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 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 summed, 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.
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.