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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

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....

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Autores principales: Xie, E. Bailin, Simpson, Kaeley M., Reynolds, Kristin A., Giuliano, Ryan J., Protudjer, Jennifer L. P., Soderstrom, Melanie, Sauer-Zavala, Shannon, Giesbrecht, Gerald F., Lebel, Catherine, Mackinnon, Anna L., Rioux, Charlie, Penner-Goeke, Lara, Freeman, Makayla, Salisbury, Marlee R., Tomfohr-Madsen, Lianne, Roos, Leslie E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441821/
https://www.ncbi.nlm.nih.gov/pubmed/36064436
http://dx.doi.org/10.1186/s13063-022-06512-5
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author Xie, E. Bailin
Simpson, Kaeley M.
Reynolds, Kristin A.
Giuliano, Ryan J.
Protudjer, Jennifer L. P.
Soderstrom, Melanie
Sauer-Zavala, Shannon
Giesbrecht, Gerald F.
Lebel, Catherine
Mackinnon, Anna L.
Rioux, Charlie
Penner-Goeke, Lara
Freeman, Makayla
Salisbury, Marlee R.
Tomfohr-Madsen, Lianne
Roos, Leslie E.
author_facet Xie, E. Bailin
Simpson, Kaeley M.
Reynolds, Kristin A.
Giuliano, Ryan J.
Protudjer, Jennifer L. P.
Soderstrom, Melanie
Sauer-Zavala, Shannon
Giesbrecht, Gerald F.
Lebel, Catherine
Mackinnon, Anna L.
Rioux, Charlie
Penner-Goeke, Lara
Freeman, Makayla
Salisbury, Marlee R.
Tomfohr-Madsen, Lianne
Roos, Leslie E.
author_sort Xie, E. Bailin
collection PubMed
description 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
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spelling pubmed-94418212022-09-06 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 Xie, E. Bailin Simpson, Kaeley M. Reynolds, Kristin A. Giuliano, Ryan J. Protudjer, Jennifer L. P. Soderstrom, Melanie Sauer-Zavala, Shannon Giesbrecht, Gerald F. Lebel, Catherine Mackinnon, Anna L. Rioux, Charlie Penner-Goeke, Lara Freeman, Makayla Salisbury, Marlee R. Tomfohr-Madsen, Lianne Roos, Leslie E. Trials Study Protocol 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 BioMed Central 2022-09-05 /pmc/articles/PMC9441821/ /pubmed/36064436 http://dx.doi.org/10.1186/s13063-022-06512-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Xie, E. Bailin
Simpson, Kaeley M.
Reynolds, Kristin A.
Giuliano, Ryan J.
Protudjer, Jennifer L. P.
Soderstrom, Melanie
Sauer-Zavala, Shannon
Giesbrecht, Gerald F.
Lebel, Catherine
Mackinnon, Anna L.
Rioux, Charlie
Penner-Goeke, Lara
Freeman, Makayla
Salisbury, Marlee R.
Tomfohr-Madsen, Lianne
Roos, Leslie E.
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441821/
https://www.ncbi.nlm.nih.gov/pubmed/36064436
http://dx.doi.org/10.1186/s13063-022-06512-5
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