Maternal DepressionBRIDGE-McGillNCT07083037
Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program
A study testing Building Regulation in Dual Generations (BRIDGE; DBT + Parenting) in people with Maternal Depression and Self-Regulation, Emotion, run by McGill University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Depression, Self-Regulation, Emotion, Child Mental Disorder
- What is being tested?
- Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BRIDGE Therapy Group:
- Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:
- Above the age of 18.
- Self-identify as a mother of a child between the age of 3-7 years old.
- Currently living in Quebec, Ontario, or Manitoba
- Fluency in English.
Show all 16Show fewer
- 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.
- 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:
- Above the age of 18
- Self-identify as a mother of a child between the age of 3-7 years old
- Currently living in Quebec, Ontario, or Manitoba
- Fluency in English or bilingual
- Mothers must NOT have clinically significant symptoms of depression (mild to moderate on the Patient Health Questionnaire)
- Their child DOES NOT have attention and/or behavior problems (T-score > 65 on the Child Behavior Checklist (CBCL) ADHD subscales).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kayley Leurquin, BA Hons contact
Canada2 sites, 2 recruiting
- Recruiting
McGill University - Department of Education and Counselling Psychology
Montreal, Quebec, H3A 1G1
Tasmia, caarlab@mcgill.ca
- Enrolling by invitation
University of Manitoba - Department of Psychology
Winnipeg, Manitoba, R3T 2N2
About this study
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:
- 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.
- 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).
- 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.
Read the detailed description
Early exposure to parents' psychological distress and mental health challenges (e.g. elevated depression, anxiety, sleep problems and parenting stress) is a crucial risk factor for the development of children's own difficulties through the intergenerational transmission of a maternal mental health framework. The Building Regulation in Dual Generations (BRIDGE) program was designed to improve maternal mental health challenges (e.g. depression, anxiety, trauma, stress) and promote positive parenting thereby improving child behavior and mental health. It brings together evidence-based programs, including Dialectical Behavior Therapy (DBT), behavior management, emotion socialization and mindfulness parenting strategies, and has made significant improvement in maternal depression, as well as the mental health of their children, with greater changes observed in mothers with higher psychological distress.
This project addresses a gap in the current literature by focusing on parent-focused support for preschool and young children with attention and behavior problems. It aims to empower parents with tools and strategies to positively impact their children's behavior. The expected contribution includes understanding effective family-focused supports that address both parental and child challenges early on, promoting positive family well-being. This research has broader implications for clinicians, educators and policymakers by offering practical strategies to improve young children's behaviors and manage parental mental health challenges, ultimately enhancing overall child well-being and aligning with broader goals in child development and early education. The results will be disseminated through academic publication, and directly communicated within the investigator's network of community agencies, programs, clinics and school systems in both Quebec, Ontario and Manitoba.
The current study will conduct a non-randomized parallel assignment feasibility pilot design to evaluate the feasibility and potential efficacy of the BRIDGE program in addressing parents' mental health difficulties and children's attentional and behavioral problems. The investigators aim to recruit sixty parent-child dyads (30 participants and 30 controls) to take part in the study. Participants in the intervention group will complete the 12-week online BRIDGE program, along with in-person assessments at three time points: pre-intervention (week 0-1;T1), post-intervention (week 12; T2), and follow-up (3 months; T3). The control group will complete the same in-person assessments without participating in the intervention.
The investigator's primary aim is to examine the feasibility of BRIDGE on maternal mental health and their children's mental wellbeing, executive functioning, and social-emotional development. The investigator's secondary aims are to evaluate the efficacy of BRIDGE therapy in improving parenting stress and decreasing harsh parenting tendencies. Supplementary aims of this study include observing differences or changes for both mothers and children, in sleep quality, mental wellbeing, relationships, as well as child academic readiness before and after the BRIDGE program.
- Conditions
- Maternal Depression, Self-Regulation, Emotion, Child Mental Disorder, Child Development, Attention Problems, Behaviour Problems
- Being tested
- Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)
- Keywords
- maternal depression, child attention problems, child behaviour problems, parental stress
- Medical subject headings
- Emotional Regulation, Neurodevelopmental Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| BRIDGE arm | Experimental | 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. Receives: Behavioral: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting) |
| Support As Usual | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in child mental illness symptoms
Changes in child mental illness symptoms will be assessed using the Child Behavior Checklist (CBCL) for ages 1.5-5 and 6-18. The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 100 items, with scores ranging from 0-200. Higher scores indicated greater symptom severity. We will be analyzing changes in children's A) Total problem behaviors B) ADHD problems subscale scores C) Internalizing behaviors D) Externalizing Behaviors
Measured: 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
Changes in children's executive functioning skills will be measured using the Behavior rating Inventory of Executive Function - Preschool Edition (BRIEF-P) or Behavior rating Inventory of Executive Function - Second Edition. The BRIEF-P is a 63-item parent-report measure and it assesses executive functioning in young children (ages 2-5) across five key areas: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize, evaluating skills such as impulse control, emotional regulation, flexibility, and memory for tasks. The BRIEF-2 is a 63-item parent-report measure and is designed for older children (ages 5-18). It includes similar scales, as well as additional ones such as Initiate, Self-Monitor, and Organization of Materials, to capture more complex executive functions required in school and daily life. Both scales' scores range from 63 to 189. Higher scores reflect more frequent or severe executive functioning difficulties.
