Community-based anxiety program for autistic youth
Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA): A Randomized Control
This study is testing a new therapy program designed to help autistic kids with anxiety feel better in their local community clinics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT06046170 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of implementing a tailored cognitive-behavioral therapy program for autistic youth experiencing anxiety in community mental health clinics. Given that anxiety disorders are prevalent among autistic children, the program seeks to make effective treatment more accessible within their home communities. The intervention will be evaluated for its practicality and effectiveness in addressing anxiety symptoms in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 7 to 17 with a confirmed diagnosis of autism spectrum disorder and clinically elevated anxiety symptoms.
Not a fit: Patients who do not have a diagnosis of autism spectrum disorder or who do not exhibit clinically significant anxiety symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve access to effective anxiety treatment for autistic youth, enhancing their overall mental health and quality of life.
How similar studies have performed: Previous studies have shown that cognitive-behavioral therapy is effective for treating anxiety in autistic youth, suggesting that this tailored approach may also be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Active_not_recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Eric Storch, PhD
- Email: eric.storch@bcm.edu
- Phone: 713-798-3579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.