NCT07594743 · Women and Infants Hospital of Rhode Island
Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression
(TIP RCT)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Together in Parenting
Together in Parenting is an novel digital intervention that was designed specifically to prevent paternal postpartum depression and optimized via qualitative research with target end-users. The interpersonal therapy-based program contains four modules that include content on infant care and parenting education and a progressive, interactive interpersonal therapy-based curriculum. Each module contains four audio- and video-record podcasts that last 8-15 minutes, with most less than 10 minutes. In addition, TIP contains voluntary exercises to engage users with specific content after some podcast (there are 10 exercises in total). Those who complete all four modules and all will receive a digital certificate of completion.
Primary outcome measures
Feasibility of Together in Parenting as a paternal mental health intervention
Time frame: From randomization until 3 months postpartum
Percentage of participants who view at least 6 of the 12 audio and video podcasts
Acceptability of Together in Parenting as paternal postpartum depression prevention intervention
Time frame: 3 months postpartum
Client Satisfaction Questionnaire (8 item survey assessing satisfaction; scores range from 8-32 with higher scores indicating greater satisfaction)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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;
- 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
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations