Digital Assessment of Well-being in New Parents (DAWN-P)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase
时间窗: 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
Percentage of participants completing at least half of app-based assessments
时间窗: 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.
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
时间窗: 36 weeks gestation until 6 weeks postpartum
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Percentage of participants completing at least a third of app-based assessments
时间窗: 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
Percentage of eligible individuals recruited to the study
时间窗: Baseline
Percentage of eligible individuals recruited to the study
次要结局
- abridged Mobile App Rating Scale(6 weeks postpartum)
- 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)(Baseline (36 weeks pregnant))
- Qualitative interview data on participants' experience of using the app.(6 weeks postpartum)
- Demographic questionnaire(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)(Baseline (36 weeks pregnant))
- Edinburgh Postnatal Depression Scale - app-based version(36 weeks gestation until 6 weeks postpartum)
- Edinburgh Postnatal Depression Scale - paper version(36-37 weeks gestation; 5-6 weeks postpartum)
- BMI (from casenotes)(Baseline (36 weeks pregnant))
- Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app(6 weeks postpartum)
- Number of adverse events occurring during the app-use phase of the study(36 weeks gestation until 6 weeks postpartum)
研究者
Emily Eisner
Research Associate
Manchester Academic Health Science Centre