University of Manitoba
Winnipeg, Manitoba, Canada
NCT Number: NCT07026838
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: All measures to be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
Time frame: To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3).
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.
University of Manitoba
Other
Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program Protocol for Randomized Waitlist Control Trial
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