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临床试验/NCT04600076
NCT04600076已完成不适用

MOMSonLINE2:A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers

University of Michigan2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年11月20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
2
主要终点
Percentage of Participants Approached for Enrollment Who Signed up for the Study

研究概览

简要总结

This is a 6-week pilot study to see how research participants feel about an internet support site after a stillbirth or infant death. Losing a baby through stillbirth or early infant death is typically devastating for families. However, investigators do not know if internet on-line support for parents helps manage grief more easily.

In addition to using the BabyCenter.com website, participants will be asked to complete online surveys at the beginning and the end of the study, as well partake in an interview.

Data from this pilot study will help develop a much larger randomized control study of on-line support outcomes after perinatal loss.

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
Female
接受健康志愿者

入选标准

  • Michigan residence and infant delivery
  • Non-Caucasian race and/or Hispanic ethnicity
  • Read/speak English
  • Gave birth to a stillborn baby or had an infant death in the first 28 days of life
  • Did not give the baby up for adoption pre-loss
  • Internet access

排除标准

  • Don't Read/speak English

结局指标

主要结局

Percentage of Participants Approached for Enrollment Who Signed up for the Study

时间窗: 6 months

Feasibility of recruitment as shown by percent of those approached for enrollment who signed up for the study.

Feasibility: Retention

时间窗: 6 weeks

Number of participants that completed: * The 6 week intervention. * Pre-post surveys. * Phone interview

次要结局

  • Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)(Pre intervention (day 0), Post intervention (6 weeks))
  • Change in Post-traumatic Stress Disorder (PTSD)(Pre intervention (day 0), Post intervention (6 weeks))
  • Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7)(Pre intervention (day 0), Post intervention (6 weeks))
  • Change in Grief Based on the Perinatal Grief Scale(Pre intervention (day 0), Post intervention (6 weeks))

研究者

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

Katherine Gold

Associate Professor of Family Medicine and Associate Professor of Obstetrics and Gynecology

University of Michigan

研究点 (2)

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