NCT02680015

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

12.8 years

First QC Date

February 4, 2016

Last Update Submit

April 17, 2023

Conditions

Autism Spectrum DisorderAsperger DisorderPDD-NOSAutism

Keywords

PEERSfriendshipsbrain

Outcome Measures

Primary Outcomes (2)

  • 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.

    within two weeks of PEERS completion

  • 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.

    within two weeks of PEERS completion

Study Arms (2)

Experimental Group

EXPERIMENTAL

Immediate enrollment in the PEERS group.

Behavioral: PEERS

Waitlist Group

NO INTERVENTION

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

Interventions

PEERSBEHAVIORAL

Social-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends.

Also known as: Program for the Education and Enrichment of Relational Skills
Experimental Group

Eligibility Criteria

Age4 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • schizophrenia or bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAsperger SyndromeAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amy Van Hecke, PhD

    Marquette University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 11, 2016

Study Start

August 1, 2010

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)