Evaluating Georgia Part C Implementation Outcomes

Emory University

Status: Begins enrollment this month

Conditions: Communication Disorder, Childhood; Autism

Treatments: Other: Project ImPACT Training Plus Co-Production; Other: Project ImPACT Training As Usual; Behavioral: Routine Project ImPACT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07148258

STUDY00010098

1K23MH130651-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study aims to answer the question: What is the best way to help Early Intervention (EI) providers deliver high-quality services to children with communication delays for autism?

The primary goal of this project is to examine the outcomes associated with delivering Project ImPACT, an evidence-based autism intervention that is delivered as part of routine training within Georgia's EI system. Providers in the study will receive one of two Project ImPACT training models to help us understand which training model helps providers learn Project ImPACT better. Specifically, this study will examine the: 1) the process and quality by which Project ImPACT is implemented and adapted by EI providers across the two training conditions; 2) factors that impact how well Project ImPACT is implemented; and 3) the child (i.e., social communication) and family (i.e., parent empowerment and fidelity) outcomes associated with receiving Project ImPACT.

Full description

This study aims to determine the: 1) implementation outcomes; and 2) preliminary parent and child outcomes associated with Project ImPACT when implemented within the Georgia Early Intervention (EI) system. 150 EI providers will be trained in one of two Project ImPACT training models. Training will include the option for group consultation. This training is part of standard training requirements, so it is not considered research.

Participating caregivers who receive Project ImPACT will receive the program as part of their routine EI services. They will have two options to participate in this research: 1) complete surveys before and after participation in Project ImPACT (each set will take 20-30 minutes), as well as an exit interview; or 2) complete a confidential survey only after participating in Project ImPACT, which will take 20-30 minutes. All research activities will be conducted at the Marcus Autism Center.

Enrollment: 80 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Providers:

• Currently employed or contracted by Georgia's EI system
• Maintain an active therapy caseload
• Fluent in English.

Inclusion Criteria for Caregivers:

• Have a child under 36 months currently enrolled in services through Georgia's Early Intervention system
• Are being seen by a provider participating in Project ImPACT training and research
• Fluent in English.

Exclusion Criteria for both Providers and Caregivers:

• Not meeting the eligibility criteria.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Early Intervention (EI) providers

Other group

Description:

Early Intervention (EI) providers who serve young children with social communication delays and/or autism will report on their experiences delivering Project ImPACT via one of two training models. Providers will have the option of consenting to share videos of their Project ImPACT sessions to help us understand the quality of Project ImPACT delivery.

Treatment:

Other: Project ImPACT Training As Usual

Other: Project ImPACT Training Plus Co-Production

Caregivers

Other group

Description:

Caregivers of children under 36 months of age in the Georgia EI system who are receiving services within the EI system will report on their experiences with the providers who have been trained in one of the two Project ImPACT models. Caregivers will either: 1) complete surveys before and after they receive Project ImPACT, or 2) complete a confidential survey after receiving Project ImPACT from their provider. Caregivers will have the option of consenting to share videos of their Project ImPACT sessions to help us understand the quality of Project ImPACT delivery.

Treatment:

Behavioral: Routine Project ImPACT