Clinical trial NCT04347707: Building Regulation in Dual Generations
Official title: Building Regulation in Dual Generations: Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Self-regulation
Child Development
Keywords: maternal mental health
self-regulatory mechanisms
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: 2020-04-15
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_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 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.
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. 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:

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 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.
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. The investigators predict that our dual generation approach to intervention will improve self-regulatory outcomes in both mother and child.

Methodology

Intervention Group:

Mothers experiencing symptoms of mental illness will be recruited from the local agencies serving this population and the general community. All interested participants will be phone screened to determine eligibility. If a participant passes the phone screener questionnaire, they will be scheduled for the intake interview in which a PhD level clinical psychology graduate student will complete the MINI Neuropsychiatric Interview (Sheehan et al., 1997) to determine if the participant has experienced a recent major depressive episode. If this is found to be the case, the participant is scheduled for a 2.5 hour laboratory assessment (T1) in which mother and child will participate a variety of self-report, behavioral, and biological assessments (see primary outcome measures for more details).

After the T1 assessment, mothers will participate in the novel BRIDGE Therapy Program, which occurs once a week for 2 hours for 20 weeks. The BRIDGE Therapy Program is a mix of Dialectical Behaviour Therapy (DBT) and parent skills training. DBT aims to support clients in achieving "a life worth living" by reducing self-destructive behaviours and scaffolding self-regulatory skills while acknowledging the inherently difficult experiences individuals have endured (Valentine, Bankoff, Poulin, Reidler, \& Pantalone, 2015). DBT has proven to be effective in treating a wide range of mental illnesses characterized by self-regulatory deficits (Valentine et al., 2015; Tomlinson \& Hoaken, 2017; Behavioral Research \& Therapy Clinics, 2018). DBT content also shares many characteristics with evidence-based interventions aimed at promoting childhood self-regulation (Maag, 2016; Bierman \& Motamedi, 2015), and because of this, the parenting component of the BRIDGE Therapy program is matched to the four DBT modules; mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance. Throughout the program, data will be collected weekly on attendance, DBT/parenting skill implementation through the use of diary cards, and at weeks 2, 9, 15 on child behavior and symptoms of depression (see secondary outcome measures).

After the completion of the 20-week BRIDGE Therapy Program participants will come in for a second laboratory assessment (T2) which will follow identical procedures to those outlined in T1.

Participants will be compensated for their time at each assessment on an ascending pay scale. They will be provided with $30.00 compensation for their intake interview, $60.00 for assessment 1, and $90.00 for assessment 2. The ascending pay scale is provided to encourage retention and has been used in previous projects by the primary researcher and collaborators. Furthermore, systematic efforts will be taken to reduce barriers to treatment and encourage retainment. Participants will be aided in transportation costs (i.e. bus tickets) and provided with meals and childcare services while in group therapy sessions and for lab visits.

Control Group:

A sample of household income and age-matched mother-child dyads not exposed to maternal mental illness will be recruited and participate in identical intake and assessment (T1) procedures to the ones described above. The primary goal of the income-matched control families is to provide comparison information about baseline differences in child characteristics associated with maternal mental illness that informs the directionality of expected intervention effects.

Planned Analyses:

The investigators will examine the extent to which our measures are related using correlational analyses. The investigators will use Mplus software to examine multivariate analyses. Mother age, child age, and child gender will be examined as covariates. Child gender will also be examined as a moderator in domains that have a theoretical and evidence base.

Objective 1. When group differences emerge, structural equation models will characterize the extent to which maternal self-regulation predicts child characteristics and parenting mediates effects. Chronic stress exposure will also be examined as a moderator of associations. Objective 2.To measure the effects of the intervention repeated measure analyses will be used to examine the changes in our primary measures for mothers and children in the BRIDGE Therapy program. Next, exploratory analyses will be used to determine the extent to which changes in maternal function predict changes in each child outcome. Structural equation models will be employed to identify the relative contributions of maternal characteristics to changes in child outcomes as well as moderating (i.e. chronic stress, child gender) and mediating (i.e. parenting) paths of interest.

Expected Outcomes:

The BRIDGE Therapy Program is a novel intervention that is designed to target self-regulatory deficits and prevent the inter-generational transmission of mental illness due to these deficits. The program addresses the gaps in the literature by targeting parenting skills and both mother and child mental health outcomes. Although this is just the pilot study of the program, data from this project will be used to influence further development of the program so that outcome measures can be further improved. By taking a rapid-cycle approach to the development of materials along with the precise evaluation of the mechanisms involved, the investigators are setting the stage for the program to be adapted to meet the needs of at-risk families and to be tested in a large-scale RCT. Furthermore, by evaluating the processes involved in self-regulation for children exposed to maternal mental illness and how they respond to the intervention will inform us of how maternal mental illness impacts development. The ultimate goal of the project is to develop a dual-generation program that can prevent the intergenerational transmission of mental illness and improve outcomes for at-risk families.

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: 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 Parent Inhibitory Control from pre-intervention to post-intervention - Exploratory Outcome
timeFrame: 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).
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: 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: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Lauren Kaminski, MA
role: STUDY_DIRECTOR
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