Investigating Social Competence in Youth With Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: SENSE Theatre; Behavioral: Tackling Teenage Together

• Registration Number: NCT03368001
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-11-22
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Primary Completion: 2022-08-15
• Study Completion: 2023-01-03
• Results First Submitted: 2023-06-29
• Results First Submitted QC: 2024-08-02
• Results First Posted: 2024-08-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

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

Read More

Exclusion Criteria

• Children who evidence aggression toward other people.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SENSE Theatre	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).
Tackling Teenage Together	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.

Primary Outcome Measures

Name	Time	Method
Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed	Change from baseline to end of treatment (10 weeks).	A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.
Incidental Face Memory (IFM) Event-Related Potential (ERP) Task	Change from baseline to end of treatment (10 weeks) and at two-month follow-up.	The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS) Communication	Baseline, post-treatment (10 weeks), and two-month follow-up.	The SRS is a measure of social competence that is administered by parents pertaining to behaviors characteristic of children with autism. Raw scores on the Social Communication domain range from 0 - 66. Higher scores indicate more impairment. Raw scores were used in the analyses. A decrease in scores from pre- to post-treatment suggests a better outcome.
Adaptive Behavior Scales for Children (ABAS)	Baseline, post-treatment (10 weeks), and two-month follow-up.	The ABAS is a parental rating scale pertaining to various adaptive behaviors in a child, such as social and communication skills. Standard scores for the subscales range from 1 to 19. Higher scores reflect better skills in each domain. The primary variable of interest was the Communication subscale, ranging from 1 to 19 with higher scores reflecting better communication skills.
Contextual Assessment of Social Skills (CASS) Interested	Baseline, post-treatment (10 weeks), and two-month follow-up.	The CASS is an observational measure of social interaction skills with two similar age peers. There are two conditions which include an Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability. Only the Interested Condition was analyzed.
Child Behavior Checklist (CBCL)	Baseline, post-treatment (10 weeks), and two-month follow-up.	The CBCL is a parent report measure of a variety of symptom domains relevant for children with autism and related neurodevelopment disorders. T scores range from 40 to 100 with a mean of 50 and a deviation of 10. Primary variable of interest was Social Problems. Higher scores indicate more social problems. T scores of 64 or higher are considered clinically significant.

Trial Locations

Locations (3)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

University of Alabama; 🇺🇸 Tuscaloosa, Alabama, United States