Clinical trial NCT03368001: Investigating Social Competence in Youth With Autism
Official title: Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 318
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Institutional Review Board (IRB) approved protocol dated 9/13/2017.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Children who evidence aggression toward other people.

Primary outcomes:
measure: Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed
timeFrame: Change from baseline to end of treatment (10 weeks).
measure: Incidental Face Memory (IFM) Event-Related Potential (ERP) Task
timeFrame: Change from baseline to end of treatment (10 weeks) and at two-month follow-up.
Secondary outcomes:
measure: Social Responsiveness Scale (SRS) Communication
timeFrame: Baseline, post-treatment (10 weeks), and two-month follow-up.
measure: Adaptive Behavior Scales for Children (ABAS)
timeFrame: Baseline, post-treatment (10 weeks), and two-month follow-up.
measure: Contextual Assessment of Social Skills (CASS) Interested
timeFrame: Baseline, post-treatment (10 weeks), and two-month follow-up.
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline, post-treatment (10 weeks), and two-month follow-up.
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: