Clinical trial NCT05959538: Building Regulation in Dual Generations 2022-2025
Official title: Building Regulation in Dual Generations (BRIDGE) 2022-2025
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Self-Regulation, Emotion
Child Mental Disorder
Child Development
Keywords: maternal depression
childhood development
child psychopathology
emotion regulation
parenting
stress
prevention science
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-07-25
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in depression symptoms
timeFrame: The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in child mental illness symptoms
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Secondary outcomes:
measure: Change in Parenting stress
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in harsh parenting
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Other outcomes:
measure: Change in couples' relationship satisfaction.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in social support.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in parenting practices related to children's negative emotions.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in anxiety symptoms.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in self-compassion.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in anger.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in sleep disturbance.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in alcohol use.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in cannabis use.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in observed maternal sensitivity
timeFrame: Assessed at pre-intervention (T1) and within a month following the intervention.
measure: Change in observed child emotional regulation
timeFrame: Assessed at pre-intervention (T1) and within a month following the intervention.
measure: Change in health and social services use.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in recent stressful experiences.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Program engagement
timeFrame: Measured weekly throughout the 16-week program and immediately after the intervention (T2).
measure: Change in physical activity
timeFrame: Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
measure: Change in sleep quality
timeFrame: Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
measure: Change in sleep duration
timeFrame: Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
measure: Change in heart rate
timeFrame: Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention.
measure: Change in co-parents' depression symptoms.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' rating of child behaviour.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' parenting stress.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' harsh parenting.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' couples' satisfaction.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' social support.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' parenting practices related to children's negative emotions.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents's self-compassion.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' anxiety symptoms.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' anger.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' sleep disturbances.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' alcohol use.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' cannabis use.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' recent stressful experiences.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
measure: Change in co-parents' health and social services use.
timeFrame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba - Department of Psychology
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Leslie R. Roos, PhD
role: PRINCIPAL_INVESTIGATOR
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