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Investigating Social Competence in Youth 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: NCT03368001
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Blythe Corbett, Vanderbilt University Medical Center

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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SENSE Theatre
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).
Behavioral: SENSE Theatre
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).

Active Comparator: Tackling Teenage Together
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Behavioral: Tackling Teenage Together
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.




Primary Outcome Measures :
  1. NEPSY Memory for Faces Delayed [ Time Frame: Change from baseline to end of treatment (10 weeks). ]
    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.

  2. Incidental Face Memory (IFM) Event-Related Potential (ERP) task [ Time Frame: Change from baseline to end of treatment (10 weeks). ]
    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.

  3. Computer memory for faces [ Time Frame: Change from baseline to end of treatment (10 weeks) ]
    a computer-based face memory task; similar to the NEPSY Memory for Faces, it requires the child to identify persons that were recently perceived immediately after viewing and again after a 20 minute delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.


Secondary Outcome Measures :
  1. Social Responsiveness Scale (SRS) [ Time Frame: Baseline, post-treatment (10 weeks), and two-month follow-up. ]
    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.

  2. Adaptive Behavior Scales for Children (ABAS) [ Time Frame: Baseline, post-treatment (10 weeks), and two-month follow-up. ]
    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.

  3. Contextual Assessment of Social Skills (CASS) [ Time Frame: Baseline, post-treatment (10 weeks), and two-month follow-up. ]
    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.

  4. Child Behavior Checklist (CBCL) [ Time Frame: Baseline, post-treatment (10 weeks), and two-month follow-up. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with high-functioning ASD (IQ > or = to 70).

Exclusion Criteria:

  • Children who evidence aggression toward other people.

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): NCT03368001


Contacts
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Contact: Blythe A Corbett, Ph.D. 615-936-0280 blythe.corbett@vanderbilt.edu
Contact: Sara C Ioannou, MS 615-513-9562

Locations
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United States, Alabama
University of Alabama Active, not recruiting
Tuscaloosa, Alabama, United States, 35487
United States, New York
Stony Brook University Active, not recruiting
Stony Brook, New York, United States, 11794
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Blythe Corbett, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] March 12, 2020

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Responsible Party: Blythe Corbett, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03368001    
Other Study ID Numbers: 171153
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Currently sharing with the National Database for Autism Research.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available after study completion and published all primary results.
Access Criteria: Interested investigators must apply to NDAR to receive access once it is made available.

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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
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders