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

Stress, Psychological Clinical Trial

— BEAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455397
• Other study ID #: BEAM 2024-2027
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: University of Manitoba
• Contact: Leslie E Roos, PhD
• Phone: 2044747400
• Email: leslie.roos[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Being a parent or primary caregiver of any gender to an 24- to 71-month-old (i.e., 2-5 year old) child.

• Living in Manitoba.

• Able to participate in check ins (15 to 60 minutes) via Zoom, phone, direct messaging with a parent peer coach.

• 18 years or older.

• Able to understand/read/speak in English.

• Willing to complete four 45-min questionnaires.

• 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.

• 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:

• Living outside of Manitoba.

• Being a parent or primary caregiver to a child outside of the ages of 24- to 71-months (i.e., 2-5 years).

• Previously participated in an earlier BEAM trial.

• 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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Manitoba - Department of Psychology & Pediatrics	Winnipeg	Manitoba

Sponsors (6)

Lead Sponsor	Collaborator
Leslie E. Roos	Canadian Institutes of Health Research (CIHR), Children's Hospital Research Institute of Manitoba, Family Dynamics, Manitoba, Canada, George & Fay Yee Centre for Healthcare Innovation, Manitoba Centre for Health Policy

Country where clinical trial is conducted

Canada, 

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* Note: There are 72 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in parenting self-efficacy.	Parenting self-efficacy will be measured using 4 items from the Parenting Stress Index - 4th Edition - Short Form (PSI-4-SF). These 4 items measure parenting self-efficacy. Total scores range from 4 to 20, with higher scores indicating less parenting self-efficacy.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Other	Change in social support.	Social support will be measured using the Social Support Effectiveness Questionnaire (SSEQ). The SSEQ is a self-report measure of partner support effectiveness. Total scores range from 0 to 80, with higher scores indicating greater partner support effectiveness.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Other	Discriminatory experiences.	Discrimination will be measured using the Everyday Discrimination Scale (EDS). The EDS is a self-report measure of discriminatory experiences. Total scores range from 0 to 54, with higher scores indicating more discriminatory experiences. This measure may be used as an exploratory mediator or moderator of change.	To be assessed pre-intervention (T1).
Other	Adverse childhood experiences.	Adverse childhood experiences will be measured using the Adverse Childhood Experiences questionnaire (ACEs). The ACEs is a self-report measure of experiences from childhood that may have been neglectful, abusive, or violent. Total scores range from 0 to 10, with higher scores indicating more adverse childhood experiences. This measure may be used as an exploratory mediator or moderator of change.	To be assessed pre-intervention (T1).
Other	Therapeutic alliance.	Therapeutic alliance between peer coaches and participants will be assessed using the Brief Revised Working Alliance Inventory (BR-WAI). The BR-WAI is a 16-item measure assessing bonds, tasks, and goals within the therapeutic relationship. Higher scores indicate stronger alliance. This measure may be used as an exploratory mediator or moderator of change.	To be assessed immediately after intervention (T2).
Other	Change in administrative measures of family health, education, and social service use.	Government records from the Manitoba Population Research Data Repository will assess change in family health, education, and social service use from age 0 to 8. The Families First Home Screening Form assesses perinatal health conditions, perinatal substance use. Mental Health Management Information System assesses parent and child mental illness, mental health service access. Hospital Abstracts Data measures parent and child physical illness, hospitalizations, emergency room visits. Manitoba Immunization Monitoring System assesses vaccination history. Drug Program Information Network measures medication prescribed. Early Developmental Instrument assesses language development, social competence. Enrollment, Marks, and Assessment measures age-appropriate grade, literacy/numeracy in grade 3. Manitoba Education Special Needs assesses if the child has been allotted special needs funding by the province of Manitoba. Vital Statistics Mortality Registry Data measures cause of death.	Administrative data will be drawn from date of childbirth (age 0) to age 8.
Primary	Change 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.	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).
Primary	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.	To be assessed immediately after intervention (T2).
Primary	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).	To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Secondary	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.	To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

External Links

•   Health Canada. Canadian Community Health Survey, Cycle 2.2, Nutrition (2004): Income-related household food security in Canada. [Internet]. 2007
•   Statistics Canada. Canadian housing survey, 2022. [Internet]. 2022
•   Statistics Canada. Leading causes of death, total population, by age group [Internet]. Government of Canada; [accessed 2024 Jan 14]