Depression, AnxietyNCT07026838
Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program
A study testing The Light Building Emotional Awareness and Mental Health (BEAM) Program in people with Depression, Anxiety and Anger, run by University of Manitoba at 1 site in Canada.
Trial summary
Early childhood is a critical period for developmental outcomes, and the parent-child relationship plays a vital role in shaping cognitive and social development. However, elevated parental distress (e.g., depression, anxiety, anger) can disrupt healthy relationships, increasing the risk of negative child outcomes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Anger, Parenting
- What is being tested?
- The Light 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
- 202 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2025to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identify as a primary caregiver of any gender to an 18- to 107-month-old child
- reside in Canada with access to internet connection
- be aged 18 years or older
- able to understand/read/speak in English
- report at least mild emotional distress across depression, anxiety, anger, or parenting stress symptoms as assessed by the PHQ-9, GAD-7, PROMIS-Anger, and PSI
- have access to an electronic device
Who cannot join
- below the age of 18 years
- parenting a child outside the designated age range
- live outside Canada
- have participated in previous iterations of BEAM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program Protocol for Randomized Waitlist Control Trial
Early childhood is a critical period for developmental outcomes, and the parent-child relationship plays a vital role in shaping cognitive and social development. However, elevated parental distress (e.g., depression, anxiety, anger) can disrupt healthy relationships, increasing the risk of negative child outcomes such as difficult temperaments, altered cognitive development, and socio-emotional challenges. Despite the well-documented effects of untreated parental distress, Canadian families face significant barriers to accessing timely and effective mental health support. To address this gap, our team developed BEAM, an app-based program that provides parenting and mental health resources. BEAM includes expert-led videos, online forums, progress monitoring, and peer-coaching sessions. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. Building on BEAM's success, we have developed the LightBEAM program, which aims to expand these supports into a scalable, accessible, massive online open intervention (MOOI) to reach a larger number of families across Canada, particularly in underserved areas or those on waitlists for individualized services. LightBEAM has the potential to support parental mental health, fostering healthier child and family development while addressing barriers to traditional mental health care. This trial involves a pre-post randomized trial design with primary aims of (1) assessing feasibility and acceptability metrics of LightBEAM including recruitment/retention, sustainability, satisfaction, and unmet needs, (2) examining the efficacy of LightBEAM versus waitlist control at improving family and mental health outcomes, and (3) determine for whom LightBEAM is more or less effective at engaging with and addressing mental health needs.
This trial will evaluate the feasibility and effectiveness of LightBEAM with a sample of up to 300 parent participants with a child aged 18-107 months. Co-parents of parent participants are permitted to participate in the study as well but are not included in this sample of 300 parent participants. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app. The LightBEAM program will consist of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content.
Read more
Assessments of parent and child symptoms will occur at pre-test before LightBEAM begins (T1), immediately after the last week of the LightBEAM intervention (post-test, T2), and 6-month follow-up (T3).
The LightBEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related metrics of child well-being. By adapting BEAM, an evidence-based parenting and mental health app, into LightBEAM, a large-scale online intervention, the present trial aims to provide accessible mental health support for Canadian families. LightBEAM could reach families in remote areas with limited services, offer interim support during waitlists, or function as a self-referral program.
Read the detailed description
Early childhood is a formative period in which the parent-child relationship plays a central role in child cognitive and social development. When parents of young children experience elevated distress (e.g., depression, anxiety, and anger), it can disrupt healthy parent-child relationships, putting children at risk for negative outcomes, including difficult temperaments, altered cognitive development, and socioemotional risks. Parental distress also can increase children's stress levels, heightening their risk for mental health challenges through both genetic and environmental pathways. The severity of parental distress has been linked to worse child developmental outcomes, but research shows that improving parental mental health can positively impact child functioning. Providing parents with effective mental health support can mitigate the adverse effects of parental distress on children and interrupt the cycle of mental health challenges within families. However, despite the significant impact of untreated parental distress on child development, families face numerous obstacles to accessing timely and effective mental health resources. Some barriers include long wait times and limited availability of affordable services. These barriers increase the risk of cognitive and socioemotional challenges for children.
In response to this growing need, the BEAM (Building Emotional Awareness and Mental Health) program was launched as an app-based intervention that integrates parenting and mental health supports for parents. BEAM offers expert-led videos and activities, online group forums, progress monitoring, and facilitated support through telehealth sessions with parent-peer coaches. The program has demonstrated success in reducing parental anxiety, anger, and sleep difficulties, as well as in improving parent-child interactions. Building on BEAM's success, the investigators translated BEAM into LightBEAM, a massive online open intervention designed to deliver accessible mental health support through an app-based platform. The LightBEAM program is designed with four key components to provide comprehensive support for parenting and mental health: (1) weekly parenting and mental health videos, (2) weekly progress tracking, (3) a group forum, and (4) weekly exercises/activities. Each week, participants will have access to professionally produced psychoeducational videos that offer evidence-based information on topics such as managing stress, fostering positive parent-child interactions, and promoting emotional well-being. Alongside the videos, participants will complete weekly progress tracking to monitor changes in their emotional health and parenting experiences, helping them identify patterns and track their progress over time. To foster a sense of community, the program also features a moderated group forum where parents can connect, share experiences, and provide mutual support. Additionally, participants will engage in weekly exercises designed to reinforce the skills and strategies introduced in the videos. Parent participants have the option to invite a co-parent or other primary caregiver to participate in the LightBEAM program alongside them.
Massive online open interventions, such as LightBEAM, provide evidence-based behavioural support via websites or apps, and allow participants to engage autonomously. This format increases scalability by removing barriers associated with traditional services, such as limited clinician availability and high costs. However, massive online interventions are not without limitations. They may lack the direct clinical oversight needed for individuals requiring more personalized support. While such interventions hold promise for broad mental health service delivery, further research is necessary to evaluate their effectiveness. Thus, this trial will assess the effectiveness and potential of the LightBEAM program through three primary objectives. First, it will evaluate the feasibility and acceptability of the program by examining recruitment and retention rates, participant satisfaction, and the identification of unmet needs. Second, the trial will measure the efficacy of LightBEAM in improving family outcomes by comparing it to a waitlist control group. Key outcomes for parents include emotional well-being and parenting quality, while outcomes for children focus on well-being and socioemotional development. Finally, the trial will identify subgroups of participants who demonstrate the greatest engagement and improvement, using this information to promote equity and inform future program development.
By translating BEAM into LightBEAM, the investigators aim to create a scalable mental health program for families. LightBEAM has the potential to serve families in remote areas with limited access to in-person services, provide interim support during waitlists for individualized care, and function as a self-referral program. By addressing parental mental health, LightBEAM may improve family dynamics and child development, helping to mitigate the negative effects of parental distress.
- Conditions
- Depression, Anxiety, Anger, Parenting, Stress Psychological, Parent Child Relationship, Child Development
- Being tested
- The Light Building Emotional Awareness and Mental Health (BEAM) Program
- Keywords
- parenting, mental health, anxiety, depression, psychoeducation, massive online open 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 Light Building Emotional Awareness and Mental Health (BEAM) ProgramBehavioural
The LightBEAM Program builds on mHealth best practices and evidence-based program design principles with the core objectives of improving parental 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.
Program delivery will be facilitated through a mobile application. The LightBEAM program consists of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content.
| Study group | Role | What they receive |
|---|---|---|
| The LightBEAM Program Group | Experimental | Participants will complete 12 weeks of the LightBEAM program. Participants will be instructed to move through the weekly videos and practice exercises at a self-guided pace. Each week of LightBEAM includes: (a) 12-16 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, and (d) a brief in-app survey for progress monitoring. Receives: Behavioral: The Light Building Emotional Awareness and Mental Health (BEAM) Program |
| Waitlist Control Group | No intervention | Participants in the waitlist control group will be informed via email that they have been assigned to the waitlist condition. Along with this notification, they will receive a list of Canada-wide mental health and parenting resources, which they may choose to access at their discretion. Participants will be instructed to continue with any existing services or support they are utilizing as usual during the wait period. Following the completion of the wait period, participants will be notified and provided access to begin the 12-week LightBEAM program. Once enrolled in LightBEAM participants will complete 12 weeks of the LightBEAM 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).
Feasibility and Acceptability of LightBEAM program.
Acceptability and uptake of the LightBEAM 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, number of videos watched).
Measured: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Secondary outcomes (16)
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).
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).
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).
Change in parent self-compassion.
