Связь до рождения: Мобильное приложение для будущих родителей впервые (B³)
Связь до рождения: Кластерное рандомизированное контролируемое исследование с использованием мобильного здравоохранения для развития осознанности и эмоциональной регуляции у будущих родителей
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Santhi Ponmudi, MPh
- Номер телефона: +65-64070100
- Электронная почта: santhi_ponmudi@a-star.edu.sg
Места учебы
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Singapore, Сингапур, 117609
- Рекрутинг
- Institute for Human Development and Potential (IHDP), Singapore
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Контакт:
- Santhi Ponmudi, MPh
- Номер телефона: +65-64070100
- Электронная почта: santhi_ponmudi@a-star.edu.sg
-
Главный следователь:
- Michelle Z.L Kee, PhD
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Главный следователь:
- Cornelia Y.I Chee, MBBS, MMed
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Главный следователь:
- Bibhas Chakraborty, PhD
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Младший исследователь:
- Xiaoxi Yan, PhD
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Младший исследователь:
- Evelyn C Law, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: 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. |
|
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Parents' Depressive Symptoms
Временное ограничение: 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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Parents' emotional regulation skills
Временное ограничение: 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.
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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.
|
Соавторы и исследователи
Следователи
- Главный следователь: Michelle Z.L Kee, PhD, Institute for Human Development and Potential
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-049
- H22P0M0001 (Другой номер гранта/финансирования: A*STAR Human Health and Potential Prenatal/Early Childhood Grant)
- H22P0M0009 (Другой номер гранта/финансирования: A*STAR Human Health and Potential Prenatal/Early Childhood Grant)
- NUHSRO/2025/082/NUSMed/024/B3 (Другой номер гранта/финансирования: National University of Singapore)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
The decision regarding the availability of individual participant data for sharing requires further discussions between the institutes.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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