Investigating Social Competence in Youth With Autism

Autism Spectrum Disorder Clinical Trial

Official title: Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial

Status Completed

Clinical Trial 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).

Clinical Trial 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 IRB approved protocol dated 9/13/2017. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT03368001
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Completion date: January 3, 2023