Trial design {8}
OUD
This is a single-site cluster randomized controlled trial. One hundred eight pregnant and parenting women receiving treatment for OUD from one single opioid treatment program will be enrolled into the study. Twenty-six consecutive clusters—based on the one-month birth intervals of participants’ infants—of ~ 4 dyads will be randomized in a 1:1 ratio to one of two study arms. Thirteen clusters will be randomized to individual WCC (control group), and 13 birth clusters will be randomized to group WCC (intervention arm), with concealment of randomization from participants until after they have completed their initial enrollment study visit, or, for those who are pregnant at time of enrollment, immediately following delivery. Randomization by birth month was selected to ensure a close age range among infants receiving group WCC together in the intervention arm. Blocking or stratification was not used in the randomization. Dyads in both study arms will be followed prospectively for 18 months, and data will be compared between the two study arms. Primary outcomes include well child care quality and utilization, child health knowledge, and parenting quality. We hypothesize that at the end of the study period, participants in the intervention arm will have increased WCC engagement, knowledge about parenting, and maternal responsiveness compared to participants in the control arm.