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.
The initial five years of a child's life mark a critical developmental phase and a period of high sensitivity to environmental stressors, including the impact of parental mental illness (MI) and parenting stress. Research has consistently linked parental MI with a broad range of child-related issues, including irritability, sleep disturbances, and socio-emotional developmental impairments. These adverse outcomes are often attributed to environmental factors, including parental modeling of maladaptive emotion coping strategies such as avoidance and aggression and harsh parenting practices characterized by reactive discipline and conflictual interactions. Notably, when parental MI is accompanied by additional stressors such as domestic conflict or financial strains, the long-term risks for children are exacerbated. Further, the chronicity of parental MI has critical implications for children. When stressors and parental MI are persistent, the risk of adverse developmental outcomes for children increases, putting children at heightened risk for stress and development of their own psychopathology. This highlights the critical need for interventions that address parental MI and the broader spectrum of parenting stress and its multifaceted impacts on children. Despite the need for parents to improve their stress and mental health symptoms, the majority of parents do not access evidence-based treatments. Previous research has documented many barriers preventing parents from accessing care. These barriers include service backlogs, long waitlists, high costs of individual therapy, lack of information of where to access interventions, and overwhelming childcare demands. Additionally, although evidence-based treatments exist, most interventions do not comprehensively address the mental health of both parents and children. This gap in services is significant, given meta-analytic evidence indicating that dual-generation programs, which simultaneously target parent MI and child well-being, yield impacts that are 50% larger in promoting positive child outcomes compared to programs focused solely on addressing parental MI. There is a clear need to provide accessible and scalable solutions that promote positive mental health and developmental outcomes in at-risk children. Digital mental health interventions offer a potential avenue for addressing family needs and barriers to care that are an accessible and low-cost option, and research shows great promise for treating adult depression using these methods. Additional emerging research highlights the efficacy of app-based programs in improving parental MI and parent-child interactions. However, very limited existing app-based or mHealth programs address both parental mental health and parenting skills, which indirectly targets child well-being. In response to this need, the investigators conducted qualitative research (i.e., focus groups and individual interviews with parents with lived experience) and consulted with a parent advisory board to co-develop a program that simultaneously addressed parental MI and parenting. Results suggested that parents wanted accessible, online services grounded in expert research. Alongside patient-partners and community providers the investigators then developed the BEAM (Building Emotional Awareness and Mental Health) app-based program. The BEAM program is aligned with best practices in mHealth programs including patient-driven priorities, rapid-cycle iterations to facilitate continual improvements, and a commitment to evidenced-based care. Key elements of the original BEAM program include: (1) expert-led educational videos using transdiagnostic therapy and emotion-focused parenting strategies; (2) brief group sessions to consolidate therapeutic content and build social support; (3) a community forum to enhance social connection; and (4) symptom monitoring to track progress. In case of a mental health or parenting-related crisis, clinical coaches also consult via phone. BEAM builds on evidence from the investigative team's knowledge synthesis work suggesting that mHealth therapeutics can address parent MI and while appealing to parents. The BEAM intervention has consistently demonstrated promising outcomes across various trials to date. The investigative team's latest phase II RCT with mothers of toddlers found that the BEAM program outperformed a services-as-usual (SAU) control condition. Significant improvements in parental MI symptoms including anxiety, anger, and alcohol use were observed. Additionally, BEAM was effective in reducing harsh parenting practices and negative parent-child interactions, with substantial improvements observed for families living in poverty. This trial also showed noteworthy participant engagement with retention rates (84%), comparable to in-person therapy sessions. This phase of research built on and replicated the success of earlier trials with both an open pilot and pilot RCT demonstrating BEAM's efficacy in reducing MI symptoms such as depression, anxiety, anger, sleep issues, and substance use. Qualitative feedback from the initial trials emphasized the positive impact of the BEAM program on mental health and parenting, leading to enhanced quality of life and improved family relationships. Participants also highlighted the value of the social support gained through the online community. To further address family mental health needs, this trial will test the readiness of the BEAM program for scalability. The current study involves a hybrid effectiveness-implementation trial design to build on previous work. The investigators will use both effectiveness and implementation metrics including short-term follow ups of primary outcomes alongside longer-term follow-ups of mental health and socio-developmental outcomes with linked administrative data. This hybrid design follows the "type 2" model, in which effectiveness and implementation are co-primary aims and can be tracked simultaneously as the trial progresses. This approach is consistent with the investigative team's rapid-cycle program development to date in which BEAM has been tested and adapted in response to patient and provider feedback through each iteration. This implementation trial aims to maximize BEAM's accessibility, equitability, and effectiveness for future nation-wide implementation. For the current implementation trial, the investigators conducted a full App rebuild to create BEAM Version 2.0 based on participant and Parent Advisory Board feedback. BEAM 2.0 updates include improvements to psychoeducational video content (e.g. high-quality video production, animations, closed captioning), the mobile application user experience (e.g. push notifications, direct messaging, integrated video player that adjusts video quality based on available bandwidth, easy-to-navigate platform), and functionality across mobile device operating systems (iOS, Android). The weekly psychoeducational videos, short symptom tracking surveys, and social support community forum are now housed seamlessly within the BEAM app. Other aspects of the program include individual check ins with trained peer coaches, group drop-in sessions, and a connection to a systems navigator, whose role will be to support participants in accessing community resources.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
The BEAM Program builds on mHealth best practices and evidence-based program design principles with the core objectives of improving maternal mental health and fostering supportive parenting. Program content draws on transdiagnostic emotion-focused mental health and third wave Cognitive Behavioural Therapy principles such as Dialectical Behavioural Therapy, Acceptance and Commitment Therapy, and the Unified Protocol. Program delivery will be facilitated through a mobile application. The BEAM program uses a stepped care model to address the pressing need for accessible and effective mental health interventions. Stepped care is a framework that provides mental health services in a tiered manner, ensuring that participants receive appropriate levels of support based on the severity of needs. At the heart of this model are BEAM peer coaches, who will have the most direct contact with participants. Peer coaches are trained to escalate concerns to the program clinical team as required.
University of Manitoba - Department of Psychology & Pediatrics
Winnipeg, Manitoba, Canada
RECRUITINGChange in parent mental health symptom composite.
The parent mental health composite score will be defined uniquely for each participant using a weighted average of their pre-intervention (T1) mental health profile (i.e., self-report symptoms of depression, anxiety, anger, sleep problems, and parenting stress). Pre-intervention symptoms above established clinical cut-offs will be mean-centred, standardized, and included in the participant's composite mental health symptom score weighted by the symptom's pre-intervention severity. In this way, the primary outcome will track mean change in each participant's most clinically elevated pre-intervention symptoms. This composite will use validated measures of depression symptom severity (Patient Health Questionnaire-9), anxiety symptom severity (Generalized Anxiety Disorder-7), anger (PROMIS Anger), sleep disturbances (PROMIS Sleep Disturbance), and parenting stress (Parenting Stress Index - 4th Edition - Short Form). Change in each measure is also a secondary outcome, described below.
Time frame: All measures to be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Feasibility of the BEAM program.
Feasibility of the BEAM program will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ is a self-report measure with three subscales that rate ease of use (scores range from 5-35), interface and satisfaction (scores range from 7-49), and usefulness (scores range from 6-42), where high scores indicate better useability.
Time frame: To be assessed immediately after intervention (T2).
Acceptability and uptake of the BEAM program.
Acceptability and uptake of the BEAM program will be assessed in three ways: (1) rates of attrition, (2) qualitative analysis of responses to post-intervention focus group questions that probe barriers and facilitators to program engagement, and (3) program engagement measures from back-end app data (e.g., number of logins, time spent on the app, forum posts, coach engagement, drop-in session engagement, and systems navigator engagement).
Time frame: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Change in parent depressive symptoms.
Parent depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a self-report measure of depression symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depression symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in parent anxiety symptoms.
Parent anxiety symptoms will be measured using the Generalized Anxiety Disorder questionnaire (GAD-7). The GAD-7 is a self-report measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in parent anger symptoms.
Parent anger symptoms will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger scale. The PROMIS-Anger is a self-report measure of anger symptoms. Total scores range from 5 to 25, with higher scores indicating more anger symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in parent sleep problems.
Parent sleep problems will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scale. The PROMIS-Sleep Disturbance is a self-report measure of sleep disturbances. Total scores range from 8 to 40, with higher scores indicating more severe sleep disturbances.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in parent alcohol use.
Parent anxiety symptoms will be measured using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a self-report measure of alcohol consumption frequency, drinking behaviors, and frequency of alcohol-related psychological features. Total scores range from 0 to 40, with higher scores indicating more severe alcohol use problems.
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Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in parent cannabis use.
Parent anxiety symptoms will be measured using the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). The CUDIT-R is a self-report measure of cannabis consumption frequency, problems, dependence, and cannabis-related psychological features. Total scores range from 0 to 40, with higher scores indicating more severe cannabis use problems.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in parenting stress.
Parenting stress will be measured using the Parenting Stress Index - 4th Edition - Short Form (PSI-4-SF). The PSI-4-SF is a self-report measure that captures three sources of stress; from parent stress, from a difficult child, and from parent-child interactions. Total scores range from 36 to 180, with higher scores indicating more parenting stress.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in harsh parenting disciplinary practices.
Harsh parenting practices will be measured using 10 items measuring Overreactivity from The Parenting Scale (PS-Overreactivity). The PS-Overreactivity is a self-report measure of parenting behavior and dysfunctional discipline in parents with young children. Total scores range from 10 to 70, with higher scores indicating higher levels of ineffective discipline practices.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in child mental health symptoms.
Child mental health symptoms will be measured using the Child Behavior Checklist (CBCL). The CBCL is a parent-report measure of emotional and behavioral problems in children. Total scores range from 0 to 198, with higher scores indicating more mental health challenges.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in child socioemotional development.
Child socioemotional development will be measured using the Ages and Stages Questionnaires: Socioemotional, Second Edition (ASQ:SE-2). The ASQ:SE-2 is a screening tool that identifies socioemotional challenges across a range of developmental domains. The number of items on the ASQ:SE-2 depend on the age of the child. Higher scores represent more severe socioemotional challenges.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Change in child development.
Child development will be measured using the Ages and Stages Questionnaire, Third Edition (ASQ-3). The ASQ-3 is a parent-report screening tool that measures child developmental progress across domains of communication, motor, problem solving, and personal-social. The number of items on the ASQ:SE-2 depend on the age of the child. Higher scores represent a greater number of met developmental milestones and greater school readiness.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).