|Title:||Adaptive Trial of Parent Empowerment and Coaching in Early Intervention: AT PEACE Study|
|Principal Investigator:||Pellecchia, Melanie||Awardee:||University of Pennsylvania|
|Program:||Early Intervention and Early Learning [Program Details]|
|Award Period:||5 years (07/01/2023 – 06/30/2028)||Award Amount:||$3,799,999|
|Type:||Initial Efficacy||Award Number:||R324A230102|
Purpose: The purpose of this study is to investigate the effectiveness of tiered levels of implementation support for the Parent Empowerment and Coaching in Early Intervention (PEACE) toolkit in increasing early intervention (EI) providers' use of caregiver coaching for families of young children with autism spectrum disorder (ASD). Intervention for ASD initiated in earlier ages improves children's long-term cognition, language, behavior, and development. Caregiver-mediated intervention is considered an evidence-based practice for young children with ASD, resulting in improved child and parent outcomes. However, caregiver coaching, a critical component of all caregiver-mediated interventions, is often not implemented within publicly funded EI programs. This study will provide insight into the level of implementation support needed to accelerate the use and fidelity of caregiver coaching with families of young children with ASD.
Project Activities: This project will use a SMART (sequential, multiple-assignment, randomized trial) design to assess the effectiveness of the PEACE toolkit at increasing fidelity for caregiver coaching as well as a mixed-methods design to identify provider and family characteristics associated with the need for increasing levels of implementation support.
Products: The products of this project will include evidence of the efficacy of the PEACE toolkit for use in EI systems for families of young children with ASD. The project will also result in a final dataset to be made publicly available as well as peer-reviewed publications and presentations.
Setting: The research will take place in the EI systems (both IDEA Part C and Part B) serving children from birth to 5 years of age identified as being with or at risk for disabilities in a large urban city in Pennsylvania.
Population/Sample: Approximately 200 EI providers and 400 families of children with ASD receiving publicly funded EI services (2 per participating provider) will participate in the study. All participating children will be diagnosed with ASD or determined to be high likelihood for ASD by the EI system.
Intervention: The PEACE implementation toolkit is a theory-informed toolkit of strategies designed to improve EI providers' use of caregiver coaching for families of young children with ASD. It has three components: 1) an online resource library and virtual communication application, 2) weekly group facilitation meetings, and 3) individual facilitation meetings. The PEACE toolkit allows for a tiered approach to implementation support based on provider needs. The online resource library includes a series of self-paced training modules covering the foundations of caregiver coaching, caregiver perspectives toward participating in coaching sessions, strategies for aligning with caregivers, and strategies to empower caregivers from minoritized or marginalized backgrounds. Weekly group facilitation meetings focus on assessing providers' coaching fidelity through video review or role play and performance feedback. Individual facilitation is delivered to providers who need additional support.
Research Design and Methods: The research team will use a SMART design to evaluate the efficacy of tiered levels of implementation support at increasing EI provider's coaching fidelity. The SMART design uses two assessment points of coaching fidelity and subsequent randomizations to increasing levels of implementation support, at 8 weeks and 16 weeks of intervention. Providers with low fidelity will be randomized to receive either (a) increasing levels of implementation support (i.e., group facilitation or individual facilitation) or (b) continue with the current level of implementation support at each time point. More specifically, during the initial 8 weeks of implementation, all providers will have access to the PEACE online resource library. After 8 weeks, providers with low coaching fidelity will be randomized to continue with online resources or to participate in weekly group facilitation. Group facilitation will consist of an expert coach leading 1-hour virtual meetings with a structured agenda that includes assessing providers' coaching fidelity through video review or live role-playing, providing feedback, and addressing barriers to implementation. After another 8 weeks of implementation, providers with low coaching fidelity will be randomized to either weekly group facilitation or weekly individual facilitation. Providers with high coaching fidelity will receive only the online resources. Changes in caregivers' responsiveness and children's social communication will be assessed at baseline and after 24 weeks of intervention. Mixed methods will be used to assess whether the toolkit addressed identified implementation barriers and a cost analysis will be conducted.
Control Condition: Given the nature of SMART designs, the comparison group will change throughout the course of the study. All participating providers will receive access to the PEACE online resources. Providers will be randomized to receive additional implementation support or continue with the PEACE online resources as they progress through the stages of the SMART design.
Key Measures: The primary study outcome will be provider coaching fidelity. This will be assessed via direct observation of recorded EI sessions using the PEACE Caregiver Coaching Fidelity Tool. Measures of intervention acceptability, feasibility, and appropriateness for the PEACE toolkit will also be collected using the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Changes in caregivers' responsive interaction will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes. Changes in children's social communication skills will be assessed using the Autism Impact Measure and the Social Communication Checklist.
Data Analytic Strategy: Linear mixed-effects modeling and linear regression models will be used to examine the efficacy of PEACE at the various implementation levels. Weighted regression methods and linear regression models will be used to assess caregiver and child outcomes for families receiving caregiver coaching. Linear mixed-effects modeling, linear regression models, and mixed methods will be used to identify provider and family characteristics associated with the need for increasing levels of implementation support. Qualitative interviews will be analyzed using an iterative process based on an integrated approach that incorporates both inductive and deductive features.
Cost Analysis: The cost analysis will take a payer (in this case, the EI system) perspective by focusing on programmatic costs and use with Time-Driven Activity-Based Costing, a micro-costing method based on process mapping. Total and per-provider costs for each randomization group and implementation strategy during the study period will be determined. Activity, personnel, and agency-level variation in costs and its determinants will be examined.
Related IES Projects: Partnering with Early Intervention Providers to Increase Implementation of Parent Coaching for Families of Children with ASD (R324B180017)