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Completed

NCT Number: NCT04349644

Enhancing Social Competence in Adults With Autism

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SENSE Theatre

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 16, 2020
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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