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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Greater Manchester
-
Manchester, Greater Manchester, Spojené království, M13 9PL
- University of Manchester
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
Časové okno: 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
Časové okno: 6 weeks postpartum
|
abridged Mobile App Rating Scale score
|
6 weeks postpartum
|
|
Edinburgh Postnatal Depression Scale - app-based version
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 6 weeks postpartum
|
Qualitative interview data on participants' experience of using the app.
|
6 weeks postpartum
|
|
Demographic questionnaire
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline (36 weeks pregnant)
|
parity (total number of pregnancies reaching viable gestational age)
|
Baseline (36 weeks pregnant)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 274007
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .