Digital Assessment of Well-being in New Parents (DAWN-P)
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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Greater Manchester
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Manchester、Greater Manchester、イギリス、M13 9PL
- University of Manchester
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
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 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
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
時間枠:36 weeks gestation until 6 weeks postpartum
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Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
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36 weeks gestation until 6 weeks postpartum
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Percentage of eligible individuals recruited to the study
時間枠:Baseline
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Percentage of eligible individuals recruited to the study
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Baseline
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Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase
時間枠:36 weeks gestation until 6 weeks postpartum
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Percentage of participants who consent to take part in the study dropping out during the app use phase
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36 weeks gestation until 6 weeks postpartum
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Percentage of participants completing at least a third of app-based assessments
時間枠:36 weeks gestation until 6 weeks postpartum
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Percentage of participants completing at least a third of app-based assessments.
The a priori "accept" criterion will be >33% data points completed
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36 weeks gestation until 6 weeks postpartum
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Percentage of participants completing at least half of app-based assessments
時間枠:36 weeks gestation until 6 weeks postpartum
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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.
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36 weeks gestation until 6 weeks postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
時間枠:6 weeks postpartum
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Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
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6 weeks postpartum
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abridged Mobile App Rating Scale
時間枠:6 weeks postpartum
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abridged Mobile App Rating Scale score
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6 weeks postpartum
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Edinburgh Postnatal Depression Scale - app-based version
時間枠:36 weeks gestation until 6 weeks postpartum
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Edinburgh Postnatal Depression Scale - app-based version
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36 weeks gestation until 6 weeks postpartum
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Edinburgh Postnatal Depression Scale - paper version
時間枠:36-37 weeks gestation; 5-6 weeks postpartum
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Edinburgh Postnatal Depression Scale - paper version
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36-37 weeks gestation; 5-6 weeks postpartum
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Number of adverse events occurring during the app-use phase of the study
時間枠:36 weeks gestation until 6 weeks postpartum
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Number of adverse events occurring during the app-use phase of the study
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36 weeks gestation until 6 weeks postpartum
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Qualitative interview data on participants' experience of using the app.
時間枠:6 weeks postpartum
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Qualitative interview data on participants' experience of using the app.
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6 weeks postpartum
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Demographic questionnaire
時間枠:Baseline (36 weeks pregnant)
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Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g.
age, gender, employment status.
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Baseline (36 weeks pregnant)
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BMI (from casenotes)
時間枠:Baseline (36 weeks pregnant)
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BMI (from casenotes)
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Baseline (36 weeks pregnant)
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past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
時間枠:Baseline (36 weeks pregnant)
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past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
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Baseline (36 weeks pregnant)
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Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
時間枠:Baseline (36 weeks pregnant)
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Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
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Baseline (36 weeks pregnant)
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Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
時間枠:Baseline (36 weeks pregnant)
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Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
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Baseline (36 weeks pregnant)
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parity (total number of pregnancies reaching viable gestational age)
時間枠:Baseline (36 weeks pregnant)
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parity (total number of pregnancies reaching viable gestational age)
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Baseline (36 weeks pregnant)
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 274007
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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