Bonding Before Birth: A mobile program to support first-time expectant couples

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-arm, cluster-randomized trial enrolls 286 expectant couples (572 individuals) and follows them from less than 20 weeks of pregnancy through the child’s first six months. Couples are assigned to either a weekly, 2-5 minute audio-based emotional regulation program or a control condition, with randomization by blocks of 10. The study uses weekly feedback and encouragement delivered via the app, and assesses depressive symptoms with the Edinburgh Postnatal Depression Scale and emotional regulation skills over time. Blinding is limited to operational staff; enrollment staff are kept unaware of the full randomization scheme to reduce bias. Outcomes include maternal and paternal mental health, parenting self-efficacy, and child-related early outcomes in a Singaporean setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Mothers:

1. 21-50 years of age
2. Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment
3. Singleton pregnancy
4. Nulliparous
5. Plan to deliver in Singapore
6. Proficient and able to respond to questionnaires in English
7. Intends for herself and her child to stay in Singapore for the next 2 years
8. Access to a smartphone
9. Willing to download the study app
10. Score of 7 or more in the Edinburgh Postnatal Depression Scale

Fathers:

1. 21-75 years of age
2. Proficient and able to respond to questionnaires in English
3. Intends for himself and his child to stay in Singapore for the next 2 years
4. Access to a smartphone
5. Willing to download the study app

Exclusion Criteria:

Mothers:

1. Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders
2. Currently on oral/IV steroids and/or thyroid medication
3. History of thyroid disease
4. Pregnant using assisted reproductive technologies
5. Multiple pregnancies
6. Currently enrolled in interventional randomised controlled trials
7. 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

Where it's running

• Institute for Human Development and Potential (IHDP), Singapore
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Michelle Z.L Kee, PhD — Institute for Human Development and Potential
• Study coordinator: Santhi Ponmudi, MPh
• Email: santhi_ponmudi@a-star.edu.sg
• Phone: +65-64070100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.