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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Greater Manchester
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Manchester, Greater Manchester, Verenigd Koninkrijk, M13 9PL
- University of Manchester
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 274007
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