Clinical Trials Directory

Trials / Completed

CompletedNCT04349644

Enhancing Social Competence in Adults With Autism

Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. The intervention has the potential to enhance social cognition and behavior in adults with autism spectrum disorder.

Detailed description

Autism spectrum disorder (ASD) is characterized by primary impairment in social competence. Effects of current psychosocial interventions often fail to maintain or generalize and few employ rigorous experimental methods. Our treatment, SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. 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 an RCT of SENSE Theatre with a sample of approximately 40 adult participants with ASD (18 to 35 years) randomized to experimental (EXP; N = 20) and a wait list control group (WLC; N = 20) in two separate cohorts. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers using examiners blind to study treatment group assignment. The significance and size of treatment effects on these cognitive and behavioral outcomes will be measured using ANOVA and linear mixed models. 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 adults with ASD.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSENSE TheatreA peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.

Timeline

Start date
2020-10-21
Primary completion
2024-03-15
Completion
2025-03-30
First posted
2020-04-16
Last updated
2026-01-29
Results posted
2025-03-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04349644. Inclusion in this directory is not an endorsement.