This is a single-blind, two-site randomized clinical trial which evaluated the effectiveness of the Smart Beginnings model on early school readiness in low-income families. The Smart Beginnings intervention includes a Video Interaction Project (VIP), a 14-session universal primary prevention program delivered in the pediatric clinic at the time of well-child visits from birth through 36 months, and Family Check-Up (FCU), a targeted secondary prevention home-visiting program lasting 3-4 sessions. A total of 403 mother-infant dyads were enrolled from postpartum units in Bellevue Hospital (New York, NY) and Pittsburgh Children’s Hospital (Pittsburgh, Pennsylvania) between 2015 and 2017. 201 mother-infant pairs were randomly assigned to the intervention and 202 pairs were randomly assigned to the control group.

Study outcomes are assessed via a structured parent interview (StimQ₂) and video-recorded observations of parent-child interactions that were coded based on the Parent–Child Interaction Rating Scales–Infant Adaptation. A baseline assessment was completed at recruitment within the first six weeks of the child’s life. Follow-up visits were completed at 6, 18, and 24 months. 6- and 24- month assessments were primarily conducted in the laboratory setting, and 18-month assessments were conducted in the home if feasible. Further details on the methodology can be found in the associated publications. The study will be completed in 2024 (estimated).