NCT04349644

Brief Summary

SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. The intervention has the potential to enhance social cognition and behavior in adults with autism spectrum disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 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

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 7, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

April 14, 2020

Results QC Date

January 17, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

autismsocial competencetheatre

Outcome Measures

Primary Outcomes (4)

  • Change in Incidental Face Memory

    An event-related Potential Task that presents 51 novel faces and 51 novel houses one of each is randomly selected and presented 50 times (repeated). We are examining an increase in amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Change in Contextual Assessment of Social Skills

    An observational assessment measure of social cognition and communication which includes two 3-minutes conversations with typically developing peers showing interested or bored demeanor. The behaviors are rated based on raw scores on a likert scale from 1 to 7 with 7 reflecting better ability. Only the Interested Condiiton was analyzed.

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Change in Social Responsiveness Scale - Self (SRS)

    The SRS is a standardized measure of social competence self-administered by participants pertaining to behaviors characteristic of adults with ASD. T-scores range from scores of 38 to 90 with a mean of 50 and a standard deviation of 10. Higher scores reflect greater impairment. T-scores were used in the analyses. A decrease in scores from pretest to posttest or follow-up suggests a better outcome.

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Change in Social Responsiveness Scale - Other (SRS)

    The SRS is a standardized measure of social competence administered by care-givers pertaining to behaviors characteristic of adults with ASD. T-scores range from scores of 38 to 90 with a mean of 50 and standard deviation of 10. Higher scores reflect greater impairment. T-scores were used in analyses. Decrease in scores from Pretest to Posttest or follow-up suggest better outcome.

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Secondary Outcomes (8)

  • Cambridge Face Memory Test

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Wechsler Memory Scale Face Memory Delay Test

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Wechsler Memory Scale Face Memory Test

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Adaptive Behavior Assessment System (ABAS) - Self-Report Global Adaptive Composite

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • Adaptive Behavior Assessment System (ABAS) - Other-Report Global Adaptive Composite

    Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

  • +3 more secondary outcomes

Study Arms (2)

SENSE Theatre

EXPERIMENTAL

A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.

Behavioral: SENSE Theatre

Waitlist Control Group

NO INTERVENTION

This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.

Interventions

SENSE TheatreBEHAVIORAL

A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.

SENSE Theatre

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with ASD based on DSM-V criteria (APA, 2013), by a psychologist, pediatrician or psychiatrist with expertise in ASD will be enrolled. ASD diagnosis will be corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) (Lord, 2012).
  • Only adults not currently supported by educational opportunities will be enrolled.
  • Participants must have a full-scale IQ \> or = 70 (WASI; (Wechsler, 2011))

You may not qualify if:

  • Adults with intellectual impairment (WASI; (Wechsler, 2011) score \< 70.
  • Participants with current, frequent and uncontrolled aggression toward other persons or property in the past 6 months will be excluded based on phone screening and questions from the Adult Behavior Checklist (Achenbach, 2001) (e.g., "Physically attacks people").
  • Participants with evidence of suicidality based on care-provider report, self-report, or clinical interview (i.e., endorsement of suicidal ideation in the past month and/or suicidal behavior in the past three months on the Columbia Suicide Severity Rating Scale (Posner, 2011),
  • Previous SENSE Theatre® participants will be excluded.
  • must be at least 18 years of age
  • must be a parent, close relative, or spouse of the adult participant with ASD.
  • must be able to provide current and historical observations of the functioning of the participant with ASD.
  • must live in close proximity to and have frequent contact with the participant with ASD.
  • must be at least 18 years of age
  • typically developing individual with no neurodevelopmental disorder.
  • must successfully complete training and demonstrate consistent administration of research protocols.
  • must be at least 18 years of age
  • typically developing individual with no neurodevelopmental disorder.
  • must have an expressed interest in supporting young adults and adults with developmental disabilities or ASD
  • must successfully complete SENSE Theatre® training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • Corbett BA, Key AP, Klemencic ME, Muscatello RA, Jones D, Pilkington J, Burroughs C, Vandekar S. Investigating Social Competence in a Pilot Randomized Clinical Trial of a Theatre-Based Intervention Enhanced for Adults with Autism Spectrum Disorder. J Autism Dev Disord. 2025 Jan;55(1):130-146. doi: 10.1007/s10803-023-06214-0. Epub 2023 Dec 18.

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Results Point of Contact

Title
Blythe Corbett, Ph.D.
Organization
Vanderbilt University Medical Center

Study Officials

  • Blythe A Corbett, Ph.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

October 21, 2020

Primary Completion

March 15, 2024

Study Completion

March 30, 2025

Last Updated

January 29, 2026

Results First Posted

March 7, 2025

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations