = .01; adapted CBT vs TAU, −0.126 [95% CI, −0.243 to −0.010]; P = .04), ASD-associated social-communication symptoms (estimated group mean difference: adapted vs standard-of-practice CBT, −0.115 [95% CI, −0223 to −0.007]; P = .04; adapted CBT vs TAU: −0.235 [95% CI,−0.406 to −0.065]; P = .01); and anxiety-associated social functioning (estimated group mean difference: adapted vs standard-of-practice CBT, −0.160 [95% CI, −0.307 to −0.013]; P = .04; adapted CBT vs TAU: −0.284 [95% CI, −0.515 to −0.053]; P = .02). Both CBT conditions achieved higher rates of positive treatment response than TAU (BIACA, 61 of 66 [92.4%]; Coping Cat, 47 of 58 [81.0%]; TAU, 2 of 18 [11.1%]; P < .001 for each comparison). CONCLUSIONS AND RELEVANCE In this study, CBT was efficacious for children with ASD and interfering anxiety, and an adapted CBT approach showed additional advantages. It is recommended that clinicians providing psychological treatments to school-aged children with ASD consider developing CBT expertise. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02028247 JAMA Psychiatry. 2020;77(5):474-483. doi:10.1001/jamapsychiatry.2019.4160 Published online November 22, 2019. Supplemental content Author Affiliations: Department of Education, University of California, Los Angeles, Los Angeles (J. J. Wood, Seltzer); Department of Psychiatry, University of California, Los Angeles, Los Angeles (J. J. Wood, K. S. Wood); Department of Psychology, Temple University, Philadelphia, Pennsylvania (Kendall); Department of Psychology, University of British Columbia, Vancouver, British Columbia, Canada (Kerns); University of South Florida School of Aging Studies, Tampa (Small); Departments of Pediatrics and Psychiatry, University of South Florida, Tampa (Lewin); Baylor College of Medicine, Houston, Texas (Storch). Corresponding Author: Jeffrey J. Wood, PhD, University of California, Los Angeles, 405 Hilgard Ave, 3132 Moore Hall, Los Angeles, CA 90095 ([email protected]) and Philip C. Kendall, PhD, Department of Psychology, Temple University, 1701 N 13th St, Philadelphia, PA 19122 ([email protected]). Research JAMA Psychiatry | Original Investigation 474 (Reprinted) jamapsychiatry.com © 2019 American Medical Association. All rights reserved. https://clinicaltrials.gov/ct2/show/NCT02028247 https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 https://jamanetwork.com/journals/psy/fullarticle/10.1001/jamapsychiatry.2019.4160/?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 mailto:[email protected] mailto:[email protected] http://www.jamapsychiatry.com/?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 A utism spectrum disorder (ASD) affects about 1 of 59school-aged youth in the United States.1 Maladaptiveand interfering anxiety is common among youth with ASD and associated with functional impairment above and be- yond the presence of ASD.2 In addition to common childhood fears (eg, separation, generalized anxiety), maladaptive dis- tinctive fears (eg, fears of beards, specific sounds, minor change) are also common.3,4 Higher levels of child anxiety are associated with greater difficulties with school adjustment, so- cial skills, friendship, loneliness, self-injurious behavior, and family conflict in youth with and without ASD.5-8 Studies of youth with ASD in the United States have esti- mated that psychological therapy (often referred to as psycho- therapy) is among the most frequently used mental health ser- vices for youth with ASD, with as many as 23% to 43% of youth accessing this type of treatment.9,10 Several small random- ized clinical trials using wait-list or usual-care control condi- tions suggest that a specific form of psychotherapy, cognitive behavioral therapy (CBT), may be beneficial for school-aged youth with ASD and anxiety.11-18 However, no psychological or pharmacological treatments for anxiety in school-aged chil- dren with ASD meet contemporary evidentiary standards19 as efficacious or well-established. Several CBT programs have been adapted for the charac- teristics of ASD.11-15 The rationale for adapted CBT programs for youth with ASD is multifaceted: (1) achieving generaliz- able symptom change in youth with ASD has been a chal- lenge in some treatment programs,20 (2) contextual factors that cause anxiety (eg, social communication challenges, ASD- associated stressors) likely necessitate a psychological treat- ment that addresses these contextual factors,14 and (3) youth with ASD may benefit from more parental involvement in psy- chological treatment than is typical in standard-of-practice CBT.21 Other CBT programs have been developed for typi- cally developing youth but also tested for youth with ASD.16,17 These initial studies suggest that CBT is a promising modality for treating anxiety in youth with ASD, but study limitations (eg, small samples, use of wait-list control arms) preclude efficacy conclusions.18 It is unknown whether adapted CBT differs from standard-of-practice CBT in its effects on youth outcomes. The present study evaluated the efficacy of 2 versions of CBT (adapted CBT and standard-of-practice CBT) for anxiety in youth with ASD using a study design capable of testing relative treatment efficacy with sufficient statistical power, and assessed the effect of CBT on anxiety symptoms, ASD symptom severity, and adaptive functioning. It was hypoth- esized that (1) children randomized to CBT would exhibit greater improvement in these domains relative to children randomized to treatment as usual (TAU) and (2) CBT adapted for youth with ASD would show advantages over standard- of-practice CBT. Methods The study protocol is included in Supplement 1 and has been summarized elsewhere.22 Details about the sample and a brief description of the measures, eligibility criteria, and treat- ment conditions are presented. The Consolidated Standards of Reporting Trials guidelines were followed. Participants Participants were a volunteer sample of children with ASD and maladaptive and interfering anxiety; the eligible age range was 7 to 13 years. Three universities in major US metropolitan areas (Los Angeles, California; Tampa, Florida; and Philadelphia, Pennsylvania) served as data collection sites. A power analy- sis was conducted to determine target sample size.22 This study was approved by university-based institu- tional review boards at each site (University of California, Los Angeles general institutional review board, University of South Florida institutional review board, and Temple Univer- sity’s Human Research Protection Program). Parents gave writ- ten informed consent and children gave assent to participate after receiving a complete description of the study. Telephone contact was initiated by parents to the study coordinator, and an initial screening was conducted. Fami- lies received $75 for participating in the assessments. Recruit- ment began April 2014, and final data were collected in Janu- ary 2017, coinciding with the grant support period. Eligibility criteria included having a clinical diagnosis of ASD confirmed by the study’s clinical research evaluation, an IQ of 70 or more points (±SEM), and anxiety (as defined by a Pediatric Anxiety Rating Scale [PARS] total score of ≥14 points, which corresponds with maladaptive and interfering anxiety)23,24 (complete criteria are in the protocol [Supple- ment 1]). The site principal investigator determined eligibil- ity status at screening. Participants were notified of their eligibility status by the study coordinator and, if eligible, pro- ceeded to complete secondary outcome measures. Interventions Participants were randomized using a computer-generated algorithm in a parallel study design with a 4.5:4.5:1 ratio to (1) standard-of-practice CBT (termed the Coping Cat program),25 (2) CBT adapted for ASD (the Behavioral Interventions for Anxi- ety in Children with Autism [BIACA] program),14 or (3) TAU. Randomization was conducted by the study statistician (B.J.S.), Key Points Question Does cognitive behavioral therapy (CBT) reduce anxiety symptoms in children with autism spectrum disorder (ASD) and maladaptive and interfering anxiety? Findings In this randomized clinical trial of 167 children with ASD and maladaptive and interfering anxiety, 2 variants of CBT were compared with a treatment-as-usual condition. Cognitive behavioral therapy designed for children with ASD yielded significantly lower anxiety scores on the primary outcome measure than standard-of-practice CBT and treatment as usual; both types of CBT yielded higher rates of positive treatment response than treatment as usual. Meaning Per this analysis, CBT is efficacious for the treatment of maladaptive and interfering anxiety in children with ASD. