Clinical trial NCT02276534: SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)
Official title: SENSE Theatre Research Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-10-28
Enrollment: 136
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: NEPSY Memory for faces
timeFrame: Change from Baseline at Week 10 and Week 16
measure: Measurement of Salivary Cortisol levels
timeFrame: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes
measure: Event Related Potentials (ERP) incidental memory task
timeFrame: Change from baseline at Week 10 and Week 16
measure: Social Responsiveness Scale
timeFrame: Change from baseline at Week 10 and Week 16
measure: Peer Interaction Playground Paradigm
timeFrame: Change from baseline at Week 10 and Week 16
measure: Adaptive Behavior Assessment System
timeFrame: Change from baseline at Week 10 and Week 16
measure: Parenting Stress Index
timeFrame: Change from baseline at Week 10 and Week 16
Secondary outcomes:
measure: Clinical Evaluation of Fundamentals Recalling Sentences subtest
timeFrame: Change from baseline at Week 10 and Week 16
measure: Peabody Picture Vocabulary Test
timeFrame: Change from baseline at Week 10 and Week 16
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Kennedy Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Blythe A Corbett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.