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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046170
• Other study ID #: H-54327
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Baylor College of Medicine
• Contact: Whitney Shepherd, B.A
• Phone: 713-798-8563
• Email: whitney.shepherd[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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 > 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety, Separation
• Autism Spectrum Disorder
• Autistic Disorder
• Generalized Anxiety Disorder
• Phobia, Social
• Separation Anxiety
• Social Anxiety Disorder of Childhood

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Participants will receive cognitive behavioral therapy with elements of exposure in order to target anxious behaviors.

Other:
• Treatment as Usual
Participants will receive treatment as usual at a community mental health center, including receiving skills training.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Anxiety Rating Scale - ASD	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	baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Secondary	Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings	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.	baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Secondary	Clinical Global Impression-Improvement	Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse).	baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up