Measured: 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
Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.
Measured: 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
Program engagement will be assessed in a variety of ways. Clinicians will take attendance during therapy sessions. At post-intervention, the investigators will ask participants to report on their use of the videos and homework assignments throughout the intervention. Participants will also complete a program acceptability questionnaire at post-intervention, which was created by the investigators for this project. The program acceptability questionnaire asks participants to rate how important various program components were to them and includes several open-ended questions for participants to describe their experiences in the program.
Measured: Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2).
Secondary outcomes (2)
Changes in parenting stress
Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a self-report questionnaire that requires respondents to answer questions regarding their overall experience with parenting stress using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores range from 36-180. Higher scores indicate higher levels of stress.
Measured: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in harsh parenting
Harsh parenting will be measured using the Overreactivity subscale of the Parenting Scale (PS). The Overreactivity subscale contains 10 items related to harsh parenting behaviors. Harsh parenting includes expressing inappropriate anger, irritability, or meanness towards one's child. Totals scores range from 10 to 70, with higher scores indicating higher levels of harsh parenting.
Measured: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Feb 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will recruit a group of caregivers who meet the current criteria for elevated symptoms of psychological distress as measured by a score of 5 and indicate symptoms to "somewhat cause difficulties" above on the Patient Health Questionnaire 9-item, AND who have children with elevated levels of attention and/or behavior problems as measured by a CBCL ADHD subscale T-Score score of \> 65 OR confirmation of attention/behavior problems through a clinical interview. Eligible female caregivers (mothers, grandmothers, aunts, guardians) will be recruited, and the recruitment will occur concurrently over 12 weeks, will incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training (BRIDGE).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba, Social Sciences and Humanities Research Council of Canada
- Responsible party
- Principal investigator, Tasmia Hai, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083037
- Sponsor's protocol ID
- 24-06-073
- Other IDs
- 430-2024-00718
- Acronym
- BRIDGE-McGill
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Penner-Goeke L, Belows M, Kristjanson A, Andrade BF, Cameron EE, Giuliano R, Katz LY, Kelly LE, Letourneau N, Mota N, Reynolds K, Zalewski M, Pharazyn A, Roos LE. 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. Trials. 2023 Sep 19;24(1):597. doi: 10.1186/s13063-023-07591-8.
PubMed 37726821Landstedt E, Almquist YB. Intergenerational patterns of mental health problems: the role of childhood peer status position. BMC Psychiatry. 2019 Sep 18;19(1):286. doi: 10.1186/s12888-019-2278-1.
PubMed 31533680Brikell I, Kuja-Halkola R, Larsson H. Heritability of attention-deficit hyperactivity disorder in adults. Am J Med Genet B Neuropsychiatr Genet. 2015 Sep;168(6):406-413. doi: 10.1002/ajmg.b.32335. Epub 2015 Jun 30.
PubMed 26129777Bridgett DJ, Burt NM, Edwards ES, Deater-Deckard K. Intergenerational transmission of self-regulation: A multidisciplinary review and integrative conceptual framework. Psychol Bull. 2015 May;141(3):602-654. doi: 10.1037/a0038662.
PubMed 25938878
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program
- ClinicalTrials.gov ID
- NCT07083037
- Acronym / sponsor ID
- BRIDGE-McGill / 24-06-073
- Conditions
- Maternal Depression, Self-Regulation, Emotion, Child Mental Disorder, Child Development, Attention Problems, Behaviour Problems
- Keywords
- maternal depression, child attention problems, child behaviour problems, parental stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- University of Manitoba, Social Sciences and Humanities Research Council of Canada
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
- 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.
Detailed description
Early exposure to parents' psychological distress and mental health challenges (e.g. elevated depression, anxiety, sleep problems and parenting stress) is a crucial risk factor for the development of children's own difficulties through the intergenerational transmission of a maternal mental health framework. The Building Regulation in Dual Generations (BRIDGE) program was designed to improve maternal mental health challenges (e.g. depression, anxiety, trauma, stress) and promote positive parenting thereby improving child behavior and mental health. It brings together evidence-based programs, including Dialectical Behavior Therapy (DBT), behavior management, emotion socialization and mindfulness parenting strategies, and has made significant improvement in maternal depression, as well as the mental health of their children, with greater changes observed in mothers with higher psychological distress.
This project addresses a gap in the current literature by focusing on parent-focused support for preschool and young children with attention and behavior problems. It aims to empower parents with tools and strategies to positively impact their children's behavior. The expected contribution includes understanding effective family-focused supports that address both parental and child challenges early on, promoting positive family well-being. This research has broader implications for clinicians, educators and policymakers by offering practical strategies to improve young children's behaviors and manage parental mental health challenges, ultimately enhancing overall child well-being and aligning with broader goals in child development and early education. The results will be disseminated through academic publication, and directly communicated within the investigator's network of community agencies, programs, clinics and school systems in both Quebec, Ontario and Manitoba.
