Clinical trial NCT04639557: Building Regulation in Dual Generations - Telehealth Model
Official title: Building Regulation in Dual Generations - A Telehealth Parenting Program for Depressed Mothers of Preschoolers, Matched With Dialectical Behavior Therapy Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Child Development
Child Mental Health
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Research Manitoba
name: Centre for Addiction and Mental Health
name: University of Oregon
First posted: 2020-11-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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. 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.


Eligibility 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)

Primary outcomes:
measure: Change in Maternal Depression from pre-intervention to post-intervention - Beck Depression Inventory
timeFrame: 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).
measure: Change in Maternal Emotion Regulation pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale
timeFrame: 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).
measure: 3. Change in Parenting Stress from pre-intervention to post-intervention - Parenting Stress Index (Short form)
timeFrame: 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:
measure: Change in the Child Behaviour Checklist from pre-intervention to post-intervention
timeFrame: 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).
measure: Change in Parental Sensitivity from pre-intervention to post-intervention
timeFrame: 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:
measure: Change in Child Cognitive Function from pre-intervention to post-intervention - Exploratory Outcome
timeFrame: 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).
measure: 2. Change in Child Stress System Reactivity and Recovery from pre-intervention to post-intervention - Exploratory Outcome
timeFrame: 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).
Locations:
city: Winnipeg
country: Canada
facility: The University of Manitoba - Department of Psychology
state: Manitoba
Study officials:
References: