- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926471
Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders
A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Virginia Polytechnic Institute and State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioral Therapy (CBT) Program
Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20)
Time Frame: Measured at baseline, post-treatment, and 3-month follow-up
|
Measured at baseline, post-treatment, and 3-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan W White, PhD, Virginia Polytechnic Institute and State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01MH079945 (U.S. NIH Grant/Contract)
- DDTR B2-MBA (Other Grant/Funding Number: National Institute of Mental Health)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autistic Disorder
-
Mahidol UniversityCompleted
-
Hadassah Medical OrganizationTerminated
-
Fundatia Bio-ForumSpitalul AngiomedicaCompletedAutistic Spectrum DisorderRomania
-
University of JazanCompletedAutistic Spectrum DisorderSaudi Arabia
-
Assistance Publique - Hôpitaux de ParisHopital Universitaire Robert-Debre; Henri Mondor University Hospital; Fondation... and other collaboratorsCompleted
-
Sutter Medical FoundationCompleted
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hospital Parc Taulí, SabadellUnknownSexual Behavior | Adolescent Development | Autistic Disorders Spectrum | Sexual InadequacySpain
-
Université de Reims Champagne-ArdenneNot yet recruitingImpact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder (RAMAu)Autistic Spectrum Disorder
-
Addis Ababa UniversityCompletedAutistic Spectrum DisorderEthiopia
Clinical Trials on Cognitive Behavioral Therapy (CBT) Program
-
University of California, Los AngelesNational Institute of Nursing Research (NINR)Completed
-
Linkoeping UniversityOstergotland County Council, SwedenActive, not recruitingCardiac Anxiety | Non-cardiac Chest PainSweden
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
Emory UniversityAlzheimer's AssociationCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
Massachusetts General HospitalActive, not recruitingDepression | Obsessive Compulsive Disorder | Generalized Anxiety Disorder | Attention Deficit Hyperactivity Disorder | Trichotillomania | Panic Disorder | Social Phobia | Specific Phobia | Tourette Syndrome | Post-Traumatic Stress Disorder | Body Dysmorphic Disorder | Eating Disorder | General Medical ConditionUnited States
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)CompletedSomatoform Disorders | Body Dysmorphic DisorderUnited States
-
Florida State UniversityCompleted
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedDepression | Traumatic Brain InjuryUnited States
-
VA Connecticut Healthcare SystemUnited States Department of DefenseRecruitingBinge-Eating Disorder | Bulimia Nervosa | Cognitive Behavioral Therapy | Veterans HealthUnited States