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

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ClinicalTrials.gov Identifier: NCT02028247
Recruitment Status : Active, not recruiting
First Posted : January 7, 2014
Last Update Posted : December 4, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 2/3 Treatment of Anxiety in Autism Spectrum Disorder
Study Start Date : July 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline in anxiety severity on the Pediatric Anxiety Rating Scale after 16 weeks of treatment. [ Time Frame: 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.

Secondary Outcome Measures :
  1. Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment. [ Time Frame: 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).

  2. 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 ]
    This questionnaire is completed by parents and will be used to assess anxiety with higher scores representing worse anxiety.

  3. 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 ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028247

United States, Florida
Rothman Center for Neuropsychiatry, University of South Florida
Saint Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
Temple University
University of California, Los Angeles
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

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02028247     History of Changes
Obsolete Identifiers: NCT02111395
Other Study ID Numbers: NICHD CBT for ASD
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobic Disorders
Mental Disorders
Neurodevelopmental Disorders
Personality Disorders
Phobia, Social
Developmental Disabilities
Asperger Syndrome
Anxiety, Separation
Pathologic Processes