NCT05959538: BRIDGE

Building Regulation in Dual Generations 2022-2025

Completed NA Last updated 6 April 2025

What this trial tests

NA trial testing Building Regulation in Dual Generations (BRIDGE) in Maternal Depression in 197 participants. Completed in 16 December 2024.

Timeline

28 October 2022

Primary endpoint
26 June 2024

16 December 2024

Quick facts

Lead sponsor	University of Manitoba
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	197
Start date	28 October 2022
Primary completion	26 June 2024
Estimated completion	16 December 2024
Sites	1 location across Canada

Drugs / interventions tested

• Building Regulation in Dual Generations (BRIDGE)
• Dialectical Behavioural Therapy Skill Training

Conditions studied

• Maternal Depression — all drugs for Maternal Depression →
• Self-Regulation, Emotion — all drugs for Self-Regulation, Emotion →
• Child Mental Disorder — all drugs for Child Mental Disorder →
• Child Development — all drugs for Child Development →

Sponsor

University of Manitoba

Who can join

18 and older, any sex, with Maternal Depression or Self-Regulation, Emotion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children.
   Penner-Goeke L, Belows M, Kristjanson A, Andrade BF, et al · · 2023 · PMID 37726821 · DOI 10.1186/s13063-023-07591-8
2. Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE); Preventing the intergenerational transmission of mental illness in at-risk preschool children
   Penner-Goeke L, Belows M, Kristjanson A, Andrade BF, et al · · 2023 · DOI 10.21203/rs.3.rs-3200761/v1