The current study will conduct a non-randomized parallel assignment feasibility pilot design to evaluate the feasibility and potential efficacy of the BRIDGE program in addressing parents' mental health difficulties and children's attentional and behavioral problems. The investigators aim to recruit sixty parent-child dyads (30 participants and 30 controls) to take part in the study. Participants in the intervention group will complete the 12-week online BRIDGE program, along with in-person assessments at three time points: pre-intervention (week 0-1;T1), post-intervention (week 12; T2), and follow-up (3 months; T3). The control group will complete the same in-person assessments without participating in the intervention.
The investigator's primary aim is to examine the feasibility of BRIDGE on maternal mental health and their children's mental wellbeing, executive functioning, and social-emotional development. The investigator's secondary aims are to evaluate the efficacy of BRIDGE therapy in improving parenting stress and decreasing harsh parenting tendencies. Supplementary aims of this study include observing differences or changes for both mothers and children, in sleep quality, mental wellbeing, relationships, as well as child academic readiness before and after the BRIDGE program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will recruit a group of caregivers who meet the current criteria for elevated symptoms of psychological distress as measured by a score of 5 and indicate symptoms to "somewhat cause difficulties" above on the Patient Health Questionnaire 9-item, AND who have children with elevated levels of attention and/or behavior problems as measured by a CBCL ADHD subscale T-Score score of > 65 OR confirmation of attention/behavior problems through a clinical interview. Eligible female caregivers (mothers, grandmothers, aunts, guardians) will be recruited, and the recruitment will occur concurrently over 12 weeks, will incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training (BRIDGE).
| Arm | Type | Receives |
|---|---|---|
| BRIDGE arm | Experimental | Behavioral: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)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. |
| Support As Usual | No 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:
- Above the age of 18.
- Self-identify as a mother of a child between the age of 3-7 years old.
- Currently living in Quebec, Ontario, or Manitoba
- Fluency in English.
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | BRIDGE arm |
Primary outcome
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 child mental illness symptoms will be assessed using the Child Behavior Checklist (CBCL) for ages 1.5-5 and 6-18. The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 100 items, with scores ranging from 0-200. Higher scores indicated greater symptom severity. We will be analyzing changes in children's A) Total problem behaviors B) ADHD problems subscale scores C) Internalizing behaviors D) Externalizing Behaviors
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 children's executive functioning skills will be measured using the Behavior rating Inventory of Executive Function - Preschool Edition (BRIEF-P) or Behavior rating Inventory of Executive Function - Second Edition. The BRIEF-P is a 63-item parent-report measure and it assesses executive functioning in young children (ages 2-5) across five key areas: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize, evaluating skills such as impulse control, emotional regulation, flexibility, and memory for tasks. The BRIEF-2 is a 63-item parent-report measure and is designed for older children (ages 5-18). It includes similar scales, as well as additional ones such as Initiate, Self-Monitor, and Organization of Materials, to capture more complex executive functions required in school and daily life. Both scales' scores range from 63 to 189. Higher scores reflect more frequent or severe executive functioning difficulties.
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).
Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.
Program Engagement
Time frame: Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2).
Program engagement will be assessed in a variety of ways. Clinicians will take attendance during therapy sessions. At post-intervention, the investigators will ask participants to report on their use of the videos and homework assignments throughout the intervention. Participants will also complete a program acceptability questionnaire at post-intervention, which was created by the investigators for this project. The program acceptability questionnaire asks participants to rate how important various program components were to them and includes several open-ended questions for participants to describe their experiences in the program.
2 secondary outcomes
Changes in parenting stress
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in harsh parenting
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 37726821Penner-Goeke L, Belows M, Kristjanson A, Andrade BF, Cameron EE, Giuliano R, Katz LY, Kelly LE, Letourneau N, Mota N, Reynolds K, Zalewski M, Pharazyn A, Roos LE. 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. Trials. 2023 Sep 19;24(1):597. doi: 10.1186/s13063-023-07591-8.
- Background: PubMed 31533680Landstedt E, Almquist YB. Intergenerational patterns of mental health problems: the role of childhood peer status position. BMC Psychiatry. 2019 Sep 18;19(1):286. doi: 10.1186/s12888-019-2278-1.
- Background: PubMed 26129777Brikell I, Kuja-Halkola R, Larsson H. Heritability of attention-deficit hyperactivity disorder in adults. Am J Med Genet B Neuropsychiatr Genet. 2015 Sep;168(6):406-413. doi: 10.1002/ajmg.b.32335. Epub 2015 Jun 30.
- Background: PubMed 25938878Bridgett DJ, Burt NM, Edwards ES, Deater-Deckard K. Intergenerational transmission of self-regulation: A multidisciplinary review and integrative conceptual framework. Psychol Bull. 2015 May;141(3):602-654. doi: 10.1037/a0038662.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kayley Leurquin, BA Hons contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Regulation in Dual Generations (BRIDGE; DBT + Parenting) in people with Maternal Depression and Self-Regulation, Emotion, run by McGill University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasmia Hai, PhD (204-474- 8258, tasmia.hai@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083037, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.