N/A
N=76
Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety
Cognitive Behavioral Therapy · Autism Spectrum Disorder · Anxiety Disorders · Obsessive-Compulsive Disorder · Social Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03720795 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: 7-item Pediatric Anxiety Rating Scale — 11.87 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stepped Care CBT (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-item Pediatric Anxiety Rating Scale |
11.87 | — |
| PRIMARY Clinical Global Impression-Improvement |
42 | — |
| SECONDARY Clinical Global Impression-Severity |
1.88 | — |
Summary
This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.
Eligibility Criteria
Inclusion Criteria
- Child is between the ages 4-14 years at consent/assent.
- The child meets criteria for ASD.
- The child meets criteria for clinically significant anxiety and/or OCD symptoms.
- Anxiety and/or OCD is the primary presenting problem.
- One parent/guardian is able and willing to attend.
- The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70.
Exclusion Criteria
- The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
- The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
- The child is receiving concurrent psychotherapy for anxiety.
- Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT03720795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.