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder Original Investigation Research jamapsychiatry.com (Reprinted) JAMA Psychiatry May 2020 Volume 77, Number 5 475 © 2019 American Medical Association. All rights reserved. https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 http://www.jamapsychiatry.com/?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 who had no contact with participants. The statistician in- formed the study coordinator of the random assignment for each participant, who subsequently notified participants. Fami- lies were not informed of study hypotheses. Therapists (19 graduate students and postdoctoral fellows) received 8 hours of training in the treatment proto- cols, read the treatment manuals, and attended weekly super- vision sessions with a licensed psychologist. Children were assigned to an available therapist based on availability. The same therapists were trained in and provided both CBT treatments. Both CBT treatments have been desc ribed extensively elsewhere12-15,22,26-29 and in the study protocol (Supplement 1). Standard-of-Practice CBT Participants received 16 weekly 60-minute sessions of the Coping Cat program, which was found to be effective in trials of typically developing youth aged 7 to 13 years.26-29 The main features are (1) recognizing anxious feelings and somatic reac- tions to anxiety, (2) identifying cognition in anxiety-provoking situations (eg, expectations of threat), (3) developing a plan to cope (eg, reappraisal), (4) imaginal and in vivo exposure tasks, and (5) self-reinforcement for effort. The treatment uses mod- eling, role-play, and contingent reinforcement. Specific home- work tasks are assigned. Parent involvement in the child’s treatment includes a regular 15-minute check-in at the start of each session and 2 meetings with the therapist. Adapted CBT (BIACA) Like Coping Cat, BIACA uses CBT strategies, such as reap- praisal and exposure. The BIACA program differs from Coping Cat in the following ways: (1) children receive 16 weekly 90-minute sessions (split evenly between children and par- ents) to facilitate parent engagement; (2) BIACA uses a modu- lar format guided by an algorithm to personalize treatment, given the multifaceted clinical presentations in ASD; (3) chil- dren’s disruptive behavior is addressed as needed with ante- cedent and incentive-based practices to reduce the influence of aggression and noncompliance on treatment engagement; (4) children are taught social engagement skills as needed (eg, playdate hosting, joining peers at play) to facilitate suc- cessful peer-oriented exposure-therapy assignments; (5) the children’s special interests are treated as an asset and incor- porated into treatment to promote engagement; (6) target be- haviors are reinforced with a comprehensive reward system at home and, when relevant, in school to promote motivation and treatment engagement. Further clinical description of BIACA and its treatment algorithm has been published elsewhere.30-34 An app with training and clinician guidance in- corporating the algorithm has been developed for BIACA and associated practices and is available free of charge at https:// meya.ucla.edu. Treatment as Usual Participants in the TAU arm continued in their usual services and were provided with referrals. No specific treatment rec- ommendations were given. Families were permitted to choose or maintain any treatment approach for 4 months. After TAU, for ethical reasons, families were offered their choice of either CBT condition if their children were still symptomatic. Therapist Fidelity Therapists’ adherence to the interventions was monitored through session audio recordings. A random selection of ses- sions (92 for BIACA and 70 for Coping Cat) was coded for fidelity by the principal investigators (P.C.K. and J.J.W.) and trained research assistants. Coders noted the presence or absence of required topics for each session. There was ad- herence to 97% and 96% of the required topics in BIACA and Coping Cat sessions, respectively. A second coder rated 14.3% of the coded tapes to assess interrater reliability (intraclass correlations: BIACA, 0.85; Coping Cat, 1.00). Measures Assessments were conducted by trained, research-certified independent evaluators blinded to treatment condition. Mea- sures were selected based on strong psychometric profiles for youth with ASD. The ASD diagnoses were assigned by an in- dependent evaluator using the Childhood Autism Rating Scale Second Edition–High Functioning Version and the Autism Di- agnostic Observation Schedule–2 (ADOS-2). Eligible children met criteria for ASD on algorithm scores from both assess- ments. A second independent evaluator, unaware of the origi- nal scores, independently rated 18 Autism Diagnostic Obser- vation Schedule–2 and 18 Childhood Autism Rating Scale interviews selected randomly, with 100% agreement for meet- ing ASD criteria on both measures. Each participant’s IQ score was assessed using the Wechsler Intelligence Scale for Children– IV; estimated full-scale IQ was based on the Vocabulary and Matrix Reasoning subscales. The primary outcome measure was the PARS,35 an inde- pendent evaluator–administered scale assessing anxiety symp- toms and associated severity and impairment over the past week. The PARS Severity Scale item scores range from 0 to 5 points, with higher scores reflecting more maladaptive and in- terfering anxiety; a mean of scores on the 7 items was calcu- lated. The PARS, which is psychometrically sound and treat- ment sensitive in samples of children with ASD,12-15,36 was administered at baseline, midtreatment (session or week 8), and after treatment (within 1 week of the last session). The me- dian interrater reliability across assessments (r) was 0.88. The Clinical Global Impression–Improvement scale37 was rated by the independent evaluator after the postbaseline PARS inter- views. This scale is a 7-point rating of treatment response rang- ing from 1 (very much improved) to 7 (very much worse). A rat- ing of 1 or 2 designated a positive treatment response. Secondary outcome rating-scale measures were com- pleted by parents, including the Child Behavior Checklist, Social Responsiveness Scale–2, and the Child Anxiety Impact Scale (CAIS).38 Higher scores on all outcome measures reflect more symptoms or impairment; scores are the mean item value of each scale. Secondary outcome measures were adminis- tered before and after treatment. Additional detail about these measures is provided in the eMethods in Supplement 2. The Service Assessment for Children and Adolescents39 was ad- ministered to parents after TAU. Research Original Investigation Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder 476 JAMA Psychiatry May 2020 Volume 77, Number 5 (Reprinted) jamapsychiatry.com © 2019 American Medical Association. All rights reserved. https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 https://meya.ucla.edu https://meya.ucla.edu https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 http://www.jamapsychiatry.com/?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 Protocol Changes Changes made to the protocol prior to trial onset are detailed in the protocol in Supplement 1. Most importantly, a no- treatment wait-list control condition was initially added; how- ever, because TAU is a more robust comparator than a wait- list control group,40 it was selected instead. Additionally, during the trial, baseline PARS scores were calculated based on all 7 PARS severity items, instead of 6 of the 7 severity items, as planned at the study onset.22 As a result, 3 children who were randomized actually had 6-item PARS scores less than the intended inclusion criterion cut score of 14 points; following intent-to-treat principles, these children were included in all analyses. Notably, a cut score of 17.5 on the 7-item PARS has been established as optimal in recent psychometric research23; just 2 children in the sample scored at slightly less than this threshold (scores of 17 each). Statistical Analysis The primary analyses tested treatment effects using general