Investigating Social Competence in Youth With Autism

NCT ID: NCT03368001

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2023-01-03

Brief Summary

Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).

Detailed Description

Recent findings from a randomized control trial (RCT) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (ERP) measures. Moreover, the RCT demonstrated treatment effects on social communication skills that generalized to home and community settings. Finally, maintained treatment effects were observed on communication symptoms. The proposed project will extend these findings and provide a stronger test of efficacy using a multisite RCT of SENSE Theatre with a large sample of participants with ASD (8 to 16 years) randomized to an experimental and an active control group. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers. Thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the SENSE Theatre treatment and the extent to which these changes generalize and maintain. If predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for children and adolescents with ASD.

8/18/2021: Record was updated to delete the outcome measure "Computer memory for faces" as it was not included as a primary outcome variable in the Institutional Review Board (IRB) approved protocol dated 9/13/2017.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SENSE Theatre

SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).

Group Type: EXPERIMENTAL

SENSE Theatre

Intervention Type: BEHAVIORAL

SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).

Tackling Teenage Together

The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.

Group Type: ACTIVE_COMPARATOR

Tackling Teenage Together

Intervention Type: BEHAVIORAL

The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.

Interventions

SENSE Theatre

SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).

Intervention Type: BEHAVIORAL

Tackling Teenage Together

The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children with high-functioning ASD (IQ > or = to 70).

Exclusion Criteria

• Children who evidence aggression toward other people.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Blythe Corbett

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama

Tuscaloosa, Alabama, United States

Stony Brook University

Stony Brook, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Corbett BA, White S, Lerner M, Preacher KJ, Klemencic ME, Simmons GL, Pilkington J, Gable P, Gioia A, Key AP. Peers, play, and performance to build social salience in autistic youth: A multisite randomized clinical trial. J Consult Clin Psychol. 2023 Jul;91(7):411-425. doi: 10.1037/ccp0000821. Epub 2023 May 18.

Reference Type: DERIVED

PMID: 37199977 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

171153

Identifier Type: -

Identifier Source: org_study_id