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.

BACKGROUND: The prevalence of maternal depression and anxiety has increased during the COVID-19 pandemic, and pregnant individuals are experiencing concerningly elevated levels of mental health symptoms worldwide. Many individuals may now be at heightened risk of postpartum mental health disorders. There are significant concerns that a cohort of children may be at-risk for impaired self-regulation and mental illness due to elevated exposure to perinatal mental illness. With both an increased prevalence of depression and limited availability of services due to the pandemic, there is an urgent need for accessible eHealth interventions for mothers of young children. The aims of this trial are to evaluate the efficacy of the Building Emotion Awareness and Mental Health (BEAM) app-based program for reducing maternal depression symptoms (primary outcome) and improve anxiety symptoms, parenting stress, family relationships, and mother and child functioning (secondary outcomes) compared to treatment as usual (TAU).
METHODS: A two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to TAU among a sample of 140 mothers with children aged 18 to 36 months, who self-report moderate-to-severe symptoms of depression and/or anxiety. Individuals will be recruited online, and those randomized to the treatment group will participate in 10 weeks of psychoeducation modules, an online social support forum, and weekly group teletherapy sessions. Assessments will occur at 18-36 months postpartum (pre-test, T1), immediately after the last week of the BEAM intervention (post-test, T2), and at 3 months after the intervention (follow-up, T3). DISCUSSION: eHealth interventions have the potential to address elevated maternal mental health symptoms, parenting stress, and child functioning concerns during and after the COVID-19 pandemic and to provide accessible programming to mothers who are in need of support. This RCT will build on an open pilot trial of the BEAM program and provide further evaluation of this evidence-based intervention. Findings will increase our understanding of depression in mothers with young children and reveal the potential for long-term improvements in maternal and child health and family well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT05306626 . Registered on April 1, 2022.

Administrative information

Note: The numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).

Introduction

Background and rationale {6a}

The COVID-19 pandemic, including the social and public health restrictions implemented to limit the spread of the disease, has resulted in unprecedented stress for families. Physical isolation from support and social networks, economic uncertainty, and additional childcare responsibilities can have unexpected and pernicious effects. Infectious disease outbreaks can increase psychological distress [1, 2] and people in the perinatal period may be especially vulnerable to the negative psychological effects of the COVID-19 pandemic [3, 4]. The COVID-19 pandemic has disproportionally impacted individuals who identify as female, particularly if they are caregivers [5, 6]. Maternal mental health symptoms in the first few years following childbirth are common [7-10] and can have intergenerational impacts on mother and baby. Depression and anxiety, which are the most common perinatal mental health concerns, are risk factors for developing insecure mother-child attachments and higher levels of social, emotional, mental, and behavioral challenges in children [11, 12].

The prevalence of maternal depression and anxiety has increased during the COVID-19 pandemic in Canada and around the world [13-15]. Evidence from the Pregnancy During the COVID-19 Pandemic study has highlighted concerningly elevated levels of mental illness in Canada, with 37% and 57% of pregnant individuals reporting clinically-elevated symptoms of depression and anxiety, respectively [16]. These prevalence rates are much higher than what is normally expected during pregnancy or observed in other populations during the COVID-19 pandemic [16]. These rates are consistent with other reports of elevated levels of depression and anxiety among pregnant individuals during the pandemic worldwide [17].

Many individuals who were pregnant during the COVID-19 pandemic are now in the postpartum period, a time in which new parenting and pandemic-related stressors are introduced. Since the previous history of depression and anxiety is one of the most robust risk factors in predicting postpartum depression [18, 19], the alarming rates of depression and anxiety among pregnant individuals during the pandemic [16] have put new mothers at heightened risk of mental health disorders. These mental health problems are associated with chronic physical conditions and low quality of life, and the overall cost of perinatal mental illness is large [20, 21]. Furthermore, COVID-19 has posed additional challenges to families, thereby increasing the support needs of mothers. Research suggests that since the onset of COVID-19, mothers with young children are experiencing heightened parenting stress due to deprivation of family support and altered family relationships [22]. For mothers with depression, these additional stressors could worsen the severity of their symptoms.

In line with the developmental origins of health and disease framework, ample evidence indicates that exposure to maternal depression in the first 5 years of life is linked to alterations in physiological regulation, cognitive impairments, and mental illness, with up to 60% of exposed children developing life course psychopathology [23, 24]. In early childhood, exposure to maternal mental illness predicts risk for children’s own mental health problems, developmental delays, atopic diseases, and injury risk [23-25]. Emerging research has raised significant concerns about the detrimental impact of COVID-19 on early child cognitive development. Infants who were born during the pandemic seem to have elevated risks for developmental delay in communication and personal-social functioning domains compared to infants born prior to the pandemic [26]. The intergenerational transmission of self-regulation model [27] suggests that maternal mental illness might impact child developmental outcomes through the self-regulation problems of mental illness on parenting abilities. Poor self-regulation can limit engagement in responsive parenting practices and lead to low supervision, poor planning, and harsh discipline, which in turn impede the development of children’s self-regulation [28]. Moreover, meta-analyses indicate that interventions that address both maternal (e.g., depression) and child (e.g., parenting) needs have larger effects than targeting either one alone [29].

Intervening early among mothers with depression is crucial in order to prevent long-term adverse consequences for mothers and their children. Without treatment, maternal depressive symptoms tend to remain consistent throughout the preschool years [8]. The negative consequences of maternal mental illness are most pronounced when depression persists [25, 30]. Untreated anxiety is also a concern as persistent maternal anxiety is associated with adverse child psychological outcomes, such as emotional and conduct problems [31, 32]. Although evidence-based treatments exist to address maternal mental illness, there are significant barriers to accessing care, and these barriers have been exacerbated by the COVID-19 pandemic. Prior to the pandemic, mothers in the perinatal period (i.e., pregnancy and the year following childbirth) identified lack of time and childcare as barriers to seeking mental health services [33]. These barriers may be particularly pertinent during the current COVID-19 pandemic due to overwhelming childcare demands, physical isolation from social and support networks, unemployment and financial strain, and closure of existing services [34-36].

Mothers with existing mental health problems in the perinatal period have identified web-based resources as a preference for additional mental health support [33]. Furthermore, peer support during the perinatal period is both protective against and associated with reductions in depressive symptoms [37, 38]. Mothers often rely on social support in the postnatal period to care for their infants, resume daily activities, and recover from childbirth [39]. Support from other mothers has been found to be particularly important in the recovery of postpartum depression and including peer support in the treatment of postpartum depression is associated with greater levels of treatment satisfaction [40].

Addressing the intergenerational impact of perinatal mental health problems requires innovative program design methods to simultaneously treat maternal mental illness and promote parenting abilities [25, 30]. In collaboration with a parent advisory board, we have developed the Building Emotion Awareness and Mental Health (BEAM) program to respond to the needs of mothers managing depression, anxiety, and parenting stress. The BEAM program provides app-based psychoeducation and group telehealth sessions with a mental health professional while prioritizing peer support as a central component of the program. Following the ORBIT model for developing behavioral therapies to treat or prevent chronic diseases and enhance health-promoting behaviors [41, 42], our research team previously conducted a phase II (preliminary testing) pilot trial of the BEAM program for mothers of children aged 18 to 36 months of age who self-reported moderate-to-severe symptoms of depression and or anxiety. The results revealed interaction effects with greater reductions in overall mental health problems among participants in the BEAM program compared to the control group [43]. Findings were used to determine the clinical impact of the program and inform improvements. The current study represents the phase III (efficacy testing) randomized controlled trial (RCT) of the BEAM program.

Objectives {7}

The primary aim of this interventional study is to conduct an RCT to evaluate the efficacy of the BEAM app-based program for improving maternal mental health and parenting stress compared to a treatment as usual (TAU) control group. We hypothesize that participants who receive the BEAM intervention will report fewer depression symptoms (primary outcome) compared to the control group.

The secondary aims of the trial are to determine the benefits of BEAM for family relationships, parenting, and maternal and child socioemotional functioning. We hypothesize that participants who receive the BEAM intervention will report reduced anxiety symptoms, improved family relationship quality, more positive parenting skills, less parenting stress, and better child development outcomes. We will also explore whether changes in these outcomes occur as a function of treatment effects on maternal depression and parenting stress.

The current study will also examine exploratory outcomes of observed parent-child relationship quality, maternal sensitivity, and child emotion regulation via remote Zoom online assessments. Furthermore, exploratory outcomes will include physiological indices of wellbeing (e.g., sleep and daily activity) measured via Fitbits that participants will wear during the program. We hypothesize that participants who receive the BEAM intervention will display improved parent-child relationship quality, maternal sensitivity, and physiological health (e.g., improved sleep quality and increased daily activity) and that their children will demonstrate improved emotional regulation.

Trial design {8}

A two-armed, parallel-design randomized controlled superiority trial with repeated measures will be used to evaluate the efficacy of the 10-week app-based BEAM intervention for mental health and parenting outcomes in parents of children aged 18–36 months (at study enrollment) compared to the treatment as usual (TAU) control group. Participants will be randomly allocated, using central randomization stratified based on telehealth session availability, in a 1:1 ratio to the BEAM program or TAU. Primary (depression) and secondary (anxiety, family relationship quality, parenting stress and behaviors, and maternal and child socioemotional functioning) outcomes will be assessed during the enrollment period (pre-test, T1), after the last week of the BEAM intervention (post-test, T2), and at follow-up (T3). Exploratory outcomes (parent-child relationship quality, maternal sensitivity, child emotional reactivity, and physiological indices) will be assessed at T1 and T2.

This trial adheres to the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines [82] and was registered with ClinicalTrials.gov (NCT05306626). All procedures will be performed in accordance with the Research Ethics Board at the University of Manitoba, Fort Garry campus and the 1964 Helsinki Declaration and its later amendments. All participants will provide informed consent prior to enrollment in the study.

Methods: participants, interventions, and outcomes

Study setting {9}

Participants residing in Manitoba and Alberta will be recruited online. The intervention will be offered on an app-based psychoeducation platform with a private online forum, hosted on University of Manitoba servers. Assessments will be conducted online via the Research Electronic Data Capture (REDcap) tools for Personal Health Information Act (PHIA)-compliance and data security [44, 45].

Eligibility criteria {10}

Inclusion and exclusion criteria

Eligibility includes identifying as a mother or female primary caregiver with a child aged 18–36 months; English speaking; above the age of 18; residing in Manitoba or Alberta, Canada; self-reported moderate-to-severe symptoms of depression and/or anxiety (above a clinical threshold) at the pre-test assessment that will occur prior to randomization; and consent to wearing a Fitbit. Eligible mothers will also need to be available to attend weekly telehealth sessions, complete the baseline Zoom assessment and/or Zoom orientation and complete the pre-test self-report assessment. Participants will also need access to an iOS or Android device. If a participant reports not having access to a device, they will be provided one to use for the duration of the study period. Eligible participants who consent to be randomized will be invited to participate in the study through email. In terms of exclusion criteria, mothers who report a history of attempted suicide in the past year or self-harm in the past 6 months will not be eligible for the current study as the BEAM program is not suitable to treat acute mental health needs. Instead, these participants will receive a list of mental health resources in their province that may be more appropriate.

Screening and enrollment

After informed consent is obtained, potential participants will automatically receive an online eligibility screener to complete. The eligibility screener will be used to confirm that they are 18 years or older, speak English, have at least one child between 18 and 36 months, and meet the threshold for moderate-to-severe (≥ 10) depression and/or anxiety using the Patient Health Questionnaire (PHQ-9) and the General Anxiety Disorder (GAD-7) scale; have access to an iOS or Android phone or tablet; are available to attend weekly telehealth sessions; and consent to wearing a Fitbit. Initial eligibility will be determined based on screener responses. Research coordinators will schedule a pre-test Zoom assessment (or Zoom check-in for those who are unable to complete the Zoom assessment) with individuals who meet eligibility based on the initial online eligibility screener. Participants will be considered eligible after they complete the screener questionnaire and the pre-test Zoom assessment or check-in and consent to randomization. Individuals who do not meet the eligibility criteria will be excluded from the RCT.

Who will take informed consent? {26a}

Prospective participants are identified via online recruitment posters. Interested participants who click the study link will automatically be directed to an online informed consent form where they will read information explaining the study procedures in full detail before providing electronic written consent. Participants will have the option to contact the research coordinators through the BEAM program email address should any questions regarding the informed consent form arise.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

We will potentially conduct a longer term follow-up pending positive funding. If this follow-up occurs, further consent will be sought from all participants. No biological samples will be collected.

Interventions

Explanation for the choice of comparators {6b}

The treatment as usual (TAU) control arm of the study is designed to account for the potential effects of time on depression symptoms [46]. The TAU group will continue to receive their standard care. The control group will be used to assess whether receiving the BEAM intervention is associated with improved outcomes (e.g., mental health, reduced parenting stress) compared to TAU.

Intervention description {11a}

The BEAM Program is based on best practices in telehealth and science-based program design principles aimed at promoting maternal mental health and supportive parenting. The BEAM Program will be delivered via a mobile application, which is designed and maintained by Tactica Interactive, managed by the research staff, and hosted on the University of Manitoba secure servers. The BEAM Program will also be delivered through weekly group telehealth sessions led by a mental health professional or trainee via the secure videoconferencing platform Zoom (Healthcare license). The BEAM application will include weekly 10–20 min asynchronous video modules on mental health and parenting as well as access to a private online forum for peer support from other participants and research staff.

An overview of the program materials is attached in the appendix (Appendix 1). Activities will be available each week where participants are encouraged to (a) reflect on the content and how it applies to their specific mental health and parenting situations and (b) engage in discussions related to the weekly topics with the community in the BEAM forum (described in detail below).

Psychoeducation

The BEAM program includes a psychoeducation component which will be composed of video modules on mental health and parenting delivered via the app. There will be at least one mental health video and one parenting video each week (approximately 10 min each).

Mental health videos will provide information and emotion regulation strategies for the transdiagnostic treatment of depression and anxiety disorders [47, 48]. The content draws principles from Unified Protocol (UP), a cognitive-behavioral therapy approach that addresses underlying features thought to contribute to emotional disorders (e.g., avoidance). Based on user feedback from the pilot study, self-compassion will also be a large focus of the mental health content given the link between self-compassion and psychopathology and the efficacy of self-compassion for improving a wide range of psychosocial outcomes [49, 50].

Supportive parenting videos will provide parents with emotion-focused parenting strategies that include information on child emotional development, sensitive responding, and behavior management strategies. These videos focus on helping parents understand their children’s challenging emotions and behaviors and focus on teaching parents to take a proactive approach in preventing negative interactions, tolerating extreme child emotions, encouraging compliant behaviors, and promoting a positive parent-child relationship.

Mood tracking

BEAM participants will complete brief weekly surveys responding to questions on depression, anxiety, parenting stress, positive mood, and recent stressful experiences. Participants will be provided with a weekly score for their depression, anxiety, and parenting stress. Participants will track and graph these weekly scores in a therapy notebook that is provided to them by the research team. Recent work analyzing mood-tracking within applications has found that apps with mood-tracking functionalities increase user self-awareness and understanding of emotions, making it an effective active therapeutic component [51].

Social support and community connection

Weekly group telehealth sessions will provide an opportunity for the clinical research team (i.e., those on the research team who have direct interactions with the participants) to check in with participants throughout the program. Participants will have the opportunity to discuss the material with their clinical coach (described below) and with other parents in the program, to ask questions about specific topics of interest, and increase a sense of community and social support.

Online Community Forum: The BEAM application also includes an online community forum designed to provide a space to reflect on skills learned in the intervention and access social support through connections with other mothers (participants and parent coaches; described below). All participants in the intervention group will participate in a closed online community forum that is moderated by a peer parent coach in consultation with our clinical research team of mental health professionals. The forum will consist of open-ended discussions between BEAM participants, peer advice, and sharing of anecdotes and/or non-identifying photos of their wellness journey. Furthermore, participants will have the ability to ask clinical coaches about specific mental health and parenting questions related to the program.

Coaching

Parent coaches will be mothers who have recently completed another research group-based intervention for their own mental health needs and who are interested in being a part of the community to promote the mental wellness of mothers. Parent coaches will help to conduct Zoom orientation meetings (detailed below) with participants prior to the program start date, will engage with participants on the forum, and co-facilitate weekly telehealth sessions.

Clinical coaches will be clinical trainees or registered mental health professionals. Clinical coaches will monitor the forums, facilitate weekly group telehealth sessions, and manage participant contact by email as needed. Clinical coaches will also participate in weekly consultation meetings with clinical supervisors (i.e., registered psychologists).

Criteria for discontinuing or modifying allocated interventions {11b}

Should participants disclose suicidal behavior, the clinical team will consult about these instances and advise on whether or not continued participation in the BEAM program is in the best interest of the participant. In accordance with Best Practice Guidelines for Telepsychology Services, clinical coaches may also decide to terminate a participant’s involvement in the e-health program if they deem it inappropriate for the participant to continue (e.g., if the participant cannot ensure confidentiality is maintained through access to a secure space and stable internet connection) [52]. Furthermore, participants may have discontinued access to the forum and may be denied access to the telehealth sessions if they engage in repeated violations of the terms of use (Appendix 2). In these cases, participants would still have access to psychoeducation materials and would still be invited to complete the assessments. The clinical coaches may also provide a referral to another provider or clinic if deemed appropriate.

Strategies to improve adherence to interventions {11c}

To promote engagement in the BEAM program, participants will be required to confirm availability for the Zoom telehealth sessions and complete the pre-test assessment (including the online survey and Zoom assessment) in order to be eligible for the study. Participants may opt out of the full Zoom assessment and complete a brief Zoom check-in instead if preferred. During the program, three scheduled weekly study-related notifications will be sent to participants in the intervention group through the BEAM app. Sending engagement reminders to participants has been found to contribute to greater mental health benefits from e-health interventions [53, 54] and increase the effectiveness of online parenting programs [55]. The proposed trial incorporates strategies such as reminders via email and telephone (SMS), which have also been shown to increase engagement [56]. Participants will receive a 1-page summary detailing the next steps in the BEAM program and will participate in a Zoom orientation meeting with a parent coach or clinical coach. The purpose of the orientation meetings is to welcome participants to the program, explain the program components, and answer questions, in an attempt to increase attendance and engagement in the program. Participants will be contacted by their clinical coach if they have not attended telehealth sessions for two weeks in a row. Parent coaches will also be assigned to facilitate and promote participant engagement on the forum.

Relevant concomitant care permitted or prohibited during the trial {11d}

Participants will be permitted to receive concomitant care for mental health problems, such as psychotherapy, medication, and/or support groups. No concomitant care and interventions are prohibited.

Provisions for post-trial care {30}

If further treatment is deemed necessary, a referral to another provider or clinic will be made, and a list of community services will be provided. No trial-related harms are expected.

Outcomes {12}

Primary outcomes

The primary outcome is mean change in depression symptoms from pre- to post-intervention and from pre-intervention to follow-up, assessed using the Patient Health Questionnaire-9 (PHQ-9) [57], a self-report questionnaire that measures depression severity. Participant depression symptoms will be measured during eligibility screening pre-intervention (T1), immediately after intervention (T2), and at a 6-month follow-up (T3). The PHQ-9 includes nine items, asking participants to report over the past week how often they have been bothered by certain problems. Participants respond to each item using a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Possible scores range from 0 to 27, with higher scores indicating more severe depression symptoms. Participant scores are summed, and a cutoff score of ≥ 10 will be used to identify participants who present with clinically concerning symptoms of depression [57]. The PHQ-9 cutoff score of 10 has been shown to demonstrate high sensitivity and specificity in detecting depression in a perinatal population [58].

Secondary outcomes

Secondary outcomes include mean change in maternal anxiety symptoms from pre- to post-intervention and from pre-intervention to follow-up assessed using the Generalized Anxiety Disorder 7-Item Scale (GAD-7) [59]. The GAD-7 is a self-administered scale with 7 items that are rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day). A cutoff score of ≥ 10 will be used to identify participants who present with clinically concerning symptoms of anxiety. Scores range from 0 to 21, and participant scores are summed to obtain a total score. Higher scores indicate more severe GAD symptoms. The following suggested cutoff scores will be used: 10–14 (moderate anxiety) and 15 (severe anxiety). The mean change in parenting stress from pre- to post-intervention and from pre-intervention to follow-up will also be assessed using the Parenting Stress Index (PSI) [60], a self-report measure of parenting stress and interactional style. Scores are summed to obtain a total raw score ranging from 36 to 180, with higher scores indicating higher levels of parenting stress.

Additional secondary measures of parenting will be used to assess the mean change in family relationship quality across time points (T1 to T2 and T1 to T3). Parental assistance with child emotion regulation will be measured using the Parental Assistance with Child Emotion Regulation scale (PACER), a self-report measure of how parents use strategies to assist children with regulating their emotions [61]. Participant scores are summed to obtain a total score ranging from 50 to 350, with higher scores indicating greater engagement in strategies that support child emotion regulation. The mean change in parenting discipline practices will be assessed using the Parenting Scale, a self-report measure that assesses parenting behavior and dysfunctional discipline of in parents with young children [62]. Scores are summed to create a total score ranging from 30 to 210, with higher scores indicating higher levels of ineffective discipline practices. Parenting behaviors will be measured using the Parenting Young Children (PARYC) measure, a self-report of parenting strategies and behaviors of caregivers with young children [63]. Scores will be summer, and the mean change in scores from pre- to post-intervention and from pre- to follow-up will be assessed. Scores range from 21 to 105, with higher scores indicating more proactive parenting behaviors.

Other secondary measures include co-parent relationship quality and support, additional mother socioemotional functioning measures related to mental illness, and child outcomes. The mean change in all measures will be assessed from pre- to post-intervention and pre-intervention to follow-up. Change in partner support across time points will be measured using the Social Support Effectiveness Questionnaire (SSEQ), a self-report measure of partner support effectiveness [64]. Scores are summed to obtain a total score with possible scores ranging from 0 to 80. Higher scores reflect more effective social support. Change in romantic relationship satisfaction will be measured using the 4-item Couple Satisfaction Index (CSI-4) [65]. The CSI-4 measures global evaluations of romantic relationships. Scores range from 0 to 21 with higher scores indicating higher levels of satisfaction. Anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form, a self-report measure of frequency and severity of anger [66]. The mean change in anger scores will be assessed between T1 and T2 and T1 and T3. Total scores range from 5 to 25 with higher scores indicating more anger. Change in self-compassion across time points will be assessed using the Self-Compassion Scale Short Form (SCS-SF), a self-report measure of self-compassion [67]. Scores range from 12 to 60 with higher scores indicating higher self-compassion. Self-esteem will also be measured with the Single Item Self-Esteem Scale (SISE), a single-item measure that assesses global self-esteem [68]. Scores range from 1 to 7 with higher scores indicating higher self-esteem. Sleep problems will be measured using the PROMIS Sleep Disturbance Scale, a self-report measure of sleep disturbance [69]. Scores range from 8 to 40 with higher scores indicative of greater severity of sleep disturbance. Change in suicidal ideation severity will be measured using the Depression Symptom Index Suicidality Subscale (DSI-SS), a 4-item self-report measure of suicidal ideation [70]. Scores are summed to obtain a total score with possible scores ranging from 0 to 12. Higher scores indicate higher suicide ideation. The change in substance use (alcohol and cannabis) will be assessed using the Alcohol Use Disorder Identification Test (AUDIT) [71] and Cannabis Use Identification Test - Revised (CUDIT-R) [72], respectively. The AUDIT is a self-report measure of alcohol consumption, drinking behaviors, and alcohol related problems with scores ranging from 0 to 40. Higher scores are indicative of more hazardous alcohol use. The CUDIT-R is a self-report measure of cannabis misuse. Scores on this measure range from 0 to 32, with higher scores indicating more hazardous cannabis use. Scores of 12 or more indicate a possible cannabis use disorder. The mean change in child emotional and behavioral problems will be measured using the Preschool Pediatric Symptom Checklist (PPSC), an 18-item parent report measure of emotional and behavioral problems in young children [73]. Item scores are summed to obtain a total score ranging from 0 to 34, with higher scores indicating higher incidences of emotional and behavioral problems. Finally, the mean change in child temperament will be assessed using a subset of questions from the Early Child Behavior Questionnaire (ECBQ), a parent measure of temperament in children aged 1 to 3 [74]. Scores range from 1 to 7 with higher scores indicating higher levels of the temperamental trait.

Exploratory outcomes

Exploratory outcomes include changes in parent-child relationship quality, sensitive parenting, and child emotional reactivity, using observational measures obtained during a remote Zoom video assessment with mothers and their children that will occur at pre- and post-intervention. Participants will also be asked to wear a Fitbit Inspire 2 throughout the trial. Various types of physiological data will be collected (i.e., heart rate, sleep quality and duration, and daily physical activity) at pre- and post-intervention in order to measure changes in heart rate, sleep duration, sleep quality, and physical activity. The Fitabase software will be used to manage data from participants’ Fitbits as Fitabase allows researchers to amalgamate data from across participant Fitbits [75]. The feasibility of the BEAM program will be assessed at post-intervention using the mHealth App Usability Questionnaire (MAUQ) [76] and other questionnaires developed for the BEAM program. Engagement and adherence linked to user IDs will be tracked from back-end app data using Firebase and Google Analytics, such as number of logins and time spent on the app, forum posts, and telehealth session attendance. A final exploratory outcome will involve analyzing the qualitative program data which will include the content of posts and comments within the forum and feedback from participants after the program completion (post-intervention) for program improvement purposes.

Descriptive measures

Descriptive data will be collected via survey questions on demographic and socioeconomic characteristics at pre-intervention. Items will include education level (high school degree or lower vs. post-secondary education), age, household income, changes in household income due to COVID-19, marital status (married or in a domestic partnership vs. other), number and ages of all children, type of community in which one lives (large city vs rural area), and medications. A measure of personality using the Big Five Inventory-10 (BFI-10), which will be adapted from the original questionnaire [77], will be administered at pre-intervention. Participants will also be asked about other treatments and service use throughout the duration of the BEAM intervention.

Participant timeline {13}

The overall participant timeline is illustrated in Fig. 1.

Fig. 1

SPIRIT schedule of enrollment, intervention, and assessments

Week 0 (T1): Eligible participants who consent to randomization and to participate in the program will receive notice of enrollment. Participants will participate in a clinical orientation meeting with a member of the clinical research team (i.e., a parent or clinical coach) and complete the pre-test assessments, including primary, secondary, and exploratory outcome measures.

Week 1: Participants randomized to the experimental condition will receive an email regarding login and account information. Program information will be sent electronically to participants from the study team, and participants will watch introductory videos to become familiar with the app. Participants will begin engaging in the forum.

Weeks 2–11: Participants will watch weekly videos and will complete mood tracking questions on depression and anxiety symptoms, parenting stress, recent stressful experiences, and positive mood for self-monitoring purposes. Participants will also participate in weekly Zoom telehealth group sessions and continue engaging in the forum.

Weeks 12–16 (post, T2): Participants will complete a full post-test assessment of primary, secondary, and exploratory outcome measures.

Month 6 (follow-up, T3): Participants will complete a follow-up assessment of primary and secondary outcome measures.

Sample size {14}

Based on the findings from a meta-analysis, digital interventions for depression that include a human therapeutic guidance component (as is the case with the BEAM program group therapy sessions) have a moderate effect on depression (g = .63) [78]. Thus, an a priori, one-tailed, two-group power analysis was conducted using a moderate effect size (d = .5) using the G* Power 3 software [79]. The power analysis indicated that we would need 51 participants per group to reach 80% power (α = .05) to detect a clinically significant change in depression. To account for anticipated attrition of approximately 25%, a total sample of 140 with 70 in each group (intervention and control) will be the target for recruitment.

Recruitment {15}

Participants in Alberta and Manitoba, Canada, will be recruited online via multiple sources such as advertisements on social media platforms including the Hearts and Minds Research Lab Facebook, Twitter, and Instagram accounts. Recruitment materials will also be emailed to relevant community agencies and daycares. Individuals will respond to program advertisements by clicking a link to the online eligibility screener. Individuals who meet all the eligibility criteria and consent to randomization will be invited to participate in the study. The recruitment duration period will last 3 months, and recruitment will be monitored by the research staff. Participants will be eligible to receive up to $150 Canadian (CAD) compensation for their enrollment and participation for the entire study duration. There are no incentives provided to trial investigators for participant enrollment.

