Building Regulation in Dual Generations 2022-2025

Study Overview
=================
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.

Official Title
-----------------
Building Regulation in Dual Generations (BRIDGE) 2022-2025

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

Intervention / Treatment
-----------------
* Behavioral: Building Regulation in Dual Generations (BRIDGE)
* Behavioral: Dialectical Behavioural Therapy Skill Training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)<br>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)<br>* 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.<br>|
| Active Comparator: Dialectical Behavioural Skills Training (DBT)<br>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<br>* 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.<br>|
| No Intervention: Services-As-Usual (SAU)<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maternal depression, childhood development, child psychopathology, emotion regulation, parenting, stress, prevention science