Psychotherapy for Anxiety in Children With Autism Spectrum Disorder (NCT02028247) | Clinical Trial Compass
CompletedNot Applicable
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
United States214 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range7 Years – 13 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 durin…
What they're measuring
1
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
Timeframe: Baseline and After 16 Weeks of Treatment