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

29 april 2022 uppdaterad 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.

Studieöversikt

Studietyp

Observationell

Inskrivning (Faktisk)

23

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.

No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 april 2020

Primärt slutförande (Faktisk)

9 september 2020

Avslutad studie (Faktisk)

9 september 2020

Studieregistreringsdatum

Först inskickad

14 februari 2020

Först inskickad som uppfyllde QC-kriterierna

18 februari 2020

Första postat (Faktisk)

20 februari 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Obeslutsam

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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Kliniska prövningar på Postnatal depression

3
Prenumerera