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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Mood Disorders | Study protocol

Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months

Authors: E. Bailin Xie, Kaeley M. Simpson, Kristin A. Reynolds, Ryan J. Giuliano, Jennifer L. P. Protudjer, Melanie Soderstrom, Shannon Sauer-Zavala, Gerald F. Giesbrecht, Catherine Lebel, Anna L. Mackinnon, Charlie Rioux, Lara Penner-Goeke, Makayla Freeman, Marlee R. Salisbury, Lianne Tomfohr-Madsen, Leslie E. Roos

Published in: Trials | Issue 1/2022

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Abstract

Background

The prevalence of maternal depression and anxiety has increased during the COVID-19 pandemic, and pregnant individuals are experiencing concerningly elevated levels of mental health symptoms worldwide. Many individuals may now be at heightened risk of postpartum mental health disorders. There are significant concerns that a cohort of children may be at-risk for impaired self-regulation and mental illness due to elevated exposure to perinatal mental illness. With both an increased prevalence of depression and limited availability of services due to the pandemic, there is an urgent need for accessible eHealth interventions for mothers of young children. The aims of this trial are to evaluate the efficacy of the Building Emotion Awareness and Mental Health (BEAM) app-based program for reducing maternal depression symptoms (primary outcome) and improve anxiety symptoms, parenting stress, family relationships, and mother and child functioning (secondary outcomes) compared to treatment as usual (TAU).

Methods

A two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to TAU among a sample of 140 mothers with children aged 18 to 36 months, who self-report moderate-to-severe symptoms of depression and/or anxiety. Individuals will be recruited online, and those randomized to the treatment group will participate in 10 weeks of psychoeducation modules, an online social support forum, and weekly group teletherapy sessions. Assessments will occur at 18–36 months postpartum (pre-test, T1), immediately after the last week of the BEAM intervention (post-test, T2), and at 3 months after the intervention (follow-up, T3).

Discussion

eHealth interventions have the potential to address elevated maternal mental health symptoms, parenting stress, and child functioning concerns during and after the COVID-19 pandemic and to provide accessible programming to mothers who are in need of support. This RCT will build on an open pilot trial of the BEAM program and provide further evaluation of this evidence-based intervention. Findings will increase our understanding of depression in mothers with young children and reveal the potential for long-term improvements in maternal and child health and family well-being.

Trial registration

ClinicalTrials.​govNCT05306626. Registered on April 1, 2022
Appendix
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Metadata
Title
Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months
Authors
E. Bailin Xie
Kaeley M. Simpson
Kristin A. Reynolds
Ryan J. Giuliano
Jennifer L. P. Protudjer
Melanie Soderstrom
Shannon Sauer-Zavala
Gerald F. Giesbrecht
Catherine Lebel
Anna L. Mackinnon
Charlie Rioux
Lara Penner-Goeke
Makayla Freeman
Marlee R. Salisbury
Lianne Tomfohr-Madsen
Leslie E. Roos
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06512-5

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