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Clinical Trials/NCT06374381
NCT06374381Enrolling By InvitationNot Applicable

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

University of Pennsylvania2 sites in 1 country600 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
600
Locations
2
Primary Endpoint
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool

Study Overview

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessors will be masked to randomization condition.

Eligibility Criteria

Ages
12 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Adherent: Continue Online Resources

No Intervention

Providers 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 Comparator

After 8 and 16 weeks, providers with low coaching adherence could be randomized to continue using the PEACE online resources with no further implementation supports.

Intervention: PEACE Online Resources (Behavioral)

Non Adherent: Group Facilitation

Experimental

After 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation.

Intervention: PEACE Weekly Group Facilitation (Behavioral)

Non Adherent: Individual Facilitation

Experimental

After 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.

Intervention: PEACE Weekly Individual Facilitation (Behavioral)

Outcomes

Primary Outcomes

Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool

Time Frame: Weeks 8, 16, and 24 weeks of intervention

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).

Secondary Outcomes

  • 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)
  • Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)(6 months (Baseline and Week 24))
  • Acceptability, Appropriateness, and Adoption measure(6 months (Week 24))
  • Qualitative Interview(6 months (Week 24))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melanie Pellecchia, PhD

Assistant Professor

University of Pennsylvania

Study Sites (2)

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