Lien avant la naissance : Une intervention mHealth pour les futurs parents primipares (B³)
Bonding Before Birth : un essai contrôlé en grappes et randomisé utilisant la santé mobile pour développer la pleine conscience et la régulation émotionnelle chez les couples en attente
Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms.
This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.
Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.
Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The overall goal of this study is to answer the following main questions:
- Does the intervention improve parents' depressive symptoms scores, using the Edinburgh Postnatal Depression Scale as a proxy?
- Does the intervention improve parents' emotional regulation skills?
The study involves 286 expectant couples (572 individuals) in a two-arm, cluster-randomized controlled trial with longitudinal observational follow-up until the child turns 6 months old. The active intervention comprises of customized, weekly recommendations of short (2-5 minute) audio clips featuring activities such as breathing exercises, meditation, mindful walking. These will be provided to adult participants (expectant couples). Couples enrolling in the study will randomly be allocated to either the control or intervention group by prespecified block sizes of 10. That is, a random number generator will be used to preset the assignments in groups of 10, such that every 10 consecutive enrolments will have exactly 5 controls and 5 interventions (1:1 allocation). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm.
Participants in the control, no-intervention group will have access to a mobile app with similar functions as the participants in the intervention group, except that no personalized modules are given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
Participants in the intervention group will have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Participants will also be re-randomized weekly to different modules within the app. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
The intervention will take place throughout pregnancy, beginning at enrollment ( when the mother is less than 20 gestational weeks of pregnancy), and continuing until the child is born. As gestational duration varies among participants, the total intervention period will range approximately from 17 to 28 weeks, depending on the timing of recruitment and delivery. All study arms will be assessed up to 6 months after birth.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Santhi Ponmudi, MPh
- Numéro de téléphone: +65-64070100
- E-mail: santhi_ponmudi@a-star.edu.sg
Lieux d'étude
-
-
-
Singapore, Singapour, 117609
- Recrutement
- Institute for Human Development and Potential (IHDP), Singapore
-
Contact:
- Santhi Ponmudi, MPh
- Numéro de téléphone: +65-64070100
- E-mail: santhi_ponmudi@a-star.edu.sg
-
Chercheur principal:
- Michelle Z.L Kee, PhD
-
Chercheur principal:
- Cornelia Y.I Chee, MBBS, MMed
-
Chercheur principal:
- Bibhas Chakraborty, PhD
-
Sous-enquêteur:
- Xiaoxi Yan, PhD
-
Sous-enquêteur:
- Evelyn C Law, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Mothers:
- 21-50 years of age
- Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment
- Singleton pregnancy
- Nulliparous
- Plan to deliver in Singapore
- Proficient and able to respond to questionnaires in English
- Intends for herself and her child to stay in Singapore for the next 2 years
- Access to a smartphone
- Willing to download the study app
- Score of 7 or more in the Edinburgh Postnatal Depression Scale
Fathers:
- 21-75 years of age
- Proficient and able to respond to questionnaires in English
- Intends for himself and his child to stay in Singapore for the next 2 years
- Access to a smartphone
- Willing to download the study app
Exclusion Criteria:
Mothers:
- Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders
- Currently on oral/IV steroids and/or thyroid medication
- History of thyroid disease
- Pregnant using assisted reproductive technologies
- Multiple pregnancies
- Currently enrolled in interventional randomised controlled trials
- Responded "Yes, quite often" to EPDS item 10 ("The thought of harming myself has occurred to me")
Fathers:
1. Currently enrolled in interventional randomised controlled trials
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Group A (Control)
Participants' will have access to a mobile app with similar functions as the participants in the intervention group, except that there are no personalized modules given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
|
|
Expérimental: Group B (Intervention)
Participants have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
Participants in the intervention group will receive recommended modules in the mHealth app installed on their phones. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parents' Depressive Symptoms
Délai: Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. The average of the three postnatal EPDS measurements will be used as the primary outcome assessment
|
Parents' level of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale. |
Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. The average of the three postnatal EPDS measurements will be used as the primary outcome assessment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parents' emotional regulation skills
Délai: Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months.
|
Examining self-reported parental emotional regulation skills using the Cognitive Emotion Regulation Questionnaire |
Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months.
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Michelle Z.L Kee, PhD, Institute for Human Development and Potential
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-049
- H22P0M0001 (Autre subvention/numéro de financement: A*STAR Human Health and Potential Prenatal/Early Childhood Grant)
- H22P0M0009 (Autre subvention/numéro de financement: A*STAR Human Health and Potential Prenatal/Early Childhood Grant)
- NUHSRO/2025/082/NUSMed/024/B3 (Autre subvention/numéro de financement: National University of Singapore)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The decision regarding the availability of individual participant data for sharing requires further discussions between the institutes.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .