Enhancing Social Competence in Adults With Autism

January 28, 2026 updated by: Blythe Corbett, Vanderbilt University Medical Center

Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Autism spectrum disorder (ASD) is characterized by primary impairment in social competence. Effects of current psychosocial interventions often fail to maintain or generalize and few employ rigorous experimental methods. Our treatment, 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. Recent findings from a randomized control trial (RCT) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (ERP) measures. Moreover, the RCT demonstrated treatment effects on social communication skills that generalized to home and community settings. Finally, maintained treatment effects were observed on communication symptoms. The proposed project will extend these findings and provide a stronger test of efficacy using an RCT of SENSE Theatre with a sample of approximately 40 adult participants with ASD (18 to 35 years) randomized to experimental (EXP; N = 20) and a wait list control group (WLC; N = 20) in two separate cohorts. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers using examiners blind to study treatment group assignment. The significance and size of treatment effects on these cognitive and behavioral outcomes will be measured using ANOVA and linear mixed models. Thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the SENSE Theatre® treatment and the extent to which these changes generalize and maintain. If predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for adults with ASD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

ASD Inclusion Criteria:

  • 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))

ASD Exclusion Criteria:

  • 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.

Care-giver Inclusion Criteria:

  • 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.

Care-giver Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Confederates Inclusion Criteria:

  • 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.

Confederate Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Peers Inclusion Criteria:

  • 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.

Peers Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SENSE Theatre
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.
Behavioral: SENSE Theatre
A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
No Intervention: Waitlist Control Group
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Incidental Face Memory
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
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
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
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)
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
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)
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cambridge Face Memory Test
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
A standardized measure of face memory with 72 items. Total raw score ranges from 0-72. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Wechsler Memory Scale Face Memory Delay Test
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
A standardized measure of face memory in which the participant is exposed to 24 faces in which they must remember amidst an array of 48 faces presented after a 30-minute delay. Raw scores range from 0-48 and are converted to age-adjusted scaled scores ranging from 1 to 19 (Mean of 10 and standard deviation of 3). Higher scaled scores reflect better delayed face memory. Scaled scores were used for analyses.
Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Wechsler Memory Scale Face Memory Test
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
A standardized measure of face memory in which the participant is exposed to 24 faces in which they must remember amidst an array of 48 faces presented immediately. Raw scores range from 0-48 and are converted to age-adjusted scaled scores ranging from 1 to 19 (Mean of 10 and standard deviation of 3). Higher scaled scores reflect better face memory. Scaled scores were used for analyses.
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
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The ABAS measures adaptive living skills, completed via self-administration, using a Standardized Scale in which in which scores ranging from ~70 to ~120, with 85 to 115 reflecting the broad average range. Lower scores represent greater impairment.
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
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The ABAS measures adaptive living skills, completed by a caregiver or partner, using a Standardized Scale in which scores ranging from ~70 to ~120, with 85 to 115 reflecting the broad average range. Lower scores represent greater impairment.
Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
State-Trait Anxiety Inventory (STAI) Scale
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The STAI is a measure of current (State) and enduring (Trait) anxiety that is completed by the participant. There are 20 items for each domain on a 4-point scale (1 = Almost Never, 4 = Almost Always). Scores range from 20 to 80, with higher scores reflecting greater anxiety.
Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The Adult Self Report (ASR)
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The ASR is a 126-item self-report questionnaire assessing aspects of emotional health. T scores range from 40 to 100 with a mean of 50 and a standard deviation of 10. The primary variables of interest were Depressive Problems and Anxiety Problems. Higher scores indicate more depressive or anxiety problems. A T score of 70 or higher is considered clinically significant.
Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The Adult Behavior Checklist (ABCL)
Time Frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The ABCL is a 126-item caregiver-report questionnaire assessing aspects of emotional health. T scores range from 40 to 100 with a mean of 50 and a standard deviation of 10. The primary variables of interest were Depressive Problems and Anxiety Problems. Higher scores indicate more depressive or anxiety problems. A T score of 70 or higher is considered clinically significant.
Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Blythe A Corbett, Ph.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 192271
  • 1R33MH120149-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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