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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06046170

Collaborator

University of Pennsylvania (Other)

Enrollment

Locations

Arms

12.6

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Anxiety is very common in autistic youth. Recently, an intervention has been created 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Autism Spectrum Disorder Separation Anxiety Generalized Anxiety Disorder Social Anxiety Disorder of Childhood	Behavioral: Cognitive Behavioral Therapy Other: Treatment as Usual	N/A

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. We have tailored the treatment to make it more accessible to families in their 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized assignment to one of two conditionsRandomized assignment to one of two conditions

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessor is blinded

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2024

Anticipated Primary Completion Date :

Jan 15, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Cognitive Behavioral Therapy Participants will receive cognitive behavioral therapy with elements of exposure in order to target anxious behaviors.
Placebo Comparator: 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.	Other: Treatment as Usual Participants will receive treatment as usual at a community mental health center, including receiving skills training.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: Cognitive Behavioral Therapy

Participants will receive cognitive behavioral therapy with elements of exposure in order to target anxious behaviors.

Placebo Comparator: 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.

Other: Treatment as Usual

Participants will receive treatment as usual at a community mental health center, including receiving skills training.

Outcome Measures

Primary Outcome Measures

Pediatric Anxiety Rating Scale - ASD [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 Outcome Measures

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]
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.
Clinical Global Impression-Improvement [baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up]
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse).

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 > 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.