Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

29 avril 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

23

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Royaume-Uni
    • Greater Manchester
      • Manchester, Greater Manchester, Royaume-Uni, M13 9PL
        • University of Manchester

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Emily Eisner

Collaborateurs

Manchester University NHS Foundation Trust

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 avril 2020

Achèvement primaire (Réel)

9 septembre 2020

Achèvement de l'étude (Réel)

9 septembre 2020

Dates d'inscription aux études

Première soumission

14 février 2020

Première soumission répondant aux critères de contrôle qualité

18 février 2020

Première publication (Réel)

20 février 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2022

Dernière vérification

1 avril 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 274007

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Indécis

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Dépression postnatale

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Mauritius

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner