Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)

NCT06046170 | Completed

• 1 other identifier: H-54327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.

Conditions

Anxiety; Autism Spectrum Disorder; Separation Anxiety; Generalized Anxiety Disorder; Social Anxiety Disorder of Childhood

Keywords

cognitive behavioral therapy; children; adolescents; anxiety; Community mental health clinics

Outcome Measures

Primary Outcomes (1)

• Pediatric Anxiety Rating Scale - ASD

  Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35. This measure has been modified for autistic youth

  baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up

Secondary Outcomes (2)

• Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings

  baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up

• Clinical Global Impression-Improvement

  baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Participants will receive cognitive behavioral therapy that has been adapted for autistic youth with anxiety. These sessions will also include components of exposure. Participants will receive therapy around once a week for 14 weeks.

Behavioral: Cognitive Behavioral Therapy

Treatment as Usual

PLACEBO COMPARATOR

Participants will complete treatment as usual. They will be referred to other community resources, including skills training. Additionally, participants may begin or end therapy and/or medication.

Other: Treatment as Usual

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Participants will receive cognitive behavioral therapy with elements of exposure in order to target anxious behaviors.

Cognitive Behavioral Therapy

Treatment as Usual OTHER

Participants will receive treatment as usual at a community mental health center, including receiving skills training.

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The adolescent is between the ages of 7 to 17 upon enrollment with an established autism spectrum disorder diagnosis (ASD) made by a standardized assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition), confirmed by the Social Communication Questionnaire (SCQ) ≥ 11 and/or total score ≥ 7 on the Autism Diagnostic Observation Schedule-2 (ADOS-2). Dr. Storch will review diagnostic reports to determine whether an appropriate ASD diagnosis has been established.
• The adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\>12).
• Anxiety is the primary concern and the child is appropriate for intervention focus, as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview) by an independent evaluator (IE) supervised by an experienced, licensed psychologist determines that the child is appropriate for the intervention focus.
• Child has a verbal intelligence quotient greater than or equal to 70, as measured by the Verbal Comprehension Index of the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V).
• One parent/guardian is able and willing to participate (i.e., available during therapy sessions, attend study assessments).
• Child is eligible to receive services at the participating clinic.
• Both parent and child can read and/or understand English and/or Spanish.
• Both parent and child reside in Texas or Pennsylvania.

You may not qualify if:

• ) The child has a diagnosis of psychotic disorder as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview).
• ) The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
• ) The child is receiving concurrent psychotherapy for anxiety.
• ) If child is taking psychotropic medication, regimen must have been started 8 weeks ago and stable for the past 4 weeks (or 2 weeks for stimulants or benzodiazepines). If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage s/he may be enrolled.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Pennsylvania: collaborator
• Johns Hopkins University: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Autism Spectrum Disorder; Anxiety, Separation; Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized assignment to one of two conditions

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: January 15, 2024
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)