Clinical trial NCT06455397: Building Emotional Awareness and Mental Health (BEAM) 2024-2027
Official title: Implementing BEAM: An mHealth Tool to Prevent Mental Health Problems and Improve Developmental Outcomes in Young Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Anger
Parenting
Stress, Psychological
Parent-Child Relations
Child Development
Keywords: Parenting
Mental health
Depression
Anxiety
Psychoeducation
App-based intervention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Manitoba Centre for Health Policy
name: George & Fay Yee Centre for Healthcare Innovation
name: Children's Hospital Research Institute of Manitoba
name: Family Dynamics, Manitoba, Canada
First posted: 2024-06-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants will complete 12 weeks of the BEAM program. This involves weekly mental health and parenting education videos, app-based social support forum, and check ins with a peer parent coach. Participants will additionally have access to systems navigation to help participants find community supports. 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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Being a parent or primary caregiver of any gender to an 24- to 71-month-old (i.e., 2-5 year old) child.
3. Living in Manitoba.
4. Able to participate in check ins (15 to 60 minutes) via Zoom, phone, direct messaging with a parent peer coach.
5. 18 years or older.
6. Able to understand/read/speak in English.
7. Willing to complete four 45-min questionnaires.
8. At eligibility screening, a question asks if participants have access to an electronic device for viewing videos and participating in Zoom meetings. Participants who do not have access will be asked to contact the research team. The team may be able to accommodate a limited number of participants by providing relevant devices for the duration of the study.
9. Participants have IP addresses within Manitoba, Canada, as determined by IP address in REDCap at time of eligibility screener questionnaire completion. Participants will be required to securely upload a photo that includes both a valid piece of Manitoba government identification and the participant's face (i.e., a 'selfie').

Exclusion Criteria:

1. Living outside of Manitoba.
2. Being a parent or primary caregiver to a child outside of the ages of 24- to 71-months (i.e., 2-5 years).
3. Previously participated in an earlier BEAM trial.
4. 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.

Co-parents will be permitted to participate in BEAM regardless of current mental health challenges. Therefore, co-parents are only subject to inclusion criterion (3) and criteria (5-9). Instead of meeting inclusion criteria (2), parenting partners must be a "co-parent (e.g., the child's mom, dad, step-parent) or other primary caregiver (e.g., the child's grandma, cousin, uncle, auntie)" to the corresponding participant's 24- to 71-month-old (i.e., 2-5 year old) child. Co-parents will not receive the same pre-trial screening as parent participants, and thus will not be subject to exclusion criteria.

Primary outcomes:
measure: Change in parent mental health symptom composite.
timeFrame: 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).
measure: Feasibility of the BEAM program.
timeFrame: To be assessed immediately after intervention (T2).
measure: Acceptability and uptake of the BEAM program.
timeFrame: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Secondary outcomes:
measure: Change in parent depressive symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in parent anxiety symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in parent anger symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in parent sleep problems.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in parent alcohol use.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in parent cannabis use.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in parenting stress.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in harsh parenting disciplinary practices.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in child mental health symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in child socioemotional development.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in child development.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Other outcomes:
measure: Change in parenting self-efficacy.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Change in social support.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
measure: Discriminatory experiences.
timeFrame: To be assessed pre-intervention (T1).
measure: Adverse childhood experiences.
timeFrame: To be assessed pre-intervention (T1).
measure: Therapeutic alliance.
timeFrame: To be assessed immediately after intervention (T2).
measure: Change in administrative measures of family health, education, and social service use.
timeFrame: Administrative data will be drawn from date of childbirth (age 0) to age 8.
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba - Department of Psychology & Pediatrics
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Leslie E Roos, PhD
role: PRINCIPAL_INVESTIGATOR
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