Clinical trial NCT07026838: Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program
Official title: Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program Protocol for Randomized Waitlist Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Anger
Parenting
Stress Psychological
Parent Child Relationship
Child Development
Keywords: parenting
mental health
anxiety
depression
psychoeducation
massive online open intervention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
name: Children's Hospital Research Institute of Manitoba
name: Manitoba Centre for Health Policy
name: George & Fay Yee Centre for Healthcare Innovation
First posted: 2025-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* below the age of 18 years
* parenting a child outside the designated age range
* live outside Canada
* have participated in previous iterations of BEAM

Primary outcomes:
measure: Change in parent mental health symptom composite.
timeFrame: All measures to be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Feasibility and Acceptability of LightBEAM program.
timeFrame: To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).
Secondary outcomes:
measure: Change in parent depressive symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in parent anxiety symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in parent anger symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in parent self-compassion.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Changes in parent sleep problems.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in parenting stress.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in harsh parenting disciplinary practices.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in child behaviour.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent mental health symptom composite.
timeFrame: All measures to be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent depressive symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent anxiety symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent anger symptoms.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent self-compassion.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Changes in co-parent sleep problems.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent parenting stress.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
measure: Change in co-parent harsh parenting disciplinary practices.
timeFrame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
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