Psychotherapy for Anxiety in Children With Autism Spectrum Disorder

Autism Clinical Trial

— TAASD  

Official title:

3/3 Treatment of Anxiety in Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02111395
• Other study ID #: 3556192
• Secondary ID: R01HD080097-01A1
• Status: Recruiting
• Phase: Phase 3
• First received: April 9, 2014
• Last updated: February 22, 2016
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: National Institutes of HealthUnited States: Data Safety and Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Description:

Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Furthermore, this study will employ a waitlist control group to assess the efficacy of each CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, and the efficacy of both these treatments relative to a waitlist control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes. A total of 201youth across 3 study locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the three conditions. The three recruitment sites for this study are University of California, Los Angeles, the University of South Florida (USF), and Temple University. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Asperger Syndrome
• Asperger's Syndrome
• Autism
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Compulsive Behavior
• Developmental Disabilities
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Obsessive-Compulsive Disorder
• Pervasive Developmental Disability - Not Otherwise Specified
• Separation Anxiety Disorder
• Social Phobia
• Specific Phobia

Intervention

Behavioral:
• Personalized Cognitive-behavioral therapy

• Standard Practice Cognitive-behavioral therapy

Locations

Country	Name	City	State
United States	Temple University Child and Adolescent Anxiety Disorders Clinic	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Temple University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in anxiety severity on the Pediatric Anxiety Rating Scale after 16 weeks of treatment	This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.	After 16 weeks of treatment	No
Secondary	Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.	This measure is completed by the clinician and assesses the severity of anxiety on a 7 point scale (1-7; higher scores correspond to worse anxiety).	After 16 weeks of treatment	No
Secondary	Change from Baseline in anxiety severity on the Child and Adolescent Symptom Inventory after 16 weeks of treatment.	This questionnaire is completed by parents and will be used to assess anxiety with higher scores representing worse anxiety.	After 16 weeks of treatment	No
Secondary	Change from Baseline in anxiety related impairment as measured by the Childhood Anxiety Impact Scale after 16 weeks of treatment.	The Childhood Anxiety Impact Scale is a questionnaire completed by parents about the impact of the child's anxiety on functioning in certain situations. Higher scores correspond to more associated impact.	After 16 weeks of treatment	No