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Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT00926471
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : November 7, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan White, Virginia Polytechnic Institute and State University

Tracking Information
First Submitted Date  ICMJE June 22, 2009
First Posted Date  ICMJE June 23, 2009
Last Update Posted Date November 7, 2013
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and 3-month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and a 3-month follow-up ]
Change History Complete list of historical versions of study NCT00926471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
Official Title  ICMJE A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders
Brief Summary This study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.
Detailed Description

Autism spectrum disorders (ASDs) are developmental disorders with similar features, including problems communicating, problems interacting socially, and the presence of routines or repetitive behaviors. These disorders can have a range of severities. They include autistic disorder, Asperger's syndrome, and pervasive developmental disorder not otherwise specified (PDD-NOS). In addition to their core impairment in social functioning, children and adolescents with ASDs often have anxiety about social interactions, which compounds their difficulties and can limit the benefits of treatment. This study will develop and test a treatment program for developing social skills and reducing anxiety in children and adolescents with ASDs.

Participation in this study will last 12 to 14 weeks, with follow-up visits occurring 3 and 12 months after that. Participants will be randomly assigned to receive the treatment program either immediately or after being on a wait list. The treatment program will consist of 12 to 14 weekly individual therapy sessions that teach children and adolescents about ASDs, use cognitive-behavioral interventions to address problematic thinking and acting, deliver social skills instruction, and give opportunities to practice skills—including some practice outside the clinic in naturalistic settings. Every 2 weeks, starting at Week 4, children and adolescents will also attend group sessions to discuss strategies and practice social skills. Parents of the participants will be included at the end of each individual session for several minutes. After the participants assigned to immediate treatment complete the program, participants from the wait list will be offered the treatment.

Child and adolescent participants and their parents will complete assessments at baseline, midpoint in treatment, post-treatment (Week 12 or 14), and 3- and 12-month follow-ups. Participants assigned to the wait list condition will complete assessments only at baseline, before entering treatment (Week 12 or 14), and after completing treatment. Assessments will involve questionnaires about social and emotional functioning, interviews with study researchers, and surveys on satisfaction with the study. The child or adolescent's primary teacher will also complete questionnaires about the child.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autistic Disorder
  • Child Development Disorders, Pervasive
Intervention  ICMJE Behavioral: Cognitive Behavioral Therapy (CBT) Program
12 to 14 weekly sessions of individual CBT and parent training with 5 sessions of group counseling every other week
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy (CBT) Program
    Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
    Intervention: Behavioral: Cognitive Behavioral Therapy (CBT) Program
  • No Intervention: Wait list control
    Participants will be placed on a 12-week wait list with no active treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2013)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2009)
29
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of autism, Asperger's syndrome, or pervasive developmental disorders not otherwise specified (PDD-NOS), as determined by clinical interview and supported by the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS)
  • Has completed assessment of brief verbal intelligence quotient (IQ), with a score of 70 or higher on the Weschler Abbreviated Scale of Intelligence (WASI)
  • Symptoms of anxiety, defined as a clinical severity rating of 4 or higher on one of the following sections of the Anxiety Disorders Interview Schedule for Children (ADIS-C) and parents (ADIS-P): generalized anxiety disorder (GAD), social phobia, specific phobia, agoraphobia, or separation anxiety disorder
  • If on psychiatric medication, on stable dose for 4 weeks prior to baseline assessment with no planned changes to medication for anxiety

Exclusion Criteria:

  • Psychopathology that warrants a different type of immediate clinical care
  • Severe aggression, as determined by clinical judgment
  • Mental retardation, as reported by parents or in previous psychoeducational testing supplied by parents
  • Child and family currently in therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00926471
Other Study ID Numbers  ICMJE K01MH079945( U.S. NIH Grant/Contract )
K01MH079945 ( U.S. NIH Grant/Contract )
DDTR B2-MBA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan White, Virginia Polytechnic Institute and State University
Study Sponsor  ICMJE Virginia Polytechnic Institute and State University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Susan W White, PhD Virginia Polytechnic Institute and State University
PRS Account Virginia Polytechnic Institute and State University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP