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Building Regulation in Dual Generations (BRIDGE)

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ClinicalTrials.gov Identifier: NCT04347707
Recruitment Status : Terminated (The trial was ended after one year due to the suspension of in-person research as a result of the COVID-19 pandemic. We have returned to the program development stage as we explore telehealth alternative options.)
First Posted : April 15, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
Research Manitoba
Centre for Addiction and Mental Health
University of Oregon
Information provided by (Responsible Party):
University of Manitoba

Brief 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, 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. The objectives for this study are to 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) develop and evaluate a novel dual-generation intervention for mothers with mental illness and their 3 to 5-year-old children based on existing gold-standard evidence-based approaches.

Condition or disease Intervention/treatment Phase
Depression Self-regulation Child Development Behavioral: BRIDGE Therapy Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will recruit a group of mother-child dyads in which the mother meets the current criteria for depression. Those mothers will participate in a 20-week group therapy intervention that incorporates Dialectical Behavior Therapy (DBT) and parent skills training. A control group of mother-child dyads who will be income and child age-matched to the intervention sample will also be recruited. These mothers will not meet the criteria for depression and will not receive the group therapy intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Building Regulation in Dual Generations: Pilot Study
Actual Study Start Date : September 15, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BRIDGE Clinical Group
This group of mother-child dyads will have mothers who have been screened for and met diagnostic criteria for depression. Mothers in this group will participate in the 20-week group therapy and parent skills training intervention.
Behavioral: BRIDGE Therapy Program
The BRIDGE Therapy Program is a novel structured form of 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. The program involves 20, once per week, scheduled group therapy sessions that last for 2 hours. There are two components of the program, the first is the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and will target maternal mental health symptomology. The second section is the parent skill training materials, which have been designed to correspond to the 4 core DBT modules (Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.

No Intervention: Baseline Comparison Group
This group of mother-child dyads will not meet diagnostic criteria for depression and will serve as a comparison group for baseline measures. Dyads will be matched to the BRIDGE clinical group based on household income and child age.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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). ]
    103-item questionnaire that asks parents to describe their child's behavioural and emotional problems within the past 2 months.

  2. 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). ]
    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.


Other Outcome Measures:
  1. Change in Parent Inhibitory Control from pre-intervention to post-intervention - Exploratory Outcome [ Time Frame: Parent inhibitory control through the stop signal task will be measured 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). ]
    Parent inhibitory control will be measured with the stop signal computer task and the effect it has on parasympathetic and sympathetic nervous activity. Participants will have 11 electrodes placed on their body to allow for recording of cardiovascular activity. They will then participate in the stop signal computer task, in which they are required to press keys on the computer keyboard in response to shapes on the screen. Participants are required to try and withhold from pressing the keys when they hear a beep. Their ability to resist their response is an indication of inhibitory control.

  2. Change in Child Cognitive Function from pre-intervention to post-intervention - Exploratory Outcome [ Time Frame: Child cognitive function will be assessed 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). ]
    Child cognitive function will be assessed with behavioural regulation tasks. Specifically, children will participate in the child version of the Stroop task, in which they will be required to say the opposite in response to pictures of Day/Night images and Happy/Sad faces. Additionally, they will also participate in the Head-Toes-Knees-Shoulders task, where they will be required to point to the opposite body part as instructed.

  3. Change in Child Stress System Reactivity and Recovery from pre-intervention to post-intervention - Exploratory Outcome [ Time Frame: Child stress system reactivity and recovery will be measured 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). ]
    Child stress system reactivity will be measured through parasympathetic and sympathetic nervous system activity and salivary cortisol. Children will participate in an acute stressor task during which they will be wearing 11 electrodes on their bodies that will be recording cardiovascular activity. Salivary cortisol will also be collected immediately before the acute stressor, immediately after, and then 15, 30, and 45 minutes after.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only mothers are eligible to participate.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347707


Locations
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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Research Manitoba
Centre for Addiction and Mental Health
University of Oregon
Investigators
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Study Director: Lauren Kaminski, MA University of Manitoba
Publications:
Reupert, A., Maybery, D., Nicholson, J., Göpfert, M., & Seeman, M. V. (Eds.). (2015). Parental psychiatric disorder: Distressed parents and their families. Cambridge University Press.
Chartier, M. (2016). The Mental Health of Manitoba's Children. Manitoba Centre for Health Policy, Rady Faculty of Health Sciences, Max Rady Colledge of Medicine, University of Manitoba.
Sheehan, D. V., Lecrubier, Y., Sheehan, K. H., Janavs, J., Weiller, E., Keskiner, A., ... & Dunbar, G. C. (1997). The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability. European Psychiatry, 12(5), 232-241.
Tomlinson, M. F., & Hoaken, P. N. (2017). The Potential for a Skills-Based Dialectical Behavior Therapy Program to Reduce Aggression, Anger, and Hostility in a Canadian Forensic Psychiatric Sample: A Pilot Study. International Journal of Forensic Mental Health, 16(3), 215-226.
Behavioral Research & Therapy Clinics. (2018). Publications. Retrieved from: http://depts.washington.edu/uwbrtc/research/publications/
Maag, J. W. (2016). Behavior management: From theoretical implications to practical applications. Cengage Learning.
Bierman, K. L., & Motamedi, M. (2015). Social and emotional learning programs for preschool children. Handbook of social and emotional learning: Research and practice, 135-151.
Abidin, R. R., & Abidin, R. R. (1990). Parenting Stress Index (PSI) (p. 100). Charlottesville, VA: Pediatric Psychology Press.
Fabes, R.A., Eisenberg, N., & Bernzweig, J. (1990).The Coping with Children's Negative Emotions Scale: Procedures and scoring. Available from authors. Arizona State University
Achenbach, T. M. (1999). The Child Behavior Checklist and related instruments. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (pp. 429-466). Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers.
Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385-401.
Chamberlain, P., & Reid, J. B. (1987). Parent observation and report of child symptoms. Behavioral Assessment.

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04347707    
Other Study ID Numbers: P2019:063
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manitoba:
maternal mental health
self-regulatory mechanisms
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms