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Clinical Trials/NCT06046170
NCT06046170
Completed
N/A

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

Baylor College of Medicine3 sites in 1 country32 target enrollmentJanuary 15, 2024

Overview

Phase
N/A
Intervention
Cognitive Behavioral Therapy
Conditions
Anxiety
Sponsor
Baylor College of Medicine
Enrollment
32
Locations
3
Primary Endpoint
Pediatric Anxiety Rating Scale - ASD
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
February 28, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric A Storch

Professor

Baylor College of Medicine

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Cognitive Behavioral Therapy

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.

Intervention: Treatment as Usual

Outcomes

Primary Outcomes

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

  • Clinical Global Impression-Improvement(baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up)
  • Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings(baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up)

Study Sites (3)

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