A digital program to help new fathers see if they can prevent paternal postpartum depression

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 interventional pilot study will adapt an interpersonal-therapy–based digital program for new fathers, delivering podcasts and educational handouts. It aims to determine feasibility and acceptability, identify the best timing for delivery to expectant or new fathers, and generate preliminary estimates of effect to inform a future efficacy trial. Eligible participants are English-speaking men over 18 with access to a smartphone or the internet who have a partner or infant receiving care at Women & Infants Hospital of Rhode Island. The study will monitor safety and use patient-reported measures to gauge mood symptoms and perceived stress. The lead site is Women and Infants Hospital of Rhode Island, with participation limited to that institution at this time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. English-speaking (for now, TIP is only available in English)
2. age \>18 years old,
3. smartphone ownership or access to home internet,
4. partner or patient received or receiving prenatal care from a resident or nurse-practitioner/midwifery clinic at the Obstetrics and Gynecologic Care Center (OGCC) at Women \& Infants Hospital of Rhode Island (WIHRI) or receiving an ultrasound at the WIHRI's Prenatal Diagnosis Center ,
5. planned delivery or status post delivery at WIHRI.

Exclusion Criteria:

1. Any self-reported active diagnosis or history of mental health conditions including depression, anxiety, or other psychiatric condition, as per patient report;
2. Endorsing active suicidality on intake survey or screening positive on the MDS (≥13)16 or GAD-7 (≥8) at time of enrollment;
3. prisoners;
4. infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;
5. inability to consent. If new results on the MDS or GAD-7 indicate a positive screening or the father's infant(s) is diagnosed with a genetic abnormality, significant anatomic malformation, or NICU admission after the enrollment and randomization period, the father will still be eligible to continue participation in the study. This information will be tracked in the REDCap database.

Where it's running

• Women & Infants Hospital of Rhode Island
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: Stephanie Nunez, MS
• Email: snunez@wihri.org
• Phone: 401-274-1122

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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.