Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374381
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-18
First Post:
2024-03-19
Brief Title:
PEACE for ImPACT Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Adaptive Trial of Parent Empowerment and Coaching in Early Intervention PEACE for ImPACT Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit The investigators will enroll 200 early intervention providers and 400 parent-child dyads
Detailed Description:
Investigators are partnering with the two early intervention systems and their respective agencies in Philadelphia that serve young children receiving early intervention services under the age of 5 Investigators will enroll 200 early intervention providers who deliver services to young children in Philadelphia All providers will receive training on Project ImPACT The investigators will also recruit 400 parent-child dyads from participating providers caseloads and follow them over a 6 month period Providers will be given access to the PEACE Implementation Toolkit to aid their implementation of Project ImPACT with enrolled families At week 8 providers caregiver coaching fidelity with enrolled families will be assessed Non-adherent providers will be randomized to either 1 continue using the PEACE Online Resources or 2 receive added support through 8 weeks of group facilitation with an EI consultant The fidelity assessment will occur again at week 16 of the intervention Non-adherent providers will be re-randomized to either 1 continue using the PEACE Online Resources 2 receive 8 weeks of group facilitation with an EI consultant or 3 receive 8 weeks of individual facilitation with an EI consultant At week 24 investigators will assess implementation fidelity for a final time Secondary outcomes related to caregiver and child outcomes will be assessed at baseline and week 24 Planned analyses for all research questions can be found in the research study protocol available for review
Completion of this project could radically transform the Philadelphia EI systems capacity to implement caregiver coaching with families of young children with ASD by providing critical supports to historically marginalized families thereby improving learning trajectories for many young children with ASD Data gathered through this project will be directly generalizable to EI systems across the country and inform the large-scale implementation of caregiver-mediated interventions for ASD within other publicly funded EI systems
Completion of this project could radically transform the Philadelphia EI systems capacity to implement caregiver coaching with families of young children with ASD by providing critical supports to historically marginalized families thereby improving learning trajectories for many young children with ASD Data gathered through this project will be directly generalizable to EI systems across the country and inform the large-scale implementation of caregiver-mediated interventions for ASD within other publicly funded EI systems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None