Building Regulation in Dual Generations

NCT04347707 | Terminated

• 1 other identifier: P2019:063
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Self-regulation; Child Development

Keywords

maternal mental health; self-regulatory mechanisms

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

• 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.

  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

  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 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).

Other Outcomes (3)

• Change in Parent Inhibitory Control from pre-intervention to post-intervention - Exploratory Outcome

  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).

• Change in Child Cognitive Function from pre-intervention to post-intervention - Exploratory Outcome

  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).

• Change in Child Stress System Reactivity and Recovery from pre-intervention to post-intervention - Exploratory Outcome

  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).

Study Arms (2)

BRIDGE Clinical Group

EXPERIMENTAL

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

Baseline Comparison Group

NO INTERVENTION

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.

Interventions

BRIDGE Therapy Program BEHAVIORAL

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.

BRIDGE Clinical Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only mothers are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (35)

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MeSH Terms

Conditions

Depression; Self-Control

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Lauren Kaminski, MA

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: September 15, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)