Investigating Social Competence in Youth With Autism

NCT03368001 | Completed Results DMC

• 1 other identifier: 171153
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 3

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).

Conditions

Autism Spectrum Disorder

Keywords

Autism

Outcome Measures

Primary Outcomes (2)

• Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed

  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.

  Change from baseline to end of treatment (10 weeks).

• Incidental Face Memory (IFM) Event-Related Potential (ERP) Task

  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.

  Change from baseline to end of treatment (10 weeks) and at two-month follow-up.

Secondary Outcomes (4)

• Social Responsiveness Scale (SRS) Communication

  Baseline, post-treatment (10 weeks), and two-month follow-up.

• Adaptive Behavior Scales for Children (ABAS)

  Baseline, post-treatment (10 weeks), and two-month follow-up.

• Contextual Assessment of Social Skills (CASS) Interested

  Baseline, post-treatment (10 weeks), and two-month follow-up.

• Child Behavior Checklist (CBCL)

  Baseline, post-treatment (10 weeks), and two-month follow-up.

Study Arms (2)

SENSE Theatre

EXPERIMENTAL

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

Tackling Teenage Together

ACTIVE COMPARATOR

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

Interventions

SENSE Theatre 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).

SENSE Theatre

Tackling Teenage Together BEHAVIORAL

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

Tackling Teenage Together

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children who evidence aggression toward other people.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (3)

University of Alabama

Tuscaloosa, Alabama, 35487, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 37199977 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

There is data loss due to the Coronavirus -19 pandemic, which resulted in reduction in the number of participants who completed the study, data loss of specific primary variables, and differential attrition between the groups. This is reflected in Participant Flow.

Results Point of Contact

• Title: Blythe Corbett, Ph.D.
• Organization: Vanderbilt University Medical Center

blythe.corbett@vumc.org

615-936-0280

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: November 22, 2017
• Primary Completion: August 15, 2022
• Study Completion: January 3, 2023
• Last Updated: October 8, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available after study completion and published all primary results.
• Access Criteria: Interested investigators must apply to National Database for Autism Research (NDAR) to receive access once it is made available.

Locations

US (3)