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Completed

NCT Number: NCT04279093

Digital Assessment of Well-being in New Parents

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention, but participants will use a smartphone app daily to complete the EPDS

Other

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

Primary outcomes

  1. Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase

    Time frame: 36 weeks gestation until 6 weeks postpartum

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

  2. Percentage of eligible individuals recruited to the study

    Time frame: Baseline

    Percentage of eligible individuals recruited to the study

  3. Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase

    Time frame: 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

  4. Percentage of participants completing at least a third of app-based assessments

    Time frame: 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

  5. Percentage of participants completing at least half of app-based assessments

    Time frame: 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.

Secondary outcomes

  1. Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app

    Time frame: 6 weeks postpartum

    Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app

  2. abridged Mobile App Rating Scale

    Time frame: 6 weeks postpartum

    abridged Mobile App Rating Scale score

  3. Edinburgh Postnatal Depression Scale - app-based version

    Time frame: 36 weeks gestation until 6 weeks postpartum

    Edinburgh Postnatal Depression Scale - app-based version

  4. Edinburgh Postnatal Depression Scale - paper version

    Time frame: 36-37 weeks gestation; 5-6 weeks postpartum

    Edinburgh Postnatal Depression Scale - paper version

  5. Number of adverse events occurring during the app-use phase of the study

    Time frame: 36 weeks gestation until 6 weeks postpartum

    Number of adverse events occurring during the app-use phase of the study

  6. Qualitative interview data on participants' experience of using the app.

    Time frame: 6 weeks postpartum

    Qualitative interview data on participants' experience of using the app.

  7. Demographic questionnaire

    Time frame: Baseline (36 weeks pregnant)

    Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.

  8. BMI (from casenotes)

    Time frame: Baseline (36 weeks pregnant)

    BMI (from casenotes)

  9. past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)

    Time frame: 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)

  10. Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)

    Time frame: Baseline (36 weeks pregnant)

    Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)

  11. Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)

    Time frame: Baseline (36 weeks pregnant)

    Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)

  12. parity (total number of pregnancies reaching viable gestational age)

    Time frame: Baseline (36 weeks pregnant)

    parity (total number of pregnancies reaching viable gestational age)

Sponsors and collaborators

Lead sponsor

Emily Eisner

Other

Collaborators

  • Manchester University NHS Foundation Trust

Registry information

Official study title

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

Acronym: DAWN-P

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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