Clinical trial NCT06374381: PEACE for ImPACT Study
Official title: Adaptive Trial of Parent Empowerment and Coaching in Early Intervention: PEACE for ImPACT Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Early Intervention
Caregiver Mediated Interventions
Caregiver or Parent Coaching
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
name: Michigan State University
First posted: 2024-04-18
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Provider is employed by a Philadelphia EI agency
2. Provider has \> 5 children with/at risk for ASD on their caseload.
3. Child is receiving EI services from a participating provider.
4. Child has a classification of ASD or high ASD risk as determined by the EI system.
5. Child is not transitioning from EI services for at least 6 months.
6. Caregiver speaks English or Spanish (Project ImPACT materials are available in Spanish).
7. 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.

Primary outcomes:
measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
timeFrame: Weeks 8, 16, and 24 weeks of intervention
Secondary outcomes:
measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
timeFrame: 6 months (Baseline and Week 24)
measure: Autism Impact Measure (AIM)
timeFrame: 6 months (Baseline and Week 24)
measure: Social Communication Checklist (SCC)
timeFrame: 6 months (Baseline and Week 24)
measure: Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: Baseline
measure: Acceptability, Appropriateness, and Adoption measure
timeFrame: 6 months (Week 24)
measure: Qualitative Interview
timeFrame: 6 months (Week 24)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Mental Health
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Melanie Pellecchia, PhD
role: PRINCIPAL_INVESTIGATOR
References: