Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA) (NCT06046170) | Clinical Trial Compass
CompletedNot Applicable
Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)
United States32 participantsStarted 2024-01-15
Plain-language 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.
Who can participate
Age range7 Years ā 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. 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) ā„ 11 and/or total score ā„ 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.
ā. The adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\>12).
ā. 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.
ā. 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).
ā. One parent/guardian is able and willing to participate (i.e., available during therapy sessions, attend study assessments).
ā. Child is eligible to receive services at the participating clinic.
ā. Both parent and child can read and/or understand English and/or Spanish.
ā. Both parent and child reside in Texas or Pennsylvania.
Exclusion criteria
What they're measuring
1
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
ā.) The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
ā.) The child is receiving concurrent psychotherapy for anxiety.
ā.) 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.