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

Study Overview
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Brief Summary
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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
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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.

Official Title
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SENSE Theatre Research Program

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: SENSE Theatre
* Behavioral: Delayed Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children diagnosed with autism spectrum disorder with IQ ≥ to 70. Exclusion Criteria: IQ ≤ 70, children with current aggression toward self or others.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theatre<br>The participants will receive 10 sessions of peer-mediated, theatre-based intervention. | Behavioral: SENSE Theatre<br>* A peer-mediated, theatre-based intervention.<br>|
| Experimental: No Intervention then Theatre<br>The participants will not receive the treatment for a period of time. | Behavioral: Delayed Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEPSY Memory for faces | 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. | Change from Baseline at Week 10 and Week 16 | 
| Measurement of Salivary Cortisol levels |  | Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes | 
| Event Related Potentials (ERP) incidental memory task |  | Change from baseline at Week 10 and Week 16 | 
| Social Responsiveness Scale |  | Change from baseline at Week 10 and Week 16 | 
| Peer Interaction Playground Paradigm | A playground play session conducted with trained typically developing peers. | Change from baseline at Week 10 and Week 16 | 
| Adaptive Behavior Assessment System | Parent questionnaire of child's adaptive behavior | Change from baseline at Week 10 and Week 16 | 
| Parenting Stress Index | parent-based questionnaire | Change from baseline at Week 10 and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation of Fundamentals Recalling Sentences subtest |  | Change from baseline at Week 10 and Week 16 | 
| Peabody Picture Vocabulary Test |  | Change from baseline at Week 10 and Week 16 |