BEAM Program for Parental Mental Health

(BEAM Trial)

Overseen By Grace Zhou

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Leslie E. Roos

Disqualifiers: Outside Manitoba, Child not 2-5, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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). 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, especially since the trial focuses on a mobile health program rather than medication changes.

What data supports the effectiveness of the BEAM Program for Parental Mental Health treatment?

Research on similar emotional awareness-based parenting programs shows promising results, with participants experiencing reduced stress and improved emotional awareness. Additionally, emotion-focused family therapy has been effective in helping parents resolve emotional issues and gain confidence in supporting their children's mental health. ^{1 2 3 4 5}

How is the BEAM treatment different from other treatments for parental mental health?

The BEAM program is unique because it is an app-based treatment that simultaneously targets both maternal mental health and parenting skills, addressing the gap where most programs focus on one or the other. It is designed to be accessible and mitigate the impacts of pandemic stress on family well-being, making it particularly relevant during times when traditional services are limited. ^{6 7 8 9 10}

Research Team

Leslie E Roos, PhD

Principal Investigator

University of Manitoba

Eligibility Criteria

The BEAM trial is for parents with a child aged 2-5 years, who may be experiencing depression, stress, or other mental health issues. It's designed to help improve the parent-child relationship and support child development.

Inclusion Criteria

I am 18 years old or older.

At eligibility screening, participants must have access to an electronic device for viewing videos and participating in Zoom meetings. The research team may provide devices for those who do not have access

Participants must have IP addresses within Manitoba, Canada, as determined by IP address in REDCap at the time of eligibility screener questionnaire completion. Participants need to upload a photo with valid Manitoba government identification and their face

Exclusion Criteria

Living outside of Manitoba

Previous participation in an earlier BEAM trial

I am a parent or primary caregiver of a child who is not between 2 and 6 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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.

12 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month and 12-month intervals.

12 months

Assessments at 6-month and 12-month intervals

Treatment Details

Interventions

• Building Emotional Awareness and Mental Health (BEAM) Program

Trial Overview This study tests the BEAM program, a mobile app providing psychoeducation modules and social support for parents. Its effectiveness on children's mental health and developmental outcomes will be measured over one year.

Participant Groups

Group I: The BEAM Program Group Experimental Treatment 1 Intervention

All study participants will complete 12 weeks of the BEAM program. Each week of BEAM includes: (a) 15-20 minutes of therapeutic mental health and parenting 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) via Zoom for Healthcare, phone, or direct messaging, and (e) a brief in-app survey for symptom monitoring to track progress. Participants will also be invited to virtual group drop-in sessions facilitated by peer coaches and be connected with a systems navigator who can support participants in accessing other community resources (e.g., childcare programs, legal aid, housing).

Who Is Running the Clinical Trial?

Leslie E. Roos

Lead Sponsor

Trials

1

Recruited

400+

George & Fay Yee Centre for Healthcare Innovation

Collaborator

Trials

1

Recruited

400+

Children's Hospital Research Institute of Manitoba

Collaborator

Trials

9

Recruited

3,400+

Family Dynamics, Manitoba, Canada

Collaborator

Trials

1

Recruited

400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Manitoba Centre for Health Policy

Collaborator

Trials

1

Recruited

400+

Findings from Research

In a study of 734 adult patients with mental illness, only 17% had complete assessments using the Family Assessment Conversation tool, indicating a significant gap in identifying and supporting children affected by parental mental illness.

Documentation regarding whether children were informed about their parent's mental health was lacking, with 55% of assessments indicating that children had not been informed, highlighting the need for improved communication and support systems for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family assessment conversations as a tool to support families affected by parental mental illness: a retrospective review of electronic patient journals. Lauritzen, C., Kolmannskog, AB., Iversen, AC.[2022]

The study involved 60 mothers with serious mental illness (SMI) and found that an online parenting education intervention significantly improved their parenting and coping skills while also reducing parental stress over a 3-month period.

Although the intervention was effective in enhancing skills and reducing stress, it did not show improvements in parental efficacy or support, indicating that while mothers with SMI can benefit from online education, there may be other areas that need additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing an Internet-based parenting intervention for mothers with a serious mental illness: a randomized controlled trial. Kaplan, K., Solomon, P., Salzer, MS., et al.[2014]

The study evaluated a nurse-led emotional awareness parenting program for parents with mental illness, showing significant reductions in difficult parenting moments and related stress.

Participants also experienced promising improvements in overall emotional awareness and distress, indicating the program's potential effectiveness in supporting families affected by mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Emotional Awareness Based Parenting Group for Parents with Mental Illness: A Mixed Methods Feasibility Study of Community Mental Health Nurse Facilitation. Isobel, S., Meehan, F., Pretty, D.[2017]

Emotion-focused family therapy (EFFT) effectively helps parents address their emotional fears and improve their confidence in supporting children with mental health issues, as shown in a study involving four therapists and 16 parents.

The two-chair intervention in EFFT facilitates awareness and interrupts negative parenting patterns, leading to significant emotional resolution for most parents after the therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processes and outcomes of an emotion-focused family therapy two-chair intervention for transforming problematic parenting patterns. Sabey, AK., Stillar, A., Lafrance, A.[2022]

A web-based program significantly improved parents' knowledge and self-efficacy regarding youth mental health issues, as demonstrated in a study with 99 participants randomized into intervention and control groups.

The results suggest that such multimedia programs can effectively equip parents with the skills needed for early intervention in mental health problems, making them accessible in various settings like workplaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based mental health program: reaching parents at work. Deitz, DK., Cook, RF., Billings, DW., et al.[2022]

The BEAM program is a mobile health initiative designed to improve both maternal mental health and parenting skills simultaneously, addressing the increased rates of maternal depression and anxiety during the COVID-19 pandemic.

A pilot randomized controlled trial will assess the feasibility and effectiveness of the BEAM program among mothers with depression and/or anxiety, providing valuable data to inform larger future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial. Joyce, KM., Rioux, C., MacKinnon, AL., et al.[2023]

The BEAM app-based program is being tested in a randomized controlled trial with 140 mothers experiencing moderate-to-severe depression and/or anxiety, aiming to reduce maternal depression symptoms and improve overall family functioning over a 10-week intervention period.

This study addresses the urgent need for accessible mental health support for mothers during the COVID-19 pandemic, with the potential to enhance maternal and child health outcomes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Xie, EB., Simpson, KM., Reynolds, KA., et al.[2022]

The BEAM program, an App-based intervention co-developed with mothers, showed promise in improving mental health outcomes, particularly reducing anxiety and sleep symptoms among mothers with moderate-to-severe depression, compared to a treatment as usual control group.

With 65 participants in a 10-week randomized control trial, the program was found to be feasible and acceptable, with high engagement rates, and no adverse events reported, indicating it could be a valuable resource for supporting maternal mental health during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers. MacKinnon, AL., Simpson, KM., Salisbury, MR., et al.[2023]

Various intervention programs aimed at improving outcomes for children of parents with mental illness were identified, including family interventions, peer-support programs, online interventions, and bibliotherapy.

The most effective programs focus on providing psychosocial education to children about mental illness, but more rigorous research is needed to determine the best conditions for enhancing children's outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention programs for children whose parents have a mental illness: a review. Reupert, AE., Cuff, R., Drost, L., et al.[2019]

The project provided low-threshold anonymous counseling services to 150 families with mentally ill parents, offering up to 10 sessions of family-oriented support from 2011 to 2014.

Survey results showed high satisfaction among participants, with most respondents willing to recommend the service or use it again, highlighting the effectiveness of collaboration between mental health and child welfare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

['NischE - Nicht von schlechten Eltern' - Evaluation of a Multidisciplinary Teamwork Approach to Support Children in Families with Mentally Ill Parents]. Nienaber, A., Wieskus-Friedemann, E., Kliem, S., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Family assessment conversations as a tool to support families affected by parental mental illness: a retrospective review of electronic patient journals. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Assessing an Internet-based parenting intervention for mothers with a serious mental illness: a randomized controlled trial. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

An Emotional Awareness Based Parenting Group for Parents with Mental Illness: A Mixed Methods Feasibility Study of Community Mental Health Nurse Facilitation. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Processes and outcomes of an emotion-focused family therapy two-chair intervention for transforming problematic parenting patterns. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A web-based mental health program: reaching parents at work. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Intervention programs for children whose parents have a mental illness: a review. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

['NischE - Nicht von schlechten Eltern' - Evaluation of a Multidisciplinary Teamwork Approach to Support Children in Families with Mentally Ill Parents]. [2018]