一项混合型 I 类随机对照试验方案,评估针对青少年怀孕的护士家访计划对母婴结局的有效性和实施情况。

Protocol for a hybrid type I randomized controlled trial evaluating the effectiveness and implementation of a nurse home visiting program for adolescent pregnancy on maternal and infant outcomes.

作者信息

Becker Natália, Soares Vinícius Nagy, Chou Débora Tseng, Neto Emilio Abelama, da Silva Letícia Aparecida, Osório Ana Alexandra Caldas, Nascimento Ariana Gomes, Marchisio Vinnie, Menegócio Alexandro Marcos, Pereira Adriana Tebaldi, Haas Andrea Bernardinetti Muller, Pina-Oliveira Alfredo Almeida, Miguel Eurípedes Constantino, Menezes Paulo Rossi, Caye Arthur, Fracolli Lislaine Aparecida

机构信息

National Center for Research and Innovation in Mental Health (CISM), São Paulo, Brazil.

Graduate Program on Human Developmental Sciences, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil.

出版信息

Front Psychiatry. 2025 Aug 7;16:1576428. doi: 10.3389/fpsyt.2025.1576428. eCollection 2025.

Abstract

BACKGROUND

Adolescent pregnancy poses significant public health challenges, particularly among vulnerable populations. Nurse home visiting programs, such as , show promise in improving maternal and child health outcomes, yet their integration into primary healthcare remains underexplored, especially in low-resource settings.

AIM

to evaluate the effectiveness and feasibility of integrating into primary healthcare services across two municipalities of the state of São Paulo, Brazil.

METHOD

A hybrid type I randomized controlled trial will be conducted to assess both the clinical effectiveness and implementation feasibility of the program. The study will enroll 200 pregnant adolescents (aged 14-24), who will be randomized into two groups: an intervention group, receiving up to 38 structured nurse home visits from pregnancy until the child's 24th month, and a control group, receiving standard care. The home visits will focus on promoting maternal and child health, positive parenting practices, and secure mother-infant attachment. Data collection will include validated tools to assess maternal mental health (Alcohol, Smoking, and Substance Involvement Screening Test - ASSIST, Edinburgh Postnatal Depression Scale - EPDS, Tilburg Pregnancy Distress Scale - TPDS, and Generalized Anxiety Disorder-7 - GAD-7), infant development (Infant Behavior Questionnaire - Revised - IBQ-R, Bayley Scales of Infant and Toddler Development - Bayley-III, and Ages and Stages Questionnaire - ASQ-3), mother-infant interactions (Ainsworth's Maternal Sensitivity Scales, and Maternal Postnatal Attachment Scale), and the quality of the home environment (Infant/Toddler Home Observation for Measurement of the Environment - IT-HOME). Implementation outcomes will be evaluated using the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, semi-structured interviews with key stakeholders (e.g., healthcare providers, program staff, and participants), and the Program Sustainability Assessment Tool to identify factors influencing long-term program viability. Quantitative data will be analyzed using an intention-to-treat approach, while qualitative data will undergo thematic analysis to identify barriers and facilitators to program integration.

EXPECTED RESULTS

The intervention is hypothesized to improve maternal and infant outcomes, such as prenatal care adherence, breastfeeding rates, and cognitive and emotional development, while fostering positive parenting practices and secure mother-infant attachment. The implementation analysis will identify key barriers and facilitators to program integration.

IMPACT

This study will provide evidence on the clinical and practical benefits of nurse home visiting programs for adolescent pregnancy in primary care, guiding their integration, scale-up, and potential adaptation for global maternal and child health initiatives. The findings aim to inform policymakers and healthcare providers on effective strategies to address adolescent pregnancy and improve health outcomes in low-resource settings.

摘要

背景

青少年怀孕带来了重大的公共卫生挑战,在弱势群体中尤为如此。诸如[具体项目名称未给出]之类的护士家访计划在改善母婴健康结局方面显示出前景,但它们融入初级医疗保健的情况仍未得到充分探索,尤其是在资源匮乏的环境中。

目的

评估在巴西圣保罗州的两个城市将[具体项目名称未给出]融入初级医疗保健服务的有效性和可行性。

方法

将进行一项混合型I随机对照试验,以评估该计划的临床有效性和实施可行性。该研究将招募200名怀孕青少年(年龄在14 - 24岁之间),他们将被随机分为两组:干预组,从怀孕到孩子24个月时接受多达38次结构化护士家访;对照组,接受标准护理。家访将侧重于促进母婴健康、积极的育儿实践以及稳固的母婴依恋关系。数据收集将包括用于评估产妇心理健康的经过验证的工具(酒精、吸烟和物质使用筛查测试 - ASSIST、爱丁堡产后抑郁量表 - EPDS、蒂尔堡孕期困扰量表 - TPDS和广泛性焦虑障碍量表 - GAD - 7)、婴儿发育(修订版婴儿行为问卷 - IBQ - R、贝利婴幼儿发展量表 - 贝利III和年龄与阶段问卷 - ASQ - 3)、母婴互动(安斯沃思母婴敏感性量表和产后母婴依恋量表)以及家庭环境质量(婴儿/幼儿家庭环境测量观察 - IT - HOME)。将使用EPIS(探索、准备、实施、维持)框架、与关键利益相关者(如医疗保健提供者、项目工作人员和参与者)的半结构化访谈以及项目可持续性评估工具来评估实施结果,以确定影响项目长期可行性的因素。定量数据将采用意向性分析方法进行分析,而定性数据将进行主题分析,以确定项目整合的障碍和促进因素。

预期结果

假设干预措施能改善母婴结局,如产前护理依从性、母乳喂养率以及认知和情感发育,同时促进积极的育儿实践和稳固的母婴依恋关系。实施分析将确定项目整合的关键障碍和促进因素。

影响

本研究将为护士家访计划在初级保健中对青少年怀孕的临床和实际益处提供证据,指导其整合、扩大规模以及可能对全球母婴健康倡议的调整。研究结果旨在为政策制定者和医疗保健提供者提供有关在资源匮乏环境中应对青少年怀孕并改善健康结局的有效策略的信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4d0f/12367722/9a4d284c53c8/fpsyt-16-1576428-g001.jpg

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