Assignment of interventions: allocation

Sequence generation {16a}

Allocation will be conducted using a randomized intervention model. Participants will be randomly allocated in a 1:1 ratio to the BEAM program or TAU. Randomization will be stratified based on which telehealth group timeslot participants identified being available for. Central randomization, by computer-generated sequencing using an online tool (https://www.randomlists.com/team-generator), will be conducted by a research assistant that is not affiliated with the BEAM clinical research team.

Concealment mechanism {16b}

Central randomization using computer-generated sequencing will be conducted by a research assistant who is not involved in clinical care (i.e., group therapy sessions, forum engagement) or pre- and post-test assessments to ensure allocation concealment.

Implementation {16c}

A research staff member who is not associated with the study will conduct the randomization and sequence generation. After the completion of the pre-test assessment, a research assistant will enroll participants in the trial, check the computer-generated assignment and inform participants of their enrollment and condition in the trial.

Assignment of interventions: blinding

Who will be blinded {17a}

Participants, clinical coaches, and parent coaches will not be blinded to condition. Data analysts will not be blinded to conditions either as the analysis will be conducted by the research team. The trial did not have the funding for separate statisticians. The research assistants responsible for coding observational measures in assessments will be blinded to participants’ group assignments.

Procedure for unblinding if needed {17b}

Not applicable as participants, clinical coaches, and parent coaches will not be blinded to condition.

Data collection and management

Plans for assessment and collection of outcomes {18a}

Data will be collected via self-report measures, Fitbit devices (Fitbit Inspire 2), online video assessment, the use of back-end app data via Firebase and Google Analytics, and forum content.

The primary outcome of change in depression symptoms will be assessed using the Patient Health Questionnaire (PHQ-9) [57]. Secondary outcomes include changes in anxiety symptoms, assessed using the Generalized Anxiety Disorder 7-Item Scale (GAD-7) [59], family relationship quality, assessed with the Parental Assistance with Child Emotion Regulation (PACER) [61], the Social Support Effectiveness Questionnaire (SSEQ) [64], and the Couple Satisfaction Index (CSI) [65], parenting, assessed using the Parenting Stress Index (PSI) [60], the Parenting Scale [62], and the Parenting Young Children (PARYC) measure [63], and maternal functioning assessed using a variety of validated self-report questionnaires for mental health symptoms, including the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Subscale [66], the Self-Compassion Scale Short-Form [67], the PROMIS Sleep Disturbance Scale [69], the Depression Symptom Index Suicidality Subscale [70], the Single Item Self-Esteem Scale [68], the Alcohol Use Disorder Identification Test (AUDIT) [71], and the Cannabis Use Disorder Identification Test – Revised (CUDIT-R) [72]. There will also be additional measures of suicidality and self-harm, depression persistence, recent stressful experiences, mental health medication and service use, and an additional measure of substance use, which have been developed for the BEAM project. Child Functioning will be measured using validated questionnaires for child mental health and behavior, including the Preschool Pediatric Symptom Checklist [73] and a subset of questions from the Early Child Behavior Questionnaire [74]. Additional measures of screen time and child health, which have been developed for the BEAM program, will also be used.

Online video assessments will be conducted to measure exploratory outcomes of parent-child relationship quality, child emotional reactivity, maternal sensitivity (e.g., Maternal Q-sort), and sensitive parenting (e.g., child-directed speech). Online video assessments will take place over Zoom with mother-child dyads. Assessors will be undergraduate psychology students who have undergone extensive training in conducting Zoom assessments with families. Training involves watching practice videos and practicing the assessments with pilot families under the supervision of psychology graduate students as well as registered psychologists on the research team. Exploratory outcomes will also include physiological measures obtained through the use of Fitbit devices (Fitbit Inspire 2), including heart rate, sleep quality and duration, and physical activity. Feasibility of the BEAM program will be assessed using the mHealth App Usability Questionnaire self-report questionnaire (MAUQ) [76] and other questionnaires developed for the BEAM program. Firebase and Google Analytics will be used to track program engagement and adherence and the content of posts and comments within the forum will be used for program improvement purposes.

Additional self-report questions will be administered to assess demographic and socioeconomic characteristics and personality will be assessed using the Big Five Inventory-10 (BFI-10) measure, which will be adapted from the original questionnaire [77].

Plans to promote participant retention and complete follow-up {18b}

Three scheduled study-related reminders will be sent to participants each week through the BEAM app and participants will receive one weekly email reminder which will include information for group telehealth sessions. Eligible participants will receive up to $150 Canadian (CAD) compensation for participating for the entire duration of the study. Participants will receive an honorarium of $20 CAD for completing the pre-assessment questionnaires, $30 CAD for completing the post-intervention assessment, $20 CAD for completing the follow-up assessment, and $30 CAD if they complete all weekly surveys ($3 CAD per week) and will receive another $50 CAD if they choose to mail back the Fitbit used for data collection during the study. Furthermore, the clinical research team will have weekly meetings to monitor the adherence and retention of participants. For instance, group attendance will be discussed and additional email check-ins with participants will be performed when advised by the registered psychologists on the team.

Data management {19}

REDCap is managed by The George and Fay Yee Centre for Healthcare Innovation, which is a hired consultant on the proposed project and will support secure data collection and management. RCT data will be stored on a secure server in accordance with the University of Calgary’s Data Retention Policy and the University of Manitoba’s PHIA policies. Once data is downloaded, all identifying information will be removed, which aligns with the University of Manitoba’s REDCap policies. All patient health information and identifiable information will be kept for up to 5 years. Birth dates will be converted into age in months, and birthdate information will then be destroyed. For the storage of Zoom assessment data, raw video data will be destroyed no later than 5 years after collection. Once videos have been coded by trained observers, the original file and all copies will be deleted. Measures to promote the quality of data entry will include range checks for all data values entered and having three research assistants review and ensure correct data entry in REDCap.

Confidentiality {27}

The BEAM program will occur on a secure online platform and participant confidentiality will be protected throughout all phases of the study in accordance with University of Manitoba and University of Calgary ethics guidelines. Only the research team will have access to study data and only de-identified data will be transmitted to coinvestigators. All those with access to data are trained in the University of Manitoba’s and University of Calgary’s ethics and data safety protocols, have completed additional training on the Public Health Information Act, and have taken an oath of confidentiality.

Assessment data will be stored securely on REDCap or on password-protected University of Manitoba secure data servers. Any documents including identifying information will be password-protected and stored on University of Manitoba secure data servers. All questionnaire data will be exclusively linked to de-identified participant ID numbers once it has been downloaded from REDCap. Qualitative data from forums will be anonymous and not linked to any identifying information on the platform. Fitbit data will be stored in Fitabase’s high-security cloud-based database [75] until the trial is complete, at which point it will be downloaded and deleted.

Precautions will be taken to manage any risks to confidentiality of personal data on the forum. These precautions include a Risk Management Protocol, Data Management Protocol, participant agreed upon Terms of Use, and the ability for program coaches to remove any posts that violate the terms or use and to email any participants should there be concerns.

To protect participant privacy and confidentiality and to ensure that no health information is shared on the forum, all participants will be required to agree to the community guidelines including the Rules and Terms of Use of the online forum and will agree not to disclose any identifying information to other participants. Security measures include monitoring of the forums by the study team, and the ability for other participants to anonymously flag posts for review. A risk management protocol will be put in place by clinician leads in each province to manage any potential crisis-related mental health or child safety needs.

During the weekly telehealth sessions, participant anonymity cannot be guaranteed. The telehealth sessions will be hosted on a secure Zoom Healthcare account and will be password-protected. The clinical coaches will outline the limitations of confidentiality and anonymity at the beginning of the first telehealth session. Telehealth meetings will not be recorded or included in any assessment; however, attendance will be tracked. The Jane app will also be used as the clinical record management tool (i.e., to track attendance to telehealth sessions and make session notes).

Participants will become familiar with the limitations to confidentiality and of the measures that will be taken to protect the confidentiality during the informed consent process before beginning in the study.

Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Not applicable, no biological specimens will be collected.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}

Between-group differences in primary and secondary outcome variables, as well as quantitative exploratory outcome variables (observational and Fitbit data), will be analyzed using linear mixed models. Models will test both a linear and quadratic time coefficient, where quadratic time coefficients will be removed from final models if not significant. An α of 0.05 will be used to determine statistical significance. Effect sizes of 0.20, 0.50, and 0.80 will be interpreted as indicating small, medium, and large effects, respectively [80]. Standardized effect sizes for linear mixed models will be derived based on existing recommendations for linear mixed models [80, 81]. The research team will also investigate if there is baseline moderation by symptom severity to examine whether the BEAM intervention is more effective than the control group for participants who have higher symptom levels at pre-intervention (e.g., depression, anxiety, insomnia).

Exploratory qualitative data will be analyzed thematically [82]. First, two analysts will concurrently, but independently read the transcripts for surface descriptive content, and organize like-with-like ideas. Second, transcripts will be re-read for latent meaning to better understand participants’ meaning, including looking for contradictory or confirmatory statements. Each analyst will independently generate and systematically apply themes across all transcripts. Semantic validity checks will ensure different words and phrases within a category have similar meanings [82]. To further enhance rigor, constructs will be deemed saturated (akin to statistical significance in quantitative work) when no new or additional constructs are identified, consensus is reached on all overarching themes, and no alternative explanations were found with subsequent interviews [82].

Interim analyses {21b}

No interim analyses are planned.

Methods for additional analyses (e.g., subgroup analyses) {20b}

Subgroup analyses will be conducted to explore the differences in outcomes for those who do and do not attend telehealth sessions regularly. Additional subgroup analyses may be explored based on emergent research questions of interest.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Analyses will be conducted on an intent-to-treat (ITT) basis [83]. Regardless of participants’ adherence to the intervention or whether they withdrew from the study, data for every participant who was randomized to either the control or intervention group will be included in ITT analyses. Analyses that include only participants who completed the intervention will also be conducted for comparison purposes. Missing data will be handled using maximum likelihood [84], which estimates values based on all available data and thus produces unbiased model parameters [85].

Plans to give access to the full protocol, participant-level data, and statistical code {31c}

The full trial protocol will be made publicly available through BMC Trials. Dr. Tomfohr-Madsen and Dr. Leslie Roos will remain the custodians of the data, as the primary investigators. Data will be analyzed independently and will not be released to any third party (including the funder) before the trial is completed. In accordance with the International Committee of Medical Journal Editor’s guidelines, the authors will share de-identified patient data that underlies results presented in reports no later than 6 months after publication. The primary investigators will ensure data is available upon request.

Oversight and monitoring

Composition of the coordinating center and trial steering committee {5d}

Dr. Tomfohr-Madsen and Dr. Roos, as the primary investigators, will be responsible for the overall management of the project. Dr. Tomfohr-Madsen has expertise in program development, intergenerational transmission of stress, and clinical trials and will be the clinical lead in the preparation and delivery of mental health psychoeducation content. Dr. Roos has expertise in maternal-child health interventions and will lead platform development and parenting content for participants. Dr. Reynolds is a clinical psychologist with expertise in maternal mental health, program evaluation, knowledge translation, and mixed-methods data analysis. Dr. Reynolds will assist with exploratory qualitative analyses and integrating participant feedback into specific revisions to existing protocols. Dr. Sauer-Zavala is a co-developer of the Unified Protocol and has experience with efficacy testing for online interventions. Dr. Giuliano will lead cardiac and cognitive data processing teams. Dr. Soderstrom focuses on language development across cultures and contexts and examines conversational interactions between caregivers and infants. Dr. Protudjer has expertise in mixed methods and will co-lead exploratory qualitative data analysis to develop content for patient-identified needs.

Composition of the data monitoring committee, its role, and reporting structure {21a}

Study investigators will monitor the trial. There will be weekly meetings with research assistants and the primary investigators (i.e., Dr. Tomfohr-Madsen and Dr. Roos) to discuss and review each phase of the trial (e.g., recruitment, randomization, and data collection). There will also be weekly meetings with the clinical coaches and tech facilitators (i.e., those who are interacting with research participants) and primary investigators to discuss and resolve all potential questions and concerns of participants. Given the minimal risks of the program, short duration (10 weeks of intervention), and relatively small sample size, the current trial does not require a formal data monitoring committee.

Adverse event reporting and harms {22}

No known risks to mothers are associated with digital psychoeducational interventions. Should participants report significant distress or request additional support, clinical coaches follow up with these participants and consult with clinical supervisors using a risk management protocol. The primary investigators will check in with clinical coaches and parent coaches regularly to ensure that the study participants’ questions and concerns are responded to appropriately. No adverse events were reported in our pilot study.

We will follow the University of Manitoba’s standard procedures for reporting adverse events and protocol violations/deviations to the Research Ethics Office at the Fort Garry Campus and privacy breaches to the Access and Privacy Office.

Frequency and plans for auditing trial conduct {23}

The Research Ethics Board may request an audit. However, the study team has no plans for independent auditing of trial conduct.

Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}

Any amendments to the protocol will be submitted to the Ethics Board at the University of Manitoba, who will review and approve the amendments. If the amendment requires that revised information be communicated with enrolled research participants, this will be done through a consent addendum, which will be provided to participants through email.

Dissemination plans {31a}

Research findings will be disseminated to academic and nonacademic audiences, regardless of the magnitude or direction of the effect, within 12 months of trial completion. We will prepare several articles describing the effects of the BEAM program on parenting stress, mental health, and child well-being for publication in peer-reviewed journals. Papers will also be posted rapidly on preprint servers and will be open access to allow for wider reach. The principal investigators and trainees on the research team will present findings at national (e.g., Canadian National Perinatal Research meeting) and international (e.g., Society for Research in Child Development) conferences. Dissemination of infographics and bimonthly reports will occur through our partnerships with community agencies and existing knowledge users in government (e.g., Leanne Boyd, director of policy development, research, and evaluation, Healthy Child Manitoba). Research findings will be shared in lay summaries on lab and study websites and social media pages. We will work with media relations at the University of Calgary and our networks to disseminate research findings rapidly through local and national media. Furthermore, if trial findings substantiate the efficacy of the BEAM program we will explore opportunities for health system integration through scale-up funding.

Discussion

Digital mental health and parenting interventions have the potential to (1) address the alarming rates of maternal mental health concerns during the COVID-19 pandemic, (2) help to protect against the adverse intergenerational consequences on child development, and (3) provide easily accessible programming to mothers who are in need of mental health and parenting supports, both during the COVID-19 pandemic and beyond. The BEAM program is a newly developed evidence-based app program that prioritizes social connection and provides psychoeducation and weekly telehealth sessions with mental health professionals. This RCT will build on a pilot trial of the intervention and provide further efficacy testing of this treatment for mothers experiencing depression and/or anxiety. Investing in maternal mental health early is expected to yield high health and economic benefits by preventing the long-term consequences of maternal depression from becoming imbedded in children’s biological and behavioral development [25]. Findings from this RCT will improve our understanding of mental health and parenting among mothers with young children and in turn help to improve maternal and child health and family well-being.

Trial status

Recruitment began in mid-November 2021 and finished in February 2022. The date of first enrollment was November 17. The intervention was launched at the end of February 2022 (with estimated completion in October 2022 for the collection of all primary outcomes).

Title {1}	Building Emotional Awareness and Mental Health (BEAM): study protocol for a randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months
Trial registration {2a and 2b}	The trial was registered with ClinicalTrials.gov (NCT05306626) on April 1, 2022. All items from the WHO Trial Registration Dataset can be found within the protocol.
Protocol version {3}	[May, 2022] (Version 1)
Funding {4}	This work was supported by funding from Research Manitoba and the Children’s Hospital Research Institute of Manitoba (July 2020 - July 2022).
Author details {5a}	E. Bailin Xie, University of Calgary Kaeley M. Simpson, University of Manitoba Kristin A. Reynolds, University of Manitoba Ryan J. Giuliano, University of Manitoba Jennifer LP Protudjer, University of Manitoba, Children’s Hospital Research Institute of Manitoba Melanie Soderstrom, University of Manitoba Shannon Sauer-Zavala, University of Kentucky Gerald F. Giesbrecht,, University of Calgary Catherine Lebel, University of Calgary Anna L. Mackinnon, University of Calgary Charlie Rioux, University of Manitoba, Children’s Hospital Research Institute of Manitoba, and University of Calgary Lara Penner-Goeke, University of Manitoba Makayla Freeman, University of Calgary Marlee R. Salisbury, York University Leslie Roos, University of Manitoba Lianne Tomfohr-Madsen, University of Calgary Authors’ contributions LER, LTM, AM, CR, CL, GG, SSZ, MRS, JP, RJG, and KR contributed to the conceptualization and design of the trial. LER, LTM, AM, CR, EBX, KS, LPG, MF, and MRS contributed to the preparation of the materials and will contribute to conducting the trial. EBX prepared the first draft of the protocol. All authors reviewed and approved the final submission.
Name and contact information for the trial sponsor {5b}	Leslie Roos Department of Psychology, University of Manitoba University of Manitoba, 66 Chancellors Cir, Winnipeg, MB, R3T 2N2. E-mail: leslie.roos@umanitoba.ca. Please contact Dr. Leslie Roos for public and scientific queries.
Role of sponsor {5c}	This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.