Building Regulation in Dual Generations

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04639557
Study type	Interventional
Source	University of Manitoba
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	September 1, 2020
Completion date	December 15, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06315036` - Effects of Developmental Gymnastics on Preschoolers' Motor Skills	N/A
Active, not recruiting	`NCT05143294` - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions	N/A
Completed	`NCT05267730` - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions	N/A
Completed	`NCT03680157` - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed	`NCT00362076` - The Role of Motion in Infants' Ability to Categorize	N/A
Recruiting	`NCT05525962` - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed	`NCT03232606` - Physical Activity of Asthmatic Children
Completed	`NCT05955755` - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear	N/A
Recruiting	`NCT04443855` - WASH Benefits Child Development Follow up	N/A
Not yet recruiting	`NCT06335524` - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants	N/A
Not yet recruiting	`NCT05783141` - Prebiotic Effects in Healthy Toddlers	N/A
Completed	`NCT02451059` - Reducing Socioeconomic Disparities in Health at Pediatric Visits	N/A
Completed	`NCT02539251` - Arabic Ages and Stages Questionnaire-III
Completed	`NCT02800616` - The Healthy Elementary School of the Future	N/A
Completed	`NCT02242539` - Tools to Improve Parental Recognition of Developmental Deficits in Children	N/A
Completed	`NCT03010306` - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru	N/A
Completed	`NCT01683565` - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood	Phase 4
Completed	`NCT00989859` - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting	`NCT00980733` - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits	Phase 3
Terminated	`NCT04347707` - Building Regulation in Dual Generations	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Building Regulation in Dual Generations - Telehealth Model — BRIDGE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms