Building Emotional Awareness and Mental Health (BEAM): study protocol for a hybrid implementation-effectiveness trial of the BEAM app-based program for parents with clinical mental health problems | BMC Psychiatry

Intervention description {11a}

The BEAM Program is built upon mHealth best practices and evidence-based program design principles, with the core objectives of improving parental mental health and fostering supportive parenting. The program’s delivery will be facilitated through a mobile application, developed and overseen by MindSea. The BEAM program is a 12-week app-based mental health and parenting intervention, appropriate for the treatment of transdiagnostic emotion-based mental health symptoms (e.g., mood, anxiety, anger). In the 12-week self-guided BEAM program, participants will complete modules with a cohort of 40 to 80 parents. Each week includes: (a) 15–20 min of therapeutic video content, (b) exercises to practice key skills, (c) access to the online forum to cultivate social support through interaction with other parents and peer coaches, (d) individual check ins with peer coaches (i.e., trained and supervised staff with lived experience, employed by the University of Manitoba) via videoconference, phone, or direct messaging, lasting between 15 to 60 min depending on needs and preferences of participants, (e) a brief in-app survey for symptom monitoring to track progress across well-being and parenting metrics. Over the course of the program, participants will be invited to optional group drop-in sessions (e.g., tea and chat) facilitated by peer coaches on Zoom for Healthcare to connect and discuss program content and/or invite experts to discuss and answer questions for topics of interest identified by participants. Participants will also be connected with a Systems Navigator who can support them in accessing other resources (e.g., childcare programs, legal aid, housing) within their community. Peer coaches will be supervised at arm’s length by our clinical research team and will monitor the forums (i.e., encourage discussion, provide support) and lead all check ins with participants. The clinical research team will train peer coaches to flag signs of acute mental health risks, such as suicidal ideation, in which case the clinical team will assess the next steps for supporting the parent (e.g., crisis support resources). Additionally, peer coaches will be trained to deliver the BEAM program with fidelity by the research team (including recruitment, enrolment, participant tracking, coaching, and all aspects of delivery) using materials we have developed. The BEAM program aims to address the pressing need for accessible and effective mental health interventions by adopting a stepped care model. Stepped care is a comprehensive framework that offers a structured approach to providing mental health services in a tiered manner, ensuring that participants receive appropriate levels of support based on the severity of their needs. Within BEAM, at the heart of this model are peer coaches, who will have the most direct contact with participants. Peer coaches will monitor the online forum, facilitate individual check ins, and facilitate group drop ins. Peer coaches are supervised directly by a registered clinical psychologist, and will be trained to escalate concerns to our clinical team (i.e., clinical psychologists, senior students in clinical psychology) as needed.

Core components of the BEAM program are more thoroughly described below:

Each week, 15 to 20 min of therapeutic video content will be released on the BEAM mobile application. Videos will consist of psychoeducational parenting and mental health content. Parenting content was developed by Dr. Roos using emotion-focused parenting, parent management training, and attachment parenting theoretical orientations. Mental health content was developed by Dr. Roos and Dr. Tomfohr-Madsen drawing from 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. Short weekly exercises will be released within the app alongside the therapeutic video content. Participants will be able to open the exercises and complete it using their device. The purpose of these exercises is to allow for the opportunity to practice key skills and consolidate program content.

Participants will complete a brief survey every week (i.e., modified symptom rating sliding scale, see Appendix 1; Appendix 2) within the BEAM app for symptom monitoring and feedback informed treatment. Each completed weekly survey will populate a graph in the app, displaying the trends of the participants’ symptom scores over time. This graph is visible to researchers, participants and their peer coach and can be discussed during check ins.

Each participant will have individual 15 to 60-min check-ins with a peer coach. These check-ins will occur at a frequency defined by the participant in consultation with the peer coach, and may occur anywhere from weekly to monthly. The first check-in of the program will be an orientation, where program goals are reviewed and participants can have their questions answered. Subsequent check ins will have coaches asking participants how they are feeling as they progress through the program materials and content. These check-ins are intended to support program progression and to answer any program-related questions. Participant attendance at these check ins will be tracked. Check-ins will take place through Zoom for Healthcare, phone, or direct messaging based on participant preference, needs, and availability. Participants will schedule their check-in using the scheduling software Calendly. Participants will be sent a link with the peer coach’s monthly availability and will be asked to input their first name and personal email to schedule an appointment. Calendly invitee data (i.e., first name and email) is hosted by Google and Amazon Web Services in the United States. Calendly data will not be linked to the BEAM app or BEAM data in any manner.

Participants will also have access to the app-based online forum to cultivate social support through interaction with other parents and peer coaches. The forum will be monitored by peer coaches who will also be active in the forum providing support and prompting discussion. Peer coaches will also facilitate optional drop-in groups via Zoom for Healthcare to provide an additional opportunity for participants to connect with peers and discuss program content.

All participants will be connected to a Systems Navigator who can support participants in accessing a wide variety of services. The Systems Navigator can connect participants to community resources such as housing supports, couples counselling, fun kids summer activities, culturally aligned resources and programming, and meet ups at community centres for to support ongoing relationship building. To ensure that the implementation of this Systems Navigator service aligns with the needs of our community partners, we hosted a Knowledge Exchange event with front-line service providers and community workers. At this event, we discussed the acceptability and feasibility of connecting their organizations and/or resource centres with a Systems Navigator. We will work to implement their feedback to ensure the Systems Navigator role appropriately supports parents and families. Additionally, we are building reciprocal relationships with community organizations where they will recommend parents to the BEAM program and our System Navigator will recommend parents back to their organizations for community services.

Criteria for discontinuing or modifying allocated interventions {11b}

Should participants disclose suicidal behaviour, peer coaches will notify the clinical team. The clinical team will meet independent of the peer coaches to advise on whether or not continued participation in the BEAM program is in the best interest of the participant. In accordance with Best Practice Guidelines for Telepsychology Services, clinical research staff may also decide to terminate a participant’s involvement in the mHealth program if they deem it inappropriate for the participant to continue (e.g., if the participant cannot ensure confidentiality is maintained through access to a secure space and stable internet connection) [46]. Furthermore, participants may have discontinued access to the forum and may be denied access to the drop-in sessions if they engage in repeated violations of the terms of use. In these cases, participants would still have access to psychoeducation materials and would still be invited to do the assessments. The peer coaches may also provide a referral to another provider or clinic if deemed appropriate.

Strategies to improve adherence to interventions {11c}

The proposed trial incorporates strategies such as reminders via in-app messaging, email, and telephone (SMS), which have also been shown to increase engagement [47]. Participants will be contacted through email by their peer coach if they have not attended check ins or engaged with the program material. Peer coaches will also be assigned to facilitate and promote participant engagement on the forum.

Relevant concomitant care permitted or prohibited during the trial {11 d}

Participants will be permitted to receive concomitant care for mental health problems, such as psychotherapy, medication, and/or support groups. No concomitant care and interventions are prohibited. Concomitant care and interventions will be measured so they can be controlled for in analyses.

Provisions for post-trial care {30}

If further treatment is deemed necessary, a referral to another provider or clinic will be made, and a list of community services will be provided.

Outcomes {12}

Primary outcomes

This trial has co-primary aims evaluating: (1) BEAM’s effectiveness in improving parent mental health outcomes, and (2) the implementation of BEAM in the community through metrics of feasibility, acceptability, and uptake.

The co-primary effectiveness outcome is mean change in a composite score of parent mental health symptoms across all four timepoints: pre-intervention (T1), post-intervention (T2), 6-month follow-up (T3), and 12-month follow-up (T4). This 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, and sleep problems). 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. Depressive symptoms will be assessed using the PHQ-9 [42], a 9-item self-report measure of depression severity. Each item taps the frequency of depressive symptoms over the past week on a 4-point Likert scale (0 = not at all to 3 = nearly every day). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. A PHQ-9 cut-off score of ≥ 10 will identify participants with clinically elevated symptoms of depression. Anxiety symptoms will be assessed using the GAD-7 [43], a 7-item self-report measure of anxiety severity. Each item taps the frequency of anxiety symptoms over the past week on a 4-point Likert scale (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. A GAD-7 cut-off of ≥ 10 will identify participants with clinically elevated symptoms of anxiety. Anger will be assessed using the PROMIS Short Form, a 5-item self-report measure of anger frequency and severity [45]. Total scores range from 5 to 25, with higher scores indicating more anger. A PROMIS cut-off ≥ 16 will identify participants with clinically elevated anger symptoms. Sleep problems will be measured using the PROMIS Sleep Disturbance Scale, an 8-item self-report measure of sleep disturbances [48]. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A PROMIS Sleep Disturbance Scale cut-off ≥ 30 will identify participants with clinically elevated sleep disturbances. All outcome measures are outlined in Table 1. We have obtained the necessary licenses to use all instruments mentioned in the protocol, ensuring compliance with their respective copyright and usage requirements.

The co-primary implementation metrics of feasibility, acceptability, and uptake when BEAM is implemented in the community will be assessed relative to previous trial benchmarks. Feasibility of the BEAM program will be assessed at post-intervention using the mHealth App Usability Questionnaire (MAUQ) [49] and other questionnaires developed for the BEAM program. Acceptability and uptake of the BEAM program will be assessed in three ways: (1) rates of recruitment, retention, (2) qualitative analysis of responses to post-intervention focus group questions that probe barriers and facilitators to program engagement, and (3) general program engagement measures from back-end app data. A list of implementation outcomes are outlined in Table 2.

Secondary outcomes

Secondary outcomes include mean change in parent mental health symptoms, harsh parenting behaviour, child mental health symptoms, child development, and child school readiness across all four timepoints: pre-intervention (T1), post-intervention (T2), 6-month follow-up (T3), and 12-month follow-up (T4). Change in parent mental health symptoms of depression, anxiety, anger, and sleep problems will be respectively measured by the PHQ-9, GAD-7, PROMIS Short Form, and PROMIS Sleep Disturbance scales, as previously defined [42, 43, 45, 48]. Mean change in substance use will also be assessed using the 10-item Alcohol Use Disorders Identification Test (AUDIT) [50] and 8-item Cannabis Use Disorders Identification Test – Revised (CUDIT-R) [51]. The AUDIT measures frequency of alcohol consumption, drinking behaviours, and alcohol-related psychological features. Total scores on the AUDIT range from 0 to 40, with higher scores indicating more severe alcohol use problems. The CUDIT-R measures frequency of cannabis consumption, problems, dependence, and cannabis-related psychological features. Total scores on the CUDIT-R range from 0 to 40, with higher scores indicating more severe cannabis use problems.

Other secondary measures include mean change in parenting stress and harsh parenting across all four timepoints: pre-intervention (T1), post-intervention (T2), 6-month follow-up (T3), and 12-month follow-up (T4). Mean change in parenting stress will be assessed using the 36-item PSI-4-SF [44], a self-report measure of parental stress due to individual parent and child factors as well as parent–child interactions. Total PSI-4-SF scores range from 36 to 180, with higher scores indicating higher levels of parenting stress. Mean change in harsh parenting disciplinary practices will be assessed using the Parenting Scale [52], a 30-item self-report measure that assesses parenting behavior and dysfunctional discipline in parents with young children. Total scores range from 30 to 210, with higher scores indicating higher levels of ineffective discipline practices.

Mean change in child mental health, development, and school readiness will similarly be measured across all four timepoints. Child mental health symptoms will be assessed at each timepoint using the CBCL [53], a parent-report questionnaire that is used to detect behavioural and emotional problems in children. The CBCL demonstrates adequate internal reliability (α’s ≥ 0.78) and has precedent as a measure of change in intervention research [46, 54,55,56]. The CBCL includes 99 items in which parents are asked to rate their child on how true each item is from 0 (not true) to 2 (very true or often true of the child). Possible scores range from 0 to 198, where higher scores indicate more mental health symptoms. Items are scored on the following syndrome scales: emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems, aggressive behaviour, and sleep problems. The CBCL total score and syndrome scores will be examined. Change in child socioemotional development will be assessed using the Ages and Stages Questionnaires: Socioemotional, Second Edition (ASQ:SE-2), a screening tool that identifies socioemotional challenges across a range of developmental domains [57]. Different versions of the ASQ:SE-2 exist depending on the age of the child. For this trial, five versions of the ASQ:SE-2 cover the age of all eligible children. Depending on version, the ASQ:SE-2 has approximately 30 items which sum to a total score. Higher scores represent more severe socioemotional challenges. Change in child school readiness will be measured by the Ages and Stages Questionnaire, Third Edition (ASQ-3), a parent-report screening tool that taps child developmental progress across domains of communication, motor, problem solving, and personal-social [57]. Nine versions of the ASQ-3 cover the age of all eligible children. The ASQ-3 contains 30-items which sum to a total score. Higher scores represent a greater number of met developmental milestones, indicative of school readiness.

Exploratory outcomes

Exploratory outcomes include changes in positive parenting behaviour and social support [58]. Change in positive parenting will be measured by four items of the PSI-4-SF that tap parenting self-efficacy [44, 59, 60]. Change in social support will be measured using the SSEQ [61]. Total scores range from 0 to 80, with higher scores representing greater social support effectiveness [57].

