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临床试验/NCT04929405
NCT04929405已完成不适用

Pilot-Testing a Theoretically Based Digital Intervention for Bereaved Parents (ADAPT)

East Carolina University4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
4
主要终点
Recruitment

研究概览

简要总结

Parental bereavement experiences are unique and require interventions adaptable to individual experiences.The web-based, multi-modal intervention, labeled ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). A quasi-experimental, treatment-only design will be used for this study. The hypothesis is that the ADAPT intervention will promote positive adaptation to influence grief integration and consequently affect health outcomes (improved sleep and social interactions, and decreased anxiety and depressive symptoms).The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes.

详细描述

ADAPT, is multi-modal intervention that promotes a targeted approach to individual parental bereavement experiences. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using weblink.

B. Study Purpose and Objective(s)

The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes. The Specific Aims are:

Aim 1: Assess the acceptability and feasibility of the ADAPT intervention components. Acceptability will be assessed with a modified standardized acceptability survey and cognitive interviews. Feasibility will be assessed by accrual (recruitment), attrition, and intervention engagement (i.e., frequency, duration, and interaction). Intervention engagement data will be obtained via Google analytics and cognitive interviews.

Hypothesis 1.1: ADAPT is acceptable to participants (> 80% acceptability based on survey).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biological parent and legal guardian of a deceased child who was 18 years old or younger at time of death
  • Cause of death of the deceased child is illness
  • Parent age 18 years or older at time of child's death
  • Ability to speak and read English sufficient to participate in the study

排除标准

  • Step-, foster-, grand- or fictive parent of a child who has died
  • Deceased child was unborn or over age 18 years at time of death
  • Deceased child was in legal custody of county or state jurisdiction
  • Cause of child's death was in utero or traumatic
  • Parent age less than 18 years
  • Inability to speak and read English sufficient to participate

结局指标

主要结局

Recruitment

时间窗: 3 months

Recruited 35 participants in the study timeframe

Retention

时间窗: 3 months

Participants complete surveys at pre and post intervention.

次要结局

  • Sleep(3 months)
  • Grief(3 months)
  • Social isolation(3 months)
  • Anxiety(3 months)
  • Depression(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Dias

Assistant Professor

East Carolina University

研究点 (4)

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