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Building Regulation in Dual Generations 2022-2025 (BRIDGE)

Primary Purpose

Maternal Depression, Self-Regulation, Emotion, Child Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Building Regulation in Dual Generations (BRIDGE)
Dialectical Behavioural Therapy Skill Training
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Depression focused on measuring maternal depression, childhood development, child psychopathology, emotion regulation, parenting, stress, prevention science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Have at least one 3-5-year-old child. Residing in Manitoba or British Columbia, Canada. Report elevated symptoms of depression (PHQ-9 score ≥10) at the eligibility screener, pre-randomization. Self-identify as being comfortable understanding, speaking and reading English. Self-identify as having internet access. Report being available to attend telehealth groups. Report being willing to complete pre- and post-intervention questionnaires. Exclusion Criteria: Mothers who report a suicide attempt in the past year or who have engaged in self-harm that required medical attention in the past 6 months will not be eligible to participate in the study, as the BRIDGE program is not intended to address these mental health needs. In addition, mothers who report a diagnosis of, or treatment for, Post-Traumatic Stress Disorder, Alcohol Use Disorder, Substance Use Disorder, or Psychotic Disorder in the last year will be followed up with a senior clinician to evaluate whether the BRIDGE program would be suitable for their needs. If the clinician (through consultation with clinical leads) indicates that the participant will be able to participate and engage in BRIDGE and/or DBT as the program is to be delivered, they will be considered eligible. Some participants may be encouraged to follow-up with group clinicians to ensure their mental health needs are being managed appropriately within or outside of the group.

Sites / Locations

  • University of Manitoba - Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)

Dialectical Behavioural Skills Training (DBT)

Services-As-Usual (SAU)

Arm Description

The BRIDGE program is a manualized therapy that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 16 weeks of 20-30 minute DBT and parenting skills training that will be delivered asynchronously via video (participants will access these by logging onto a password protected website). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions as well as DBT and parenting skills worksheets to complete between sessions.

Participants in the DBT arm will participate in 16 weeks of DBT skills training through weekly, synchronous 1.5-hour virtual group therapy sessions. Participants will also be asked to complete worksheets on the content between sessions.

Participants in the SAU arm will receive a list of local mental health and parenting resources, curated by our research team. Participants can access any intervention or resource participants would like throughout the duration of the program.

Outcomes

Primary Outcome Measures

Change in depression symptoms
Depressive symptoms will be measured using the PHQ-9. The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.
Change in child mental illness symptoms
Changes in child mental illness symptoms will be assessed using the Child Behaviour Checklist (CBCL). The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 113 items, with scores ranging from 0-226. Higher scores indicated greater symptom severity.

Secondary Outcome Measures

Change in Parenting stress
Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a self-report questionnaire that requires respondents to answer questions regarding their overall experience with parenting stress using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores range from 36-180. Higher scores indicate higher levels of stress.
Change in harsh parenting
Harsh parenting will be measured using the Overreactivity subscale of the Parenting Scale (PS). The Overreactivity subscale contains 10 items related to harsh parenting behaviours. Harsh parenting includes expressing inappropriate anger, irritability, or meanness towards one's child. Totals scores range from 10 to 70, with higher scores indicating higher levels of harsh parenting.

Full Information

First Posted
June 8, 2023
Last Updated
July 24, 2023
Sponsor
University of Manitoba
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05959538
Brief Title
Building Regulation in Dual Generations 2022-2025
Acronym
BRIDGE
Official Title
Building Regulation in Dual Generations (BRIDGE) 2022-2025
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized control trial aims to investigate whether a novel intervention, the "Building Regulation in Dual Generations (BRIDGE)" program, improves mental wellness and parenting practices among mothers of 3 to 5-year-old children who have elevated symptoms of depression. The main two questions this study aims to answer are: Does participation in the BRIDGE program reduce maternal depression symptoms? Does participation in the BRIDGE program improve children's mental health? Researchers will compare the BRIDGE intervention to an established mental health intervention (i.e., Dialectical Behaviour Therapy skills group) and to a services-as-usual control group to see if participation in BRIDGE leads to greater improvements than either the general mental health treatment or community services as usual. Participants will: Complete a set of questionnaires pre- and post-intervention, and at 6-month follow-up. Complete a virtual assessment with their child at pre- and post-intervention. Be randomized to BRIDGE, Dialectical Behavioural Therapy(DBT) skills group, or a services-as-usual control group. Participate in the 16-week BRIDGE or DBT Skills only group, if randomized to either of these groups. If they are randomized to services-as-usual they will receive a list of community resources they can access. Complete weekly symptom monitoring via questionnaires, if randomized to BRIDGE or DBT Skills Wear a Fitbit device during pre- and post-intervention, as well as throughout the 16-week intervention period.
Detailed Description
Diagnosed in 10-15% of children worldwide, childhood mental illness [MI] remains a prominent public health concern. Early exposure to maternal depression is a notable risk factor for the development of childhood MI. Maternal depression is most common in the first few years following childbirth, and clinically significant depressive symptoms are on the rise, with recent estimates at 26.9% for mothers worldwide. This increase highlights the current and critical need for interventions to address maternal depression and the prevention of childhood MI concurrently. To simultaneously address maternal and child MI, the Building Regulation in Dual Generations (BRIDGE) group-based intervention was created. BRIDGE aims to increase intergenerational emotion regulation by pairing Dialectical Behaviour Therapy (DBT) skills training with a theoretically aligned parenting skills program. DBT has been shown to be a propitious transdiagnostic treatment for underlying mechanisms of psychopathology, including emotion regulation difficulties common in depression, anxiety, and traumatic stress. Developmentally supportive parenting requires mothers to have the ability to regulate emotions effectively; in so doing, a mother can simultaneously limit over-reactive responses within themselves and towards their child, as well as teach their child about emotions. These objectives map nicely to the skills being learned in DBT. Within BRIDGE, the aligned parenting content also includes best-practice behaviour management training techniques, such as creating positive family routines and using positive reinforcement, framed within the context of DBT skills. The integration of DBT with parenting programs in BRIDGE is a promising approach for addressing intergenerational needs. The current study will expand on previous evaluations of BRIDGE by conducting a randomized controlled trial (RCT) comparing (1) BRIDGE (DBT skills training + Parenting Skills), (2) DBT (DBT skills training only), and (3) services as usual (SAU). Our primary aim is to examine the effects of BRIDGE on maternal depression and child MI symptoms. We hypothesize that participants who receive the BRIDGE and DBT interventions will report fewer depressive symptoms than participants in the SAU group. Participants who receive the BRIDGE intervention are hypothesized to report fewer child MI symptoms than those in the DBT and SAU groups. A secondary aim of this study is to evaluate the efficacy of BRIDGE in reducing parenting stress and harsh parenting. Participants who receive the BRIDGE intervention are hypothesized to show lower levels of parenting stress and harsh parenting than those in the DBT and SAU groups. Interim analyses of primary and secondary outcomes will be conducted at the mid-way point of the RCT, when approximately 90 participants have completed the post-intervention questionnaires (T2). Minor changes in intervention delivery (e.g., offering optional in-person group therapy, updating DBT homework, changing video production) may be made based on results from interim analyses. Any changes to intervention delivery will be documented in a protocol deviation document. Additional aims of the RCT are to examine the effects of BRIDGE and DBT on family relationships, other service use (e.g., hospital visits, interactions with police), and maternal psychopathology symptoms. The investigators hypothesize that mothers who receive the BRIDGE or DBT intervention will report lower psychopathology symptoms, reduced service use, and improved family relationship quality. The investigators will also assess participants' engagement in each intervention. Exploratory outcomes of observed maternal sensitivity and child emotion regulation will also be examined via remote Zoom assessments. The investigators hypothesize that mothers in the BRIDGE group will show greater maternal sensitivity and that their children will demonstrate improved emotion regulation, more than those in the DBT or SAU groups. Additional exploratory outcomes will come from physiological feedback and coparent participation. Physiological indices of wellbeing (e.g., sleep and daily activity) will be measured via Fitbits that mothers will wear during the program. The investigators hypothesize that participants who receive the BRIDGE or DBT interventions will display improved sleep quality and reduced sedentary behaviour. The investigators will invite participants' co-parents to complete questionnaires on their own mental health and family relationships. Inviting co-parents to complete questionnaires during this trial is exploratory and will allow us to evaluate the feasibility of including assessments of co-parents in future trials. The investigators hypothesize that some spill-over effects of the BRIDGE and DBT interventions may occur, such that co-parents of participants in either intervention group will show fewer MI symptoms and improved family relationship quality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression, Self-Regulation, Emotion, Child Mental Disorder, Child Development
Keywords
maternal depression, childhood development, child psychopathology, emotion regulation, parenting, stress, prevention science

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will recruit a group of caregivers in which the caregiver meets the current criteria for elevated symptoms of psychological distress as measured by a score of 9 and above on the Patient Health Questionnaire 9-item. Eligible female caregivers (mothers, grandmothers, aunts, guardians) will be randomly assigned to one of three intervention arms, which will occur concurrently over 16-weeks. One arm will incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training (BRIDGE), another will provide DBT only, while the third will provide community family support services as usual.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)
Arm Type
Experimental
Arm Description
The BRIDGE program is a manualized therapy that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 16 weeks of 20-30 minute DBT and parenting skills training that will be delivered asynchronously via video (participants will access these by logging onto a password protected website). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions as well as DBT and parenting skills worksheets to complete between sessions.
Arm Title
Dialectical Behavioural Skills Training (DBT)
Arm Type
Active Comparator
Arm Description
Participants in the DBT arm will participate in 16 weeks of DBT skills training through weekly, synchronous 1.5-hour virtual group therapy sessions. Participants will also be asked to complete worksheets on the content between sessions.
Arm Title
Services-As-Usual (SAU)
Arm Type
No Intervention
Arm Description
Participants in the SAU arm will receive a list of local mental health and parenting resources, curated by our research team. Participants can access any intervention or resource participants would like throughout the duration of the program.
Intervention Type
Behavioral
Intervention Name(s)
Building Regulation in Dual Generations (BRIDGE)
Intervention Description
The BRIDGE intervention includes 16 weeks of 20-30 minute DBT and parenting skills training videos, delivered asynchronously via an online website requiring a participant login. Video content was drawn from concepts outlined in the DBT Skills Training Manual 2nd Edition (Linehan, 2015). Parenting videos will provide mothers with parenting skills education based on best practices in evidence-based positive parenting interventions (e.g., Parent Management Training, Positive Parenting, Kazdin, 1997; Sanders et al., 2014). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions and worksheets to complete weekly (as an opportunity to practice skill use). The clinical team will consist of two Master's or PhD level clinical psychology trainees and a parent peer coach. Mood tracking will be completed using a brief weekly survey, including questions on depression, parenting stress, positive mood, and recent stressful experiences.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavioural Therapy Skill Training
Intervention Description
Participants in the DBT arm will participate in 16 weeks of DBT skills training only led by two Master's or PhD level clinical psychology trainees. Participants in the DBT Skills condition will participate in a skills group which follows the DBT Skills Training Manual 2nd Edition (Linehan, 2015) through weekly, synchronous 1.5-hour virtual group therapy sessions. Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness skill domains will be covered. Participants will be asked to complete worksheets between sessions to practice using skills, and will be asked to complete a Diary Card to track DBT skills use each week (Linehan, 2015). Mood tracking will be completed using a brief weekly survey including questions on depression, parenting stress, positive mood, and recent stressful experiences.
Primary Outcome Measure Information:
Title
Change in depression symptoms
Description
Depressive symptoms will be measured using the PHQ-9. The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.
Time Frame
The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in child mental illness symptoms
Description
Changes in child mental illness symptoms will be assessed using the Child Behaviour Checklist (CBCL). The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 113 items, with scores ranging from 0-226. Higher scores indicated greater symptom severity.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Secondary Outcome Measure Information:
Title
Change in Parenting stress
Description
Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a self-report questionnaire that requires respondents to answer questions regarding their overall experience with parenting stress using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores range from 36-180. Higher scores indicate higher levels of stress.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in harsh parenting
Description
Harsh parenting will be measured using the Overreactivity subscale of the Parenting Scale (PS). The Overreactivity subscale contains 10 items related to harsh parenting behaviours. Harsh parenting includes expressing inappropriate anger, irritability, or meanness towards one's child. Totals scores range from 10 to 70, with higher scores indicating higher levels of harsh parenting.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Other Pre-specified Outcome Measures:
Title
Change in couples' relationship satisfaction.
Description
Using the Couples Satisfaction Index (CSI-4), the investigators will examine participants' satisfaction with their romantic relationships. The CSI-4 contains 4 -items. Total scores range from 0-21, with higher scores indicating greater relationship satisfaction.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in social support.
Description
The Multidimensional Scale of Perceived Social Support (MSPSS) will be used to measure participant's levels of social support from significant others, family, and friends. Scores can range from 12-84. Higher scores indicated higher levels of perceived social support.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in parenting practices related to children's negative emotions.
Description
The Coping with Children's Negative Emotions Scale (CCNES) presents hypothetical scenarios in which a child gets upset or angry. Parents are asked to indicate the degree to which the parent responds to each scenario in 6 theoretically meaningful ways of coping with children's negative emotions. The CCNES has 6 subscales: Problem-Focused Reactions (PRF), Emotion-Focused Reactions (EFR), Expressive Encouragement (EE), Minimization Reactions (MR), Punitive Reactions PR), and Distress Reactions (DR). Each subscale has a score range from 12-84. Higher scores on each subscale represent higher levels of that type of parenting response (e.g., high expressive encouragement scores represent parenting practices in which parents encourage their children to express their emotions).
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in anxiety symptoms.
Description
Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). The GAD-7 contains 7 items with possible scores ranging from 0 to 21. Higher scores represent higher levels of anxiety symptoms.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in self-compassion.
Description
The Self-Compassion Scale-Short Form (SCS-SF) will be used to measure changes in participants' self-compassion. Possible scores range from 12-60, with higher scores indicating high levels of self-compassion.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in anger.
Description
Changes in anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger subscale. The subscale contains 5-items with scores ranging from 5-25. Higher scores indicate more anger.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in sleep disturbance.
Description
The Patient-Reported Outcomes Measurement Information System-Sleep Disturbance Subscale Short Form will be used to measure change in sleep disturbances. The subscale contains 8 items. Total scores range from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in alcohol use.
Description
The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure participants' use of alcohol. The AUDIT contains 10 question and scores may range from 10 to 40. Higher scores indicate greater hazardous or harmful alcohol consumption.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in cannabis use.
Description
The Cannabis Use Disorder Identification Test (CUDIT) will be used to measure participants' cannabis use. The scale contains 8 items. Scores may range from 0 to 32. Higher scores indicate more hazardous cannabis use.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in observed maternal sensitivity
Description
Participants and their children will attend pre- and post-intervention virtual assessments, where they will be asked to complete a free-play and clean-up task, which will be video recorded. Video recordings of the task will be coded using the Maternal Q-Sort developed by Pederson et al. (1999).
Time Frame
Assessed at pre-intervention (T1) and within a month following the intervention.
Title
Change in observed child emotional regulation
Description
Participants and their children will attend pre- and post-intervention virtual assessments, where children will be asked to complete an emotion-inducing task, which will be video recorded. Video recordings of the task will be coded using a coding scheme developed by the research team.
Time Frame
Assessed at pre-intervention (T1) and within a month following the intervention.
Title
Change in health and social services use.
Description
A self-report scale created for use in this project will assess participants' use of 14 types of health and social services in the previous 3 months. The scale does not produce a total score; rather, the scale asks participants if they had accessed services, and if yes, the frequency of their use of those services.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in recent stressful experiences.
Description
The Recent Stressful Experiences checklist (RSE) was developed by study authors, based on recommendations from the JBP Research Network on Toxic Stress at the Harvard's Center on the Developing Child, to measure familial exposure to various stressors which may affect participants (2022). The scale contains two items which ask about various stressors that participants may have experienced. Each of these items' scores can range from 0 to 10, with higher scores indicating more stressful experiences. The scale also contains five items assessing participants' ability to cope with stressful events. Scores for these five questions range from 4-21, with higher scores indicating a greater ability to cope with stress.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Program engagement
Description
