Child Development Clinical Trial
— BRIDGEOfficial title:
Building Regulation in Dual Generations (BRIDGE) 2022-2025
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | October 30, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Manitoba - Department of Psychology | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Canadian Institutes of Health Research (CIHR) |
Canada,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in couples' relationship satisfaction. | Using the Couples Satisfaction Index (CSI-4), the investigators will examine participants' satisfaction with their romantic relationships. The CSI-4 contains 4 -items. Total scores range from 0-21, with higher scores indicating greater relationship satisfaction. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in parenting practices related to children's negative emotions. | The Coping with Children's Negative Emotions Scale (CCNES) presents hypothetical scenarios in which a child gets upset or angry. Parents are asked to indicate the degree to which the parent responds to each scenario in 6 theoretically meaningful ways of coping with children's negative emotions. The CCNES has 6 subscales: Problem-Focused Reactions (PRF), Emotion-Focused Reactions (EFR), Expressive Encouragement (EE), Minimization Reactions (MR), Punitive Reactions PR), and Distress Reactions (DR). Each subscale has a score range from 12-84. Higher scores on each subscale represent higher levels of that type of parenting response (e.g., high expressive encouragement scores represent parenting practices in which parents encourage their children to express their emotions). | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in self-compassion. | The Self-Compassion Scale-Short Form (SCS-SF) will be used to measure changes in participants' self-compassion. Possible scores range from 12-60, with higher scores indicating high levels of self-compassion. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in sleep disturbance. | 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in alcohol use. | The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure participants' use of alcohol. The AUDIT contains 10 question and scores may range from 10 to 40. Higher scores indicate greater hazardous or harmful alcohol consumption. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in observed maternal sensitivity | Participants and their children will attend pre- and post-intervention virtual assessments, where they will be asked to complete a free-play and clean-up task, which will be video recorded. Video recordings of the task will be coded using the Maternal Q-Sort developed by Pederson et al. (1999). | Assessed at pre-intervention (T1) and within a month following the intervention. | |
Other | Change in observed child emotional regulation | Participants and their children will attend pre- and post-intervention virtual assessments, where children will be asked to complete an emotion-inducing task, which will be video recorded. Video recordings of the task will be coded using a coding scheme developed by the research team. | Assessed at pre-intervention (T1) and within a month following the intervention. | |
Other | Change in health and social services use. | A self-report scale created for use in this project will assess participants' use of 14 types of health and social services in the previous 3 months. The scale does not produce a total score; rather, the scale asks participants if they had accessed services, and if yes, the frequency of their use of those services. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in recent stressful experiences. | 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Program engagement | Program engagement will be assessed in a variety of ways. In both the BRIDGE and DBT Skills-only groups, clinicians will take attendance during therapy sessions. In the BRIDGE group, the investigators will extract aggregate data on the number of views on the psychoeducational videos using Google Analytics. At post-intervention, the investigators will ask participants to report about their use of the videos, homework assignments, and mood tracking throughout the intervention. Participants in the BRIDGE group 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 weekly throughout the 16-week program and immediately after the intervention (T2). | |
Other | Change in physical activity | Physical activity will be assessed via step-count using Fitbit devices worn by participants. | Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention. | |
Other | Change in sleep quality | Sleep quality will be measured throughout the intervention using Fitbit devices worn by participants. | Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention. | |
Other | Change in sleep duration | Sleep duration will be measured throughout the intervention using Fitbit devices worn by participants. | Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention. | |
Other | Change in heart rate | Heart rate will be measured throughout the intervention using Fitbit devices worn by participants. | Measured at pre-intervention (T1), throughout the 16-week intervention, and for a month following the intervention. | |
Other | Change in co-parents' depression symptoms. | Co-parents of participants will be invited to complete a set of questionnaires. The PHQ-9 will be used to measure co-parents' depression symptoms. 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' rating of child behaviour. | Co-parents of participants will be invited to complete a set of questionnaires. The CBCL will be used to assess co-parents' ratings of child behaviour. 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). | |
