Development, feasibility, and acceptability of a NICU-based parent responsiveness and engagement program across two hospitals using program evaluation, pilot randomized and single-arm trial, and quality improvement methodologies

Abstract Objective Parents of infants hospitalized in neonatal intensive care units (NICUs) are at elevated risk for emotional dysregulation and distress, disrupting early parent–infant interactions and infant self-regulation. This paper describes the development, refinement, and evaluation of the feasibility and acceptability of the NICU Parent Engagement and Readiness Program (N-PREP), a brief, site-of-care intervention designed to promote parental emotional regulation and responsive caregiving. Methods Through a five-stage iterative process grounded in implementation science, N-PREP was developed and refined. Feasibility and acceptability were evaluated using session delivery metrics and semi-structured qualitative interviews. Outcomes were assessed across three small pilot implementations: a randomized delayed-start pilot trial (n = 12), a prospective single-arm trial (n = 10), and a quality improvement implementation project (n = 9) using standardized measures of parental emotional regulation, parenting self‑efficacy, sensitivity to infant cues, and bonding, along with post‑then‑pre ratings of improvement. Results Across two NICUs, intervention delivery demonstrated strong feasibility, with 94% of dyads receiving at least one session and 60% completing all four. Qualitative findings indicated high acceptability, with parents describing the intervention as supportive, appropriately timed, and responsive to emotional and practical needs during hospitalization. Quantitative findings showed within‑subject improvements across parental emotional regulation, self‑efficacy, sensitivity to infant cues, and bonding. Improvements in emotional regulation were associated with reductions in parent mood, anxiety, and trauma symptoms over time. Conclusions N-PREP is highly feasible and acceptable, with promising signals of improving emotional regulation and decreasing distress in parents and infants. Findings support further evaluation in a fully powered hybrid effectiveness-implementation trial.