N/A
N=167
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Autism Spectrum Disorders · Autism · Asperger's Syndrome · Pervasive Developmental Disability - Not Otherwise Specified · Obsessive-compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02028247 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment. — 3.43; 3.47; 3.28; 2.13 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Personalized Cognitive-behavioral therapy (Behavioral); Standard Practice Cognitive-behavioral therapy (Behavioral); Treatment as Usual (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment. |
3.43; 3.47; 3.28; 2.13; 2.43; 2.93 | — |
| SECONDARY Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale |
92.42; 81.03; 11.11 | — |
| SECONDARY Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment. |
0.83; 0.88; 0.73; 0.51; 0.69; 0.77 | — |
| SECONDARY Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment. |
1.38; 1.48; 1.19; 0.77; 0.88; 1.24 | — |
Summary
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Eligibility Criteria
Inclusion Criteria
- Outpatient boys and girls with ASD between the ages 7-13 years at consent/assent.
- The child meets criteria for ASD.
- The child meets criteria for clinically significant anxiety symptoms.
- The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test.
Exclusion Criteria
- Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration.
- (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
- Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years.
- Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.
- Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).
Data sourced from ClinicalTrials.gov (NCT02028247). 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.