Ingalls Allison, Barlow Allison, Kushman Elizabeth, Leonard Amanda, Martin Lisa, Team Precision Family Spirit Study, West Allison L, Neault Nicole, Haroz Emily E
Center for American Indian Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Maternal, Infant and Early Childhood Services, Inter-Tribal Council of Michigan, Inc., Sault Sainte Marie, MI, USA.
Pilot Feasibility Stud. 2021 Jan 6;7(1):8. doi: 10.1186/s40814-020-00753-4.
Home visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibility of a precision approach to home visiting and 2) examine the difference between Standard Family Spirit and Precision Family Spirit on participants' program satisfaction, client-home visitor relationship, goal alliance, and the impact of these factors on participant engagement and retention. Secondary aims are to explore potential differences on maternal behavioral and mental health outcomes and child development outcomes to inform sample size estimations for a fully powered study.
This is a pilot Hybrid Type 3 implementation trial. Four Michigan communities primarily serving the Native American families and already using Family Spirit were randomized by site to receive Standard Family Spirit or Precision Family Spirit. Participants include N = 60 mothers at least 14 years of age (pregnant or with a newborn < 2 months of age) currently enrolled in Family Spirit. Precision Family Spirit participants receive core lessons plus additional lessons based on needs identified at baseline and that emerge during the trial. Control mothers receive the standard sequence of Family Spirit lessons. Data is collected at baseline (< 2 months postpartum), and 2, 6, and 12 months postpartum. All Precision Family Spirit participants are invited to complete qualitative interviews at study midpoint and endpoint. All home visitors are invited to participate in focus groups between study midpoint and endpoint. Exploratory data analysis will assess feasibility, acceptability, client-home visitor relationship, retention, adherence, and potential differences in intervention outcomes.
This trial will provide new information about the acceptability and feasibility of precision home visiting and pilot data on program satisfaction, client-home visitor relationship, goal alliance, retention, and targeted maternal-child intervention outcomes. Findings will inform the design of a fully powered randomized implementation trial of precision vs. standard home visiting.
ClinicalTrials.gov # NCT03975530 ; Registered on June 5, 2019.
家访是一种解决母婴健康差异问题的得到充分支持的策略。然而，基于证据的模式在大规模实施时通常面临共同的挑战，包括家庭的参与和留存。精准家访可能会解决这个问题。本文描述了首次已知的精准家访方法与标准实施方法的试点随机实施试验。主要目标是：1）探索精准家访方法的可接受性和可行性；2）研究标准家庭精神模式与精准家庭精神模式在参与者项目满意度、客户 - 家访员关系、目标联盟以及这些因素对参与者参与度和留存率的影响方面的差异。次要目标是探索在孕产妇行为和心理健康结果以及儿童发育结果方面的潜在差异，以为一项充分有力的研究进行样本量估计提供依据。
这是一项试点混合3型实施试验。四个主要服务于美国原住民家庭且已采用家庭精神模式的密歇根社区按地点随机分组，分别接受标准家庭精神模式或精准家庭精神模式。参与者包括60名年龄至少14岁（怀孕或有小于2个月新生儿）且目前已参加家庭精神模式的母亲。精准家庭精神模式的参与者除了接受核心课程外，还会根据基线时确定的需求以及试验期间出现的需求接受额外课程。对照组母亲接受家庭精神模式课程的标准顺序。在产后不到2个月、产后2个月、6个月和12个月时收集数据。所有精准家庭精神模式的参与者都被邀请在研究中期和终点完成定性访谈。所有家访员都被邀请在研究中期和终点之间参加焦点小组。探索性数据分析将评估可行性、可接受性、客户 - 家访员关系、留存率、依从性以及干预结果的潜在差异。
这项试验将提供有关精准家访的可接受性和可行性的新信息，以及关于项目满意度、客户 - 家访员关系、目标联盟、留存率和针对性母婴干预结果的试点数据。研究结果将为精准家访与标准家访的充分有力的随机实施试验的设计提供信息。
ClinicalTrials.gov # NCT03975530；于2019年6月5日注册。
