一种针对患有危及生命的慢性病儿童家长的新型叙事电子写作干预措施：一项试点、开放标签随机对照试验方案

A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial.

作者信息

Ho Andy Hau Yan, Dutta Oindrila, Tan-Ho Geraldine, Tan Toh Hsiang Benny, Low Xinyi Casuarine, Ganapathy Sashikumar, Car Josip, Ho Ringo Moon-Ho, Miao Chun Yan

机构信息

Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.

Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.

出版信息

JMIR Res Protoc. 2020 Jul 5;9(7):e17561. doi: 10.2196/17561.

DOI:10.2196/17561

PMID:32623367

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7380996/

Abstract

BACKGROUND

A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children.

OBJECTIVE

This study's aim was to provide an accessible platform, NeW-I-which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform-that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses.

METHODS

The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed.

RESULTS

Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing.

CONCLUSIONS

NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17561.

摘要

背景

一种新型的循证叙事电子写作干预措施（NeW-I）已在新加坡开发并进行了测试，以加强对患有危及生命的慢性病患儿家长的心理社会精神支持。NeW-I基于一项国际系统评价以及一项关于父母丧亲经历的新加坡定性调查，并得到了关于预期性悲伤干预措施的文献支持，这些文献旨在改善重症患儿家长照顾者的整体幸福感。

目的

本研究的目的是提供一个易于使用的平台NeW-I，它是一个以优势和意义为重点、由治疗师协助的移动应用程序和基于网络的咨询平台，旨在提高生活质量、精神幸福感、希望和感知到的社会支持，并减少患有危及生命的慢性病患儿家长的抑郁症状、照顾者负担和复杂性悲伤的风险。

方法

NeW-I由治疗师协助的基于网络的平台包括一个移动应用程序和一个网站（两者内容和功能相同）。NeW-I在新加坡作为一项开放性标签随机对照试验进行实施，包括干预组和对照组。主要和次要结局均由参与者通过问卷进行自我报告。与新加坡领先的儿科姑息治疗提供者合作，该试验旨在每组招募36名参与者（N = 72），以便在随访时考虑到30%的失访率，样本量将足以在主要结局指标中检测到0.2的小效应量，检验效能为90%，双侧显著性水平至少为0.05。将评估NeW-I的潜在有效性以及实施和提供该干预措施的可及性和可行性。