Understanding the Effects of Intervention on the Brain in Autism

April 17, 2023 updated by: Amy Vaughan Van Hecke, Marquette University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Marquette University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • schizophrenia or bipolar disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within two weeks of PEERS completion
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.
within two weeks of PEERS completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marquette University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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