CompletedNot Applicable

Building Regulation in Dual Generations 2022-2025

Canada197 participantsStarted 2022-10-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Change in depression symptoms

Timeframe: 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

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

Trial details

NCT IDNCT05959538

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-26

View on ClinicalTrials.gov More Maternal Depression trials