Building Regulation in Dual Generations: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Manitoba
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Change in Maternal Emotion Regulation pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale
Study Overview
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.
Detailed Description
Exposure to maternal mental illness early in life can have a negative effect on children's own mental health and behavior problems putting them at risk for intergenerational transmission of mental illness (Comaskey et al., 2017; Reupert, Maybery, Nicholson, Gopfert, & Seeman, 2015; Goodman et al., 2011; O'Connor, Monk, & Burke, 2016; Dean et al., 2018; Roos et al., 2016). In order to address this concern, there have been recent calls for action for the development of early intervention programs (Shonkoff, 2016; Chartier, 2016; Patel et al., 2016; Waddell et al., 2007) that support both mother and child in a dual generation capacity (Luthar & Eisenberg, 2017; Shonkoff & Fisher, 2013). In this study, the investigators are particularly interested in the mechanisms involved in maternal self-regulation, defined as the effortful regulation of one's emotions and behaviors and what effect it has on children's self-regulation. The investigators propose that dysfunction in maternal self-regulation serves as a risk factor for the intergenerational transmission of mental illness. Partially due to the fact that dysregulation in mother's own emotions puts them at risk for mental illness and can also lead to challenges in developmentally supportive parenting (Aldao, Gee, De Los Reyes, & Seager, 2016; Kochanska, Philibert, & Barry, 2009; Strauman, 2017; Zeytinoglu, Calkins, Swingler, & Leerkes, 2017) such as scaffolding emotional socialization, stress management, impulse control (Zeytinoglu et al., 2017, Crandall, Deater-Deckard, & Riley, 2015) and often at times leads to implementation of poor parenting practices (Choi et al., 2018; Dittrich et al., 2018). Children ages 3-5 are of particular interest as they are in a developmentally sensitive period of self-regulation skills (Blair & Diamond, 2008; Gilliom, Shaw, Beck, Schonberg, & Lukon, 2002; Woodward, Lu, Morris, & Healey, 2017). The aim of this study is to gain further insight into what factors of maternal mental illness are most relevant to the development of children's self-regulatory impairments and negative outcomes. The study will also investigate how exposure to chronic stress interacts with maternal mental illness to affect development. The investigators are especially interested in studying the effects of chronic stress exposure on biological stress-related systems such as the hypothalamic-pituitary-adrenal axis (HPA) and the autonomic nervous system (ANS) to see how intervention can target these systems.
The study has two primary objectives:
- 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 The investigators predict that children with mothers who have a mental illness will have more self-regulatory deficits and that this relationship will be partially mediated by parenting skills. Whereas the effects of maternal mental illness will be exacerbated by exposure to chronic stress.
- 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. The investigators predict that our dual generation approach to intervention will improve self-regulatory outcomes in both mother and child.
Methodology
Intervention Group:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
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.
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 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
- 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).)
- 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).)