Investigating Social Competence in Youth With Autism
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSE Theatre
Tackling Teenage Together
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism
Eligibility Criteria
Inclusion Criteria:
- Children with high-functioning ASD (IQ > or = to 70).
Exclusion Criteria:
- Children who evidence aggression toward other people.
Sites / Locations
- University of Alabama
- Stony Brook University
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SENSE Theatre
Tackling Teenage Together
Arm Description
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Outcomes
Primary Outcome Measures
NEPSY Memory for Faces Delayed
A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.
Incidental Face Memory (IFM) Event-Related Potential (ERP) task
The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.
Secondary Outcome Measures
Social Responsiveness Scale (SRS)
The SRS is a measure of social competence that is administered by parents pertaining to behaviors characteristic of children with autism. T scores range from 38-90 with higher scores reflecting more pathology.
Adaptive Behavior Scales for Children (ABAS)
The ABAS is a parental rating scale pertaining to various adaptive behaviors in a child, such as social and communication skills. Standard scores for the subscales range from 1 to 19. Higher scores reflect better skills in each domain.
Contextual Assessment of Social Skills (CASS)
The CASS is an observational measure of social interaction skills with two similar age peers. There are two conditions which include a Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability.
Child Behavior Checklist (CBCL)
The CBCL is a parent report measure of a variety of symptom domains relevant for children with autism and related neurodevelopment disorders. T scores range from 40 to 100.
Full Information
NCT ID
NCT03368001
First Posted
December 5, 2017
Last Updated
February 13, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03368001
Brief Title
Investigating Social Competence in Youth With Autism
Official Title
Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
January 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
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
Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).
Detailed Description
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 a multisite RCT of SENSE Theatre with a large sample of participants with ASD (8 to 16 years) randomized to an experimental and an active control group. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers. 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 children and adolescents with ASD.
8/18/2021: Record was updated to delete the outcome measure "Computer memory for faces" as it was not included as a primary outcome variable in the IRB approved protocol dated 9/13/2017.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSE Theatre
Arm Type
Experimental
Arm Description
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
Arm Title
Tackling Teenage Together
Arm Type
Active Comparator
Arm Description
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Intervention Type
Behavioral
Intervention Name(s)
SENSE Theatre
Intervention Description
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
Intervention Type
Behavioral
Intervention Name(s)
Tackling Teenage Together
Intervention Description
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Primary Outcome Measure Information:
Title
NEPSY Memory for Faces Delayed
Description
A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.
Time Frame
Change from baseline to end of treatment (10 weeks).
Title
Incidental Face Memory (IFM) Event-Related Potential (ERP) task
Description
The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.
Time Frame
Change from baseline to end of treatment (10 weeks).
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS)
Description
The SRS is a measure of social competence that is administered by parents pertaining to behaviors characteristic of children with autism. T scores range from 38-90 with higher scores reflecting more pathology.
Time Frame
Baseline, post-treatment (10 weeks), and two-month follow-up.
Title
Adaptive Behavior Scales for Children (ABAS)
Description
The ABAS is a parental rating scale pertaining to various adaptive behaviors in a child, such as social and communication skills. Standard scores for the subscales range from 1 to 19. Higher scores reflect better skills in each domain.
Time Frame
Baseline, post-treatment (10 weeks), and two-month follow-up.
Title
Contextual Assessment of Social Skills (CASS)
Description
The CASS is an observational measure of social interaction skills with two similar age peers. There are two conditions which include a Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability.
Time Frame
Baseline, post-treatment (10 weeks), and two-month follow-up.
Title
Child Behavior Checklist (CBCL)
Description
The CBCL is a parent report measure of a variety of symptom domains relevant for children with autism and related neurodevelopment disorders. T scores range from 40 to 100.
Time Frame
Baseline, post-treatment (10 weeks), and two-month follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with high-functioning ASD (IQ > or = to 70).
Exclusion Criteria:
Children who evidence aggression toward other people.
Facility Information:
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Currently sharing with the National Database for Autism Research.
IPD Sharing Time Frame
Data will be available after study completion and published all primary results.
IPD Sharing Access Criteria
Interested investigators must apply to NDAR to receive access once it is made available.
Learn more about this trial
Investigating Social Competence in Youth With Autism
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