ClinConnect ClinConnect Logo
Search / Trial NCT06046170

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

Launched by BAYLOR COLLEGE OF MEDICINE · Sep 14, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cognitive Behavioral Therapy Children Adolescents Anxiety Community Mental Health Clinics

ClinConnect Summary

The CAPTA trial is studying a new program designed to help young people with autism who are experiencing anxiety. Anxiety is a common issue for many kids on the autism spectrum, and this study aims to see how well the program works in community care centers. The researchers are looking for participants between the ages of 7 and 17 who have a confirmed diagnosis of autism and are showing signs of anxiety. To join, children must have elevated anxiety symptoms and be able to communicate in English or Spanish. Additionally, a parent or guardian must be willing to participate and attend therapy sessions.

Participants in this study can expect to take part in a community-based program aimed at reducing anxiety symptoms. They will receive support tailored to their needs, and the researchers will monitor the program's effectiveness. It is important to note that children with certain severe mental health conditions or those already receiving other anxiety treatments may not be eligible. The goal of this trial is to find out if this program can be effectively implemented in community settings to better support autistic youth dealing with anxiety.

Gender

ALL

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.

About Baylor College Of Medicine

Baylor College of Medicine is a leading academic institution dedicated to advancing health through innovative research, education, and clinical care. Located in Houston, Texas, it is renowned for its commitment to excellence in medical education and translational research, fostering collaborations that bridge laboratory discoveries with clinical application. As a clinical trial sponsor, Baylor College of Medicine leverages its robust infrastructure, interdisciplinary expertise, and access to diverse patient populations to conduct cutting-edge clinical studies aimed at improving patient outcomes and enhancing therapeutic approaches across a wide range of medical conditions.

Locations

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Baltimore, Maryland, United States

Patients applied

1 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported