Clinical trial NCT06046170: Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)
Official title: Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA): A Randomized Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Autism Spectrum Disorder
Separation Anxiety
Generalized Anxiety Disorder
Social Anxiety Disorder of Childhood
Keywords: cognitive behavioral therapy
children
adolescents
anxiety
Community mental health clinics
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Johns Hopkins University
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized assignment to one of two conditions
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pediatric Anxiety Rating Scale - ASD
timeFrame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
timeFrame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
measure: Clinical Global Impression-Improvement
timeFrame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: