此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Digital Assessment of Well-being in New Parents (DAWN-P)

2022年4月29日 更新者:Emily Eisner

Digital Assessment of Well-being in New Parents (DAWN-P)

The mental health of new parents around the time of the birth of their baby has been identified as a key priority in the NHS (National Health Service) Long Term plan. At present, there is no nationally implemented method for monitoring parents' mental health, although the use of the Edinburgh Postnatal Depression Scale (EPDS) has been recommended. This is a paper based questionnaire administered by health visitors in the postnatal period. For the purposes of this project, the investigators contacted health visitors in Manchester to find out how they use EPDS in practice. Currently, health visitors only use the questionnaire if they feel there is a need during visits, and the questionnaire is not kept (only the overall score). Since almost 20% of mums develop postnatal depression, more systematic and thorough screening is needed.

The investigators developed an app version of the EPDS which takes less than 2 minutes to complete on a smartphone. It is anticpated that this will be a more accessible and practical method of conducting this important assessment. This project is a feasibility study to find out whether an app would be a feasible, acceptable, valid and safe way to monitor perinatal mental health in women and their partners.

The investigators aim to recruit 20 women and their partners in late pregnancy (after 36 weeks gestation) and ask them to use the app. The app will prompt completion of the EPDS once per day until 6 weeks postnatally. Participants' responses on the app will be transferred to a secure server at the University of Manchester. Participants will be invited to complete a paper version of the EPDS at the beginning and end of the study to check validity. They will also be asked to complete a questionnaire measuring the acceptability of the app and to take part in a brief qualitative interview at the end of the study.

研究概览

研究类型

观察性的

注册 (实际的)

23

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Greater Manchester
      • Manchester、Greater Manchester、英国、M13 9PL
        • University of Manchester

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.

描述

The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.

Inclusion criteria for pregnant women:

  • after 36 weeks gestation
  • aged over 18 years
  • fluent in English
  • under the care of Manchester University NHS Foundation Trust

Exclusion criteria for pregnant women:

  • current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)
  • fetal abnormality
  • multiple pregnancy

Inclusion criteria for partners:

  • male or female partners of a mum participating in the study
  • aged over 18
  • fluent in English.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Pregnant/postpartum women and their partners

The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital. Their partners will be invited to participate where applicable.

Inclusion and exclusion criteria for pregnant women are as follows:

  • Inclusion: after 36 weeks gestation, aged over 18 years and fluent in English, under the care of Manchester University NHS Foundation Trust
  • Exclusion: current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study), fetal abnormality, or multiple pregnancy

Inclusion criteria for partners: male or female partners of a mum participating in the study, aged over 18 and fluent in English.

No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
大体时间:36 weeks gestation until 6 weeks postpartum
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
36 weeks gestation until 6 weeks postpartum
Percentage of eligible individuals recruited to the study
大体时间:Baseline
Percentage of eligible individuals recruited to the study
Baseline
Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase
大体时间:36 weeks gestation until 6 weeks postpartum
Percentage of participants who consent to take part in the study dropping out during the app use phase
36 weeks gestation until 6 weeks postpartum
Percentage of participants completing at least a third of app-based assessments
大体时间:36 weeks gestation until 6 weeks postpartum
Percentage of participants completing at least a third of app-based assessments. The a priori "accept" criterion will be >33% data points completed
36 weeks gestation until 6 weeks postpartum
Percentage of participants completing at least half of app-based assessments
大体时间:36 weeks gestation until 6 weeks postpartum
Percentage of participants completing at least half of app-based assessments. The a priori target criterion will be 50% of participants submitting at least 50% of app-based assessments.
36 weeks gestation until 6 weeks postpartum

次要结果测量

结果测量
措施说明
大体时间
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
大体时间:6 weeks postpartum
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
6 weeks postpartum
abridged Mobile App Rating Scale
大体时间:6 weeks postpartum
abridged Mobile App Rating Scale score
6 weeks postpartum
Edinburgh Postnatal Depression Scale - app-based version
大体时间:36 weeks gestation until 6 weeks postpartum
Edinburgh Postnatal Depression Scale - app-based version
36 weeks gestation until 6 weeks postpartum
Edinburgh Postnatal Depression Scale - paper version
大体时间:36-37 weeks gestation; 5-6 weeks postpartum
Edinburgh Postnatal Depression Scale - paper version
36-37 weeks gestation; 5-6 weeks postpartum
Number of adverse events occurring during the app-use phase of the study
大体时间:36 weeks gestation until 6 weeks postpartum
Number of adverse events occurring during the app-use phase of the study
36 weeks gestation until 6 weeks postpartum
Qualitative interview data on participants' experience of using the app.
大体时间:6 weeks postpartum
Qualitative interview data on participants' experience of using the app.
6 weeks postpartum
Demographic questionnaire
大体时间:Baseline (36 weeks pregnant)
Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.
Baseline (36 weeks pregnant)
BMI (from casenotes)
大体时间:Baseline (36 weeks pregnant)
BMI (from casenotes)
Baseline (36 weeks pregnant)
past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
大体时间:Baseline (36 weeks pregnant)
past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
Baseline (36 weeks pregnant)
Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
大体时间:Baseline (36 weeks pregnant)
Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
Baseline (36 weeks pregnant)
Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
大体时间:Baseline (36 weeks pregnant)
Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
Baseline (36 weeks pregnant)
parity (total number of pregnancies reaching viable gestational age)
大体时间:Baseline (36 weeks pregnant)
parity (total number of pregnancies reaching viable gestational age)
Baseline (36 weeks pregnant)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年4月14日

初级完成 (实际的)

2020年9月9日

研究完成 (实际的)

2020年9月9日

研究注册日期

首次提交

2020年2月14日

首先提交符合 QC 标准的

2020年2月18日

首次发布 (实际的)

2020年2月20日

研究记录更新

最后更新发布 (实际的)

2022年5月2日

上次提交的符合 QC 标准的更新

2022年4月29日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Sharing of data beyond the research team will be on a per request basis; only that data which can be fully anonymised data will be shared.Qualitative data or full demographics will not be shared due to potential identifiability.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