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一种用于提高母亲敏感性的群组视频会议干预措施(C@nnected):一项随机可行性试验方案。

A Group Videoconferencing Intervention (C@nnected) to Improve Maternal Sensitivity: Protocol for a Randomized Feasibility Trial.

作者信息

Binda Victoria, Olhaberry Marcia, Castañon Carla, Abarca Constanza, Caamaño Catalina

机构信息

Deparment of Family Medicine, Medicine Faculty, Pontificia Universidad Católica de Chile, Santiago, Chile.

School of Psychology, Social Sciences Faculty, Pontificia Universidad Católica de Chile, Santiago, Chile.

出版信息

JMIR Res Protoc. 2022 Aug 15;11(8):e35881. doi: 10.2196/35881.

Abstract

BACKGROUND

Early childhood development is highly dependent on the sensitive care provided by caregivers, and interventions focused on supporting parents to improve their sensitivity have shown to be effective. The COVID-19 pandemic has had a significant impact on mental health, with pregnant women and mothers of infants being an especially vulnerable group and maternal sensitivity particularly affected. However, access to face-to-face interventions is restricted; thus, it is important to have remote interventions to support this group of mothers.

OBJECTIVE

The objective of this study is to evaluate the feasibility and acceptability of C@nnected, a group videoconferencing intervention to improve maternal sensitivity aimed at mother-infant dyads attending primary health care centers in vulnerable areas of Santiago, Chile.

METHODS

This is a randomized feasibility single-masked (outcome assessor) study with a qualitative component. It will involve a block randomization procedure to generate a 3:2 allocation ratio (with more people allocated to the intervention arm). The intervention consists of 4 group videoconferencing sessions adapted from a face-to-face intervention with proven effectiveness. The control group will receive treatment as usual, along with educational brochures. The feasibility and acceptability of this study will be quantitatively and qualitatively assessed. Changes in clinical outcomes relating to maternal sensitivity, depressive symptoms, postpartum maternal attachment, and infant socioemotional development will also be evaluated.

RESULTS

We finished adapting the face-to-face intervention to the videoconferencing format in July 2021. The study began recruitment in August 2021, and enrollment is expected to end in August 2022, with final study results expected in December 2022.

CONCLUSIONS

This study will contribute evidence for the use of eHealth interventions to promote maternal sensitivity. It will also inform the design and implementation of a future randomized clinical trial.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04904861; https://clinicaltrials.gov/ct2/show/NCT04904861.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35881.

摘要

背景

幼儿发展高度依赖于照顾者提供的敏感照料,而专注于支持父母提高其敏感性的干预措施已被证明是有效的。新冠疫情对心理健康产生了重大影响,孕妇和婴儿母亲是特别脆弱的群体,母亲的敏感性尤其受到影响。然而,面对面干预的机会受到限制;因此,开展远程干预以支持这组母亲非常重要。

目的

本研究的目的是评估C@nnected的可行性和可接受性,C@nnected是一种通过群组视频会议进行的干预措施,旨在提高智利圣地亚哥脆弱地区初级卫生保健中心母婴二元组中母亲的敏感性。

方法

这是一项带有定性成分的随机可行性单盲(结果评估者)研究。将采用区组随机化程序,生成3:2的分配比例(更多人分配到干预组)。干预包括4次群组视频会议,改编自一项已证实有效的面对面干预。对照组将接受常规治疗以及教育手册。将对本研究的可行性和可接受性进行定量和定性评估。还将评估与母亲敏感性、抑郁症状、产后母婴依恋以及婴儿社会情感发展相关的临床结局变化。

结果

我们于2021年7月完成了将面对面干预改编为视频会议形式的工作。该研究于2021年8月开始招募,预计招募工作将于2022年8月结束,最终研究结果预计于2022年12月得出。

结论

本研究将为使用电子健康干预措施促进母亲敏感性提供证据。它还将为未来随机临床试验的设计和实施提供信息。

试验注册

ClinicalTrials.gov NCT04904861;https://clinicaltrials.gov/ct2/show/NCT04904861。

国际注册报告识别码(IRRID):DERR1-10.2196/35881。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7825/9425171/bea96e803675/resprot_v11i8e35881_fig1.jpg

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