Exploratory mediators and moderators of change include discrimination, adverse childhood experiences, concomitant service utilization, food insecurity, housing instability, therapeutic alliance, and participant sociodemographic and socioeconomic characteristics (Table 3). Discrimination will be measured using the Everyday Discrimination Scale (EDS), a 5-item self-report scale measuring subjective experiences of discrimination [62]. Adverse childhood experiences will be assessed with the Adverse Childhood Experiences (ACEs) questionnaire. [63]. Total scores range from 0 to 10, with higher scores indicating more adverse experiences in early childhood. Concomitant service utilization will be measured by a self-report questionnaire developed for the BEAM program that is meant to supplement the collected administrative data. The service utilization questionnaire asks about the total number of contacts and total contact hours with a variety of acute (e.g., hospitalization), primary (e.g., family doctor visit), and community-based services (e.g., child care centres, family resource centres). Food insecurity will be assessed by the Household Food Security Survey Module (HFSSM) from the Canadian Community Health Survey [64]. The HFSSM taps household food insecurity over the past 12 months. Total scores range from 0 to 16, with higher scores indicating greater food insecurity. Such use of questionnaires from the Canadian federal government will enable comparison of BEAM participant food security and housing stability with Canadian population averages. Housing instability will be measured by the Housing Instability Scale (HIS) [65]. The HIS taps housing instability over the past 6 months. Total scores range from 0 to 7, with higher scores indicating greater housing instability [66]. Therapeutic alliance between the peer coaches and participants will also be assessed using the Brief Revised Working Alliance Inventory (BR-WAI), a 16-item measure assessing bonds, tasks, and goals within the therapeutic relationship [67]. Finally, participant sociodemographic and socioeconomic information will be assessed by a questionnaire developed for the BEAM program. This questionnaire asks about parent, child, and family demographics, household income, parent marital status, educational attainment, employment status, and childcare.

Administrative measures

This trial of BEAM will also examine changes in family health and education, as measured using de-identified administrative-linked data from provincial government health and social service records in partnership with the Manitoba Centre for Health Policy (MCHP). This means that participant self-report data collected as part of the BEAM program will be linked to their provincial government health and social services records from the Manitoba Population Research Data Repository. Firstly, this linkage enables the longitudinal analysis of a broader scope of participant family physical health, mental health, and education outcomes from childbirth to up to five years post-intervention (June 2030). Secondly, this linkage enables the longitudinal comparison of BEAM participants to two population-based cohorts (‘population-average,’ ‘risk-matched’ control cohorts) of families who did not participate in BEAM, allowing examination of how BEAM may lead to lasting family improvements in psychological, social, and physical health. Participants are not required to consent to administrative data linkage to participate in BEAM. Those who do not consent will be excluded from the BEAM population-based cohort, but there is no way to ensure that they will be excluded from a control cohort. This is because those who opt out may not provide sufficient demographic information (e.g., Personal Health Identification Number [PHIN], age, postal code) to ensure control cohort exclusion. Preliminary data shows more than 80% of participants opting in. Further, every possible step will be taken to remove any BEAM participants from the control cohorts (e.g., by cross-referencing participant full names). Our analysis will be securely conducted by trained analysts from the Manitoba Centre for Health Policy (MCHP), the custodians of the Manitoba Population Research Data Repository.

Administrative data will include measures of family health and wellbeing (i.e., socioeconomic status, perinatal health, mental health, and substance use) assessed through the Families First Home Screening Form. Parent medical care including, hospitalizations, emergency visits, prescription medications, physical illness (e.g., atopic dermatitis), mental illness (i.e., mood, anxiety, substance use, psychotic disorders), and cause of death will be assessed using Hospital Abstracts Data, Medical Services Data, the Mental Health Management Information System (MHMIS), the Drug Program Information Network (DPIN), and Vital Statistics Mortality Registry Data. Child medical care including traumatic injury, hospitalizations, emergency visits, physical illness (e.g., lower respiratory tract infection), mental and neurodevelopmental disorders (e.g., mood, anxiety, trauma-related disorders, ADHD), prescription medications, and vaccinations will be assessed using the Mental Health Management Information System (MHMIS), Medical Services Data, and Hospital Abstracts Data, and the Manitoba Immunization Registry. Measures related to child development including age-appropriate grade, literacy, numeracy, special needs funding status, academic accommodations, health and psychosocial development, child care centre use, family income assistance, and family employment will be measured through enrolment, Marks and Assessment (STS/ICAB), Early Developmental Instrument (EDI), Child Day Care Program, and Manitoba Education Special Needs. Finally, Child Family Services (CFS) and parent justice involvement including days in CFS care, charges, and charge categories may be examined using the Child and Family Services Information System (CFSIS) and Justice Prosecution Information and Scheduling Management (PRISM), pending indication of interest and approval from the First Nations Health and Social Secretariat of Manitoba’s Health Information Research Governance Committee. Administrative data will also include basic demographic information such as date of birth, biological sex, postal code of residence, and family registration number. These data will be drawn from the Manitoba Health Insurance Registry [49, 67].

