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Using prompt below answer the following questions: Describe the intervention as implemented in the study. What intervention was used? What category within the EBP report does this intervention fall? Were multiple interventions used? What were they? How was the intervention implemented? Give the steps of the intervention, if applicable. What setting was the intervention implemented in Prompt: 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. Autism spectrum disorder (ASD) affects about 1 of 59 school-aged youth in the United States.1 Maladaptive and interfering anxiety is common among youth with ASD and associated with functional impairment above and beyond the presence of ASD.2 In addition to common childhood fears (eg, separation, generalized anxiety), maladaptive distinctive 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, social skills, friendship, loneliness, self-injurious behavior, and family conflict in youth with and without ASD.5,6,7,8 Studies of youth with ASD in the United States have estimated that psychological therapy (often referred to as psychotherapy) is among the most frequently used mental health services for youth with ASD, with as many as 23% to 43% of youth accessing this type of treatment.9,10 Several small randomized clinical trials using wait-list or usual-care control conditions suggest that a specific form of psychotherapy, cognitive behavioral therapy (CBT), may be beneficial for school-aged youth with ASD and anxiety.11,12,13,14,15,16,17,18 However, no psychological or pharmacological treatments for anxiety in school-aged children with ASD meet contemporary evidentiary standards19 as efficacious or well-established. Several CBT programs have been adapted for the characteristics of ASD.11,12,13,14,15 The rationale for adapted CBT programs for youth with ASD is multifaceted: (1) achieving generalizable symptom change in youth with ASD has been a challenge in some treatment programs,20 (2) contextual factors that cause anxiety (eg, social communication challenges, ASD-associated stressors) likely necessitate a psychological treatment that addresses these contextual factors,14 and (3) youth with ASD may benefit from more parental involvement in psychological treatment than is typical in standard-of-practice CBT.21 Other CBT programs have been developed for typically developing youth but also tested for youth with ASD.16,17These 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 hypothesized 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.22Details about the sample and a brief description of the measures, eligibility criteria, and treatment 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 analysis was conducted to determine target sample size.22 This study was approved by university-based institutional review boards at each site (University of California, Los Angeles general institutional review board, University of South Florida institutional review board, and Temple University's Human Research Protection Program). Parents gave written 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. Families received $75 for participating in the assessments. Recruitment began April 2014, and final data were collected in January 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 [Supplement 1]). The site principal investigator determined eligibility status at screening. Participants were notified of their eligibility status by the study coordinator and, if eligible, proceeded 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 Anxiety in Children with Autism [BIACA] program),14 or (3) TAU. Randomization was conducted by the study statistician (B.J.S.), who had no contact with participants. The statistician informed the study coordinator of the random assignment for each participant, who subsequently notified participants. Families were not informed of study hypotheses. Therapists (19 graduate students and postdoctoral fellows) received 8 hours of training in the treatment protocols, read the treatment manuals, and attended weekly supervision 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 described extensively elsewhere12,13,14,15,22,26,27,28,29 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.26,27,28,29 The main features are (1) recognizing anxious feelings and somatic reactions 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 modeling, role-play, and contingent reinforcement. Specific homework 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 reappraisal 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 parents) to facilitate parent engagement; (2) BIACA uses a modular format guided by an algorithm to personalize treatment, given the multifaceted clinical presentations in ASD; (3) children's disruptive behavior is addressed as needed with antecedent 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 successful peer-oriented exposure-therapy assignments; (5) the children's special interests are treated as an asset and incorporated into treatment to promote engagement; (6) target behaviors 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.30,31,32,33,34 An app with training and clinician guidance incorporating 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 recommendations 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.

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