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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Mood Disorders | Study protocol

Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children

Authors: Lara Penner-Goeke, Madeline Belows, Amanda Kristjanson, Brendan F. Andrade, Emily E. Cameron, Ryan Giuliano, Laurence Y. Katz, Lauren E. Kelly, Nicole Letourneau, Natalie Mota, Kristin Reynolds, Maureen Zalewski, Ashley Pharazyn, Leslie E. Roos

Published in: Trials | Issue 1/2023

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Abstract

Background

Since the onset of the COVID-19 pandemic, the worldwide prevalence of maternal depression has risen sharply; it is now estimated that one quarter of mothers experience clinically significant depression symptoms. Exposure to maternal depression during early childhood increases the risk for the development of childhood mental illness (MI) in offspring, with altered parenting practices mediating the association between maternal depression and child outcomes. Dual-generation interventions, which aim to simultaneously treat parent and child mental health, show promise for improving outcomes for mothers with depression and their young children. The Building Regulation in Dual Generations (BRIDGE) program combines Dialectical Behavior Therapy (DBT) and parenting skills training to concurrently treat maternal depression and improve parenting practices. In pilot within-group studies, BRIDGE has led to large reductions in maternal depression and child MI symptoms. The aim of the current study is to evaluate the efficacy of BRIDGE in reducing maternal depression and child MI symptoms (primary outcomes) as well as parenting stress and harsh parenting (secondary outcomes).

Methods

A three-armed randomized control trial with equal group sizes will be conducted to compare the efficacy of (1) BRIDGE (DBT + parenting skills), (2) DBT skills training, and (3) services-as-usual. Participants (n = 180) will be mothers of 3- to 5-year-old children who report elevated depression symptoms. Those randomized to BRIDGE or DBT skills training will complete a 16-week group therapy intervention. Assessments will be administered at pre-intervention(T1) post-intervention (T2), and 6-month follow-up (T3).

Discussion

Dual-generation programs offer an innovative approach to prevent the intergenerational transmission of mental illness. The current study will add to the evidence base for BRIDGE by comparing it to a stand-alone mental health intervention and a services-as-usual group. These comparisons will provide valuable information on the relative efficacy of including parenting support in a mental health intervention for parents. The results will contribute to our understanding of how maternal depression affects children’s development and how intervening at both a mental health and parenting level may affect child and family outcomes.

Trial registration

Name of registry: Clinical Trials Protocol Registration and Results System; trial registration number: NCT05959538; date of registry: July 24, 2023; available: https://​classic.​clinicaltrials.​gov/​ct2/​show/​NCT05959538
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Metadata
Title
Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children
Authors
Lara Penner-Goeke
Madeline Belows
Amanda Kristjanson
Brendan F. Andrade
Emily E. Cameron
Ryan Giuliano
Laurence Y. Katz
Lauren E. Kelly
Nicole Letourneau
Natalie Mota
Kristin Reynolds
Maureen Zalewski
Ashley Pharazyn
Leslie E. Roos
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07591-8

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