Investigating Social Competence in Youth With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368001
• Other study ID #: 171153
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: January 3, 2023

Study information

• Verified date: February 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: January 3, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children who evidence aggression toward other people.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Stony Brook University	Stony Brook	New York
United States	University of Alabama	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to end of treatment (10 weeks).
Primary	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.	Change from baseline to end of treatment (10 weeks).
Secondary	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.	Baseline, post-treatment (10 weeks), and two-month follow-up.
Secondary	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.	Baseline, post-treatment (10 weeks), and two-month follow-up.
Secondary	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.	Baseline, post-treatment (10 weeks), and two-month follow-up.
Secondary	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.	Baseline, post-treatment (10 weeks), and two-month follow-up.