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RECRUITING

NCT06455397

Building Emotional Awareness and Mental Health (BEAM) 2024-2027

Sponsor: Leslie E. Roos

View on ClinicalTrials.gov

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.

Official title: Implementing BEAM: An mHealth Tool to Prevent Mental Health Problems and Improve Developmental Outcomes in Young Children

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-03-11

Completion Date

2027-06

Last Updated

2025-06-18

Healthy Volunteers

Yes

Conditions

Depression, Anxiety Anger Parenting Stress, Psychological Parent-Child Relations Child Development

Interventions

BEHAVIORAL

The Building Emotional Awareness and Mental Health (BEAM) Program

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.

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.

Locations (1)

University of Manitoba - Department of Psychology & Pediatrics

Winnipeg, Manitoba, Canada