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Understanding the Effects of Intervention on the Brain in Autism

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ClinicalTrials.gov Identifier: NCT02680015
Recruitment Status : Recruiting
First Posted : February 11, 2016
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Amy Vaughan Van Hecke, Marquette University

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
Autism Spectrum Disorder Asperger Disorder PDD-NOS Autism Behavioral: PEERS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2010
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. Social Responsiveness Scale (SRS: Constantino, 2005) [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   4 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Verbal, speaking in full sentences
  • Meets ASD criteria
  • Meets IQ criteria >70

Exclusion Criteria:

  • schizophrenia or bipolar disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680015


Contacts
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Contact: Amy V Van Hecke, PhD 414-288-4438 mu.peers@marquette.edu
Contact: Hillary Schiltz, MS 414-288-4438 mu.peers@marquette.edu

Locations
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United States, Wisconsin
Marquette University Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Alana McVey, MS    414-288-4438    mu.peers@marquette.edu   
Sponsors and Collaborators
Marquette University
Investigators
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Principal Investigator: Amy Van Hecke, PhD Marquette University

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Responsible Party: Amy Vaughan Van Hecke, Associate Professor of Psychology, Marquette University
ClinicalTrials.gov Identifier: NCT02680015     History of Changes
Other Study ID Numbers: HR 2020
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amy Vaughan Van Hecke, Marquette University:
PEERS
friendships
brain
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Asperger Syndrome
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders