Building Regulation in Dual Generations - Telehealth Model

NCT ID: NCT04639557

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-15

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.

Conditions

Maternal Depression; Child Development; Child Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Intervention

Mothers in this group will participate in 16, once per week, scheduled 2-hour virtual group therapy sessions through Zoom for Healthcare. These sessions will include both visual media (e.g., presentations, recorded examples of skills), and discussions. A technician will be present in the virtual group therapy session to manage the technical component. These sessions will be supplemented with a 1-hour drop-in session moderated by a facilitator each week in which participants will be able to clarify topics for that week, discuss the material in more depth, and/or connect with other participants to share about the skill practice.

Group Type: EXPERIMENTAL

BRIDGE Therapy Program

Intervention Type: BEHAVIORAL

The BRIDGE Therapy Program is a novel manualized 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. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target maternal mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.

Therapy Intervention Pre-recorded

Mothers in this group will have access to short pre-recorded videos of the presentations with facilitator commentary (i.e., 10-12 minutes) with additional video material as warranted each week (e.g., recorded examples of skill practice) for a maximum of 30-minutes of material per week. This arm will also have a 1-hour drop-in session each week with a group facilitator to moderate homework check-ins and discussion of the material.

Group Type: EXPERIMENTAL

BRIDGE Therapy Program

Intervention Type: BEHAVIORAL

The BRIDGE Therapy Program is a novel manualized 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. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target maternal mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.

Interventions

BRIDGE Therapy Program

The BRIDGE Therapy Program is a novel manualized 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. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target maternal mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Research Manitoba

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Manitoba - Department of Psychology

Winnipeg, Manitoba, Canada

Countries

Canada

References

Paton A, Stienwandt S, Penner-Goeke L, Giuliano RJ, Roos LE. Feasibility of an Online Acute Stressor in Preschool Children of Mothers with Depression. Dev Psychobiol. 2024 Sep;66(6):e22520. doi: 10.1002/dev.22520.

Reference Type: DERIVED

PMID: 38923527 (View on PubMed)

Other Identifiers

BRIDGEV2.0

Identifier Type: -

Identifier Source: org_study_id