Parent-Focused Program for Children's Behavioral Disorders

(BRIDGE-McGill Trial)

Recruiting at 1 trial location

Overseen By Kayley Leurquin, BA Hons

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Non-English speakers, Outside specified regions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called BRIDGE (Building Regulation in Dual Generations), designed to assist mothers with mental health challenges and their young children who have attention or behavior issues. The BRIDGE program includes video training and group sessions to improve both the mothers' mental well-being and their children's ability to manage emotions and behavior. It is well-suited for mothers in Quebec, Ontario, or Manitoba who have experienced mild to moderate depression, particularly if their child struggles with attention or behavior problems. The ultimate goal is to boost family well-being and help children develop better social and emotional skills. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance family dynamics and child development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the BRIDGE program is safe for children and caregivers?

Research has shown that the Building Regulation in Dual Generations (BRIDGE) program combines Dialectical Behavior Therapy (DBT) with parenting skills training. This method aims to help both parents and children manage their emotions more effectively. Previous studies have found that DBT is generally easy for people to handle and focuses on teaching skills to control emotions and actions.

Earlier research tested the BRIDGE program to evaluate its effectiveness in reducing emotional and behavioral problems in children. These studies did not identify any major safety issues. Participants found the program manageable and helpful. Since DBT is already known to be safe for other mental health issues, the BRIDGE program is expected to be safe for both parents and children.

Overall, evidence suggests that the BRIDGE program is safe and well-tolerated, with no major problems reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BRIDGE program because it combines Dialectical Behavior Therapy (DBT) and parenting skills in a unique, dual-generational approach. Unlike traditional treatments for children's behavioral disorders that often focus solely on the child, BRIDGE empowers parents with skills through interactive video modules and group sessions, enhancing their ability to support their children. The program is also highly accessible, offering flexible online components that can be engaged with at home, making it a convenient and comprehensive option for families seeking support.

What evidence suggests that the BRIDGE program is effective for children's behavioral disorders?

Research has shown that the BRIDGE program, which combines Dialectical Behavior Therapy (DBT) with parenting skills, holds promise for addressing children's behavior issues. In this trial, participants in the BRIDGE arm will receive this combined therapy approach. Studies have found that programs focusing on both a mother's mental health and parenting skills can be up to 50% more effective than those focusing on just one. The BRIDGE program aims to help both parents and children manage their emotions better, potentially reducing attention and behavior problems in children aged 3 to 7. Early results suggest that the BRIDGE approach improves both mothers' mental health and children's behavior. This dual focus on parents and children might also prepare children for school by enhancing their emotional and behavioral management. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for caregivers with mental health concerns and their children aged 3-7 who have attention or behavior issues. It's designed to help parents manage stress and improve kids' self-regulation, potentially reducing childhood emotional and behavioral problems.

Inclusion Criteria

BRIDGE Therapy Group: Participants must currently be living in Quebec, Ontario, or Manitoba

BRIDGE Therapy Group: Their child must have attention and/or behavior problems (T-score > 65 on the Child Behavior Checklist (CBCL) ADHD subscales) or confirmed attention and/or behavior problems through clinical interview

Control Group: Participants must currently be living in Quebec, Ontario, or Manitoba

Exclusion Criteria

Control Group: Participants will be excluded if they did not meet the inclusion criteria

I did not meet the requirements or could not attend weekly therapy sessions.

My child and I don't have significant mental health or behavioral issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants in the intervention group will complete the 12-week online BRIDGE program, including video training modules and weekly virtual group therapy sessions.

12 weeks

Weekly virtual group therapy sessions

Follow-up

Participants are monitored for changes in mental health and behavior outcomes after the intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Building Regulation in Dual Generations (BRIDGE)

Trial Overview The BRIDGE program combines dialectical behavior therapy (DBT) with parenting strategies to support both the caregiver's mental health and the child's development. The study will compare this approach against a control group to assess its effectiveness.

How Is the Trial Designed?

Group I: BRIDGE arm Experimental Treatment 1 Intervention

The BRIDGE program is a manualized therapy program that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 12 weeks of 20-60-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.

Group II: Support As Usual Active Control 1 Intervention

Control group 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.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Social Sciences and Humanities Research Council of Canada

Collaborator

Trials

28

Recruited

6,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8335713/

A Mixed-Methods Feasibility Pilot of a Parenting Program ... The BRIDGE “Building Regulation in Dual Generations” Program treats maternal MI using Dialectical Behavior Therapy Skills with a paired curriculum.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05959538

Building Regulation in Dual Generations 2022-2025 ... The BRIDGE program is a manualized therapy that provides participants with parenting and DBT skills through video training modules and in-group sessions.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07591-8

preventing the intergenerational transmission of mental illness ... Emerging evidence has found that programs that simultaneously target maternal MI and parenting skills are up to 50% more effective than programs ...

4. researchgate.net researchgate.net/publication/353699035_The_Building_Regulation_in_Dual-Generations_Program_BRIDGE_A_Mixed-Methods_Feasibility_Pilot_of_a_Parenting_Program_for_Depressed_Mothers_of_Preschoolers_Matched_with_Dialectical_Behavior_Therapy_Skil

A Mixed-Methods Feasibility Pilot of a Parenting Program ... The Building Regulation in Dual Generations (BRIDGE) program combines Dialectical Behavior Therapy (DBT) and parenting skills training to ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05959538/building-regulation-in-dual-generations-2022-2025

Building Regulation in Dual Generations 2022-2025 BRIDGE aims to increase intergenerational emotion regulation by pairing Dialectical Behaviour Therapy (DBT) skills training with a theoretically ...