SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: SENSE Theatre; Behavioral: Delayed Intervention

• Registration Number: NCT02276534
• Lead Sponsor: Vanderbilt University

Brief Summary

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

Detailed Description

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• children diagnosed with autism spectrum disorder with IQ ≥ to 70.

Exclusion Criteria

• IQ ≤ 70, children with current aggression toward self or others.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Theatre	SENSE Theatre	The participants will receive 10 sessions of peer-mediated, theatre-based intervention.
No Intervention then Theatre	Delayed Intervention	The participants will not receive the treatment for a period of time.

Primary Outcome Measures

Name	Time	Method
NEPSY Memory for faces	Change from Baseline at Week 10 and Week 16	The measure requires the child to observe 16 faces of children and then remember them immediately and following a 30-minute delay. Raw scores are generated which are converted to standardized scores based on normative data.
Measurement of Salivary Cortisol levels	Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes
Social Responsiveness Scale	Change from baseline at Week 10 and Week 16
Adaptive Behavior Assessment System	Change from baseline at Week 10 and Week 16	Parent questionnaire of child's adaptive behavior
Parenting Stress Index	Change from baseline at Week 10 and Week 16	parent-based questionnaire
Event Related Potentials (ERP) incidental memory task	Change from baseline at Week 10 and Week 16
Peer Interaction Playground Paradigm	Change from baseline at Week 10 and Week 16	A playground play session conducted with trained typically developing peers.

Secondary Outcome Measures

Name	Time	Method
Peabody Picture Vocabulary Test	Change from baseline at Week 10 and Week 16
Clinical Evaluation of Fundamentals Recalling Sentences subtest	Change from baseline at Week 10 and Week 16

Trial Locations

Locations (1)

Vanderbilt Kennedy Center; 🇺🇸 Nashville, Tennessee, United States