Building Regulation in Dual Generations 2022-2025

NCT05959538 | Completed

• 1 other identifier: BRIDGE 2022-2025
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized control trial aims to investigate whether a novel intervention, the "Building Regulation in Dual Generations (BRIDGE)" program, improves mental wellness and parenting practices among mothers of 3 to 5-year-old children who have elevated symptoms of depression. The main two questions this study aims to answer are:

• Does participation in the BRIDGE program reduce maternal depression symptoms?
• Does participation in the BRIDGE program improve children's mental health? Researchers will compare the BRIDGE intervention to an established mental health intervention (i.e., Dialectical Behaviour Therapy skills group) and to a services-as-usual control group to see if participation in BRIDGE leads to greater improvements than either the general mental health treatment or community services as usual. Participants will:
• Complete a set of questionnaires pre- and post-intervention, and at 6-month follow-up.
• Complete a virtual assessment with their child at pre- and post-intervention.
• Be randomized to BRIDGE, Dialectical Behavioural Therapy(DBT) skills group, or a services-as-usual control group.
• Participate in the 16-week BRIDGE or DBT Skills only group, if randomized to either of these groups. If they are randomized to services-as-usual they will receive a list of community resources they can access.
• Complete weekly symptom monitoring via questionnaires, if randomized to BRIDGE or DBT Skills
• Wear a Fitbit device during pre- and post-intervention, as well as throughout the 16-week intervention period.

Conditions

Maternal Depression; Self-Regulation, Emotion; Child Mental Disorder; Child Development

Keywords

maternal depression; childhood development; child psychopathology; emotion regulation; parenting; stress; prevention science

Outcome Measures

Primary Outcomes (2)

• Change in depression symptoms

  Depressive symptoms will be measured using the 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.

  The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

• Change in child mental illness symptoms

  Changes in child mental illness symptoms will be assessed using the Child Behaviour Checklist (CBCL). The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 113 items, with scores ranging from 0-226. Higher scores indicated greater symptom severity.

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

Secondary Outcomes (2)

• Change in Parenting stress

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

• Change in harsh parenting

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

Other Outcomes (33)

• Change in couples' relationship satisfaction.

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

• Change in social support.

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

• Change in parenting practices related to children's negative emotions.

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).

Study Arms (3)

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

EXPERIMENTAL

The BRIDGE program is a manualized therapy that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 16 weeks of 20-30 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)

Dialectical Behavioural Skills Training (DBT)

ACTIVE COMPARATOR

Participants in the DBT arm will participate in 16 weeks of DBT skills training through weekly, synchronous 1.5-hour virtual group therapy sessions. Participants will also be asked to complete worksheets on the content between sessions.

Behavioral: Dialectical Behavioural Therapy Skill Training

Services-As-Usual (SAU)

NO INTERVENTION

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) BEHAVIORAL

The BRIDGE intervention includes 16 weeks of 20-30 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). The clinical team will consist of two Master's or PhD level clinical psychology trainees and a parent peer coach. Mood tracking will be completed using a brief weekly survey, including questions on depression, parenting stress, positive mood, and recent stressful experiences.

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

Dialectical Behavioural Therapy Skill Training BEHAVIORAL

Participants in the DBT arm will participate in 16 weeks of DBT skills training only led by two Master's or PhD level clinical psychology trainees. Participants in the DBT Skills condition will participate in a skills group which follows the DBT Skills Training Manual 2nd Edition (Linehan, 2015) through weekly, synchronous 1.5-hour virtual group therapy sessions. Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness skill domains will be covered. Participants will be asked to complete worksheets between sessions to practice using skills, and will be asked to complete a Diary Card to track DBT skills use each week (Linehan, 2015). Mood tracking will be completed using a brief weekly survey including questions on depression, parenting stress, positive mood, and recent stressful experiences.

Dialectical Behavioural Skills Training (DBT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The terms "mother" and "maternal" will be used throughout this paper to describe all participants; however, anyone who self-identifies as a mother or female primary caregiver (e.g., grandmothers raising grandchildren, gender diverse caregivers who identify as mothers) will be eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least one 3-5-year-old child.
• Residing in Manitoba or British Columbia, Canada.
• Report elevated symptoms of depression (PHQ-9 score ≥10) at the eligibility screener, pre-randomization.
• Self-identify as being comfortable understanding, speaking and reading English.
• Self-identify as having internet access.
• Report being available to attend telehealth groups.
• Report being willing to complete pre- and post-intervention questionnaires.

You may not qualify if:

• Mothers who report a suicide attempt in the past year or who have engaged in self-harm that required medical attention in the past 6 months will not be eligible to participate in the study, as the BRIDGE program is not intended to address these mental health needs.
• In addition, mothers who report a diagnosis of, or treatment for, Post-Traumatic Stress Disorder, Alcohol Use Disorder, Substance Use Disorder, or Psychotic Disorder in the last year will be followed up with a senior clinician to evaluate whether the BRIDGE program would be suitable for their needs. If the clinician (through consultation with clinical leads) indicates that the participant will be able to participate and engage in BRIDGE and/or DBT as the program is to be delivered, they will be considered eligible. Some participants may be encouraged to follow-up with group clinicians to ensure their mental health needs are being managed appropriately within or outside of the group.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Manitoba - Department of Psychology

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (24)

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  BACKGROUND

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  PMID: 37726821 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders

Study Officials

• Leslie R. Roos, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will recruit a group of caregivers in which the caregiver meets the current criteria for elevated symptoms of psychological distress as measured by a score of 9 and above on the Patient Health Questionnaire 9-item. Eligible female caregivers (mothers, grandmothers, aunts, guardians) will be randomly assigned to one of three intervention arms, which will occur concurrently over 16-weeks. One arm will incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training (BRIDGE), another will provide DBT only, while the third will provide community family support services as usual.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 25, 2023
• Study Start: October 28, 2022
• Primary Completion: June 26, 2024
• Study Completion: December 16, 2024
• Last Updated: April 6, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data may become available upon publication of study results, in approximately October 2024.
• Access Criteria: Access will be based on the academic journal's level of access and requirements (e.g., subscription). Open access will be preferred at the time of journal selection, as possible, and preprint articles will be submitted online (e.g., psyarxiv.com) as possible based on journal requirements.

Locations

CA (1)