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Completed

NCT Number: NCT06046170

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

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Treatment as Usual

Other

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

Primary outcomes

  1. Pediatric Anxiety Rating Scale - ASD

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

    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

Secondary outcomes

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

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

    Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.

  2. Clinical Global Impression-Improvement

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

    Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse).

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Johns Hopkins University
  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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