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

NCT ID: NCT06046170

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2026-04-30

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.

Detailed Description

As many as 50% of autistic youth have at least 1 anxiety disorder. Cognitive-behavioral therapy (CBT) for autistic youth is effective at treating anxiety, but access is limited. The investigators have tailored the treatment to make it more accessible to families in the participants' home communities. The purpose of this project is to investigate how feasible it is to implement Community-Based Anxiety Programs Tailored for Autism (CAPTA) in community settings.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Therapy

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Treatment as Usual

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.

Group Type: PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type: OTHER

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

Interventions

Cognitive Behavioral Therapy

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

Intervention Type: BEHAVIORAL

Treatment as Usual

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. The adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>12).

3. 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.

4. 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).

5. One parent/guardian is able and willing to participate (i.e., available during therapy sessions, attend study assessments).

6. Child is eligible to receive services at the participating clinic.

7. Both parent and child can read and/or understand English and/or Spanish.

8. Both parent and child reside in Texas or Pennsylvania.

Exclusion Criteria

• 1.) The child has a diagnosis of psychotic disorder as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview).

2.) The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).

3.) The child is receiving concurrent psychotherapy for anxiety.

4.) 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Eric A Storch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-54327

Identifier Type: -

Identifier Source: org_study_id