Children are highly sensitive to adversity during their first five years of life, with exposure to chronic parental mental illness (MI) consistently linked to socio-emotional impairments and mental health problems in children. Children born during the COVID-19 pandemic were exposed to unprecedented level of parental distress, with parental MI reported at three times the pre-pandemic rates. This situation underscored a pressing need for scalable solutions to foster positive mental health and developmental outcomes for a generation of children. In response, the investigators developed the Building Emotional Awareness and Mental Health (BEAM) program, an innovative mobile health (mHealth) solution for parents of young children. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. This trial involves an effectiveness-implementation hybrid design with co-primary aims of (1) determining BEAM's effectiveness in improving child mental health and developmental outcomes, and (2) evaluating the implementation of BEAM in the community through metrics such as feasibility, acceptability, and uptake. The secondary aim of this trial is to measure BEAM's effectiveness in improving long-term biopsychosocial family outcomes using administrative data. A final exploratory aim of this trial will measure the cost-utility of delivering BEAM relative to extant health programming.
This trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app, with access to an online social support forum and check ins with a peer coach. Assessments of parent and child symptoms will occur at pre-test before BEAM begins (T1), immediately after the last week of the BEAM intervention (post-test, T2), 6-month follow-up (T3), and 12-month follow-up (T4).
Beginning in 2025, the trial offers participants the option to invite one parenting partner to join them in the program. A parenting partner is defined as a co-parent (e.g., the child's mother, father, or step-parent) or another primary caregiver (e.g., a grandparent, cousin, uncle, or aunt). Each participant may invite one such individual, hereafter referred to as a "co-parent." Co-parents will have access to the BEAM intervention and all its features, with the exception of peer coaching. Co-parents will be eligible to complete the same outcome measures at the same timepoints as participants. Three differences that will separate co-parents from participants are: (1) co-parents will not be asked to complete the ASQ:2-SE or ASQ-3 secondary outcome measures; (2) co-parents will not have access to peer coaching, and (3) co-parents will not be required to be experiencing moderate to severe symptoms of depression, anxiety, parenting stress, and/or anger. (Please see Eligibility \> Eligibility Criteria for the less restrictive inclusion and exclusion criteria for co-parents.) Co-parents will not be counted toward the trial sample size of n=400, and will not be included in primary analyses. Instead, co-parent data will be used in sub-studies to address exploratory research questions.
The BEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related child functioning concerns. The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program, in a next step of testing BEAM's readiness for nationwide scaling.
Moderate to severe symptoms of depression, anxiety, parenting stress, and/or anger (as measured by the PHQ-9, GAD-7, PSI, and PROMIS-Anger). Those who do not have moderate to severe symptoms will meet with a member of the program research team to determine eligibility. This eligibility decision will be based on clinical judgement, ensuring that those with need can participate.
Being a parent or primary caregiver of any gender to an 24- to 71-month-old (i.e., 2-5 year old) child.
Living in Manitoba.
Able to participate in check ins (15 to 60 minutes) via Zoom, phone, direct messaging with a parent peer coach.
Living outside of Manitoba.
Being a parent or primary caregiver to a child outside of the ages of 24- to 71-months (i.e., 2-5 years).
Previously participated in an earlier BEAM trial.
Parents who report self-harm that required medical attention within the past six months or a suicide attempt within the past year will be ineligible to participate in BEAM unless the participant is engaged in individual therapy that attends to this acute risk level with one of the following professionals for the duration of the BEAM program: psychiatrist, psychologist, social worker, or psychotherapist. The research team will email all prospective participants who are pending eligibility to schedule a phone call. This call will determine whether it is feasible to connect the participant with an individual therapist to manage specific needs before engaging in the BEAM program, and discuss if the BEAM program is the right fit for the participant's present needs.
Leslie E. Roos
Lead sponsor
University of Manitoba
Sponsor institution
Canadian Institutes of Health Research (CIHR)
Collaborator
Manitoba Centre for Health Policy
Collaborator
George & Fay Yee Centre for Healthcare Innovation
Collaborator
Children's Hospital Research Institute of Manitoba
Collaborator
Family Dynamics, Manitoba, Canada
Collaborator