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

Primary Purpose

Autistic Disorder, Child Development Disorders, Pervasive

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT) Program
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Anxiety, Autism Spectrum Disorders with Comorbid Anxiety

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Polytechnic Institute and State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy (CBT) Program

Wait list control

Arm Description

Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.

Participants will be placed on a 12-week wait list with no active treatment

Outcomes

Primary Outcome Measures

Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20)

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
November 6, 2013
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00926471
Brief Title
Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
Official Title
A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Child Development Disorders, Pervasive
Keywords
Autism, Anxiety, Autism Spectrum Disorders with Comorbid Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy (CBT) Program
Arm Type
Experimental
Arm Description
Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Participants will be placed on a 12-week wait list with no active treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT) Program
Intervention Description
12 to 14 weekly sessions of individual CBT and parent training with 5 sessions of group counseling every other week
Primary Outcome Measure Information:
Title
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20)
Time Frame
Measured at baseline, post-treatment, and 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan W White, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Polytechnic Institute and State University
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States

12. IPD Sharing Statement

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

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