Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

29. april 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

23

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • Greater Manchester
      • Manchester, Greater Manchester, Storbritannia, M13 9PL
        • University of Manchester

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: No intervention, but participants will use a smartphone app daily to complete the EPDS
No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
Tidsramme: 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
Tidsramme: 6 weeks postpartum
abridged Mobile App Rating Scale score
6 weeks postpartum
Edinburgh Postnatal Depression Scale - app-based version
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 6 weeks postpartum
Qualitative interview data on participants' experience of using the app.
6 weeks postpartum
Demographic questionnaire
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline (36 weeks pregnant)
parity (total number of pregnancies reaching viable gestational age)
Baseline (36 weeks pregnant)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Emily Eisner

Samarbeidspartnere

Manchester University NHS Foundation Trust

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. april 2020

Primær fullføring (Faktiske)

9. september 2020

Studiet fullført (Faktiske)

9. september 2020

Datoer for studieregistrering

Først innsendt

14. februar 2020

Først innsendt som oppfylte QC-kriteriene

18. februar 2020

Først lagt ut (Faktiske)

20. februar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 274007

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere