Back to resultsEnhancing Social Competence in Adults With Autism
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSE Theatre
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, social competence, theatre
Eligibility 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.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SENSE Theatre
Waitlist Control Group
Arm Description
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Outcomes
Primary Outcome Measures
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.
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.
Change in Social Responsiveness Scale - Self (SRS)
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)
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
Cambridge Face Memory Test
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
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
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
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
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
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)
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)
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.
Full Information
NCT ID
NCT04349644
First Posted
April 14, 2020
Last Updated
August 7, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04349644
Brief Title
Enhancing Social Competence in Adults With Autism
Official Title
Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, social competence, theatre
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSE Theatre
Arm Type
Experimental
Arm Description
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Intervention Type
Behavioral
Intervention Name(s)
SENSE Theatre
Intervention Description
A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Primary Outcome Measure Information:
Title
Change in Incidental Face Memory
Description
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.
Time Frame
Pretest to Week 11
Title
Change in Contextual Assessment of Social Skills
Description
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.
Time Frame
Pretest to Week 11
Title
Change in Social Responsiveness Scale - Self (SRS)
Description
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.
Time Frame
Pretest to Week 11
Title
Change in Social Responsiveness Scale - Parent (SRS)
Description
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.
Time Frame
Pretest to Week 11
Secondary Outcome Measure Information:
Title
Cambridge Face Memory Test
Description
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.
Time Frame
Pretest, Week 11, two-month follow-up
Title
Wechsler Memory Scale Face Memory Delay Test
Description
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.
Time Frame
Pretest, Week 11, two-month follow-up
Title
Wechsler Memory Scale Face Memory Test
Description
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.
Time Frame
Pretest, Week 11, two-month follow-up
Title
Adaptive Behavior Assessment System (ABAS) - Self-Report
Description
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.
Time Frame
Pretest, Week 5, Week 11, two-month follow-up
Title
Adaptive Behavior Assessment System (ABAS) - Parent-Report
Description
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.
Time Frame
Pretest, Week 5, Week 11, two-month follow-up
Title
State-Trait Anxiety Inventory (STAI) Scale
Description
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.
Time Frame
Pretest, Week 11, two-month follow-up
Title
The Adult Self Report (ASR)
Description
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.
Time Frame
Pretest, Week 5, Week 11, two-month follow-up
Title
The Adult Behavior Checklist (ABCL)
Description
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.
Time Frame
Pretest, Week 5, Week 11, two-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blythe A Corbett, Ph.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhancing Social Competence in Adults With Autism
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