lin- ear mixed models (GLMMs), with study site as a random effect and the baseline score as a covariate. Deviation effect–coding was used in the GLMMs as an initial omnibus test. All covari- ates were centered on the grand mean. Significant deviations from the grand mean were further examined in pairwise con- trasts among the relevant treatment conditions using dummy coding; significant contrasts are described with Cohen d effect size estimates, calculated as the difference of group means at the end point, using pooled baseline SDs from the full sample as the measure of variability.41 All GLMMs were estimated using HLM 7.0.1 software (Scientific Software International Inc). In- tent-to-treat analyses were conducted by replacing missing val- ues (eg, those attributable to dropout) with multiple imputa- tions using the predictive mean matching method and then testing treatment effects using ordinary least squares regres- sion with the same dummy-coded variables used in the GLMMs. All analyses were by the original assigned groups. For secondary outcomes, the familywise error rate stem- ming from multiple comparisons was addressed, with the Holm-Bonferroni method applied separately to tests of devia- tion from the grand mean for the BIACA and Coping Cat groups (familywise α = .05). Follow-up contrasts, when performed, were protected with the Fisher least-significant-difference test approach. Because no significant findings were negated by these corrections, unadjusted P values were reported. Statistical significance was defined as any P value less than .05 (2-tailed). Data analysis for this report occurred from De- cember 2018 to February 2019. All analyses except GLMMs were calculated in SPSS version 24 (IBM). Results Table 1 presents demographic information for randomized families. Of those enrolled, 167 were randomized (64, 61, and Table 1. Demographic and Clinical Characteristics for Behavioral Interventions for Anxiety in Children With Autism (BIACA), Coping Cat, and Treatment-as-Usual Groupsa Characteristics Participants, No./Total No. (%) BIACA Group Coping Cat Group Treatment-as- Usual Group Female childrenb 21/75 (28) 13/72 (18) 0/19 Latino or Latina childrenc 12/63 (19) 15/54 (28) 3/19 (16) Child’s racec African American/African 7/75 (9) 2/71 (3) 3/19 (16) Asian/Pacific Islander 6/75 (8) 3/71 (4) 1/19 (5) White 46/75 (61) 48/71 (68) 11/19 (58) Native American or Alaskan 2/75 (3) 1/71 (1) 0/19 Multiracial African American and white 0/75 2/71 (3) 1/19 (5) Asian and white 1/75 (1) 0/71 0/19 Unspecified 1/75 (1) 0/71 0/19 Total household income <$40 000 15/72 (21) 13/71 (18) 5/19 (26) Father’s education ≤High school diploma 14/72 (19) 12/69 (17) 5/17 (29) ≥4-y College degree 40/72 (56) 40/69 (60) 9/17 (53) Mother’s education ≤High school diploma 6/74 (8) 5/70 (7) 2/19 (11) ≥4-y College degree 47/74 (64) 50/70 (71) 13/19 (68) Parents currently married 58/75 (77) 52/71 (73) 12/19 (63) Autism Diagnostic Observation Schedule–2 algorithm total score, mean (SD) 12.92 (3.88) 13.01 (4.09) 12.39 (4.42) Childhood Autism Rating Scale total score, mean (SD) 34.63 (4.60) 35.63 (4.94) 33.93 (4.12) Estimated IQ by Wechsler Intelligence Scale for Children–IV, mean (SD) 102.79 (14.56) 101.64 (15.67) 102.35 (14.54) a There was a significant treatment group difference for female children (P = .02). No treatment group differences were significant for any of the other demographic variables. The sample sizes vary within groups, because some demographic data were not provided by some families. b Options for reporting a child’s sex were limited to male and female at the time of the study start. Gender identities were not included from the survey, and future research will correct this omission. c Race/ethnicity were queried in the same section of the survey, leading many families to report on race or ethnicity but not both, with limited detail. Future research will include more open-ended questions about race/ethnicity in the surveys. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder Original Investigation Research jamapsychiatry.com (Reprinted) JAMA Psychiatry May 2020 Volume 77, Number 5 477 © 2019 American Medical Association. All rights reserved. https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2019.4160?