Abstract
BACKGROUND: The United States continues to experience an alarming rise in opioid use that includes women who become pregnant and related neonatal abstinence syndrome (NAS) in newborns. Most newborns experiencing NAS require nonpharmacological care, which entails, most importantly, maternal involvement with the newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies when they are pregnant; however, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, partly because no education, training, or other interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. OBJECTIVE: In this paper, we describe a mixed methods, multistage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled trial. METHODS: Stage 1 will include 20 semistructured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected newborns to gather their recommendations on the management of NAS and explore their perspectives on the care of these newborns. The findings will guide the adaptation of existing mobile NAS tools for high-risk pregnant women. In stage 2, we will test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT). Finally, in stage 3, we will randomize 30 high-risk pregnant women receiving OAT to either receive the adapted mobile NAS caregiving tool or usual care. We will compare these women on primary outcomes-maternal drug relapse and OAT continuation-and secondary outcomes-maternal-newborn bonding; length of newborn hospital stays; readmission rates; breastfeeding initiation and duration; and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. RESULTS: This project was funded in July 2020 and approved by the institutional review board in April 2020. Data collection for stage 1 began in December 2020, and as of January 2021, we completed 18 semistructured interviews (10 with NAS providers and 8 with perinatal women receiving OAT). Common themes from all interviews will be analyzed in spring 2021 to inform the adaptation of the NAS caregiving tool. The results from stage 1 are expected to be published in summer 2021. Stage 2 data collection will commence in fall 2021. CONCLUSIONS: The findings of this study have the potential to improve NAS care and maternal-newborn outcomes and lead to commercialized product development. If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT04783558; https://clinicaltrials.gov/ct2/show/NCT04783558. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27382.