SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)
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|ClinicalTrials.gov Identifier: NCT02276534|
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: SENSE Theatre Behavioral: Delayed Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||SENSE Theatre Research Program|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
The participants will receive 10 sessions of peer-mediated, theatre-based intervention.
Behavioral: SENSE Theatre
A peer-mediated, theatre-based intervention.
Experimental: No Intervention then Theatre
The participants will not receive the treatment for a period of time.
Behavioral: Delayed Intervention
- NEPSY Memory for faces [ Time Frame: 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 [ Time Frame: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes ]
- Event Related Potentials (ERP) incidental memory task [ Time Frame: Change from baseline at Week 10 and Week 16 ]
- Social Responsiveness Scale [ Time Frame: Change from baseline at Week 10 and Week 16 ]
- Peer Interaction Playground Paradigm [ Time Frame: Change from baseline at Week 10 and Week 16 ]A playground play session conducted with trained typically developing peers.
- Adaptive Behavior Assessment System [ Time Frame: Change from baseline at Week 10 and Week 16 ]Parent questionnaire of child's adaptive behavior
- Parenting Stress Index [ Time Frame: Change from baseline at Week 10 and Week 16 ]parent-based questionnaire
- Clinical Evaluation of Fundamentals Recalling Sentences subtest [ Time Frame: Change from baseline at Week 10 and Week 16 ]
- Peabody Picture Vocabulary Test [ Time Frame: Change from baseline at Week 10 and Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276534
|United States, Tennessee|
|Vanderbilt Kennedy Center|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Blythe A Corbett, Ph.D.||Vanderbilt University|