PEACE for ImPACT Study

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06374381
• Other study ID #: 854990
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 2027

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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 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
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
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.

Locations

Country	Name	City	State
United States	Center for Mental Health	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Institute of Education Sciences, Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)	The PICCOLO is a checklist of 29 observable, developmentally supportive parenting behaviors with children ages 10-47 months. The PICCOLO has four domains: Affection, Responsiveness, Encouragement, and Teaching. Total scores on each domain are used to monitor change in parenting behaviors. The minimum score is a 0 and a maximum score is 58. Higher scores indicate higher occurrences of supportive behaviors.	6 months (Baseline and Week 24)
Secondary	Autism Impact Measure (AIM)	A 41-item parent report questionnaire designed to track incremental change in frequency and impact of core ASD symptoms. The frequency and impact of symptoms are determined by a 5-point scale. Higher scores on the measure indicate greater symptom severity.	6 months (Baseline and Week 24)
Secondary	Social Communication Checklist (SCC)	A 47-item parent report checklist that is used as part of the Project ImPACT program to help parents set their child's social communication goals and assess child progress. An initial psychometric evaluation suggests that it is reliable, sensitive to change after intervention, and strongly related to well-established measures of social-communication functioning. Respondents indicate whether a child uses a specific skill on a 3-point scale. Scores are summed for domain scores (Social Engagement, Expressive Communication, Receptive Communication, and Imitation/Play) and a Total Score. Higher scores indicate that skills are being used more frequently.	6 months (Baseline and Week 24)
Secondary	Confusion, Hubbub, and Order Scale (CHAOS)	A validated parent-report measure of disorder and chaos in the home will be used to measure home environmental factors that may interfere with the use of caregiver coaching. Responses are formatted as a True/False or Yes/No format. Once completed, the 15 items are summed for a Total Score. A higher score indicates more chaotic, disorganized, and hurried characteristics of the home.	Baseline
Secondary	Acceptability, Appropriateness, and Adoption measure	A measure that specifically queries for respondents views about the usefulness, acceptability, and the extent to which they used the components of the toolkit. Respondents rate the toolkit's acceptability, appropriateness, and their use of the components on a 5-point scale. Higher scores indicate higher levels of acceptability, appropriateness, and adoption.	6 months (Week 24)
Secondary	Qualitative Interview	We will conduct qualitative interviews with 20% of the early intervention providers in each cohort. We will interview them using an interview guide with questions eliciting feedback on the PEACE Implementation Toolkit and the implementation supports that were provided.	6 months (Week 24)