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Completed

NCT Number: NCT04639557

Building Regulation in Dual Generations - Telehealth Model

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.

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Key information

Conditions

Maternal Depression Child Development Child Mental Health

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Manitoba - Department of Psychology

Winnipeg, Manitoba, R3T 2N2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BRIDGE Therapy Program

Behavioral

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.

Primary outcomes

  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. 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 outcomes

  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 (no established range).

Other outcomes

  1. 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.

  2. 2. 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 heartrate and salivary cortisol. Children will participate in an acute stressor task during which they will be wearing a FitBit heart rate monitor that will be recording their heartrate during the task. Salivary cortisol will also be collected immediately before the acute stressor, immediately after, and then 15, 30, and 45 minutes after.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Research Manitoba
  • University of Oregon

Registry information

Official study title

Building Regulation in Dual Generations - A Telehealth Parenting Program for Depressed Mothers of Preschoolers, Matched With Dialectical Behavior Therapy Skills

Acronym: BRIDGE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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