Investigating Social Competence in Youth With Autism

• ClinicalTrials.gov Identifier: NCT03368001
• Recruitment Status: Recruiting
• First Posted: December 11, 2017
• Last Update Posted: November 8, 2021
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Blythe Corbett, Vanderbilt University Medical Center

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Behavioral: SENSE Theatre; Behavioral: Tackling Teenage Together	Not Applicable

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 IRB approved protocol dated 9/13/2017.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 405 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial
• Actual Study Start Date: November 22, 2017
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Behavioral: 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).
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. NEPSY Memory for Faces Delayed [ Time Frame: 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.
2. Incidental Face Memory (IFM) Event-Related Potential (ERP) task [ Time Frame: Change from baseline to end of treatment (10 weeks). ]
   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 :

1. Social Responsiveness Scale (SRS) [ Time Frame: 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. T scores range from 38-90 with higher scores reflecting more pathology.
2. Adaptive Behavior Scales for Children (ABAS) [ Time Frame: 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.
3. Contextual Assessment of Social Skills (CASS) [ Time Frame: 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 a Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability.
4. Child Behavior Checklist (CBCL) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Children who evidence aggression toward other people.

Contacts and Locations

Contacts

Contact: Blythe A Corbett, Ph.D.; 615-936-0280; blythe.corbett@vanderbilt.edu

Contact: Mark Klemencic, BS; 615-513-9562; mark.e.klemencic@vumc.org

Locations

United States, Alabama

University of Alabama; Active, not recruiting

Tuscaloosa, Alabama, United States, 35487

United States, New York

Stony Brook University; Active, not recruiting

Stony Brook, New York, United States, 11794

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Vanderbilt University Medical Center

  Study Documents (Full-Text)

Documents provided by Blythe Corbett, Vanderbilt University Medical Center:

Informed Consent Form  [PDF] March 12, 2020

More Information

• Responsible Party: Blythe Corbett, Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03368001
• Other Study ID Numbers: 171153
• First Posted: December 11, 2017
• Last Update Posted: November 8, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Currently sharing with the National Database for Autism Research.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• Time Frame: Data will be available after study completion and published all primary results.
• Access Criteria: Interested investigators must apply to NDAR to receive access once it is made available.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Blythe Corbett, Vanderbilt University Medical Center:

Autism

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders