NCT07148258|Recruiting
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Sponsor study identifier
Secondary identifiers
OTHER · Emory IRB
interventional
20
1 country
1
Study Start
September 3, 2025
Actual (reported)Primary Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 22, 2025
Actual (reported)August 29, 2025
Actual (reported)September 3, 2025
Actual (reported)September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Project ImPACT Coaching Fidelity
Providers' Project ImPACT therapy sessions will be video recorded and will be scored retrospectively for use of core Project ImPACT strategies. The research team will measure the project fidelity by watching recorded videos of the sessions, which will allow the team to capture how effectively the adult implements a strategy. This will be scored using the Project ImPACT fidelity checklist. Provider fidelity for each intervention strategy will be rated by a trained coder using a 5-point Likert scale, with scores of 4 or greater indicating appropriate fidelity. An average score of 4 or higher on all of the strategies indicates that fidelity has been met for Project ImPACT.
Biweekly up to 20 weeks
Provider Co-Production Quality
Following each therapy session, providers will complete a brief 20-item survey in which they will be asked what their session looked like and the rationale for any adaptations described. Providers will first indicate how long in minutes their Project ImPACT session was. They will also indicate which Project ImPACT coaching activities they completed in their session (yes/no). Providers will then be asked to indicate which of 10 additional non-Project ImPACT topics they covered in their session and subsequently how long in minutes they spent covering the additional topics. The following information will then be calculated for each session: 1) Percent of possible coaching elements delivered; 2) Percent of time spent covering additional topics; 3) Percent of time delivering other topics.
Baseline; Weekly up to 12 weeks, and 6-months
Project ImPACT Self-Efficacy.
Baseline, 1-month after baseline (post-Project ImPACT training), and 12 months
Perceived Characteristics of the Intervention Scale (Project ImPACT Perceptions)
Study completion (on average 12 months)
The Family Outcome Survey (caregivers)
Baseline and study completion (on average 6 months)
Parent Observation of Social Interaction
Baseline
Social Communication Checklist (caregivers)
Baseline and study completion (on average 6 months)
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.
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.
Project ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. The typical training model for Project ImPACT includes a 6-hour, interactive online tutorial that walks providers through the core Project ImPACT intervention strategies. After completing the online tutorial, providers attend a live interactive workshop virtually that is spread across 4, 3.5-hour days (14 hours total). Providers receive 1 hour of consultation once every other week for an hour from a trained Project ImPACT consultant (research staff member) following training.
Marcus Autism Center
Atlanta, Georgia, 30329, United States
Katherine E. Pickard, PhD
Emory University
First Submitted
August 22, 2025
First Posted
August 29, 2025
Study Start
September 3, 2025
Actual (reported)Primary Completion
September 2028
EstimatedProject ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. The second cohort for Project ImPACT training is a model in which providers receive the same typical Project ImPACT training activities, in addition to three supplemental modules on other common areas of concern for families and how best to integrate other topics within Project ImPACT to meet the diverse needs of families.
Project ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. Project ImPACT is delivered with parents meeting once or twice each week for one hour over 12- 16 weeks. In each session, parents receive: 1) didactic instruction in intervention strategies; 2) modeling of the intervention techniques by the therapist; 3) live coaching from the therapist while practicing the strategies with their child; and 4) homework to practice the strategies at home with their child, 20 minutes each day across meaningful home routines.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 19, 2026
Record last verified: 2026-05
The research team will share the data related to the primary study outcomes and study protocol.
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Source: ClinicalTrials.gov.
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