Participant timeline {13}

SPIRIT schedule of enrolment, intervention, and assessments.

Participant timeline is outlined in Fig. 2.

Eligibility (T0): Parents of young children may complete the eligibility screener to determine whether they are eligible for participation in the BEAM program.

Week 0 (T1): Eligible participants who consent to participate in the program will receive notice of enrolment. Participants will be fully enrolled in the program after they participate in an orientation meeting with their peer coach and/or a member of the research team and complete the pre-test assessments, including primary, secondary, and exploratory outcome measures.

Week 1: Participants will receive an email regarding BEAM app access login and account information. Program information will be sent electronically to participants from the study team.

Weeks 2–13: Participants will watch weekly videos and will complete symptom tracking questions for self-monitoring purposes. Participants will begin engaging in the forum and will also participate in check ins with their peer coach, continue engaging in the forum, and connect with the Systems Navigator as needed.

Weeks 13–16 (post, T2): Participants will complete a full post-test assessment of primary, secondary, and exploratory outcome measures.

Month 5–7 (follow-up, T3): Participants will complete a follow-up assessment of primary and secondary outcome measures.

Month 11–13 (follow-up, T4): Participants will complete a follow-up assessment of primary and secondary outcome measures.

Sample Size

In total, we aim for N = 400 participants to participate in the BEAM program over two years. However, we may modify or extend eligibility based on participant attrition rates and budgetary capacity. Sample size was determined based on data from our telehealth pilot in preschoolers and related effectiveness trials comparing evidence-based practices to services as usual in treatment seeking families [68]. We assume that participation in BEAM will evidence moderate reductions in parent mental health, based on prior evidence from previous BEAM trials. For this effectiveness trial, we anticipate the effect size may be approximately 25% smaller than in trials delivered directly by our practitioner team. The sample size calculation was conducted to ensure adequate power to detect this reduced effect size. Specifically, we conducted a power analysis assuming a type I error rate (α) of 0.05 and a power (1-β) of 0.80, which corresponds to a 80% probability of detecting a statistically significant effect if it exists. The calculation was based on a linear mixed-effects model, which accounts for repeated measures over time. To account for potential loss to follow-up, we conservatively assumed an attrition rate of 30%.

With these parameters, we determined that a sample size of N = 400 participants would provide sufficient power to detect the expected effect size while maintaining robustness against attrition and variability in outcomes. This calculation ensures the trial is appropriately powered for the primary analysis of intervention effectiveness.

Recruitment

Recruitment will involve a multi-faceted approach, encompassing four primary recruitment streams. First, we will collaborate closely with Manitoba’s Shared Health Crisis Response Services, including programs offering crisis assessment and post-crisis intervention to individuals across the province, to engage front-line staff in the recruitment process. Front line staff will receive training to enhance their familiarity with BEAM as a resource. The training will include comprehensive insights into BEAM program specifics, eligibility criteria, as well as introduce staff to our BEAM Systems Navigator and the stepped care model. Secondly, we will target recruitment efforts at primary care offices and provincial health services (e.g,. Shared Health Mental Health Services), in consultation with the Manitoba Pediatric Society and Doctors Manitoba. Recruitment through this stream will utilize light touch strategies such as poster and pamphlet drop-offs to sites. The third recruitment avenue involves collaborating with various community organizations, child care centres, and family resource centres (e.g., Family Dynamics, United Way Winnipeg, Acorn Family Place). Through these partnerships, we aim to expand the reach of our recruitment efforts and ensure that families from diverse backgrounds are included in the trial. Finally, our online recruitment efforts will include sharing posters and short video advertisements on social media platforms (e.g., Facebook, Instagram). Through these various approaches, we aim to facilitate comprehensive recruitment and maximize the representativeness of the trial.

Participant screening and recruitment will be done on a continuous, rolling basis over two years, from December 2023 to September 2025.

Assignment of interventions: allocation

Not applicable, there will be no assignment to different interventions.

Assignment of interventions: blinding

Not applicable.