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

NCT07483515 | Recruiting DMC

• 4 other identifiers: 2026-049H22P0M0001H22P0M0009NUHSRO/2025/082/NUSMed/024/B3
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Pregnancy; Parenting Self-efficacy; Stress (Psychology); Depression; Emotion Regulation

Keywords

Reinforcement Learning; Micro-randomization; Emotion Regulation; Depression; Pregnancy; Anxiety

Outcome Measures

Primary Outcomes (1)

• Parents' Depressive Symptoms

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

Secondary Outcomes (1)

• Parents' emotional regulation skills

  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.

Study Arms (2)

Group A (Control)

NO INTERVENTION

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.

Group B (Intervention)

EXPERIMENTAL

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.

Behavioral: Group B (Intervention)

Interventions

Group B (Intervention) BEHAVIORAL

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

Group B (Intervention)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers:
• 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:
• 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

You may not qualify if:

• 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:
• \. Currently enrolled in interventional randomised controlled trials

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• Duke-NUS Graduate Medical School: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Institute for Human Development and Potential (IHDP), Singapore

Singapore, 117609, Singapore

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Emotional Regulation

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Michelle Z.L Kee, PhD

  Institute for Human Development and Potential

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santhi Ponmudi, MPh

CONTACT

+65-64070100; santhi_ponmudi@a-star.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware of their group allocation (intervention or control). 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Scientist

Model Details: This is a parallel, 2-arm, single-centre, cluster-randomized control trial. Eligible expectant couples will be randomized at baseline to either Group 1 (Intervention group) or Group 2 (Control group) based on 1:1 allocation ratio. Participants will received the assigned intervention from baseline until the birth of their child. All participants will be followed up until 6 months after the birth of their child. The mHealth app will be installed on the phones of subjects in both Groups, but only those in Group 1 (Intervention group) will have access ot the intervention components. Each couple in Group 1 will receive randomized intervention components (delivery of self, focus, relationship, or sleep-themed app modules).

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

SG (1)