PEACE for ImPACT Study
Adaptive Trial of Parent Empowerment and Coaching in Early Intervention: PEACE for ImPACT Study
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
May 12, 2026
May 1, 2026
3.9 years
March 19, 2024
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
The tool consists of 25 items, rated on a 5-point scale with a rating of 4 or 5 indicating acceptable adherence. A score of 80% indicates adherence on the overall measure (i.e., 80% of the items rated at 4 or 5).
Weeks 8, 16, and 24 weeks of intervention
Secondary Outcomes (6)
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
6 months (Baseline and Week 24)
Autism Impact Measure (AIM)
6 months (Baseline and Week 24)
Social Communication Checklist (SCC)
6 months (Baseline and Week 24)
Confusion, Hubbub, and Order Scale (CHAOS)
Baseline
Acceptability, Appropriateness, and Adoption measure
6 months (Week 24)
- +1 more secondary outcomes
Study Arms (4)
Adherent: Continue Online Resources
NO INTERVENTIONProviders who are adherent to parent coaching strategies during the 8 and 16 week timepoints will not be randomized and continue to use the PEACE Online Resources. They will not receive further implementation supports.
Non Adherent: Continue Online Resources
PLACEBO COMPARATORAfter 8 and 16 weeks, providers with low coaching adherence could be randomized to continue using the PEACE online resources with no further implementation supports.
Non Adherent: Group Facilitation
EXPERIMENTALAfter 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation.
Non Adherent: Individual Facilitation
EXPERIMENTALAfter 16 weeks, providers may be randomized to receive individual facilitation with an expert coach if they continue to be non adherent to the use of parent coaching strategies.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Provider is employed by a Philadelphia EI agency
- Provider has \> 5 children with/at risk for ASD on their caseload.
- Child is receiving EI services from a participating provider.
- Child has a classification of ASD or high ASD risk as determined by the EI system.
- Child is not transitioning from EI services for at least 6 months.
- Caregiver speaks English or Spanish (Project ImPACT materials are available in Spanish).
- Caregiver is willing to participate in weekly coaching sessions.
You may not qualify if:
- \. Participants will be excluded if they do not speak English or Spanish, as the published intervention materials are currently available in English and Spanish and the research team is able to communicate with participants in English or Spanish only.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Institute of Education Sciencescollaborator
- Michigan State Universitycollaborator
Study Sites (1)
Center for Mental Health
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie Pellecchia, PhD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be masked to randomization condition.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 19, 2024
First Posted
April 18, 2024
Study Start
December 1, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
May 12, 2026
Record last verified: 2026-05