Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508515
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention RUBI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The increased prevalence of autism spectrum disorder 1 in 36 youth in the United States along with the exorbitant cost of care of supporting one autistic individual with and without intellectual disability across their lifespan 24 and 14 million respectively creates a sense of urgency to improve outcomes for autistic youth Schools are the primary setting in which autistic children receive intervention Despite a growing array of evidence-based interventions EBI such as behavioral management EBIs often are unavailable in schools due to misalignment of existing implementation strategies IS with that setting Large numbers of IS have been described for the education sector but there is a dire need to identify the most efficient IS to support use of EBI in resource-strapped public schools This project will apply the local Discover DesignBuild and Test DDBT framework to redesign and pilot a multifaceted IS to support educator use of a behavioral skills EBI for autistic children in public schools
Detailed Description:
Specifically this study will test the effects of the newly redesigned Research Units in Behavioral Intervention in Educational Settings RUBIES Implementation Strategy in comparison with the unadapted Research Units in Behavioral Intervention RUBI Implementation Strategy on DDBT mechanisms engagement usability appropriateness proximal implementation outcomes adoption fidelity adaptation reach and child outcomes disruptive behavior functioning top problems Compared with the un-adapted RUBI IS the newly designed implementation strategy RUBIES-Team will lead to
H3-1 greater RUBIES usability engagement and appropriateness H3-2 greater RUBIES adoption fidelity and reach with fewer reactive adaptations to the RUBIES IS H3-3 noninferiority on student disruptive behavior in autistic children and H3-4 more students with improved behavioral outcomes than deterioration or unchanged outcomes across conditions
H3-1 greater RUBIES usability engagement and appropriateness H3-2 greater RUBIES adoption fidelity and reach with fewer reactive adaptations to the RUBIES IS H3-3 noninferiority on student disruptive behavior in autistic children and H3-4 more students with improved behavioral outcomes than deterioration or unchanged outcomes across conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None