NCT03338530

Efficacy of a Comprehensive School-based Intervention for High-functioning Children With Autism Spectrum Disorder

Completed NA Last updated 9 November 2017

What this trial tests

NA trial testing Comprehensive School-Based Intervention in Autism Spectrum Disorder in 103 participants. Completed in 31 July 2017.

Timeline

1 August 2013

Primary endpoint
31 July 2017

31 July 2017

Quick facts

Lead sponsor	Canisius College
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	103
Start date	1 August 2013
Primary completion	31 July 2017
Estimated completion	31 July 2017

Drugs / interventions tested

• Comprehensive School-Based Intervention

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Canisius College

Who can join

Adults 6 to 12, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was a 4-year efficacy trial (cluster randomized trial) of a comprehensive school-based intervention (CSBI) for high-functioning elementary students with autism spectrum disorder (HFASD). The sample included children, in grades 1-5 with HFASD enrolled in public schools. School buildings were randomly assigned to either receive the CSBI or serve as the control comparison (business-as-usual \[BAU\]). School staff in the CSBI schools administered social skills groups (60-90 minutes per week), facial-emotion recognition computer instruction (60 minutes per week), therapeutic activities (40-60 minutes per week), a behavioral reinforcement system (across the school day), and parent training (60-90 minutes per month) during the school year. Children with HFASD in the BAU schools received their typical educational program. Implementation fidelity was assessed by research assistants throughout the school year in the CSBI schools using standardized fidelity monitoring sheets. The fidelity monitoring sheets were also completed by research assistants during observations in the BAU schools in order to identify the possible presence of any of the treatment elements in the control (BAU) schools. Outcome measures were completed for both groups at baseline (6 weeks into the school year prior to the initiation of the intervention) and at the end of the school year following completion of the intervention. Primary outcome measures included a test of emotion recognition and parent-teacher ratings of ASD symptoms and secondary measures included parent-teacher ratings of social/social-communication skills, a test of academic achievement skills, and a direct behavioral measure of social interaction skills (child testing and behavioral observations were completed by evaluators blinded to treatment condition; parent-teacher raters were not blinded to treatment condition). For the primary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will demonstrate significantly greater emotion-recognition skills and receive significantly lower parent-teacher ratings of ASD symptoms compared to controls. For the secondary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will receive significantly higher parent-teacher ratings of social/social-communication skills, demonstrate significantly higher academic skills, and exhibit significantly higher rates of social interactions with peers compared to controls.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cluster Randomized Trial of a School Intervention for Children with Autism Spectrum Disorder.
   Lopata C, Thomeer ML, Rodgers JD, Donnelly JP, et al · · 2019 · cited 13× · PMID 30376652 · DOI 10.1080/15374416.2018.1520121
2. Longitudinal Follow-Up Study of Social Intervention Outcomes for Children on the Autism Spectrum.
   Lopata C, Thomeer ML, Rodgers JD, Donnelly JP, et al · · 2025 · cited 2× · PMID 38326493 · DOI 10.1007/s10803-023-06221-1