Back to resultsUnderstanding the Effects of Intervention on the Brain in Autism
Primary Purpose
Autism Spectrum Disorder, Asperger Disorder, PDD-NOS
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEERS
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring PEERS, friendships, brain
Eligibility Criteria
Inclusion Criteria:
- Verbal, speaking in full sentences
- Meets ASD criteria
- Meets IQ criteria >70
Exclusion Criteria:
- schizophrenia or bipolar disorder
Sites / Locations
- Marquette University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Waitlist Group
Arm Description
Immediate enrollment in the PEERS group.
Research measures while waiting for PEERS; will receive PEERS within one year.
Outcomes
Primary Outcome Measures
Social Responsiveness Scale (SRS: Constantino, 2005)
Questionnaire completed by caregivers on social function and autism symptoms. Will be aggregated by group; no individual reports will be used.
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Questionnaire completed by participants with Autism Spectrum Disorder. Measures knowledge of the PEERS intervention concepts. Will be aggregated by group; no individual reports will be used.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02680015
Brief Title
Understanding the Effects of Intervention on the Brain in Autism
Official Title
Understanding the Effects of Intervention on the Brain in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marquette University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines how the PEERS (Laugeson & Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Asperger Disorder, PDD-NOS, Autism
Keywords
PEERS, friendships, brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Immediate enrollment in the PEERS group.
Arm Title
Waitlist Group
Arm Type
No Intervention
Arm Description
Research measures while waiting for PEERS; will receive PEERS within one year.
Intervention Type
Behavioral
Intervention Name(s)
PEERS
Other Intervention Name(s)
Program for the Education and Enrichment of Relational Skills
Intervention Description
Social-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends.
Primary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS: Constantino, 2005)
Description
Questionnaire completed by caregivers on social function and autism symptoms. Will be aggregated by group; no individual reports will be used.
Time Frame
within two weeks of PEERS completion
Title
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Description
Questionnaire completed by participants with Autism Spectrum Disorder. Measures knowledge of the PEERS intervention concepts. Will be aggregated by group; no individual reports will be used.
Time Frame
within two weeks of PEERS completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Verbal, speaking in full sentences
Meets ASD criteria
Meets IQ criteria >70
Exclusion Criteria:
schizophrenia or bipolar disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Van Hecke, PhD
Organizational Affiliation
Marquette University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Understanding the Effects of Intervention on the Brain in Autism
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