PEACE for ImPACT Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06374381
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Accepted

Interventions

  • PEACE Online Resources — BEHAVIORAL
    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.
  • PEACE Weekly Group Facilitation — BEHAVIORAL
    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.
  • PEACE Weekly Individual Facilitation — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Adherent: Continue Online Resources
    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.
  • Placebo Comparator: Non Adherent: Continue Online Resources
    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.
  • Experimental: Non Adherent: Group Facilitation
    After 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation.
  • Experimental: Non Adherent: Individual Facilitation
    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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Mental HealthPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Center for Mental Health· Philadelphia, PA

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