Parent self-compassion will be measured using the Self-Compassion Scale Short Form (SCS-SF) Questionnaire. The SCS-SF is a self-report measure of self-compassion. Scores range from 12 to 60, and a mean score is computed. Means lay between 1 and 5, with higher mean scores indicating higher levels of self-compassion.
Measured: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Changes 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).
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).
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).
Change in child behaviour.
Child behaviour will be measured using the Child Behaviour Checklist (CBCL). The CBCL is a parent-report measure of emotional and behavioural problems in children. Total scores range from 0 to 198, with higher scores indicating more emotional and behavioural challenges.
Measured: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent mental health symptom composite.
The co-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.
Measured: All measures to be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent depressive symptoms.
Co-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).
Change in co-parent anxiety symptoms.
Co-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).
Change in co-parent anger symptoms.
Co-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).
Change in co-parent self-compassion.
Co-parent self-compassion will be measured using the Self-Compassion Scale Short Form (SCS-SF) Questionnaire. The SCS-SF is a self-report measure of self-compassion. Scores range from 12 to 60, and a mean score is computed. Means lay between 1 and 5, with higher mean scores indicating higher levels of self-compassion.
Measured: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Changes in co-parent sleep problems.
Co-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).
Change in co-parent parenting stress.
Co-parent 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).
Change in co-parent harsh parenting disciplinary practices.
Harsh parenting practices in co-parents 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start14 Feb 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a two-arm clinical design, participants will be randomized in a 1:1 allocation to receive either the 12-week LightBEAM program or the waitlist control. Co-parents will be assigned to the same condition as the parent participant who invited them to join the study. After the 12-week LightBEAM program has been completed by the intervention condition, participants in the waitlist control group will complete rthe baseline questionnaires again prior to gaining access to the LightBEAM intervention. Longitudinal self-report questionnaires will be administered digitally at three timepoints: pre-intervention, post-intervention and at six months follow-up.
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Children's Hospital Research Institute of Manitoba, Manitoba Centre for Health Policy, George & Fay Yee Centre for Healthcare Innovation
- Responsible party
- Principal investigator, Leslie E. Roos, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026838
- Sponsor's protocol ID
- LightBEAM
- Other IDs
- 435-2023-0637
- Status last verified
- May 2026
- First submitted
- 10 Jun 2025
- Last updated
- 26 May 2026
- 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
Sitka M, Simpson KM, Paton A, MacKinnon A, Afifi TO, Cameron EE, Hai T, Stewart-Tufescu A, Gonzalez A, Toombs E, Unger JA, Giuliano R, Mushquash A, Archibald M, Tomfohr-Madsen L, Roos LE. Advancing family wellbeing through a Massive Online Open Intervention: the LightBEAM program protocol for randomized waitlist control trial 1a. BMC Psychol. 2026 Feb 2;14(1):293. doi: 10.1186/s40359-025-03326-3.
PubMed 41629989Muñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez-Stable, E. J. (2016). Massive open online interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science, 4(2), 194-205. https://doi.org/10.1177/2167702615601185
Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, Tryphonopoulos PD, Este D, Watson W. Postpartum depression is a family affair: addressing the impact on mothers, fathers, and children. Issues Ment Health Nurs. 2012 Jul;33(7):445-57. doi: 10.3109/01612840.2012.673054.
PubMed 22757597Keller 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 24117807Hammen, C. (2002). Context of stress in families of children with depressed parents. In Children of depressed parents: Mechanisms of risk and implications for treatment (pp. 175-199). American Psychological Association. https://doi.org/10.1037/10449-007
Giannakopoulos G, Solantaus T, Tzavara C, Kolaitis G. Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial. J Affect Disord. 2021 Jan 1;278:114-121. doi: 10.1016/j.jad.2020.09.070. Epub 2020 Sep 15.
PubMed 32956960Joyce KM, Rioux C, MacKinnon AL, Katz LY, Reynolds K, Kelly LE, Klassen T, Afifi TO, Mushquash AR, Clement FM, Chartier M, Xie EB, Penner KE, Hunter S, Berard L, Tomfohr-Madsen L, Roos LE. The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial. Pilot Feasibility Stud. 2023 Mar 9;9(1):35. doi: 10.1186/s40814-023-01260-y.
PubMed 36895006Xie EB, Simpson KM, Reynolds KA, Giuliano RJ, Protudjer JLP, Soderstrom M, Sauer-Zavala S, Giesbrecht GF, Lebel C, Mackinnon AL, Rioux C, Penner-Goeke L, Freeman M, Salisbury MR, Tomfohr-Madsen L, Roos LE. Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18-36 months. Trials. 2022 Sep 5;23(1):741. doi: 10.1186/s13063-022-06512-5.
PubMed 36064436MacKinnon AL, Simpson KM, Salisbury MR, Bobula J, Penner-Goeke L, Berard L, Rioux C, Giesbrecht GF, Giuliano R, Lebel C, Protudjer JLP, Reynolds K, Sauer-Zavala S, Soderstrom M, Tomfohr-Madsen LM, Roos LE. Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers. Front Psychiatry. 2022 Jun 24;13:880972. doi: 10.3389/fpsyt.2022.880972. eCollection 2022.
PubMed 35815022
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program Protocol for Randomized Waitlist Control Trial
- ClinicalTrials.gov ID
- NCT07026838
- Acronym / sponsor ID
- LightBEAM
- Conditions
- Depression, Anxiety, Anger, Parenting, Stress Psychological, Parent Child Relationship, Child Development
- Keywords
- parenting, mental health, anxiety, depression, psychoeducation, massive online open intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Children's Hospital Research Institute of Manitoba, Manitoba Centre for Health Policy, George & Fay Yee Centre for Healthcare Innovation
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jun 2025 (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.
Early childhood is a critical period for developmental outcomes, and the parent-child relationship plays a vital role in shaping cognitive and social development. However, elevated parental distress (e.g., depression, anxiety, anger) can disrupt healthy relationships, increasing the risk of negative child outcomes such as difficult temperaments, altered cognitive development, and socio-emotional challenges. Despite the well-documented effects of untreated parental distress, Canadian families face significant barriers to accessing timely and effective mental health support. To address this gap, our team developed BEAM, an app-based program that provides parenting and mental health resources. BEAM includes expert-led videos, online forums, progress monitoring, and peer-coaching sessions. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. Building on BEAM's success, we have developed the LightBEAM program, which aims to expand these supports into a scalable, accessible, massive online open intervention (MOOI) to reach a larger number of families across Canada, particularly in underserved areas or those on waitlists for individualized services. LightBEAM has the potential to support parental mental health, fostering healthier child and family development while addressing barriers to traditional mental health care. This trial involves a pre-post randomized trial design with primary aims of (1) assessing feasibility and acceptability metrics of LightBEAM including recruitment/retention, sustainability, satisfaction, and unmet needs, (2) examining the efficacy of LightBEAM versus waitlist control at improving family and mental health outcomes, and (3) determine for whom LightBEAM is more or less effective at engaging with and addressing mental health needs.
This trial will evaluate the feasibility and effectiveness of LightBEAM with a sample of up to 300 parent participants with a child aged 18-107 months. Co-parents of parent participants are permitted to participate in the study as well but are not included in this sample of 300 parent participants. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app. The LightBEAM program will consist of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content.
Assessments of parent and child symptoms will occur at pre-test before LightBEAM begins (T1), immediately after the last week of the LightBEAM intervention (post-test, T2), and 6-month follow-up (T3).
The LightBEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related metrics of child well-being. By adapting BEAM, an evidence-based parenting and mental health app, into LightBEAM, a large-scale online intervention, the present trial aims to provide accessible mental health support for Canadian families. LightBEAM could reach families in remote areas with limited services, offer interim support during waitlists, or function as a self-referral program.
Detailed description
Early childhood is a formative period in which the parent-child relationship plays a central role in child cognitive and social development. When parents of young children experience elevated distress (e.g., depression, anxiety, and anger), it can disrupt healthy parent-child relationships, putting children at risk for negative outcomes, including difficult temperaments, altered cognitive development, and socioemotional risks. Parental distress also can increase children's stress levels, heightening their risk for mental health challenges through both genetic and environmental pathways. The severity of parental distress has been linked to worse child developmental outcomes, but research shows that improving parental mental health can positively impact child functioning. Providing parents with effective mental health support can mitigate the adverse effects of parental distress on children and interrupt the cycle of mental health challenges within families. However, despite the significant impact of untreated parental distress on child development, families face numerous obstacles to accessing timely and effective mental health resources. Some barriers include long wait times and limited availability of affordable services. These barriers increase the risk of cognitive and socioemotional challenges for children.
In response to this growing need, the BEAM (Building Emotional Awareness and Mental Health) program was launched as an app-based intervention that integrates parenting and mental health supports for parents. BEAM offers expert-led videos and activities, online group forums, progress monitoring, and facilitated support through telehealth sessions with parent-peer coaches. The program has demonstrated success in reducing parental anxiety, anger, and sleep difficulties, as well as in improving parent-child interactions. Building on BEAM's success, the investigators translated BEAM into LightBEAM, a massive online open intervention designed to deliver accessible mental health support through an app-based platform. The LightBEAM program is designed with four key components to provide comprehensive support for parenting and mental health: (1) weekly parenting and mental health videos, (2) weekly progress tracking, (3) a group forum, and (4) weekly exercises/activities. Each week, participants will have access to professionally produced psychoeducational videos that offer evidence-based information on topics such as managing stress, fostering positive parent-child interactions, and promoting emotional well-being. Alongside the videos, participants will complete weekly progress tracking to monitor changes in their emotional health and parenting experiences, helping them identify patterns and track their progress over time. To foster a sense of community, the program also features a moderated group forum where parents can connect, share experiences, and provide mutual support. Additionally, participants will engage in weekly exercises designed to reinforce the skills and strategies introduced in the videos. Parent participants have the option to invite a co-parent or other primary caregiver to participate in the LightBEAM program alongside them.
Massive online open interventions, such as LightBEAM, provide evidence-based behavioural support via websites or apps, and allow participants to engage autonomously. This format increases scalability by removing barriers associated with traditional services, such as limited clinician availability and high costs. However, massive online interventions are not without limitations. They may lack the direct clinical oversight needed for individuals requiring more personalized support. While such interventions hold promise for broad mental health service delivery, further research is necessary to evaluate their effectiveness. Thus, this trial will assess the effectiveness and potential of the LightBEAM program through three primary objectives. First, it will evaluate the feasibility and acceptability of the program by examining recruitment and retention rates, participant satisfaction, and the identification of unmet needs. Second, the trial will measure the efficacy of LightBEAM in improving family outcomes by comparing it to a waitlist control group. Key outcomes for parents include emotional well-being and parenting quality, while outcomes for children focus on well-being and socioemotional development. Finally, the trial will identify subgroups of participants who demonstrate the greatest engagement and improvement, using this information to promote equity and inform future program development.
By translating BEAM into LightBEAM, the investigators aim to create a scalable mental health program for families. LightBEAM has the potential to serve families in remote areas with limited access to in-person services, provide interim support during waitlists for individualized care, and function as a self-referral program. By addressing parental mental health, LightBEAM may improve family dynamics and child development, helping to mitigate the negative effects of parental distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a two-arm clinical design, participants will be randomized in a 1:1 allocation to receive either the 12-week LightBEAM program or the waitlist control. Co-parents will be assigned to the same condition as the parent participant who invited them to join the study. After the 12-week LightBEAM program has been completed by the intervention condition, participants in the waitlist control group will complete rthe baseline questionnaires again prior to gaining access to the LightBEAM intervention. Longitudinal self-report questionnaires will be administered digitally at three timepoints: pre-intervention, post-intervention and at six months follow-up.
| Arm | Type | Receives |
|---|---|---|
| The LightBEAM Program Group | Experimental | Behavioral: The Light Building Emotional Awareness and Mental Health (BEAM) ProgramParticipants will complete 12 weeks of the LightBEAM program. Participants will be instructed to move through the weekly videos and practice exercises at a self-guided pace. Each week of LightBEAM includes: (a) 12-16 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, and (d) a brief in-app survey for progress monitoring. |
| Waitlist Control Group | No intervention | –Participants in the waitlist control group will be informed via email that they have been assigned to the waitlist condition. Along with this notification, they will receive a list of Canada-wide mental health and parenting resources, which they may choose to access at their discretion. Participants will be instructed to continue with any existing services or support they are utilizing as usual during the wait period. Following the completion of the wait period, participants will be notified and provided access to begin the 12-week LightBEAM program. Once enrolled in LightBEAM participants will complete 12 weeks of the LightBEAM program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- identify as a primary caregiver of any gender to an 18- to 107-month-old child
- reside in Canada with access to internet connection
- be aged 18 years or older
- able to understand/read/speak in English
- report at least mild emotional distress across depression, anxiety, anger, or parenting stress symptoms as assessed by the PHQ-9, GAD-7, PROMIS-Anger, and PSI
Key exclusion criteria (4 listed)
- below the age of 18 years
- parenting a child outside the designated age range
- live outside Canada
- have participated in previous iterations of BEAM
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 Light Building Emotional Awareness and Mental Health (BEAM) ProgramThe LightBEAM Program builds on mHealth best practices and evidence-based program design principles with the core objectives of improving parental 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. Program delivery will be facilitated through a mobile application. The LightBEAM program consists of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content. | Behavioural | The LightBEAM 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).
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 and Acceptability of LightBEAM program.
Time frame: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Acceptability and uptake of the LightBEAM 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, number of videos watched).
16 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).
Change in parent anxiety symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in parent anger symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in parent self-compassion.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Changes in parent sleep problems.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in parenting stress.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in harsh parenting disciplinary practices.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in child behaviour.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-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).
Change in co-parent depressive symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent anxiety symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent anger symptoms.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent self-compassion.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Changes in co-parent sleep problems.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent parenting stress.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Change in co-parent harsh parenting disciplinary practices.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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 26 May 2026.
- Background: PubMed 41629989Sitka M, Simpson KM, Paton A, MacKinnon A, Afifi TO, Cameron EE, Hai T, Stewart-Tufescu A, Gonzalez A, Toombs E, Unger JA, Giuliano R, Mushquash A, Archibald M, Tomfohr-Madsen L, Roos LE. Advancing family wellbeing through a Massive Online Open Intervention: the LightBEAM program protocol for randomized waitlist control trial 1a. BMC Psychol. 2026 Feb 2;14(1):293. doi: 10.1186/s40359-025-03326-3.
- BackgroundMuñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez-Stable, E. J. (2016). Massive open online interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science, 4(2), 194-205. https://doi.org/10.1177/2167702615601185
- Background: PubMed 22757597Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, Tryphonopoulos PD, Este D, Watson W. Postpartum depression is a family affair: addressing the impact on mothers, fathers, and children. Issues Ment Health Nurs. 2012 Jul;33(7):445-57. doi: 10.3109/01612840.2012.673054.
- 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.
- BackgroundHammen, C. (2002). Context of stress in families of children with depressed parents. In Children of depressed parents: Mechanisms of risk and implications for treatment (pp. 175-199). American Psychological Association. https://doi.org/10.1037/10449-007
- Background: PubMed 32956960Giannakopoulos G, Solantaus T, Tzavara C, Kolaitis G. Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial. J Affect Disord. 2021 Jan 1;278:114-121. doi: 10.1016/j.jad.2020.09.070. Epub 2020 Sep 15.
- Background: PubMed 36895006Joyce KM, Rioux C, MacKinnon AL, Katz LY, Reynolds K, Kelly LE, Klassen T, Afifi TO, Mushquash AR, Clement FM, Chartier M, Xie EB, Penner KE, Hunter S, Berard L, Tomfohr-Madsen L, Roos LE. The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial. Pilot Feasibility Stud. 2023 Mar 9;9(1):35. doi: 10.1186/s40814-023-01260-y.
- Background: PubMed 36064436Xie EB, Simpson KM, Reynolds KA, Giuliano RJ, Protudjer JLP, Soderstrom M, Sauer-Zavala S, Giesbrecht GF, Lebel C, Mackinnon AL, Rioux C, Penner-Goeke L, Freeman M, Salisbury MR, Tomfohr-Madsen L, Roos LE. Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18-36 months. Trials. 2022 Sep 5;23(1):741. doi: 10.1186/s13063-022-06512-5.
- Background: PubMed 35815022MacKinnon AL, Simpson KM, Salisbury MR, Bobula J, Penner-Goeke L, Berard L, Rioux C, Giesbrecht GF, Giuliano R, Lebel C, Protudjer JLP, Reynolds K, Sauer-Zavala S, Soderstrom M, Tomfohr-Madsen LM, Roos LE. Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers. Front Psychiatry. 2022 Jun 24;13:880972. doi: 10.3389/fpsyt.2022.880972. eCollection 2022.
- LightBEAM Program WebsiteLink 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Light Building Emotional Awareness and Mental Health (BEAM) Program in people with Depression, Anxiety and Anger, run by University of Manitoba 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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).). The study lists 2 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 NCT07026838, which also lists 9 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 26 May 2026.