Digital Assessment of Well-being in New Parents

Study Overview
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Brief Summary
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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.

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

Conditions
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Postnatal Depression

Intervention / Treatment
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* Other: No intervention, but participants will use a smartphone app daily to complete the EPDS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant/postpartum women and their partners<br>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<br>* No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital screening, mental health, smartphone app, postnatal depression, maternal mental health, paternal mental health