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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Blythe Corbett, 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: SENSE Theatre Behavioral: Delayed Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SENSE Theatre Research Program
Study Start Date : August 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Theatre
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



Primary Outcome Measures :
  1. 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.

  2. Measurement of Salivary Cortisol levels [ Time Frame: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes ]
  3. Event Related Potentials (ERP) incidental memory task [ Time Frame: Change from baseline at Week 10 and Week 16 ]
  4. Social Responsiveness Scale [ Time Frame: Change from baseline at Week 10 and Week 16 ]
  5. 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.

  6. Adaptive Behavior Assessment System [ Time Frame: Change from baseline at Week 10 and Week 16 ]
    Parent questionnaire of child's adaptive behavior

  7. Parenting Stress Index [ Time Frame: Change from baseline at Week 10 and Week 16 ]
    parent-based questionnaire


Secondary Outcome Measures :
  1. Clinical Evaluation of Fundamentals Recalling Sentences subtest [ Time Frame: Change from baseline at Week 10 and Week 16 ]
  2. Peabody Picture Vocabulary Test [ Time Frame: Change from baseline at Week 10 and Week 16 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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United States, Tennessee
Vanderbilt Kennedy Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Blythe A Corbett, Ph.D. Vanderbilt University

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Responsible Party: Blythe Corbett, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02276534     History of Changes
Other Study ID Numbers: 110082
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders