Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorInstitute for Human Development and Potential (IHDP), Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

21-50 years of age

Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment

Singleton pregnancy

Nulliparous

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group B (Intervention)

    Behavioral

    Participants in the intervention group will receive recommended modules in the mHealth app installed on their phones.

Treatment groups

572 Participants
are divided into 2 treatment groups
Group A: Group A (Control)No intervention 0 interventions
Group B: Group B (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Parents' Depressive Symptoms

Parents' level of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale.

Time frame
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. A composite outcome of the three postnatal EPDS measurements will be used as a primary outcome assessment

Secondary outcomes

1

Parents' emotional regulation skills

Examining self-reported parental emotional regulation skills using the Cognitive Emotion Regulation Questionnaire

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute for Human Development and Potential (IHDP), Singapore

Lead sponsor

Duke-NUS Graduate Medical School

Collaborator

National University of Singapore

Collaborator