Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT07148258
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Georgia Part C Implementation Outcomes
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Evaluating Georgia Part C Implementation Outcomes
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23MH130651-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |
| 2025P013101 | OTHER | Emory IRB | View |