Maternal DepressionBRIDGENCT04639557
Building Regulation in Dual Generations - Telehealth Model
A study testing BRIDGE Therapy Program in people with Maternal Depression and Child Development, run by University of Manitoba at 1 site in Canada.
Trial summary
Families who experience maternal mental illness and a variety of chronic stressors are currently underserved by the parenting programs. The investigators propose that impairments in maternal self-regulation, which result in unsupportive parenting, directly impact children's own self-regulation and neurobiology… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Depression, Child Development, Child Mental Health
- What is being tested?
- BRIDGE Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have a 3-5 year old child
- The child must not have a diagnosed developmental delay
- Must have full or joint custody of the child
- Must meet current criteria for a Major Depressive Episode
- Must be 18 years of age
Who cannot join
- Child is outside of the 3-5 year old age range
- The child has a diagnosed developmental delay
- Mother does not have full or joint custody of the child
- Mother did not meet current criteria for a Major Depressive Episode (control group)
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of Manitoba - Department of Psychology
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Building Regulation in Dual Generations - A Telehealth Parenting Program for Depressed Mothers of Preschoolers, Matched With Dialectical Behavior Therapy Skills
Families who experience maternal mental illness and a variety of chronic stressors are currently underserved by the parenting programs. The investigators propose that impairments in maternal self-regulation, which result in unsupportive parenting, directly impact children's own self-regulation and neurobiology, leading to risk for intergenerational transmission of mental illness. The objective of this study is to develop and evaluate a program that is targeted at improving underlying self-regulatory mechanisms in both mothers with depression and their 3- to 5-year-old children. It is hypothesized that children exposed to maternal mental illness will have greater self-regulatory deficits across emotional and behavioural domains compared to children not exposed to mental illness. The effects of maternal mental illness are expected to be compounded for children of mothers reporting a higher degree of chronic stressors, including poverty, housing instability, violence, and low social support. Further, it is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the mother, child, and dyad (i.e. parenting interactions) will improve both maternal capacities and child outcomes. A feasibility study has been conducted in-person (NCT04347707). Results from this trial showed positive effects on child and mother well-being as well as parenting skills. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The objectives for this study are two-fold: 1) establish a better understanding of the self-regulatory processes that are altered in preschool-aged children exposed to maternal mental illness, and determine the mediating role of parenting behaviours, as well as the moderating impact of chronic stress exposure; and 2) evaluate a novel dual-generation intervention for mothers with mental illness using a virtual format and their 3- to 5-year-old children based on existing gold-standard evidence-based approaches.
- Conditions
- Maternal Depression, Child Development, Child Mental Health
- Being tested
- BRIDGE Therapy Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGE Therapy ProgramBehavioural
The BRIDGE Therapy Program is a novel manualized therapy that incorporates key parenting concepts and related Dialectical Behavior Therapy (DBT) modules. The primary aim of the program is to promote self-regulation in the mother-child dyads. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target maternal mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Intervention | Experimental | Mothers in this group will participate in 16, once per week, scheduled 2-hour virtual group therapy sessions through Zoom for Healthcare. These sessions will include both visual media (e.g., presentations, recorded examples of skills), and discussions. A technician will be present in the virtual group therapy session to manage the technical component. These sessions will be supplemented with a 1-hour drop-in session moderated by a facilitator each week in which participants will be able to clarify topics for that week, discuss the material in more depth, and/or connect with other participants to share about the skill practice. Receives: Behavioral: BRIDGE Therapy Program |
| Therapy Intervention Pre-recorded | Experimental | Mothers in this group will have access to short pre-recorded videos of the presentations with facilitator commentary (i.e., 10-12 minutes) with additional video material as warranted each week (e.g., recorded examples of skill practice) for a maximum of 30-minutes of material per week. This arm will also have a 1-hour drop-in session each week with a group facilitator to moderate homework check-ins and discussion of the material. Receives: Behavioral: BRIDGE Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Depression from pre-intervention to post-intervention - Beck Depression Inventory
21-item self-report inventory to measure symptoms and characteristics of depression. Participants respond to statements on a 0-3 Likert scale. Higher scores indicate higher depression symptoms. The highest possible score is 60 and lowest possible score is 0.
Measured: The Beck Depression Inventory will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time once again after the program is complete (approx. 20 weeks after Time 1).
Change in Maternal Emotion Regulation pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale
18-item self-report questionnaire with 6 sub-categories to measure emotion regulation. Participants respond to items on a 5-point Likert scale. Higher scores suggest more severe problems with emotion regulation. The highest possible score is 90 and the lowest possible score is 18.
Measured: The Difficulties in Emotion Regulation Scale will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
3. Change in Parenting Stress from pre-intervention to post-intervention - Parenting Stress Index (Short form)
36-item self-report measure filled out by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. There are 3 sub categories. Responses to each item in a sub-category are totalled and then the 3 subcategory scores are summed to represent a total stress score. Higher scores indicated higher levels of parenting stress. Normal scores fall within the 15th to 85th percentile, and scores above the 85th percentile represent clinically elevated levels of stress.
Measured: The Parenting Stress Index (short form) will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
Secondary outcomes (2)
Change in the Child Behaviour Checklist from pre-intervention to post-intervention
103-item questionnaire that asks parents to describe their child's behavioural and emotional problems within the past 2 months.
Measured: The Child Behaviour Checklist will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
Change in Parental Sensitivity from pre-intervention to post-intervention
Parent-child interactions will be video recorded after the child has participated in an acute stressor task. The interaction will be coded to measure levels of parental sensitivity using a novel coding scale (no established range).
Measured: Parent-child interactions will be observed and video coded at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Sep 2020
- Primary completion15 Aug 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will recruit a group of mother-child dyads in which the mother meets the current criteria for major depressive disorder. Mothers will be randomly assigned to one of two intervention arms, which will occur concurrently over 16-weeks. Both arms incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Research Manitoba, Centre for Addiction and Mental Health, University of Oregon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639557
- Sponsor's protocol ID
- BRIDGEV2.0
- Acronym
- BRIDGE
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Paton A, Stienwandt S, Penner-Goeke L, Giuliano RJ, Roos LE. Feasibility of an Online Acute Stressor in Preschool Children of Mothers with Depression. Dev Psychobiol. 2024 Sep;66(6):e22520. doi: 10.1002/dev.22520.
PubMed 38923527
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Regulation in Dual Generations - A Telehealth Parenting Program for Depressed Mothers of Preschoolers, Matched With Dialectical Behavior Therapy Skills
- ClinicalTrials.gov ID
- NCT04639557
- Acronym / sponsor ID
- BRIDGE / BRIDGEV2.0
- Conditions
- Maternal Depression, Child Development, Child Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Research Manitoba, Centre for Addiction and Mental Health, University of Oregon
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Families who experience maternal mental illness and a variety of chronic stressors are currently underserved by the parenting programs. The investigators propose that impairments in maternal self-regulation, which result in unsupportive parenting, directly impact children's own self-regulation and neurobiology, leading to risk for intergenerational transmission of mental illness. The objective of this study is to develop and evaluate a program that is targeted at improving underlying self-regulatory mechanisms in both mothers with depression and their 3- to 5-year-old children. It is hypothesized that children exposed to maternal mental illness will have greater self-regulatory deficits across emotional and behavioural domains compared to children not exposed to mental illness. The effects of maternal mental illness are expected to be compounded for children of mothers reporting a higher degree of chronic stressors, including poverty, housing instability, violence, and low social support. Further, it is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the mother, child, and dyad (i.e. parenting interactions) will improve both maternal capacities and child outcomes. A feasibility study has been conducted in-person (NCT04347707). Results from this trial showed positive effects on child and mother well-being as well as parenting skills. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The objectives for this study are two-fold: 1) establish a better understanding of the self-regulatory processes that are altered in preschool-aged children exposed to maternal mental illness, and determine the mediating role of parenting behaviours, as well as the moderating impact of chronic stress exposure; and 2) evaluate a novel dual-generation intervention for mothers with mental illness using a virtual format and their 3- to 5-year-old children based on existing gold-standard evidence-based approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will recruit a group of mother-child dyads in which the mother meets the current criteria for major depressive disorder. Mothers will be randomly assigned to one of two intervention arms, which will occur concurrently over 16-weeks. Both arms incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training.
