Evaluating Georgia Part C Implementation Outcomes

NCT07148258 | Recruiting

• 3 other identifiers: STUDY000100981K23MH130651-01A12025P013101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication Disorder, Childhood; Autism

Keywords

Caregivers; Early Intervention (EI) Providers; Early Intervention System; Project ImPACT; Social communication delays

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• 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)

Study Arms (2)

Early Intervention (EI) providers

OTHER

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.

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

Caregivers

OTHER

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.

Behavioral: Routine Project ImPACT

Interventions

Project ImPACT Training As Usual OTHER

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.

Also known as: Usual ImPACT

Early Intervention (EI) providers

Project ImPACT Training Plus Co-Production OTHER

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 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.

Also known as: Usual ImPACT + Supplements

Early Intervention (EI) providers

Routine Project ImPACT BEHAVIORAL

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.

Caregivers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not meeting the eligibility criteria.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Georgia Department of Public Health: collaborator
• Emory University: lead

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Communication Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Officials

• Katherine E. Pickard, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine E. Pickard, PhD

CONTACT

404-7859491; katherine.e.pickard@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared by the research team after the study has been completed.
• Access Criteria: The research team will share the data through the NIH's NDAR (National Database for Autism Research).

Locations

US (1)