Evaluating Georgia Part C Implementation Outcomes
- Conditions
- Communication Disorder, ChildhoodAutism
- Registration Number
- NCT07148258
- Lead Sponsor
- Emory University
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Project ImPACT Coaching Fidelity Biweekly up to 20 weeks 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.
Provider Co-Production Quality Baseline; Weekly up to 12 weeks, and 6-months 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.
- Secondary Outcome Measures
Name Time Method Project ImPACT Self-Efficacy. Baseline, 1-month after baseline (post-Project ImPACT training), and 12 months Providers will rate their self-efficacy using a 7-item measure that asks about their perceived skills delivering Project ImPACT core strategies. Providers will rate each item using a 10-point Likert scale
Perceived Characteristics of the Intervention Scale (Project ImPACT Perceptions) Study completion (on average 12 months) All providers will complete the Perceived Characteristics of the Intervention Scale (PCIS). The PCIS is a 20-item questionnaire that measures the perceived characteristics of an intervention that are thought to impact its uptake and use. The current study will use an abbreviated measure that includes the following dimensions: Relative Advantage (e.g., "Project ImPACT is more effective than other therapies I have used"), Compatibility (e.g., "Project ImPACT is aligned with my clinical judgement"), Complexity (e.g., "Project ImPACT is easy to use"), and Potential for Reinvention (e.g., "Project ImPACT can be adapted to meet the needs of my patients"). Participants will rate each item on a 5-point Likert scale (1 = not at all, 5 = to a very great extent). Higher scores generally indicate more positive perceptions of the intervention.
The Family Outcome Survey (caregivers) Baseline and study completion (on average 6 months) The Family Outcome Survey (FOS) measures family outcomes expected to change through participation in early intervention programs for children with disabilities and their caregivers. The FOS includes five outcomes: understanding your child's strengths, needs, and abilities; knowing your rights and advocating for your child; helping your child develop and learn; having support systems; and accessing the community. The FOS comprises 24 items, with four to six items per outcome. Responses range from not at all (1) to completely (5). To get overall scores, all the responses are summed for the items within each of the five outcome areas and the three helpfulness indicators.
The Early Childhood Technical Assistance (ECTA) Center recommends that scores of 5 or greater on the family outcome items be considered an indicator of outcome attainment. Scores below 5 may indicate areas requiring further improvementParent Observation of Social Interaction Baseline Parent Observation of Social Interaction (POSI). The POSI is a 7-item measure that asks caregivers to rate their child's use of social communication skills, including communication, gesturing, and play, with each question scored as either 0 or 1. A score of 3 or more indicates a positive screen, suggesting the child may be at risk and warrants further evaluation.
Social Communication Checklist (caregivers) Baseline and study completion (on average 6 months) Social Communication Checklist (SCC). The SCC was developed as part of the Project ImPACT curriculum. The SCC is a 70-item checklist; respondents indicate if a child uses each skill, "Rarely/Not Yet (1)," "Sometimes, but not consistently (2)," or "Usually, at least 75% of the time (3)." Items correspond with the social communication domains targeted in Project ImPACT: 10 social engagement items, 24 language/ communication items, and 13 imitation/play items, and were summed for domain scores and a Total Score. Each item reflecting abnormal behavior scores 1 point; others score 0.
Total Scores: Range from 0 to 39 for verbal children and 0-33 for nonverbal children. Higher scores indicate greater social communication impairment.Project ImPACT Fidelity for Parents. Baseline and study completion (on average 6 months) The project fidelity for Parent behavior will be scored for correct use of the Project ImPACT intervention techniques during the first and final Project ImPACT sessions using the Project ImPACT fidelity checklist. Parent 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.
Project ImPACT Satisfaction. Study completion (on average 6 months) All parents will complete a 16-item survey examining: 1) treatment acceptability; 2) perceived child social communication gains; 3) burden of the treatment on the family; and 4) frequency of program use. Parents rated their agreement with statements reflecting these domains on a 7-point Likert scale.
Trial Locations
- Locations (1)
Marcus Autism Center
🇺🇸Atlanta, Georgia, United States
Marcus Autism Center🇺🇸Atlanta, Georgia, United States