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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anger; Stress, Psychological; Parent-Child Relations; Parenting; Child Development; Depression, Anxiety
• Intervention / Treatment: Behavioral: The Building Emotional Awareness and Mental Health (BEAM) Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leslie E Roos, PhD; Phone Number: 2044747400; Email: leslie.roos@umanitoba.ca
• Study Contact Backup: Name: Maryem Zahra Project Coordinator, Bachelor of Arts (Hon); Email: Maryem.Zahra@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Recruiting
      • University of Manitoba - Department of Psychology & Pediatrics
      • Contact: Leslie E Roos, PhD; Phone Number: 2044747400; Email: leslie.roos@umanitoba.ca
      • Contact: Grace Zhou; Email: grace.zhou@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The BEAM Program Group; 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). Co-parents will have access to all components of the BEAM program except for (d).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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.

Collaborators and Investigators

• Sponsor: Leslie E. Roos
• Collaborators: Canadian Institutes of Health Research (CIHR); Children's Hospital Research Institute of Manitoba; Manitoba Centre for Health Policy; George & Fay Yee Centre for Healthcare Innovation; Family Dynamics, Manitoba, Canada
• Investigators: Principal Investigator: Leslie E Roos, PhD, University of Manitoba

Publications and helpful links

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Helpful Links

• Statistics Canada. Leading causes of death, total population, by age group [Internet]. Government of Canada; [accessed 2024 Jan 14]
• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Mental health; Psychoeducation; Parenting; App-based intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Stress, Psychological
• Other Study ID Numbers: BEAM 2024-2027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary statistics (e.g., questionnaire subscales, sociodemographics, aggregated forum usage data) paired with non-identifiable participant IDs may be shared on data repositories such as the Open Science Framework.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No