An interventional study of Building Regulation in Dual Generations (BRIDGE; DBT + Parenting) in Maternal Depression, Self-Regulation, Emotion and Child Mental Disorder, sponsored by McGill University. Recruiting at 2 sites in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by McGill University · Not applicable, Interventional, and Treatment
Among 27 studies in Emotional Regulation with a site in Canada — 11 open to participants now, 12 under way, none of them phase 3. Emotional Regulation · Canada.
Among the 27 studies in Emotional Regulation with a site in Canada, this one is the 14th largest by planned enrollment of the 26 interventional ones, is one of 3 that started in 2025, is one of 25 with no phase, reaches primary completion later than 10 of the 11 other live ones, and was the 24th registered.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →11 of the 27 studies in Emotional Regulation with a site in Canada are open now, in 1 country. Each count lists the studies.
Of the 134 Emotional Regulation studies recruiting now, 36 (27%) set no upper age limit and 94 (70%) stop at 75 or younger; 45 take children under 18; 66 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2025.
Median enrollment 64 across the 26 interventional studies, 200 across the 1 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
None of the 27 has an industry lead sponsor. The 10 most frequent:
McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
McGill University has 2 studies filed under Emotional Regulation — fewer than ten, so there is no comparison to draw.
4 of the studies in Emotional Regulation with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05447312Toronto Metropolitan UniversityAdaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults | 2026-11-07 |
| NCT06777277Dalhousie UniversityCognitive-Behavioural Couple Therapy for Sexual Interest/Arousal Disorder | 2026-12-01 |
| NCT06625151McGill UniversityPerfectionism and Daily Coping and Emotion Regulation Processes: A Trial of Two Explanatory Feedback Interventions | 2027-05 |
| NCT07083037McGill UniversityEnhancing Preschool Children's Attention and Behaviour: Parent-Focused Program | 2027-07-31 |
Among the 27 studies in Emotional Regulation with a site in Canada, from their registry updates:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
BRIDGE Therapy Group:
Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:
Control Group:
Participants are deemed eligible for the Control group if they meet the following criteria:
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)
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.
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).
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
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
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.
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
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.
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
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.
Time frame: Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2).
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.
Time frame: 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.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in maternal anger
Changes in anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger subscale. The subscale contains 5-items with scores ranging from 5-25. Higher scores indicate more anger.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in maternal sleep problems
The Patient-Reported Outcomes Measurement Information System-Sleep Disturbance Subscale Short Form will be used to measure change in sleep disturbances. The subscale contains 8 items. Total scores range from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in anxiety symptoms
Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). The GAD-7 contains 7 items with possible scores ranging from 0 to 21. Higher scores represent higher levels of anxiety symptoms.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in ADHD Symptoms in parents
The Adult ADHD Self Report Scale (ASRS) will be used to measure attention problems and hyperactive behaviours in parents. The ASRS is an 18-item questionnaire that screens for ADHD symptoms in adults, based on DSM criteria. It includes two parts: Part A (6 questions) screens for the most predictive symptoms, while Part B adds more detail. Respondents rate how often they experience symptoms like inattention, impulsivity, and restlessness. The scale has a minimum score of 0 and a maximum score of 72. Higher scores indicate greater severity and frequency of adult ADHD symptoms.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in children's cognitive and language skills
Subtests from the Kaufman Assessment Battery for Children, Second Edition Normative Update (KABC-II NU) will be used. The KABC-II NU is an individually administered test that measures the cognitive abilities of children ages 3-18. It focuses on assessing problem-solving skills, memory, and reasoning, with minimal reliance on verbal instructions. The core areas evaluated include sequential and simultaneous processing, planning, learning, and knowledge. Scores range from 40 to 160. A high score means a well-developed cognitive and intellectual skills.
Time frame: Assessed at pre-intervention (T1), within a month following the intervention (T2) and at 3-month followup (T3).
Changes in pre-academic skills
The Bracken School Readiness Assessment, 4th Edition (BRSA-4) will be used to measure changes in academic readiness in children. The BSRA-4 is an individually administered test for children in preschool through second grade. It assesses core school readiness concepts such as color identification, knowledge of letters, numbers/counting ability, size and comparison words, and shape recognition. The BSRA-4 is developmentally sensitive and can help identify children who may need additional support before starting primary school. Scores reflect a child's exposure to basic academic concepts important for early learning. Scores range from 40 to 160. Higher scores indicate that the child has mastered age-appropriate early learning concepts at a level well above the average for their age group.
Time frame: Assessed at pre-intervention (T1), within a month following the intervention (T2) and at 3-month followup (T3).
Changes in parenting behaviors and practices
The Parenting Young Children Questionnaire (PARYC) will be used. The PARYC is a 21-item parent-report measure designed to assess parenting behaviors in parents of young children. It focuses on key domains such as setting expectations for behavior, supporting positive behavior, and managing misbehavior. Parents rate how often they use various effective parenting practices, which helps to identify strengths as well as areas where additional support or intervention may be needed.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in maternal perceived social support
The Multidimensional Scale of Perceived Social Support (MSPSS) will be used to measure participant's levels of social support from significant others, family, and friends. Scores can range from 12-84. Higher scores indicated higher levels of perceived social support.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in alcohol use
The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure participants' use of alcohol. The AUDIT contains 10 questions and scores may range from 10 to 40. Higher scores indicate greater hazardous or harmful alcohol consumption.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in cannabis use
The Cannabis Use Disorder Identification Test (CUDIT) will be used to measure participants' cannabis use. The scale contains 8 items. Scores may range from 0 to 32. Higher scores indicate more hazardous cannabis use.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in recent stressful events (RSE)
The Recent Stressful Experiences checklist (RSE) was developed by study authors, based on recommendations from the JBP Research Network on Toxic Stress at the Harvard's Center on the Developing Child, to measure familial exposure to various stressors which may affect participants (2022). The scale contains two items which ask about various stressors that participants may have experienced. Each of these items' scores can range from 0 to 10, with higher scores indicating more stressful experiences. The scale also contains five items assessing participants' ability to cope with stressful events. Scores for these five questions range from 4-21, with higher scores indicating a greater ability to cope with stress.
Time frame: Assessed at pre-intervention (T1), immediately after intervention (T2) and at 3-month follow-up (T3).
Changes in difficulties with Emotion regulation
The Difficulties in Emotion Regulation Scale (DERS) will be used. The DERS is a 36-item self-report questionnaire that assesses problems with emotion regulation across six areas: nonacceptance of emotions, difficulty with goal-directed behavior, impulse control, lack of emotional awareness, limited access to regulation strategies, and lack of emotional clarity. Respondents rate how often each statement applies to them on a five-point scale, with higher scores indicating greater difficulties. The DERS is widely used to identify emotion regulation challenges and monitor changes over time in both clinical and research settings. Scores range from 36 to 180. A higher score indicates more severe difficulties with emotion regulation.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Changes in Children's Sleep Habits
The Children's Sleep Habits Questionnaire (CSHQ) will be used. The CSHQ is a 45-item parent-report tool that assesses common sleep problems in children aged 4-12 across eight areas, including bedtime resistance and night wakings. Items are rated based on frequency over the past week. Higher total scores indicate more severe sleep difficulties, with scores above 41 suggesting potential clinical concerns.
Time frame: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
Plan to share: Undecided
Started Feb 2025 (actual). Primary completion is estimated for Jul 2027, 29 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 29 months is above that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.