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

June 12, 2017 updated by: Blythe Corbett, Vanderbilt University

SENSE Theatre Research Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Kennedy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline at Week 10 and Week 16
Measurement of Salivary Cortisol levels
Time Frame: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes
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
Change from baseline at Week 10 and Week 16
Social Responsiveness Scale
Time Frame: Change from baseline at Week 10 and Week 16
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.
Change from baseline at Week 10 and Week 16
Adaptive Behavior Assessment System
Time Frame: Change from baseline at Week 10 and Week 16
Parent questionnaire of child's adaptive behavior
Change from baseline at Week 10 and Week 16
Parenting Stress Index
Time Frame: Change from baseline at Week 10 and Week 16
parent-based questionnaire
Change from baseline at Week 10 and Week 16

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Blythe A Corbett, Ph.D., Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110082 (Other Identifier: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on SENSE Theatre

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe