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Digital Assessment of Well-being in New Parents

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04279093
Acronym
DAWN-P
Enrollment
23
Registered
2020-02-20
Start date
2020-04-14
Completion date
2020-09-09
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal Depression

Keywords

digital screening, mental health, smartphone app, postnatal depression, maternal mental health, paternal mental health

Brief summary

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.

Interventions

OTHERNo 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

Sponsors

Manchester University NHS Foundation Trust
CollaboratorOTHER_GOV
Emily Eisner
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase36 weeks gestation until 6 weeks postpartumPercentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Percentage of eligible individuals recruited to the studyBaselinePercentage of eligible individuals recruited to the study
Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase36 weeks gestation until 6 weeks postpartumPercentage of participants who consent to take part in the study dropping out during the app use phase
Percentage of participants completing at least a third of app-based assessments36 weeks gestation until 6 weeks postpartumPercentage of participants completing at least a third of app-based assessments. The a priori accept criterion will be \>33% data points completed
Percentage of participants completing at least half of app-based assessments36 weeks gestation until 6 weeks postpartumPercentage 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

MeasureTime frameDescription
Qualitative interview data on participants' experience of using the app.6 weeks postpartumQualitative interview data on participants' experience of using the app.
Demographic questionnaireBaseline (36 weeks pregnant)Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.
BMI (from casenotes)Baseline (36 weeks pregnant)BMI (from casenotes)
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app6 weeks postpartumTranscripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)Baseline (36 weeks pregnant)Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)Baseline (36 weeks pregnant)Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
parity (total number of pregnancies reaching viable gestational age)Baseline (36 weeks pregnant)parity (total number of pregnancies reaching viable gestational age)
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)past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
abridged Mobile App Rating Scale6 weeks postpartumabridged Mobile App Rating Scale score
Edinburgh Postnatal Depression Scale - app-based version36 weeks gestation until 6 weeks postpartumEdinburgh Postnatal Depression Scale - app-based version
Edinburgh Postnatal Depression Scale - paper version36-37 weeks gestation; 5-6 weeks postpartumEdinburgh Postnatal Depression Scale - paper version
Number of adverse events occurring during the app-use phase of the study36 weeks gestation until 6 weeks postpartumNumber of adverse events occurring during the app-use phase of the study

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026