Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedNovember 7, 2013
November 1, 2013
2.7 years
June 22, 2009
November 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20)
Measured at baseline, post-treatment, and 3-month follow-up
Study Arms (2)
Cognitive Behavioral Therapy (CBT) Program
EXPERIMENTALParticipants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
Wait list control
NO INTERVENTIONParticipants will be placed on a 12-week wait list with no active treatment
Interventions
12 to 14 weekly sessions of individual CBT and parent training with 5 sessions of group counseling every other week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan W White, PhD
Virginia Polytechnic Institute and State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 23, 2009
Study Start
September 1, 2008
Primary Completion
May 1, 2011
Study Completion
January 1, 2013
Last Updated
November 7, 2013
Record last verified: 2013-11