Recruiting

BRIDGE Program

Sponsor:

McGill University

Code:

NCT07083037

Conditions

Maternal Depression

Self-Regulation, Emotion

Child Mental Disorder

Child Development

Attention Problems

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)

Study Details

Brief summary:

This study aims to evaluate the feasibility and efficacy of the Building Regulation in Dual Generations (BRIDGE) program for caregivers with significant mental health concerns and preschool and young children (3-7 years old) with elevated attention and/or behavior problems. The BRIDGE program focuses on supporting parental psychological distress and improving young children's self-regulation (SR), thereby reducing their attention and behavior problems. The long-term goal of this work is to improve family well-being and social-emotional development for young children by implementing an accessible and scalable dual-regulation program. The investigators will achieve this through the following key objectives:

1. Assess the feasibility and accessibility of BRIDGE for preschool and young children (3-7 years old) with significant attention and behavior programs through questionnaires asking about attendance, satisfaction, and unmet needs.
2. Examine the efficacy of BRIDGE compared to control group at improving maternal mental health and child attention and behavioral difficulties in young children (primary outcomes). The investigators will also examine parenting stress (secondary outcome).
3. Identify predictors of academic readiness skills in preschool and young children. The investigators hypothesize that an increase in parental and child emotion-regulation skills and reduced attention, as well as behavioral problems, will lead to increased pre-academic skills in children.

Conditions

Maternal Depression

Self-Regulation, Emotion

Child Mental Disorder

Child Development

Attention Problems

Study ID

NCT07083037

Start date

Feb 1, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

BRIDGE Therapy Group:

Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:

1. Above the age of 18.
2. Self-identify as a mother of a child between the age of 3-7 years old.
3. Currently living in Quebec, Ontario, or Manitoba
4. Fluency in English.
5. Mothers must have clinically significant symptoms of depression (mild to moderate on the Patient Health Questionnaire and indicate symptoms to "somewhat cause difficulties") currently affecting them. Participants also need to report symptoms of depression during pregnancy or shortly after birth.
6. Their child has 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 are deemed eligible for the Control group if they meet the following criteria:

1. Above the age of 18
2. Self-identify as a mother of a child between the age of 3-7 years old
3. Currently living in Quebec, Ontario, or Manitoba
4. Fluency in English or bilingual
5. Mothers must NOT have clinically significant symptoms of depression (mild to moderate on the Patient Health Questionnaire)
6. Their child DOES NOT have attention and/or behavior problems (T-score > 65 on the Child Behavior Checklist (CBCL) ADHD subscales).

Exclusion Criteria:

BRIDGE Therapy Group:

Participants were excluded if they A) did not meet the inclusion criteria listed above or B) were unable to attend the weekly BRIDGE group therapy sessions.

Furthermore, eligible participants were invited to complete a semi-structured intake interview with principal investigator (PI) Dr. Tasmia Hai or a graduate student trainee under Dr. Hai's supervision, during which further questions about their mental health and child behavior were asked to ensure their eligibility. Based on the clinical suitability interview, participants may be excluded if they are deemed to be ineligible based on A) the mother's absence of clinically significant mental health symptoms, and/or B) the child's absence of attention and/or behavior problems. When relevant, participants may be identified to participate in the control group instead if eligibility is met.

Control Group:

Participants were excluded if they did not meet the inclusion criteria listed above. Furthermore, eligible participants were invited to complete a semi-structured intake interview with principal investigator (PI) Dr. Tasmia Hai, during which further questions about their mental health and child behavior were asked to ensure their eligibility. Based on the clinical suitability interview, participants may be excluded if they are deemed to be ineligible based on a) the mother's presence of clinically significant mental health symptoms, and/or B) the child's presence of attention and/or behavior problems. When relevant, participants may be identified to participate in the BRIDGE therapy group instead if eligibility is met.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BRIDGE arm

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.

no intervention: Support As Usual

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.

Interventions

Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)

The BRIDGE intervention includes 12 weeks of 20-60-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).

Primary outcome measure

  • Changes in child mental illness symptoms [ Time Frame: The CBCL 1.5-5 and 6-18 will be assessed during eligibility screening (T0), pre-intervention (T1), within a month following the intervention (T2), and at 3-month follow-up (T3). ]
  • Changes in parent report measures of their children's executive function skills [ Time Frame: Assessed at pre-intervention (T1) and within a month following the intervention (T2), and at 3-month follow-up (T3). ]
  • Changes in maternal mental health symptoms [ Time Frame: The PHQ-9 will be assessed during eligibility screening (T0) , pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3). ]
  • Program Engagement [ Time Frame: Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2). ]

Central Contacts and Locations

Central contacts

Locations

McGill University - Department of Education and Counselling Psychology

Recruiting

Montreal, Quebec, Canada, H3A 1G1

Contacts

More Information

Sponsor

McGill University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • maternal depression
  • child attention problems
  • child behaviour problems
  • parental stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2026-04-08.