PEACE for ImPACT Study

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool [Time frame: Weeks 8, 16, and 24 weeks of intervention]

Secondary outcome measures (6)

• Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) [Time frame: 6 months (Baseline and Week 24)]
• Autism Impact Measure (AIM) [Time frame: 6 months (Baseline and Week 24)]
• Social Communication Checklist (SCC) [Time frame: 6 months (Baseline and Week 24)]
• Confusion, Hubbub, and Order Scale (CHAOS) [Time frame: Baseline]
• Acceptability, Appropriateness, and Adoption measure [Time frame: 6 months (Week 24)]
• Qualitative Interview [Time frame: 6 months (Week 24)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

1\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Center for Mental Health — Philadelphia

Identifiers

NCT: NCT06374381 · 854990

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