Autism Spectrum DisorderNCT04349644
Enhancing Social Competence in Adults With Autism
A study testing SENSE Theatre in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SENSE Theatre
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SENSE Theatre
- Keywords
- autism, social competence, theatre
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE TheatreBehavioural
A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
| Study group | Role | What they receive |
|---|---|---|
| SENSE Theatre | Experimental | A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Secondary outcomes (8)
Cambridge Face Memory Test
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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Wechsler Memory Scale Face Memory Delay Test
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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Wechsler Memory Scale Face Memory Test
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.
Measured: 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
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.
Measured: 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
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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
State-Trait Anxiety Inventory (STAI) Scale
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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The Adult Self Report (ASR)
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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
The Adult Behavior Checklist (ABCL)
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.
Measured: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start21 Oct 2020
- Primary completion15 Mar 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Blythe Corbett, Vanderbilt University Medical Center
- Investigators
- Blythe A Corbett, Ph.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349644
- Sponsor's protocol ID
- 192271
- Other IDs
- 1R33MH120149-01A1
- Status last verified
- Jan 2026
- First submitted
- 14 Apr 2020
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muscatello RA, Klemencic ME, Calvosa R, Corbett BA. Social Adaptation to Change in Peer Behavior Before and After a Pilot Randomized Clinical Trial of a Theatre-Based Intervention for Adults With Autism. J Autism Dev Disord. 2026 Apr 27:10.1007/s10803-026-07340-1. doi: 10.1007/s10803-026-07340-1. Online ahead of print.
PubMed 42043633Corbett 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.
PubMed 38109034
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT
- ClinicalTrials.gov ID
- NCT04349644
- Acronym / sponsor ID
- 192271
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, social competence, theatre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENSE Theatre | Experimental | Behavioral: SENSE TheatreA peer-mediated, theatre-based intervention designed to improve social cognition and behavior. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSE TheatreA peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance. | Behavioural | SENSE Theatre |
Primary outcome
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 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 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 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.
8 secondary outcomes
Cambridge Face Memory Test
Time frame: 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)
Wechsler Memory Scale Face Memory Test
Time frame: 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)
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)
State-Trait Anxiety Inventory (STAI) Scale
Time frame: 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 Adult Behavior Checklist (ABCL)
Time frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42043633Muscatello RA, Klemencic ME, Calvosa R, Corbett BA. Social Adaptation to Change in Peer Behavior Before and After a Pilot Randomized Clinical Trial of a Theatre-Based Intervention for Adults With Autism. J Autism Dev Disord. 2026 Apr 27:10.1007/s10803-026-07340-1. doi: 10.1007/s10803-026-07340-1. Online ahead of print.
- Derived from this study: PubMed 38109034Corbett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blythe A Corbett, Ph.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSE Theatre in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incidental Face Memory (time frame: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04349644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.