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

SENSE Theatre Research Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02276534
Enrollment
136
Registered
2014-10-28
Start date
2014-08-31
Completion date
2017-05-31
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

BEHAVIORALSENSE Theatre

A peer-mediated, theatre-based intervention.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Peer Interaction Playground ParadigmChange from baseline at Week 10 and Week 16A playground play session conducted with trained typically developing peers.
Event Related Potentials (ERP) incidental memory taskChange from baseline at Week 10 and Week 16
Social Responsiveness ScaleChange from baseline at Week 10 and Week 16
Adaptive Behavior Assessment SystemChange from baseline at Week 10 and Week 16Parent questionnaire of child's adaptive behavior
Parenting Stress IndexChange from baseline at Week 10 and Week 16parent-based questionnaire
NEPSY Memory for facesChange from Baseline at Week 10 and Week 16The 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 levelsChange from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes

Secondary

MeasureTime frame
Peabody Picture Vocabulary TestChange from baseline at Week 10 and Week 16
Clinical Evaluation of Fundamentals Recalling Sentences subtestChange from baseline at Week 10 and Week 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026