NCT06374381

PEACE for ImPACT Study

Adaptive Trial of Parent Empowerment and Coaching in Early Intervention: PEACE for ImPACT Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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 system's 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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	PEACE Online Resources	The PEACE online resource includes self-paced training modules that cover the foundations of caregiver coaching, caregiver perspectives towards coaching, strategies for aligning with caregivers and gaining buy-in for coaching, evidence-based strategies to empower caregivers from marginalized backgrounds, and strategies to improve collaboration and cohesion among providers working with the same child. Each module includes brief example videos, easy-to read infographics, tip sheets, and checklists to guide implementation. A virtual communication application, Slack, facilitates frequent communication, enhances social networks among providers, and creates social norms related to the use of caregiver coaching. Providers can post questions or suggestions, share resources, and receive updates about other providers' accomplishments. Consultants frequently post encouraging messages and progress updates to increase motivation and shared norms for coaching.
BEHAVIORAL	PEACE Weekly Group Facilitation	Facilitation comprises interactive problem solving and support, a shared understanding of need for improvement, and a supportive interpersonal relationship. Providers participate in 12 weekly group facilitation meetings for one hour virtually with an expert consultant focused on auditing providers' fidelity to caregiver coaching through role-play and performance feedback. Each group meeting aligns with content from the PEACE online resource library modules.
BEHAVIORAL	PEACE Weekly Individual Facilitation	Individual facilitation is delivered virtually for one hour each week for eight weeks with a consultant focused on reflection and problem solving any identified implementation barriers, as well as practice and performance feedback.

Timeline

• Start date: 2023-12-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2024-04-18
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States