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NOT YET RECRUITING
NCT07742566
NA

Feasibility and Acceptability of a Novel Digital Intervention For Perinatal Men Who Have Depression or Anxiety

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

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. While screening for eligibility for an ongoing pilot feasibility trial (NCT07594743), 20% of those were ineligible because they either endorsed having depression or anxiety or screened positive on psychometric surveys for having moderate symptoms of these conditions. TThe proposed pilot study will examine the feasibility and acceptability of using TIP as an intervention for fathers who have mental health symptoms, and will generate preliminary estimates of effect of the intervention to support a future efficacy study.

Official title: Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Mental Health Intervention, For Fathers With Anxiety or Depression

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-09-01

Completion Date

2027-06-01

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Together in Parenting

Together in Parenting is an novel digital intervention that was designed specifically to improve paternal mental health symptoms and was 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.

Locations (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States