Autism Spectrum Disorders | Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Autism Spectrum Disorders research study
What is the primary objective of this study?
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 is eligible to participate?
Inclusion Criteria: - Outpatient boys and girls with ASD between the ages 8-13 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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Autism Spectrum Disorders
Pervasive Developmental Disability - Not Otherwise Specified
Generalized Anxiety Disorder
Separation Anxiety Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Personalized Cognitive-behavioral therapy
Behavioral:Standard Practice Cognitive-behavioral therapy
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Personalized Cognitive-behavioral therapyPersonalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Standard Practice Cognitive-behavioral therapyStandard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Waitlist conditionParticipants randomized to the Waitlist condition will be asked to refrain from seeking out psychotherapy for anxiety as well as making psychiatric medication changes (if applicable) for a 16-week period.
Active, not recruiting
Start Date: July 2014
Completed Date: October 2018
Phase: Phase 3
Primary Outcome: Change from Baseline in anxiety severity on the Pediatric Anxiety Rating Scale after 16 weeks of treatment.
Secondary Outcome: Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.
Study sponsors, principal investigator, and references
Principal Investigator: Eric A Storch, Ph.D.
Lead Sponsor: University of South Florida
Collaborator: Temple University