| Arm | Type | Receives |
|---|---|---|
| Virtual Intervention | Experimental | Behavioral: BRIDGE Therapy ProgramMothers in this group will participate in 16, once per week, scheduled 2-hour virtual group therapy sessions through Zoom for Healthcare. These sessions will include both visual media (e.g., presentations, recorded examples of skills), and discussions. A technician will be present in the virtual group therapy session to manage the technical component. These sessions will be supplemented with a 1-hour drop-in session moderated by a facilitator each week in which participants will be able to clarify topics for that week, discuss the material in more depth, and/or connect with other participants to share about the skill practice. |
| Therapy Intervention Pre-recorded | Experimental | Behavioral: BRIDGE Therapy ProgramMothers in this group will have access to short pre-recorded videos of the presentations with facilitator commentary (i.e., 10-12 minutes) with additional video material as warranted each week (e.g., recorded examples of skill practice) for a maximum of 30-minutes of material per week. This arm will also have a 1-hour drop-in session each week with a group facilitator to moderate homework check-ins and discussion of the material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have a 3-5 year old child
- The child must not have a diagnosed developmental delay
- Must have full or joint custody of the child
- Must meet current criteria for a Major Depressive Episode
- Must be 18 years of age
Key exclusion criteria (4 listed)
- Child is outside of the 3-5 year old age range
- The child has a diagnosed developmental delay
- Mother does not have full or joint custody of the child
- Mother did not meet current criteria for a Major Depressive Episode (control group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIDGE Therapy ProgramThe BRIDGE Therapy Program is a novel manualized therapy that incorporates key parenting concepts and related Dialectical Behavior Therapy (DBT) modules. The primary aim of the program is to promote self-regulation in the mother-child dyads. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target maternal mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship. | Behavioural | Therapy Intervention Pre-recorded, Virtual Intervention |
Primary outcome
Change in Maternal Depression from pre-intervention to post-intervention - Beck Depression Inventory
Time frame: The Beck Depression Inventory will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time once again after the program is complete (approx. 20 weeks after Time 1).
21-item self-report inventory to measure symptoms and characteristics of depression. Participants respond to statements on a 0-3 Likert scale. Higher scores indicate higher depression symptoms. The highest possible score is 60 and lowest possible score is 0.
Change in Maternal Emotion Regulation pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale
Time frame: The Difficulties in Emotion Regulation Scale will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
18-item self-report questionnaire with 6 sub-categories to measure emotion regulation. Participants respond to items on a 5-point Likert scale. Higher scores suggest more severe problems with emotion regulation. The highest possible score is 90 and the lowest possible score is 18.
3. Change in Parenting Stress from pre-intervention to post-intervention - Parenting Stress Index (Short form)
Time frame: The Parenting Stress Index (short form) will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
36-item self-report measure filled out by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. There are 3 sub categories. Responses to each item in a sub-category are totalled and then the 3 subcategory scores are summed to represent a total stress score. Higher scores indicated higher levels of parenting stress. Normal scores fall within the 15th to 85th percentile, and scores above the 85th percentile represent clinically elevated levels of stress.
2 secondary outcomes
Change in the Child Behaviour Checklist from pre-intervention to post-intervention
Time frame: The Child Behaviour Checklist will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
Change in Parental Sensitivity from pre-intervention to post-intervention
Time frame: Parent-child interactions will be observed and video coded at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 38923527Paton A, Stienwandt S, Penner-Goeke L, Giuliano RJ, Roos LE. Feasibility of an Online Acute Stressor in Preschool Children of Mothers with Depression. Dev Psychobiol. 2024 Sep;66(6):e22520. doi: 10.1002/dev.22520.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGE Therapy Program in people with Maternal Depression and Child Development, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal Depression from pre-intervention to post-intervention - Beck Depression Inventory (time frame: The Beck Depression Inventory will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time once again after the program is complete (approx. 20 weeks after Time 1).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04639557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.