Status:
ACTIVE_NOT_RECRUITING
Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
University of Pennsylvania
Johns Hopkins University
Conditions:
Anxiety
Autism Spectrum Disorder
Eligibility:
All Genders
7-17 years
Phase:
NA
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- ) 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.
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06046170
Start Date
February 16 2024
End Date
April 30 2026
Last Update
December 24 2025
Active Locations (3)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21218
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Baylor College of Medicine
Houston, Texas, United States, 77030