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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSE Theatre
Delayed Intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Vanderbilt Kennedy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Theatre

No Intervention then Theatre

Arm Description

The participants will receive 10 sessions of peer-mediated, theatre-based intervention.

The participants will not receive the treatment for a period of time.

Outcomes

Primary Outcome Measures

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.
Measurement of Salivary Cortisol levels
Event Related Potentials (ERP) incidental memory task
Social Responsiveness Scale
Peer Interaction Playground Paradigm
A playground play session conducted with trained typically developing peers.
Adaptive Behavior Assessment System
Parent questionnaire of child's adaptive behavior
Parenting Stress Index
parent-based questionnaire

Secondary Outcome Measures

Clinical Evaluation of Fundamentals Recalling Sentences subtest
Peabody Picture Vocabulary Test

Full Information

First Posted
October 15, 2014
Last Updated
June 12, 2017
Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02276534
Brief Title
SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)
Official Title
SENSE Theatre Research Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theatre
Arm Type
Experimental
Arm Description
The participants will receive 10 sessions of peer-mediated, theatre-based intervention.
Arm Title
No Intervention then Theatre
Arm Type
Experimental
Arm Description
The participants will not receive the treatment for a period of time.
Intervention Type
Behavioral
Intervention Name(s)
SENSE Theatre
Intervention Description
A peer-mediated, theatre-based intervention.
Intervention Type
Behavioral
Intervention Name(s)
Delayed Intervention
Primary Outcome Measure Information:
Title
NEPSY Memory for faces
Description
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.
Time Frame
Change from Baseline at Week 10 and Week 16
Title
Measurement of Salivary Cortisol levels
Time Frame
Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes
Title
Event Related Potentials (ERP) incidental memory task
Time Frame
Change from baseline at Week 10 and Week 16
Title
Social Responsiveness Scale
Time Frame
Change from baseline at Week 10 and Week 16
Title
Peer Interaction Playground Paradigm
Description
A playground play session conducted with trained typically developing peers.
Time Frame
Change from baseline at Week 10 and Week 16
Title
Adaptive Behavior Assessment System
Description
Parent questionnaire of child's adaptive behavior
Time Frame
Change from baseline at Week 10 and Week 16
Title
Parenting Stress Index
Description
parent-based questionnaire
Time Frame
Change from baseline at Week 10 and Week 16
Secondary Outcome Measure Information:
Title
Clinical Evaluation of Fundamentals Recalling Sentences subtest
Time Frame
Change from baseline at Week 10 and Week 16
Title
Peabody Picture Vocabulary Test
Time Frame
Change from baseline at Week 10 and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blythe A Corbett, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Kennedy Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31679960
Citation
Key AP, Corbett BA. The Unfulfilled Promise of the N170 as a Social Biomarker. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):342-353. doi: 10.1016/j.bpsc.2019.08.011. Epub 2019 Sep 13.
Results Reference
derived
PubMed Identifier
31589087
Citation
Corbett BA, Ioannou S, Key AP, Coke C, Muscatello R, Vandekar S, Muse I. Treatment Effects in Social Cognition and Behavior following a Theater-based Intervention for Youth with Autism. Dev Neuropsychol. 2019 Oct;44(7):481-494. doi: 10.1080/87565641.2019.1676244. Epub 2019 Oct 7.
Results Reference
derived

Learn more about this trial

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

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