The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: A study protocol for a pilot randomized controlled trial

Abstract

Background: Drastic increases in the rates of maternal depression and anxiety have been reported since the COVID-19 pandemic began. Most programs aim to improve maternal mental health or parenting skills separately, despite it being more effective to target both concurrently. The Building Emotional Awareness and Mental health (BEAM) program was developed to address this gap. BEAM is a mobile health program aiming to mitigate the impacts of pandemic stress on family well-being. Since many family agencies lack infrastructure and personnel to adequately treat maternal mental health concerns, a partnership will occur with Family Dynamics (a local family agency) to address this unmet need. This study aims to examine (1) the efficacy of BEAM, vs. standard of care, at reducing negative mental health, parenting, and child outcomes and (2) the efficacy/feasibility/acceptability of BEAM, vs. standard of care, while exploring opportunities for program development. Methods: A randomized controlled trial will compare 10 weeks of the BEAM program to standard of care among 160 (80 per group) mothers who have depression and/or anxiety and children 6-18 months old living in Manitoba, Canada. Primary (maternal depression [Patient Health Questionnaire-9] and/or anxiety [Generalized Anxiety Disorder-7]), secondary (other maternal mental health, parenting, and child outcomes), and exploratory (e.g., relationship functioning, cost effectiveness) outcomes will be self-reported at three time-points. Google Analytics and back-end App data will be used to assess the efficacy, feasibility, and acceptability of the BEAM program. A longitudinal analysis of covariance, using linear mixed modeling, will test treatment effects on outcomes of interest.Discussion: In partnership with a local family agency, BEAM holds the potential to promote maternal-child health via a cost-effective and easily accessible program designed to scale. Results may inform care and increase access to first line care for families typically waiting 12+ months to access mental health and parenting services. Trial Registration: This trial was registered with ClinicalTrial.gov on May 31st, 2022 (NCT05398107)