Trial Outcomes & Findings for A Trial of Project ImPACT in Early Intervention (NCT NCT04729127)

Parent/Children dyads were enrolled in the study and counted as 1 family. The total number includes the number of individual parents and children enrolled together as a dyad and individual early intervention providers that were enrolled.

Sex/gender was not collected for caregiver participants in all treatment groups. The sociodemographic form did not contain questions about the sex/gender of caregiver participants. The overall count will be 0 for caregiver participants across treatment groups.

The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.

The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.

The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.

Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching). Each item is scored as 0, 1 or 2. 0 = Behavior absent, not observed 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.

Parent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item.

Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.

The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.

The PEACE Fidelity Tool measures a provider's caregiver coaching quality by evaluating the quality and use of evidence based caregiver coaching strategies during recorded EI session across 5 domains (collaboration, daily routines, demonstration, practice and feedback, and reflection). The tool consists of 25 items scored on a 5 point scale from 1-5. Domains and total scores are calculated by averaging items. Scores can range from 1-5, with higher scores indicating better coaching competency and quality.