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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926471
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : November 7, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan White, Virginia Polytechnic Institute and State University

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Child Development Disorders, Pervasive Behavioral: Cognitive Behavioral Therapy (CBT) Program Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders
Study Start Date : September 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy (CBT) Program
Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
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

No Intervention: Wait list control
Participants will be placed on a 12-week wait list with no active treatment

Primary Outcome Measures :
  1. Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) [ Time Frame: Measured at baseline, post-treatment, and 3-month follow-up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00926471

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United States, Virginia
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, United States, 24061
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
National Institute of Mental Health (NIMH)
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Principal Investigator: Susan W White, PhD Virginia Polytechnic Institute and State University
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Responsible Party: Susan White, Assistant Professor, Virginia Polytechnic Institute and State University Identifier: NCT00926471    
Other Study ID Numbers: K01MH079945 ( U.S. NIH Grant/Contract )
K01MH079945 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013
Keywords provided by Susan White, Virginia Polytechnic Institute and State University:
Autism Spectrum Disorders with Comorbid Anxiety
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders