Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression
Recruiting · NCT07594743 · Interventional (participants receive a specific treatment) · Lead sponsor: Women and Infants Hospital of Rhode Island
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Postpartum depression (PPD) occurs almost as often among men as it does among women. However, while there have been multiple programs designed to prevent maternal PPD, few, if any, interventions exist that have been created specifically to prevent paternal PPD. After engaging in evidence-based qualitative research with soon-to-be or new fathers, a novel interpersonal-therapy based digital program was created to prevent paternal PPD called Together in Parenting (TIP), which comprises multiple podcasts and digital educational handouts. The proposed pilot study will examine the feasibility and acceptability of using TIP as a paternal PPD intervention, will determine the optimal timing of administering TIP to future/new fathers, and will generate preliminary estimates of effect of the intervention to support a future efficacy study.
Who can take part
Inclusion criteria
- English-speaking (for now, TIP is only available in English)
- age \>18 years old,
- smartphone ownership or access to home internet,
- 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 ,
- planned delivery or status post delivery at WIHRI.
Exclusion criteria
- Any self-reported active diagnosis or history of mental health conditions including depression, anxiety, or other psychiatric condition, as per patient report;
- Endorsing active suicidality on intake survey or screening positive on the MDS (≥13)16 or GAD-7 (≥8) at time of enrollment;
- prisoners;
- infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;
- 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 is running
1 location listed across 1 US state.
- Women & Infants Hospital of Rhode Island - Providence, Rhode Island, United States