Trial record 14 of 494 for:    Autism

Psychotherapy for Anxiety in Children With Autism Spectrum Disorder (TAASD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of South Florida
Sponsor:
Collaborators:
Temple University
University of California, Los Angeles
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT02028247
First received: January 2, 2014
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Autism Spectrum Disorders
Autism
Asperger's Syndrome
Pervasive Developmental Disability - Not Otherwise Specified
Obsessive-compulsive Disorder
Social Phobia
Generalized Anxiety Disorder
Specific Phobia
Separation Anxiety Disorder
Behavioral: Personalized Cognitive-behavioral therapy
Behavioral: Standard Practice Cognitive-behavioral therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 2/3 Treatment of Anxiety in Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change from Baseline in anxiety severity on the Pediatric Anxiety Rating Scale after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline in anxiety severity on the Child and Adolescent Symptom Inventory after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    This questionnaire is completed by parents and will be used to assess anxiety with higher scores representing worse anxiety.

  • Change from Baseline in anxiety related impairment as measured by the Childhood Anxiety Impact Scale after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 201
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personalized Cognitive-behavioral therapy
Personalized 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.
Behavioral: Personalized Cognitive-behavioral therapy
Other Name: Behavioral Interventions for Anxiety in Children with Autism
Active Comparator: Standard Practice Cognitive-behavioral therapy
Standard 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.
Behavioral: Standard Practice Cognitive-behavioral therapy
Other Name: Coping Cat
No Intervention: Waitlist condition
Participants 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028247

Contacts
Contact: Eric A Storch, Ph.D. 727-767-8230 estorch@health.usf.edu
Contact: Jane Mutch, Ph.D. 727-767-8230 pmutch@health.usf.edu

Locations
United States, Florida
Rothman Center for Neuropsychiatry, University of South Florida Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Eric A Storch, Ph.D.    727-767-8230    estorch@health.usf.edu   
Contact: Jane Mutch, Ph.D.    727-767-8230    pmutch@health.usf.edu   
Principal Investigator: Eric A Storch, Ph.D.         
Sub-Investigator: Jane Mutch, Ph.D.         
Sub-Investigator: Adam B Lewin, Ph.D.         
Sub-Investigator: Tanya K Murphy, MD         
Sponsors and Collaborators
University of South Florida
Temple University
University of California, Los Angeles
Investigators
Principal Investigator: Eric A Storch, Ph.D. University of South Florida
Principal Investigator: Jeff Wood, Ph.D. University of California, Los Angeles
Principal Investigator: Philip C Kendall, Ph.D. Temple University
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02028247     History of Changes
Other Study ID Numbers: NICHD CBT for ASD
Study First Received: January 2, 2014
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board
United States: National Institutes of Health
United States: Data Safety and Monitoring Board

Keywords provided by University of South Florida:
Autism spectrum disorders
Autism
Asperger's syndrome
Pervasive developmental disability - not otherwise specified
obsessive-compulsive disorder
Social phobia
Generalized anxiety disorder
Specific phobia
Separation anxiety disorder
Counseling
Cognitive-behavioral therapy
Psychotherapy

Additional relevant MeSH terms:
Autistic Disorder
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Developmental Disabilities
Obsessive-Compulsive Disorder
Phobic Disorders
Asperger Syndrome
Child Development Disorders, Pervasive
Compulsive Personality Disorder
Mental Disorders Diagnosed in Childhood
Personality Disorders

ClinicalTrials.gov processed this record on July 26, 2014