Abstract
This randomized feasibility trial aimed to 1) assess methodology for a subsequent efficacy trial and 2) examine the usability and acceptability of Project BETTER's hybrid technology-delivered educational intervention for pregnant people receiving medication for opioid use disorder within a perinatal addiction treatment clinic. Participants were randomized to the technology-delivered educational intervention or standard practice control (brochure). Project BETTER's intervention offers three modules (pregnancy-to-postpartum transition, Neonatal Opioid Withdrawal Syndrome, child welfare interactions) via Computerized Intervention Authoring System (CIAS 3.0). Inclusion criteria were: ≥18 years of age, <34 weeks pregnant, currently receiving medication for opioid use disorder (MOUD), and had engaged in care ≤10 weeks during their current pregnancy. Study visits included an online survey, brief interview, and medical record review. Mean perceived helpfulness scores were compared by study condition using independent samples t-test. The screening process identified 49 potential participants, n=31 (63%) of whom were recruited. Twenty-nine participants were randomized (intervention: n=16, control: n=13). Participants (n=29) were reproductive age [M = 30.0 years (SD = 4.4)], 66% white and 31% Black with a median estimated gestational age of 24 weeks. Most participants (69%) received buprenorphine. Study completion rate was 83%. Most participants completed study components remotely. Among participants in the intervention group, 56% completed at least one module. Participants perceived the intervention to be as helpful as the brochure (intervention: 5.28 ± 0.98, control: 5.39 ± 0.56, p=0.387) and highly acceptable. With protocol modifications, scale up to a larger clinical trial is feasible and acceptable to pregnant people receiving MOUD.