Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers

Abstract

BackgroundFamilies 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).MethodsThe 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.Results65 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.ConclusionsThe 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].

Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months

“…Following the ORBIT model for developing behavioral therapies to treat or prevent chronic diseases and enhance health-promoting behaviors [41,42], our research team previously conducted a phase II (preliminary testing) pilot trial of the BEAM program for mothers of children aged 18 to 36 months of age who self-reported moderate-to-severe symptoms of depression and or anxiety. The results revealed interaction effects with greater reductions in overall mental health problems among participants in the BEAM program compared to the control group [43]. Findings were used to determine the clinical impact of the program and inform improvements.…”

Telemedicine Interventions as an Attempt to Improve the Mental Health of Populations during the COVID-19 Pandemic—A Narrative Review

“…In this intervention category, four studies were included [ 33 , 34 , 35 , 36 ]. The remote mental support programme concerned different diagnosis groups of participants, both adults and adolescents.…”

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

“…Weekly meetings will occur with all clinical and research personnel to discuss and resolve questions/concerns and ensure consistent implementation. (MacKinnon et al, 2022). If participants report suicidality and/or self-harm risk in preintervention, post-intervention, or follow-up questionnaires, the clinical team will be notified.…”

“…Our pilot, non-superiority trial of the BEAM mHealth program in a (N=65) found clinically significant change in 66.7% of mothers with persistent depression (anxiety symptoms were not assessed; MacKinnon et al, 2022). Qualitative feedback suggests high acceptability (e.g., "[BEAM] was so helpful in establishing how to accomplish my goal.…”

“…Based on data from a related telehealth pilot study (MacKinnon et al, 2022), we hypothesize a mean improvement of 15.9 points (SD = 24.8) in the BEAM group and 3.2 points in the SOC group (assuming 80% smaller effect based on related meta-analyses). A 12-point change is described as a clinically significant difference.…”