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. The study's objective is to examine the feasibility of the BEAM program when delivered with a community partner to inform a larger randomized controlled trial (RCT). METHODS: A pilot RCT will be conducted with mothers who have depression and/or anxiety with a child 6-18 months old living in Manitoba, Canada. Mothers will be randomized to the 10 weeks of the BEAM program or a standard of care (i.e., MoodMission). Back-end App data (collected via Google Analytics and Firebase) will be used to examine feasibility, engagement, and accessibility of the BEAM program; cost-effectiveness will also be examined. Implementation elements (e.g., maternal depression [Patient Health Questionnaire-9] and anxiety [Generalized Anxiety Disorder-7]) will be piloted to estimate the effect size and variance for future sample size calculations. DISCUSSION: In partnership with a local family agency, BEAM holds the potential to promote maternal-child health via a cost-effective and an easily accessible program designed to scale. Results will provide insight into the feasibility of the BEAM program and will inform future RCTs. TRIAL REGISTRATION {2A}: This trial was retrospectively registered with ClinicalTrial.gov ( NCT05398107 ) on May 31st, 2022.
ABSTRACT
Background: Families have faced unprecedented challenges during the COVID-19 pandemic, leading to increased maternal mental health problems and barriers to accessing care. Innovative programs are needed to support both maternal mental health and parenting, and to buffer the long-term impacts of stress on young children. Using a patient-oriented approach, our research team aimed to co-develop and pilot test an App-based psychoeducation and social-connection platform: Building Emotional Awareness and Mental Health (BEAM). Methods: The co-development process involved a parent advisory board from conceptualization and design, through to direct participation in the program delivery. The BEAM program includes weekly videos and activities based on Unified Protocol therapy modules and emotion-focused parenting strategies, a weekly telehealth group review session, and access to a private online forum for support from other mothers and clinical coaches. A parallel randomized control trial was conducted across two provinces in Canada. Mothers of preschool children (aged 18-36 months old), with moderate-to-severe depression (Patient Health Questionaire-9 ≥ 10), were recruited online and randomized to either the 10-week BEAM intervention or treatment as usual (TAU) control group. Online surveys (ensuring researcher blinding) included questions about feasibility and acceptability of the program and pre/post self-report measures of mental health, parenting, positive coping and child behavior outcomes. The primary outcome measures were symptoms of depression and parenting stress. Data were analyzed using mixed models and an intention-to-treat approach. Results: 65 participants were randomized, by an online allocation tool, to the BEAM (n = 33) and TAU (n = 32) groups. Engagement was relatively high at the beginning of the program, with 78.8% starting the BEAM App and 70.6% attending ≥1 telehealth session. Most respondents felt socially supported, satisfied with the App, and found it easy to use. Pre-post results indicated interaction effects with greater reductions in overall mental health problems, and specifically anxiety and sleep symptoms, among BEAM vs. control participants. There were also time effects with reductions in depression symptoms across both groups. No significant treatment effects emerged for the other mental health symptoms, parenting problems, positive coping, or child behavior outcomes. Descriptive data are included to highlight possible areas of promise for future large efficacy trials. Technological difficulties and other challenges that may have led to attrition and impacted outcomes are discussed. There were no adverse events related to study participation. Conclusions: The BEAM program has promise as a novel, feasible and acceptable intervention for improving mental health among mothers of young children. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT04772677].