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Understanding the Effects of Intervention on the Brain in Autism

Sponsor
Marquette University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02680015
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
184
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PEERS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Understanding the Effects of Intervention on the Brain in Autism
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Immediate enrollment in the PEERS group.

Behavioral: PEERS
Social-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends.
Other Names:
  • Program for the Education and Enrichment of Relational Skills

    		•
    No Intervention: Waitlist Group

    Research measures while waiting for PEERS; will receive PEERS within one year.

    Outcome Measures

    Primary Outcome Measures

    1. Social Responsiveness Scale (SRS: Constantino, 2005) [within two weeks of PEERS completion]

      Questionnaire completed by caregivers on social function and autism symptoms. Will be aggregated by group; no individual reports will be used.

    2. Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) [within two weeks of PEERS completion]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 28 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Verbal, speaking in full sentences

    • Meets ASD criteria

    • Meets IQ criteria >70

    Exclusion Criteria:
    • schizophrenia or bipolar disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marquette University Milwaukee Wisconsin United States 53233

    Sponsors and Collaborators

    • Marquette University

    Investigators

    • Principal Investigator: Amy Van Hecke, PhD, Marquette University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amy Vaughan Van Hecke, Associate Professor of Psychology, Marquette University
    ClinicalTrials.gov Identifier:
    NCT02680015
    Other Study ID Numbers:
    • HR 2020
    First Posted:
    Feb 11, 2016
    Last Update Posted:
    Dec 10, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Amy Vaughan Van Hecke, Associate Professor of Psychology, Marquette University
    PEERS
    friendships
    brain
    Additional relevant MeSH terms:
    Disease
    Autistic Disorder
    Autism Spectrum Disorder
    Asperger Syndrome

    Study Results

    No Results Posted as of Dec 10, 2018