NCT02276534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

October 15, 2014

Last Update Submit

June 12, 2017

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (7)

  • 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.

    Change from Baseline at Week 10 and Week 16

  • Measurement of Salivary Cortisol levels

    Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes

  • Event Related Potentials (ERP) incidental memory task

    Change from baseline at Week 10 and Week 16

  • Social Responsiveness Scale

    Change from baseline at Week 10 and Week 16

  • Peer Interaction Playground Paradigm

    A playground play session conducted with trained typically developing peers.

    Change from baseline at Week 10 and Week 16

  • Adaptive Behavior Assessment System

    Parent questionnaire of child's adaptive behavior

    Change from baseline at Week 10 and Week 16

  • Parenting Stress Index

    parent-based questionnaire

    Change from baseline at Week 10 and Week 16

Secondary Outcomes (2)

  • Clinical Evaluation of Fundamentals Recalling Sentences subtest

    Change from baseline at Week 10 and Week 16

  • Peabody Picture Vocabulary Test

    Change from baseline at Week 10 and Week 16

Study Arms (2)

Theatre

EXPERIMENTAL

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

Behavioral: SENSE Theatre

No Intervention then Theatre

EXPERIMENTAL

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

Behavioral: Delayed Intervention

Interventions

SENSE TheatreBEHAVIORAL

A peer-mediated, theatre-based intervention.

Theatre
Delayed InterventionBEHAVIORAL
No Intervention then Theatre

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Kennedy Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (2)

  • 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.

    PMID: 31679960DERIVED

  • 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.

    PMID: 31589087DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Blythe A Corbett, Ph.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 28, 2014

Study Start

August 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

US(1)