Depression, AnxietyBEAMNCT06455397
Building Emotional Awareness and Mental Health (BEAM) 2024-2027
A study testing The Building Emotional Awareness and Mental Health (BEAM) Program in people with Depression, Anxiety and Anger, run by Leslie E. Roos at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Anger, Parenting
- What is being tested?
- The Building Emotional Awareness and Mental Health (BEAM) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 11 Mar 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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').
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maryem Zahra Project Coordinator, Bachelor of Arts (Hon) contact
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba - Department of Psychology & Pediatrics
Winnipeg, Manitoba, R3T 2N2
Leslie E Roos, PhD, 2044747400, leslie.roos@umanitoba.ca
Grace Zhou, grace.zhou@umanitoba.ca
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Depression, Anxiety, Anger, Parenting, Stress, Psychological, Parent-Child Relations, Child Development
- Being tested
- The Building Emotional Awareness and Mental Health (BEAM) Program
- Keywords
- Parenting, Mental health, Depression, Anxiety, Psychoeducation, App-based intervention
- Medical subject headings
- Depression, Anxiety Disorders, Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Building Emotional Awareness and Mental Health (BEAM) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The BEAM Program Group | Experimental | 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). Receives: Behavioral: The Building Emotional Awareness and Mental Health (BEAM) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start11 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leslie E. Roos
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Manitoba Centre for Health Policy, George & Fay Yee Centre for Healthcare Innovation, Children's Hospital Research Institute of Manitoba, Family Dynamics, Manitoba, Canada
- Responsible party
- Sponsor-investigator, Leslie E. Roos, University of Manitoba
- Investigators
- Leslie E Roos, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455397
- Sponsor's protocol ID
- BEAM 2024-2027
- Acronym
- BEAM
- Status last verified
- Jun 2025
- First submitted
- 29 May 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Keller PS, Kouros CD, Erath SA, Dahl RE, El-Sheikh M. Longitudinal relations between maternal depressive symptoms and child sleep problems: the role of parasympathetic nervous system reactivity. J Child Psychol Psychiatry. 2014;55(2):172-9. doi: 10.1111/jcpp.12151. Epub 2013 Oct 9.
PubMed 24117807McGrath JM, Records K, Rice M. Maternal depression and infant temperament characteristics. Infant Behav Dev. 2008 Jan;31(1):71-80. doi: 10.1016/j.infbeh.2007.07.001. Epub 2007 Aug 21.
PubMed 17714790Skipstein A, Janson H, Kjeldsen A, Nilsen W, Mathiesen KS. Trajectories of maternal symptoms of depression and anxiety over 13 years: the influence of stress, social support, and maternal temperament. BMC Public Health. 2012 Dec 27;12:1120. doi: 10.1186/1471-2458-12-1120.
PubMed 23270506Mensah FK, Kiernan KE. Parents' mental health and children's cognitive and social development: families in England in the Millennium Cohort Study. Soc Psychiatry Psychiatr Epidemiol. 2010 Nov;45(11):1023-35. doi: 10.1007/s00127-009-0137-y. Epub 2009 Oct 13.
PubMed 19823757Goodman SH, Rouse MH, Connell AM, Broth MR, Hall CM, Heyward D. Maternal depression and child psychopathology: a meta-analytic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):1-27. doi: 10.1007/s10567-010-0080-1.
PubMed 21052833Kingston D, Kehler H, Austin MP, Mughal MK, Wajid A, Vermeyden L, Benzies K, Brown S, Stuart S, Giallo R. Trajectories of maternal depressive symptoms during pregnancy and the first 12 months postpartum and child externalizing and internalizing behavior at three years. PLoS One. 2018 Apr 13;13(4):e0195365. doi: 10.1371/journal.pone.0195365. eCollection 2018.
PubMed 29652937Azak S, Raeder S. Trajectories of parenting behavior and maternal depression. Infant Behav Dev. 2013 Jun;36(3):391-402. doi: 10.1016/j.infbeh.2013.03.004. Epub 2013 Apr 17.
PubMed 23603820Vliegen N, Casalin S, Luyten P. The course of postpartum depression: a review of longitudinal studies. Harv Rev Psychiatry. 2014 Jan-Feb;22(1):1-22. doi: 10.1097/HRP.0000000000000013.
PubMed 24394219Moreno C, Wykes T, Galderisi S, Nordentoft M, Crossley N, Jones N, Cannon M, Correll CU, Byrne L, Carr S, Chen EYH, Gorwood P, Johnson S, Karkkainen H, Krystal JH, Lee J, Lieberman J, Lopez-Jaramillo C, Mannikko M, Phillips MR, Uchida H, Vieta E, Vita A, Arango C. How mental health care should change as a consequence of the COVID-19 pandemic. Lancet Psychiatry. 2020 Sep;7(9):813-824. doi: 10.1016/S2215-0366(20)30307-2. Epub 2020 Jul 16.
PubMed 32682460Hansen AS, Telleus GK, Mohr-Jensen C, Lauritsen MB. Parent-perceived barriers to accessing services for their child's mental health problems. Child Adolesc Psychiatry Ment Health. 2021 Jan 29;15(1):4. doi: 10.1186/s13034-021-00357-7.
PubMed 33514400Sztein DM, Koransky CE, Fegan L, Himelhoch S. Efficacy of cognitive behavioural therapy delivered over the Internet for depressive symptoms: A systematic review and meta-analysis. J Telemed Telecare. 2018 Sep;24(8):527-539. doi: 10.1177/1357633X17717402. Epub 2017 Jul 11.
PubMed 28696153Larkin F, Oostenbroek J, Lee Y, Hayward E, Meins E. Proof of concept of a smartphone app to support delivery of an intervention to facilitate mothers' mind-mindedness. PLoS One. 2019 Aug 22;14(8):e0220948. doi: 10.1371/journal.pone.0220948. eCollection 2019.
PubMed 31437173Catuara-Solarz S, Skorulski B, Estella-Aguerri I, Avella-Garcia CB, Shepherd S, Stott E, Hemmings NR, Ruiz de Villa A, Schulze L, Dix S. The Efficacy of "Foundations," a Digital Mental Health App to Improve Mental Well-being During COVID-19: Proof-of-Principle Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jul 1;10(7):e30976. doi: 10.2196/30976.
PubMed 34978535Roos LE, Kaminski L, Stienwandt S, Hunter S, Giuliano R, Mota N, Katz LY, Zalewski M. The Building Regulation in Dual-Generations Program (BRIDGE): A Mixed-Methods Feasibility Pilot of a Parenting Program for Depressed Mothers of Preschoolers, Matched with Dialectical Behavior Therapy Skills. Child Psychiatry Hum Dev. 2023 Feb;54(1):34-50. doi: 10.1007/s10578-021-01219-1. Epub 2021 Aug 4.
PubMed 34347227Cameron EE, Simpson KM, Pierce SK, Penner KE, Beyak A, Gomez I, Bowes JM, Reynolds KA, Tomfohr-Madsen LM, Roos LE. Paternal Perinatal Experiences during the COVID-19 Pandemic: A Framework Analysis of the Reddit Forum Predaddit. Int J Environ Res Public Health. 2023 Mar 1;20(5):4408. doi: 10.3390/ijerph20054408.
PubMed 36901417
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing BEAM: An mHealth Tool to Prevent Mental Health Problems and Improve Developmental Outcomes in Young Children
- ClinicalTrials.gov ID
- NCT06455397
- Acronym / sponsor ID
- BEAM / BEAM 2024-2027
- Conditions
- Depression, Anxiety, Anger, Parenting, Stress, Psychological, Parent-Child Relations, Child Development
- Keywords
- Parenting, Mental health, Depression, Anxiety, Psychoeducation, App-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Leslie E. RoosUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Manitoba Centre for Health Policy, George & Fay Yee Centre for Healthcare Innovation, Children's Hospital Research Institute of Manitoba, Family Dynamics, Manitoba, Canada
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| The BEAM Program Group | Experimental | Behavioral: The Building Emotional Awareness and Mental Health (BEAM) ProgramAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Building Emotional Awareness and Mental Health (BEAM) ProgramThe 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. | Behavioural | The BEAM Program Group |
Primary outcome
Change in parent mental health symptom composite.
Time frame: 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).
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.
Feasibility of the BEAM program.
Time frame: To be assessed immediately after intervention (T2).
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.
Acceptability and uptake of the BEAM program.
Time frame: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
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).
11 secondary outcomes
Change in parent depressive symptoms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 24117807Keller PS, Kouros CD, Erath SA, Dahl RE, El-Sheikh M. Longitudinal relations between maternal depressive symptoms and child sleep problems: the role of parasympathetic nervous system reactivity. J Child Psychol Psychiatry. 2014;55(2):172-9. doi: 10.1111/jcpp.12151. Epub 2013 Oct 9.
- Background: PubMed 17714790McGrath JM, Records K, Rice M. Maternal depression and infant temperament characteristics. Infant Behav Dev. 2008 Jan;31(1):71-80. doi: 10.1016/j.infbeh.2007.07.001. Epub 2007 Aug 21.
- Background: PubMed 23270506Skipstein A, Janson H, Kjeldsen A, Nilsen W, Mathiesen KS. Trajectories of maternal symptoms of depression and anxiety over 13 years: the influence of stress, social support, and maternal temperament. BMC Public Health. 2012 Dec 27;12:1120. doi: 10.1186/1471-2458-12-1120.
- Background: PubMed 19823757Mensah FK, Kiernan KE. Parents' mental health and children's cognitive and social development: families in England in the Millennium Cohort Study. Soc Psychiatry Psychiatr Epidemiol. 2010 Nov;45(11):1023-35. doi: 10.1007/s00127-009-0137-y. Epub 2009 Oct 13.
- Background: PubMed 21052833Goodman SH, Rouse MH, Connell AM, Broth MR, Hall CM, Heyward D. Maternal depression and child psychopathology: a meta-analytic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):1-27. doi: 10.1007/s10567-010-0080-1.
- Background: PubMed 29652937Kingston D, Kehler H, Austin MP, Mughal MK, Wajid A, Vermeyden L, Benzies K, Brown S, Stuart S, Giallo R. Trajectories of maternal depressive symptoms during pregnancy and the first 12 months postpartum and child externalizing and internalizing behavior at three years. PLoS One. 2018 Apr 13;13(4):e0195365. doi: 10.1371/journal.pone.0195365. eCollection 2018.
- Background: PubMed 23603820Azak S, Raeder S. Trajectories of parenting behavior and maternal depression. Infant Behav Dev. 2013 Jun;36(3):391-402. doi: 10.1016/j.infbeh.2013.03.004. Epub 2013 Apr 17.
- Background: PubMed 24394219Vliegen N, Casalin S, Luyten P. The course of postpartum depression: a review of longitudinal studies. Harv Rev Psychiatry. 2014 Jan-Feb;22(1):1-22. doi: 10.1097/HRP.0000000000000013.
- Background: PubMed 32682460Moreno C, Wykes T, Galderisi S, Nordentoft M, Crossley N, Jones N, Cannon M, Correll CU, Byrne L, Carr S, Chen EYH, Gorwood P, Johnson S, Karkkainen H, Krystal JH, Lee J, Lieberman J, Lopez-Jaramillo C, Mannikko M, Phillips MR, Uchida H, Vieta E, Vita A, Arango C. How mental health care should change as a consequence of the COVID-19 pandemic. Lancet Psychiatry. 2020 Sep;7(9):813-824. doi: 10.1016/S2215-0366(20)30307-2. Epub 2020 Jul 16.
- Background: PubMed 33514400Hansen AS, Telleus GK, Mohr-Jensen C, Lauritsen MB. Parent-perceived barriers to accessing services for their child's mental health problems. Child Adolesc Psychiatry Ment Health. 2021 Jan 29;15(1):4. doi: 10.1186/s13034-021-00357-7.
- Background: PubMed 28696153Sztein DM, Koransky CE, Fegan L, Himelhoch S. Efficacy of cognitive behavioural therapy delivered over the Internet for depressive symptoms: A systematic review and meta-analysis. J Telemed Telecare. 2018 Sep;24(8):527-539. doi: 10.1177/1357633X17717402. Epub 2017 Jul 11.
- Background: PubMed 31437173Larkin F, Oostenbroek J, Lee Y, Hayward E, Meins E. Proof of concept of a smartphone app to support delivery of an intervention to facilitate mothers' mind-mindedness. PLoS One. 2019 Aug 22;14(8):e0220948. doi: 10.1371/journal.pone.0220948. eCollection 2019.
- Statistics Canada. Leading causes of death, total population, by age group \[Internet\]. Government of Canada; \[accessed 2024 Jan 14\]Link provided by the sponsor.
- Health Canada. Canadian Community Health Survey, Cycle 2.2, Nutrition (2004): Income-related household food security in Canada. \[Internet\]. 2007Link provided by the sponsor.
- Statistics Canada. Canadian housing survey, 2022. \[Internet\]. 2022Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryem Zahra Project Coordinator, Bachelor of Arts (Hon) contact
Leslie E Roos, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Building Emotional Awareness and Mental Health (BEAM) Program in people with Depression, Anxiety and Anger, run by Leslie E. Roos at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie E Roos, PhD (2044747400, leslie.roos@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parent mental health symptom composite. (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455397, which also lists 73 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.