Program engagement will be assessed in a variety of ways. In both the BRIDGE and DBT Skills-only groups, clinicians will take attendance during therapy sessions. In the BRIDGE group, the investigators will extract aggregate data on the number of views on the psychoeducational videos using Google Analytics. At post-intervention, the investigators will ask participants to report about their use of the videos, homework assignments, and mood tracking throughout the intervention. Participants in the BRIDGE group will also complete a program acceptability questionnaire at post-intervention which was created by the investigators for this project. The program acceptability questionnaire asks participants to rate how important various program components were to them and includes several open-ended questions for participants to describe their experiences in the program.
Time Frame
Measured weekly throughout the 16-week program and immediately after the intervention (T2).
Title
Change in physical activity
Description
Physical activity will be assessed via step-count using Fitbit devices worn by participants.
Time Frame
Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
Title
Change in sleep quality
Description
Sleep quality will be measured throughout the intervention using Fitbit devices worn by participants.
Time Frame
Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
Title
Change in sleep duration
Description
Sleep duration will be measured throughout the intervention using Fitbit devices worn by participants.
Time Frame
Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
Title
Change in heart rate
Description
Heart rate will be measured throughout the intervention using Fitbit devices worn by participants.
Time Frame
Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
Title
Change in co-parents' depression symptoms.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The PHQ-9 will be used to measure co-parents' depression symptoms. The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' rating of child behaviour.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The CBCL will be used to assess co-parents' ratings of child behaviour. The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 113 items, with scores ranging from 0-226. Higher scores indicated greater symptom severity.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' parenting stress.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The PSI-SF will be used to assess co-parents' parenting stress. The PSI-SF is a self-report questionnaire that requires respondents to answer questions regarding their overall experience with parenting stress using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores range from 36-180. Higher scores indicate higher levels of stress.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' harsh parenting.
Description
Co-parents of participants will be invited to complete a set of questionnaires PS Overreactivity. Harsh parenting will be measured using the Overreactivity subscale of the Parenting Scale (PS). The Overreactivity subscale contains ten items related to harsh parenting behaviours. Harsh parenting includes expressing inappropriate anger, irritability, or meanness towards one's child. Total scores range from 10 to 70, with higher scores indicating higher levels of harsh parenting.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' couples' satisfaction.
Description
Co-parents of participants will be invited to complete a set of questionnaires. Using the Couples Satisfaction Index (CSI-4) the investigators will examine co-parents' satisfaction with their romantic relationships. The CSI-4 contains 4 -items. Total scores range from 0-21, with higher scores indicating greater relationship satisfaction.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' social support.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The MSPSS will be used to measure co-parents' social support. Scores can range from 12-84. Higher scores indicated higher levels of perceived social support.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' parenting practices related to children's negative emotions.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The Coping with Children's Negative Emotions Scale (CCNES) presents hypothetical scenarios in which a child gets upset or angry. Parents are asked to indicate the degree to which the parent responds to each scenario in 6 theoretically meaningful ways of coping with children's negative emotions. The CCNES has 6 subscales: Problem-Focused Reactions (PRF), Emotion-Focused Reactions (EFR), Expressive Encouragement (EE), Minimization Reactions (MR), Punitive Reactions PR), and Distress Reactions (DR). Each subscale has a score range from 12-84. Higher scores on each subscale represent higher levels of that type of parenting response (e.g., high expressive encouragement scores represent parenting practices in which parents encourage their children to express their emotions).
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents's self-compassion.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The SCS-SF will measure co-parents' self-compassion. Possible scores range from 12-60, with higher scores indicating high levels of self-compassion.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' anxiety symptoms.
Description
Co-parents of participants will be invited to complete a set of questionnaires. Anxiety symptoms will be measured using the GAD-7. The GAD-7 contains 7 items with possible scores ranging from 0 to 21. Higher scores represent higher levels of anxiety symptoms.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' anger.
Description
Co-parents of participants will be invited to complete a set of questionnaires. Changes in anger will be measured using PROMIS Anger subscale. The subscale contains 5-items with scores ranging from 5-25. Higher scores indicate more anger.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' sleep disturbances.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The PROMIS-Sleep Disturbance Subscale Short Form will be used to measure change in sleep disturbances. The subscale contains 8 items. Total scores range from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' alcohol use.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure coparents' use of alcohol. The AUDIT contains 10 question and scores may range from 10 to 40. Higher scores indicate greater hazardous or harmful alcohol consumption.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' cannabis use.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The Cannabis Use Disorder Identification Test (CUDIT) will be used to measure coparents' cannabis use. The scale contains 8 items. Scores may range from 0 to 32. Higher scores indicate more hazardous cannabis use.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' recent stressful experiences.
Description
Co-parents of participants will be invited to complete a set of questionnaires. The Recent Stressful Experiences checklist (RSE) was developed by study authors, based on recommendations from the JBP Research Network on Toxic Stress at the Harvard's Center on the Developing Child, to measure familial exposure to various stressors which may affect participants (2022). The scale contains two items which ask about various stressors that participants may have experienced. Each of these items' scores can range from 0 to 10, with higher scores indicating more stressful experiences. The scale also contains five items assessing participants' ability to cope with stressful events. Scores for these five questions range from 4-21, with higher scores indicating a greater ability to cope with stress.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Title
Change in co-parents' health and social services use.
Description
A self-report scale created for use in this project will assess coparents' use of 14 types of health and social services in the previous 3 months. The scale does not produce a total score; rather, the scale asks participants if they had accessed services, and if yes, the frequency of their use of those services.
Time Frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The terms "mother" and "maternal" will be used throughout this paper to describe all participants; however, anyone who self-identifies as a mother or female primary caregiver (e.g., grandmothers raising grandchildren, gender diverse caregivers who identify as mothers) will be eligible to participate.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have at least one 3-5-year-old child. Residing in Manitoba or British Columbia, Canada. Report elevated symptoms of depression (PHQ-9 score ≥10) at the eligibility screener, pre-randomization. Self-identify as being comfortable understanding, speaking and reading English. Self-identify as having internet access. Report being available to attend telehealth groups. Report being willing to complete pre- and post-intervention questionnaires. Exclusion Criteria: Mothers who report a suicide attempt in the past year or who have engaged in self-harm that required medical attention in the past 6 months will not be eligible to participate in the study, as the BRIDGE program is not intended to address these mental health needs. In addition, mothers who report a diagnosis of, or treatment for, Post-Traumatic Stress Disorder, Alcohol Use Disorder, Substance Use Disorder, or Psychotic Disorder in the last year will be followed up with a senior clinician to evaluate whether the BRIDGE program would be suitable for their needs. If the clinician (through consultation with clinical leads) indicates that the participant will be able to participate and engage in BRIDGE and/or DBT as the program is to be delivered, they will be considered eligible. Some participants may be encouraged to follow-up with group clinicians to ensure their mental health needs are being managed appropriately within or outside of the group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie E Roos, PhD
Phone
2044747400
Email
leslie.roos@umanitoba.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Penner-Goeke
Email
pennerg8@myumanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie R. Roos, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba - Department of Psychology
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie E Roos, PhD
Phone
2044747400
Email
leslie.roos@umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Lara C Penner-Goeke, BA (Hons)
Email
pennerg8@myumanitoba.ca
First Name & Middle Initial & Last Name & Degree
Leslie E Roos, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Summary statistics (e.g. questionnaire subscales, socio-demographics, aggregated forum usage data) paired with non-identifiable participant IDs may be shared on data repositories such as the Open Science Framework.
IPD Sharing Time Frame
Data may become available upon publication of study results, in approximately October 2024.
IPD Sharing Access Criteria
Access will be based on the academic journal's level of access and requirements (e.g., subscription). Open access will be preferred at the time of journal selection, as possible, and preprint articles will be submitted online (e.g., psyarxiv.com) as possible based on journal requirements.
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