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Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial

BACKGROUND: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience sym...

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Autores principales: Sawyer, Alyssa CP, Kaim, Amy L, Reece, Christy E, McDonald, Denise, Le, Huynh-Nhu, Clark, Jennifer, Lynch, John W, Sawyer, Michael G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351991/
https://www.ncbi.nlm.nih.gov/pubmed/30664487
http://dx.doi.org/10.2196/11549
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author Sawyer, Alyssa CP
Kaim, Amy L
Reece, Christy E
McDonald, Denise
Le, Huynh-Nhu
Clark, Jennifer
Lynch, John W
Sawyer, Michael G
author_facet Sawyer, Alyssa CP
Kaim, Amy L
Reece, Christy E
McDonald, Denise
Le, Huynh-Nhu
Clark, Jennifer
Lynch, John W
Sawyer, Michael G
author_sort Sawyer, Alyssa CP
collection PubMed
description BACKGROUND: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. OBJECTIVE: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. METHODS: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. RESULTS: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. CONCLUSIONS: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/11549
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spelling pubmed-63519912019-02-22 Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial Sawyer, Alyssa CP Kaim, Amy L Reece, Christy E McDonald, Denise Le, Huynh-Nhu Clark, Jennifer Lynch, John W Sawyer, Michael G JMIR Res Protoc Protocol BACKGROUND: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. OBJECTIVE: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. METHODS: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. RESULTS: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. CONCLUSIONS: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/11549 JMIR Publications 2019-01-16 /pmc/articles/PMC6351991/ /pubmed/30664487 http://dx.doi.org/10.2196/11549 Text en ©Alyssa CP Sawyer, Amy L Kaim, Christy E Reece, Denise McDonald, Huynh-Nhu Le, Jennifer Clark, John W Lynch, Michael G Sawyer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.01.2019. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Sawyer, Alyssa CP
Kaim, Amy L
Reece, Christy E
McDonald, Denise
Le, Huynh-Nhu
Clark, Jennifer
Lynch, John W
Sawyer, Michael G
Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial
title Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial
title_full Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial
title_fullStr Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial
title_full_unstemmed Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial
title_short Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial
title_sort evaluating the effectiveness of an app-based nurse-moderated program for new mothers with depression and parenting problems (emums plus): protocol for a pragmatic randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351991/
https://www.ncbi.nlm.nih.gov/pubmed/30664487
http://dx.doi.org/10.2196/11549
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