Overview

This trial has been completed.

Condition autism spectrum disorder
Treatments sense theatre, delayed intervention
Sponsor Vanderbilt University
Collaborator National Institute of Mental Health (NIMH)
Start date August 2014
End date July 2015
Trial size 34 participants
Trial identifier NCT02276534, 110082

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The participants will receive 10 sessions of peer-mediated, theatre-based intervention.
sense theatre
A peer-mediated, theatre-based intervention.
(Experimental)
The participants will not receive the treatment for a period of time.
delayed intervention

Primary Outcomes

Measure
NEPSY Memory for faces
time frame: 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
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
Adaptive Behavior Assessment System
time frame: Change from baseline at Week 10 and Week 16
Parenting Stress Index
time frame: Change from baseline at Week 10 and Week 16

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 8 years up to 16 years old.

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

Additional Information

Official title SENSE Theatre Research Program
Principal investigator Blythe A Corbett, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.