Other | Change in co-parents' parenting stress. | Co-parents of participants will be invited to complete a set of questionnaires. The PSI-SF will be used to assess co-parents' parenting stress. 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' harsh parenting. | Co-parents of participants will be invited to complete a set of questionnaires PS Overreactivity. Harsh parenting will be measured using the Overreactivity subscale of the Parenting Scale (PS). The Overreactivity subscale contains ten items related to harsh parenting behaviours. Harsh parenting includes expressing inappropriate anger, irritability, or meanness towards one's child. Total scores range from 10 to 70, with higher scores indicating higher levels of harsh parenting. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' couples' satisfaction. | Co-parents of participants will be invited to complete a set of questionnaires. Using the Couples Satisfaction Index (CSI-4) the investigators will examine co-parents' satisfaction with their romantic relationships. The CSI-4 contains 4 -items. Total scores range from 0-21, with higher scores indicating greater relationship satisfaction. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' social support. | Co-parents of participants will be invited to complete a set of questionnaires. The MSPSS will be used to measure co-parents' social support. Scores can range from 12-84. Higher scores indicated higher levels of perceived social support. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' parenting practices related to children's negative emotions. | Co-parents of participants will be invited to complete a set of questionnaires. The Coping with Children's Negative Emotions Scale (CCNES) presents hypothetical scenarios in which a child gets upset or angry. Parents are asked to indicate the degree to which the parent responds to each scenario in 6 theoretically meaningful ways of coping with children's negative emotions. The CCNES has 6 subscales: Problem-Focused Reactions (PRF), Emotion-Focused Reactions (EFR), Expressive Encouragement (EE), Minimization Reactions (MR), Punitive Reactions PR), and Distress Reactions (DR). Each subscale has a score range from 12-84. Higher scores on each subscale represent higher levels of that type of parenting response (e.g., high expressive encouragement scores represent parenting practices in which parents encourage their children to express their emotions). | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents's self-compassion. | Co-parents of participants will be invited to complete a set of questionnaires. The SCS-SF will measure co-parents' self-compassion. Possible scores range from 12-60, with higher scores indicating high levels of self-compassion. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' anxiety symptoms. | Co-parents of participants will be invited to complete a set of questionnaires. Anxiety symptoms will be measured using the GAD-7. The GAD-7 contains 7 items with possible scores ranging from 0 to 21. Higher scores represent higher levels of anxiety symptoms. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' anger. | Co-parents of participants will be invited to complete a set of questionnaires. Changes in anger will be measured using PROMIS Anger subscale. The subscale contains 5-items with scores ranging from 5-25. Higher scores indicate more anger. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' sleep disturbances. | Co-parents of participants will be invited to complete a set of questionnaires. The PROMIS-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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' alcohol use. | Co-parents of participants will be invited to complete a set of questionnaires. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure coparents' use of alcohol. The AUDIT contains 10 question and scores may range from 10 to 40. Higher scores indicate greater hazardous or harmful alcohol consumption. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' cannabis use. | Co-parents of participants will be invited to complete a set of questionnaires. The Cannabis Use Disorder Identification Test (CUDIT) will be used to measure coparents' cannabis use. The scale contains 8 items. Scores may range from 0 to 32. Higher scores indicate more hazardous cannabis use. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' recent stressful experiences. | Co-parents of participants will be invited to complete a set of questionnaires. 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Other | Change in co-parents' health and social services use. | A self-report scale created for use in this project will assess coparents' use of 14 types of health and social services in the previous 3 months. The scale does not produce a total score; rather, the scale asks participants if they had accessed services, and if yes, the frequency of their use of those services. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Primary | 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). | |
Primary | 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 | Change 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). | |
Secondary | Change 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 behaviours. 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. | Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3). |
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