An interventional study of Building Regulation in Dual Generations (BRIDGE) and Dialectical Behavioural Therapy Skill Training in Maternal Depression, Self-Regulation, Emotion and Child Mental Disorder, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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:
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:
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.
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Exclusion Criteria:
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.
Behavioral: Building Regulation in Dual Generations (BRIDGE)
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.
Behavioral: Dialectical Behavioural Therapy Skill Training
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.
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.
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.
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.
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).
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.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
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.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
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.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Change in couples' relationship satisfaction.
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).
Change in social support.
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).
Change in parenting practices related to children's negative emotions.
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).
Change in anxiety symptoms.
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).
Change in self-compassion.
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).
Change in anger.
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).
Change in sleep disturbance.
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).
Change in alcohol use.
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).
Change in cannabis use.
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).
Change in observed maternal sensitivity
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.
Change in observed child emotional regulation
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.
Change in health and social services use.
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).
Change in recent stressful experiences.
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).
Program engagement
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).
Change in physical activity
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.
Change in sleep quality
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.
Change in sleep duration
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.
Change in heart rate
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.
Change in co-parents' depression symptoms.
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).
Change in co-parents' rating of child behaviour.
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).
Change in co-parents' parenting stress.
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).
Change in co-parents' harsh parenting.
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).
Change in co-parents' couples' satisfaction.
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).
Change in co-parents' social support.
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).
Change in co-parents' parenting practices related to children's negative emotions.
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).
Change in co-parents's self-compassion.
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).
Change in co-parents' anxiety symptoms.
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).
Change in co-parents' anger.
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).
Change in co-parents' sleep disturbances.
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).
Change in co-parents' alcohol use.
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).
Change in co-parents' cannabis use.
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).
Change in co-parents' recent stressful experiences.
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).
Change in co-parents' health and social services use.
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).
Plan to share: Yes — 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.
Supporting information: Study protocol
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University of Manitoba