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Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
This study is currently recruiting participants.
Study NCT00926471   Information provided by National Institute of Mental Health (NIMH)
First Received: June 22, 2009   Last Updated: June 29, 2009   History of Changes

June 22, 2009
June 29, 2009
September 2008
October 2010   (final data collection date for primary outcome measure)
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and a 3-month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926471 on ClinicalTrials.gov Archive Site
 
 
 
Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders

This study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.

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.

Phase I
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Autistic Disorder
  • Child Development Disorders, Pervasive
Behavioral: Cognitive Behavioral Therapy (CBT) Program
  • Experimental: Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
  • No Intervention: Participants will be placed on a 12-week wait list with no active treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
29
April 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
No
Contact: Susan W. White, PhD 540-231-6174 sww@vt.edu
United States
 
NCT00926471
Susan W. White, PhD, Assistant Professor, Virginia Polytechnic Institute and State University
K01 MH079945, DDTR B2-MBA
National Institute of Mental Health (NIMH)
 
 
National Institute of Mental Health (NIMH)
June 2009

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