Building Regulation in Dual Generations 2022-2025

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.

Conditions

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

Interventions

BEHAVIORAL

Building Regulation in Dual Generations (BRIDGE)

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.

BEHAVIORAL

Dialectical Behavioural Therapy Skill Training

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• University of Manitoba

  lead OTHER

Principal Investigators

• Leslie R. Roos, PhD · University of Manitoba

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-28

Primary Completion

2024-06-26

Completion

2024-12-16

Countries

• Canada

Study Locations