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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT07742566
Status
Not Yet Recruiting

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Conditions

  • Paternal Postpartum Depression
  • Postpartum Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Together in Parenting — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women & Infants Hospital of Rhode IslandProvidenceRhode Island02903-

Find similar trials in Providence, RI

By research site
Women & Infants Hospital of Rhode Island· Providence, RI

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