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 http://www.jamapsychiatry.com/?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2019.4160 42 participants at the 3 study sites), 145 completed the study, and 22 discontinued participation (Figure 1). There was no significant difference in discontinuation across the BIACA, Coping Cat, and TAU conditions. A comparison of partici- pants with complete and incomplete data are provided in eTable 1 in Supplement 2; those who discontinued early were more likely to be Latino or Latina (those who discontinued, 8 of 21 participants [38.0%]; those who completed, 22 of 144 par- ticipants [15.3%]; P = .01) and had higher baseline scores on the CAIS-School scale (mean [SD]: those who discontinued, 1.68 [0.75]; those who completed, 1.36 [0.59]; P = .03) and CAIS- Social scale (mean [SD]: those who discontinued, 1.30 [0.70]; those who completed, 0.89 [0.55]; P = .003). Pretreatment sample characteristics (Table 1) yielded no condition differences or their interaction, with 1 exception: sig- nificant condition differences were found for child sex (fe- male participants: BIACA group, 21 of 75 individuals [28%]; Coping Cat group, 13 of 72 individuals [18%]; TAU group, 0 of 19 individuals [0%]; P = .03), with a greater proportion of boys in TAU relative to other conditions. Sex was included as a co- variate in subsequent analyses. There were several signifi- cant study-site differences on pretreatment characteristics (eTable 2 in Supplement 2). Participants at study site 1 were more likely to be Latino or Latina (site 1, 20 of 61 participants [33%]; site 2, 10 of 54 participants [16%]; site 3, 0 of 40 par- ticipants; P < .001), Asian/Pacific Islander (site 1, 9 of 61 par- ticipants [15%]; site 2, 1 of 64 participants [2%]; site 3, 0 of 40 participants; P = .005), or multiracial (site 1, 9 of 61 partici- pants [15%]; site 2, 2 of 64 participants [3%]; site 3, 2 of 40 par- ticipants [5%]; P = .04), and less likely to be white (site 1, 40 of 61 participants [66%]; site 2, 54 of 64 participants [84%]; site 3, 34 of 40 participants [85%]; P = .02) or to have an an- nual household income below $40 000 (site 1, 6 of 59 partici- pants [10%]; site 2, 18 of 63 participants [29%]; site 3, 9 of 40 participants [23%]; P = .04). Participants at study site 2 had higher pretreatment Childhood Autism Rating Scale scores than those at study site 1 (mean difference, 1.69 [95% CI, 0.05- 3.33]; P = .04) and study site 3 (mean difference, 4.02 [95% CI, 2.20-5.84]; P < .001), while participants at study site 1 had higher pretreatment Childhood Autism Rating Scale scores than those at study site 3 (mean difference, 2.33 [95% CI, 0.55- 4.11]; P = .01). Participants at study site 2 had higher pretreat- ment ADOS-2 algorithm scores than study site 1 (mean differ- ence, 2.74 [95% CI, 1.40-4.07]; P < .001) and study site 3 (mean Figure 1. CONSORT Diagram 214 Enrolled 78 Site 1 76 Site 2 60 Site 3 47 Excluded 17 Did not have ASD 6 IQ too low 5 Did not comply 2 Found study too demanding 1 Needed higher level of care 9 Did not have severe anxiety 7 Had no anxiety 167 Randomized 71 Randomized to Coping Cat 26 Site 1 27 Site 2 18 Site 3 19 Randomized to TAU 6 Site 1 7 Site 2 6 Site 3 77 Randomized to BIACA 29 Site 1 30 Site 2 18 Site 3 60 Treatment and follow-up 21 Site 1 23 Site 2 16 Site 3 18 Treatment and follow-up 6 Site 1 6 Site 2 6 Site 3 18 In the primary analytic sample 6 Site 1 6 Site 2 6 Site 3 19 In the analytic sample (intent-to treat) 6 Site 1 7 Site 2 6 Site 3 67 Treatment and follow-up 25 Site 1 29 Site 2 13 Site 3 71 In the analytic sample (intent-to treat) 26 Site 1 27 Site 2 18 Site 3 77 In the analytic sample (intent-to treat) 29 Site 1 30 Site 2 18 Site 3 60 In the primary analytic sample 21 Site 1 23 Site 2 16 Site 3 67 In the primary analytic sample 25 Site 1 29 Site 2 13 Site 3 ASD indicates autism spectrum disorder; BIACA, Behavioral Interventions for Anxiety in Children with Autism; TAU, treatment as usual. Research Original Investigation Cognitive Behavioral Treatments for Anxiety in Children With Autism …
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