与社区合作伙伴共同为婴儿母亲开发的建立情绪意识与心理健康（BEAM）项目：可行性随机对照试验方案
The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial.
作者信息
Joyce Kayla M, Rioux Charlie, MacKinnon Anna L, Katz Laurence Y, Reynolds Kristin, Kelly Lauren E, Klassen Terry, Afifi Tracie O, Mushquash Aislin R, Clement Fiona M, Chartier Mariette, Xie Elisabeth Bailin, Penner Kailey E, Hunter Sandra, Berard Lindsay, Tomfohr-Madsen Lianne, Roos Leslie E
机构信息
Department of Psychology, University of Manitoba, P314 Duff Roblin Building, 190 Dysart Road, Winnipeg, Manitoba, R3T 2N2, Canada.
University of Oklahoma, Norman, USA.
出版信息
Pilot Feasibility Stud. 2023 Mar 9;9(1):35. doi: 10.1186/s40814-023-01260-y.
BACKGROUND
Drastic increases in the rates of maternal depression and anxiety have been reported since the COVID-19 pandemic began. Most programs aim to improve maternal mental health or parenting skills separately, despite it being more effective to target both concurrently. The Building Emotional Awareness and Mental health (BEAM) program was developed to address this gap. BEAM is a mobile health program aiming to mitigate the impacts of pandemic stress on family well-being. Since many family agencies lack infrastructure and personnel to adequately treat maternal mental health concerns, a partnership will occur with Family Dynamics (a local family agency) to address this unmet need. The study's objective is to examine the feasibility of the BEAM program when delivered with a community partner to inform a larger randomized controlled trial (RCT).
METHODS
A pilot RCT will be conducted with mothers who have depression and/or anxiety with a child 6-18 months old living in Manitoba, Canada. Mothers will be randomized to the 10 weeks of the BEAM program or a standard of care (i.e., MoodMission). Back-end App data (collected via Google Analytics and Firebase) will be used to examine feasibility, engagement, and accessibility of the BEAM program; cost-effectiveness will also be examined. Implementation elements (e.g., maternal depression [Patient Health Questionnaire-9] and anxiety [Generalized Anxiety Disorder-7]) will be piloted to estimate the effect size and variance for future sample size calculations.
DISCUSSION
In partnership with a local family agency, BEAM holds the potential to promote maternal-child health via a cost-effective and an easily accessible program designed to scale. Results will provide insight into the feasibility of the BEAM program and will inform future RCTs. TRIAL REGISTRATION {2A}: This trial was retrospectively registered with ClinicalTrial.gov ( NCT05398107 ) on May 31st, 2022.
背景
自新冠疫情开始以来，有报道称孕产妇抑郁和焦虑率急剧上升。尽管同时针对孕产妇心理健康和育儿技能进行干预更为有效，但大多数项目仍分别致力于改善其中一方面。为填补这一空白，开发了建立情感意识与心理健康（BEAM）项目。BEAM是一个移动健康项目，旨在减轻疫情压力对家庭幸福的影响。由于许多家庭机构缺乏足够的基础设施和人员来充分处理孕产妇心理健康问题，将与家庭动力组织（当地一家家庭机构）合作以满足这一未被满足的需求。该研究的目的是检验BEAM项目与社区合作伙伴合作实施时的可行性，并为一项更大规模的随机对照试验（RCT）提供参考。
方法
将对加拿大曼尼托巴省患有抑郁和/或焦虑且孩子年龄在6至18个月的母亲开展一项试点随机对照试验。母亲们将被随机分配到为期10周的BEAM项目组或标准护理组（即情绪任务）。后端应用程序数据（通过谷歌分析和Firebase收集）将用于检验BEAM项目的可行性、参与度和可及性；还将检验成本效益。将对实施要素（例如孕产妇抑郁[患者健康问卷-9]和焦虑[广泛性焦虑障碍-7]）进行试点，以估计效应大小和方差，用于未来样本量计算。
讨论
与当地家庭机构合作，BEAM有潜力通过一个具有成本效益且易于推广的项目促进母婴健康。研究结果将为BEAM项目的可行性提供见解，并为未来的随机对照试验提供参考。试验注册{2A}：该试验于2022年5月31日在ClinicalTrial.gov（NCT05398107）进行了回顾性注册。
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