Recruiting

Together in Parenting

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT07594743

Conditions

Paternal Postpartum Depression

Postpartum Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Together in Parenting

Study Details

Brief summary:

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.

Conditions

Paternal Postpartum Depression

Postpartum Anxiety

Study ID

NCT07594743

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Together in Parenting (intervention)

Password protected website that contains digital intervention, Together in Parenting (TIP). TIP delivers a progressive interpersonal therapy-based curriculum through a podcast format with interactive handouts.

no intervention: Treatment As Usual (routine care)

Routine care will be provided to those randomized to this group

Interventions

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 measure

  • Feasibility of Together in Parenting as a paternal mental health intervention [ Time Frame: From randomization until 3 months postpartum ]
  • Acceptability of Together in Parenting as paternal postpartum depression prevention intervention [ Time Frame: 3 months postpartum ]

Central Contacts and Locations

Central contacts

Locations

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • paternal postpartum depression
  • paternal postpartum anxiety
  • maternal postpartum depression
  • postpartum perceived stress
  • maternal postpartum anxiety
  • dyadic adjustment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2026-07-13.