Participants and Study Design
cleft palate, mental illness, RP
DISORDER, RECRUITMENT
Mother-infant dyads were recruited shortly after delivery from the mother-infant nursery at Augusta University Medical Center in Augusta, Georgia. Recruitment spanned spring 2018 through spring 2021, with a pause from March 9 to August 31, 2020, due to the COVID-19 pandemic. Mothers were eligible if they were primiparous, aged at least 17 years, self-identified as Black or African American, spoke English, and lived within 75 miles of Augusta, Georgia. Eligible infants were singleton, had a gestational age of at least 37 weeks, and weighed at least 2500 g at birth. Dyads were excluded if the mother had a known medical condition that could impact postnatal care (eg, serious mental illness, substance use disorder), the infant had a medical condition impacting feeding or growth (eg, cleft palate), there was an adoption plan in place, or there was a plan to move out of the area within 4 months of delivery. Ethnicity was self-reported as Hispanic or non-Hispanic. Ethnicity data were collected to characterize the cohort.Mother-infant dyads received home visits from trained community research associates (CRAs) at approximately 1, 3, 8, and 16 weeks post partum. To minimize bias during the assessments, separate CRAs served as data collectors (at 1, 8, and 16 weeks) and intervention facilitators (at 3 and 8 weeks). Furthermore, intervention facilitators were trained in (and subsequently delivered) only 1 of the 2 study interventions (RP or safety control). CRAs and study participants were unaware of which condition was the experimental condition. Participating mothers received $50 after the 1-week visit, $50 after the 3-week visit, $100 after the 8-week visit, and $100 after the 16-week visit.Participants were randomized to receive the RP intervention or the child safety control intervention after the 1-week data collection visit. Randomization was stratified by sex-specific birth weight for gestational age (<50th percentile or >50th percentile) and intended feeding mode (breastfeeding or formula). Randomization was performed using a secure Microsoft Excel application prepared by a statistician unaffiliated with the study and administered by the study’s project coordinator.