Enhancing Social Competence in Adults With Autism
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ClinicalTrials.gov Identifier: NCT04349644 |
Recruitment Status :
Recruiting
First Posted : April 16, 2020
Last Update Posted : February 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder | Behavioral: SENSE Theatre | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT |
Actual Study Start Date : | October 21, 2020 |
Estimated Primary Completion Date : | April 1, 2023 |
Estimated Study Completion Date : | April 1, 2023 |

Arm | Intervention/treatment |
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Experimental: SENSE Theatre
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.
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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.
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- Change in Incidental Face Memory [ Time Frame: Pretest to Week 11 ]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 in Contextual Assessment of Social Skills [ Time Frame: Pretest to Week 11 ]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.
- Change in Social Responsiveness Scale - Self (SRS) [ Time Frame: Pretest to Week 11 ]The SRS is a standardized measure of social competence administered by participants pertaining to behaviors characteristic of adults with ASD. T-scores range from scores of 38 to 90 with higher scores reflecting greater impairment.
- Change in Social Responsiveness Scale - Parent (SRS) [ Time Frame: Pretest to Week 11 ]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 higher scores reflecting greater impairment.
- Cambridge Face Memory Test [ Time Frame: Pretest, Week 11, two-month follow-up ]A standardized measure of face memory with 72 items. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
- Wechsler Memory Scale Face Memory Delay Test [ Time Frame: Pretest, Week 11, two-month follow-up ]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 and after a 30-minute delay. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
- Wechsler Memory Scale Face Memory Test [ Time Frame: Pretest, Week 11, two-month follow-up ]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 and after a 30-minute delay. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
- Adaptive Behavior Assessment System (ABAS) - Self-Report [ Time Frame: Pretest, Week 5, Week 11, two-month follow-up ]The ABAS measures adaptive living skills using a Standardized Scale in which scores from 85 to 115 reflect the broad average range. Lower scores represent greater impairment.
- Adaptive Behavior Assessment System (ABAS) - Parent-Report [ Time Frame: Pretest, Week 5, Week 11, two-month follow-up ]The ABAS measures adaptive living skills using a Standardized Scale in which scores from 85 to 115 reflect the broad average range. Lower scores represent greater impairment.
- State-Trait Anxiety Inventory (STAI) Scale [ Time Frame: Pretest, Week 11, two-month follow-up ]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) and higher scores reflect greater anxiety.
- The Adult Self Report (ASR) [ Time Frame: Pretest, Week 5, Week 11, two-month follow-up ]The ASR is the self-report of the Achenbach empirically system which covers emotional health. We will focus on the anxiety and depressive subscales. T-scores range from 40 to 100 with higher scores representing more impairment.
- The Adult Behavior Checklist (ABCL) [ Time Frame: Pretest, Week 5, Week 11, two-month follow-up ]The ABCL is the care-giver-report version of the Achenbach system that covers emotional health. We will focus on the anxiety and depressive subscales. T-scores range from 40 to 100 with higher scores representing more impairment.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349644
Contact: Blythe A Corbett, Ph.D. | 615-513-9562 | senselab@vumc.org |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | Blythe A Corbett, Ph.D. | Vanderbilt University Medical Center |
Documents provided by Blythe Corbett, Vanderbilt University Medical Center:
Responsible Party: | Blythe Corbett, Professor of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT04349644 |
Other Study ID Numbers: |
192271 1R33MH120149-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | February 21, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
autism social competence theatre |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |