Investigating Social Competence in Youth With Autism
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ClinicalTrials.gov Identifier: NCT03368001 |
Recruitment Status :
Active, not recruiting
First Posted : December 11, 2017
Last Update Posted : August 29, 2022
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder | Behavioral: SENSE Theatre Behavioral: Tackling Teenage Together | Not Applicable |
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.
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 |
Actual Primary Completion Date : | August 15, 2022 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
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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).
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 8 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children with high-functioning ASD (IQ > or = to 70).
Exclusion Criteria:
- Children who evidence aggression toward other people.

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
United States, Alabama | |
University of Alabama | |
Tuscaloosa, Alabama, United States, 35487 | |
United States, New York | |
Stony Brook University | |
Stony Brook, New York, United States, 11794 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37203 |
Documents provided by Blythe Corbett, Vanderbilt University Medical Center:
Responsible Party: | Blythe Corbett, 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 29, 2022 |
Last Verified: | August 2022 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Autism |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |