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.

Study Overview

• Status: Completed
• Conditions: Postnatal Depression
• Intervention / Treatment: Other: No intervention, but participants will use a smartphone app daily to complete the EPDS

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9PL
      • University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app	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	abridged Mobile App Rating Scale score	6 weeks postpartum
Edinburgh Postnatal Depression Scale - app-based version	Edinburgh Postnatal Depression Scale - app-based version	36 weeks gestation until 6 weeks postpartum
Edinburgh Postnatal Depression Scale - paper version	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	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.	Qualitative interview data on participants' experience of using the app.	6 weeks postpartum
Demographic questionnaire	Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.	Baseline (36 weeks pregnant)
BMI (from casenotes)	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)	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)	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)	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)	parity (total number of pregnancies reaching viable gestational age)	Baseline (36 weeks pregnant)

Collaborators and Investigators

• Sponsor: Emily Eisner
• Collaborators: Manchester University NHS Foundation Trust

Publications and helpful links

General Publications

• Eisner E, Lewis S, Stockton-Powdrell C, Agass R, Whelan P, Tower C. Digital screening for postnatal depression: mixed methods proof-of-concept study. BMC Pregnancy Childbirth. 2022 May 23;22(1):429. doi: 10.1186/s12884-022-04756-2.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: mental health; maternal mental health; smartphone app; postnatal depression; digital screening; paternal mental health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression; Depression, Postpartum
• Other Study ID Numbers: 274007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No