Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Social Competence in Adults With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349644
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Blythe Corbett, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: SENSE Theatre Not Applicable

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.

Layout table for study information
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 : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Blythe A Corbett, Ph.D. 615-513-9562 senselab@vumc.org

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Blythe A Corbett, Ph.D. Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Blythe Corbett, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] January 14, 2020

Layout table for additonal information
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: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blythe Corbett, Vanderbilt University Medical Center:
autism
social competence
theatre
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders