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Psychotherapy for Anxiety in Children With Autism Spectrum Disorder

NCT ID: NCT02028247

Last Updated: 2021-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-10-31

Brief Summary

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Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.

Detailed Description

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Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Furthermore, this study will employ a waitlist control group to assess the efficacy of each CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, and the efficacy of both these treatments relative to a waitlist control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes. A total of 201youth across 3 study locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the three conditions. The three recruitment sites for this study are University of California, Los Angeles, the University of South Florida (USF), and Temple University. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.

Conditions

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Autism Spectrum Disorders Autism Asperger's Syndrome Pervasive Developmental Disability - Not Otherwise Specified Obsessive-compulsive Disorder Social Phobia Generalized Anxiety Disorder Specific Phobia Separation Anxiety Disorder

Keywords

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Autism spectrum disorders Autism Asperger's syndrome Pervasive developmental disability - not otherwise specified obsessive-compulsive disorder Social phobia Generalized anxiety disorder Specific phobia Separation anxiety disorder Counseling Cognitive-behavioral therapy Psychotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Personalized Cognitive-behavioral therapy

Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.

Group Type EXPERIMENTAL

Personalized Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Standard Practice Cognitive-behavioral therapy

Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.

Group Type ACTIVE_COMPARATOR

Standard Practice Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Treatment as Usual

Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.

Group Type OTHER

Treatment as Usual

Intervention Type BEHAVIORAL

Interventions

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Personalized Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Standard Practice Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Treatment as Usual

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral Interventions for Anxiety in Children with Autism Coping Cat

Eligibility Criteria

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Inclusion Criteria

* Outpatient boys and girls with ASD between the ages 7-13 years at consent/assent.
* The child meets criteria for ASD.
* The child meets criteria for clinically significant anxiety symptoms.
* The child has a Full Scale and Verbal Comprehension Intelligence Quotient \>70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test.

Exclusion Criteria

* Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration.
* (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
* Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years.
* Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.
* Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).
Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Eric Storch

McIngvale Presidential Endowed Chair & Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric A Storch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Jeff Wood, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Philip C Kendall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Rothman Center for Neuropsychiatry, University of South Florida

St. Petersburg, Florida, United States

Site Status

Countries

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United States

References

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Wood JJ, Rosenau KA, Muscatello V, Cooper K, Wood KS, Kendall PC, Storch EA. Cognitive Behavioral Therapy for Autistic School-Aged Children with Interfering Anxiety: Impact on Caregiver-Defined Goals. J Autism Dev Disord. 2025 May 8. doi: 10.1007/s10803-025-06852-6. Online ahead of print.

Reference Type DERIVED
PMID: 40338510 (View on PubMed)

Storch EA, Wood JJ, Guzick AG, Small BJ, Kerns CM, Ordaz DL, Schneider SC, Kendall PC. Moderators of Response to Personalized and Standard Care Cognitive-Behavioral Therapy for Youth with Autism Spectrum Disorder and Comorbid Anxiety. J Autism Dev Disord. 2022 Feb;52(2):950-958. doi: 10.1007/s10803-021-05000-0. Epub 2021 Apr 7.

Reference Type DERIVED
PMID: 33826038 (View on PubMed)

Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.

Reference Type DERIVED
PMID: 31755906 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NICHD CBT for ASD

Identifier Type: -

Identifier Source: org_study_id

NCT02111395

Identifier Type: -

Identifier Source: nct_alias