Testing Building Regulation in Dual Generations for maternal depression
Official title: Enhancing Preschool Children's Attention and Behaviour: Parent-Focused 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).
Canadian Sites (2)
University of Manitoba - Department of Psychology
Winnipeg, Manitoba, Canada
McGill University - Department of Education and Counselling Psychology
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Self-identify as a mother of a child between the age of 3-7 years old.
- +Self-identify as a mother of a child between the age of 3-7 years old
- +BRIDGE Therapy Group:
- +Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:
- +Above the age of 18.
- +Currently living in Quebec, Ontario, or Manitoba
- +Fluency in English.
- +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 GroupControl groupThe group a new treatment is measured against.Read more →:
- +Participants are deemed eligible for the Control group if they meet the following criteria:
- +Above the age of 18
- +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).
- +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.
Exclusion
- −BRIDGE Therapy Group:
- −Participants were excluded if they A) did not meet the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →. 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 groupControl groupThe group a new treatment is measured against.Read more → 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: The CBCL 1.5-5 and 6-18 will be assessed during eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (T0), pre-intervention (T1), within a month following the intervention (T2), and at 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (T3).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Changes in child mental illness symptoms — measured over The CBCL 1.5-5 and 6-18 will be assessed during eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (T0), pre-intervention (T1), within a month following the intervention (T2), and at 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (T3).
Changes in parent report measures of their children's executive function skills — measured over 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 — measured over 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 — measured over Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07083037 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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).
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: The CBCL 1.5-5 and 6-18 will be assessed during eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (T0), pre-intervention (T1), within a month following the intervention (T2), and at 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (T3)..
The study as a whole is currently expected to finish around 2027-08-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Winnipeg, Manitoba, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.