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

NCT07742566 | Not Yet Recruiting

• 1 other identifier: 2277329-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Paternal Postpartum Depression; Postpartum Anxiety

Keywords

paternal postpartum depression; paternal postpartum anxiety; maternal postpartum depression; maternal postpartum anxiety; dyadic adjustment; postpartum stress

Outcome Measures

Primary Outcomes (2)

• Feasibility of Together in Parenting as a paternal mental health intervention

  Percentage of participants who view at least 6 of the 12 audio and video podcasts

  From randomization until 3 months postpartum

• Acceptability of Together in Parenting as paternal mental health intervention

  Client Satisfaction Questionnaire (8 item survey assessing satisfaction; scores range from 8-32 with higher scores indicating greater satisfaction)

  3 months postpartum

Secondary Outcomes (7)

• Feasibility: recruitment

  Prior to randomization

• Acceptability: System Usability Scale

  3 months postpartum

• Paternal postpartum depressive symptoms

  Six or twelve weeks postpartum

• Paternal postpartum anxiety symptoms

  Six or twelve weeks postpartum

• Paternal postpartum perceived stress

  Six or twelve weeks postpartum

Other Outcomes (7)

• Maternal parenting self-confidence

  3 months postpartum

• Qualitative

  3 months postpartum

• Paternal dyadic adjustment

  Six or twelve weeks postpartum

Study Arms (2)

Together in Parenting (intervention)

EXPERIMENTAL

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.

Behavioral: Together in Parenting

Treatment As Usual (routine care)

NO INTERVENTION

Routine care will be provided to those randomized to this group

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.

Together in Parenting (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• self-reported history of depression/anxiety or active depression/anxiety or screen positive on GAD-7 (8 or higher) or MDS (13 or higher)

You may not qualify if:

• Endorsing active suicidality on intake survey;
• prisoners;
• infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;
• inability to consent.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

Central Study Contacts

Stephanie Nunes, MS

CONTACT

401-274-1122; snunez@wihri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant will be randomized to routine care vs a digital intervention, so they will not be masked. However, those providing clinical care to participants, the entire investigative team (aside from the research assistant who enrolls randomized participants to the intervention) will be blinded, including the outcomes assessors and data analytic team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: For three years after publication of primary manuscript
• Access Criteria: Any investigator who desires the above IPD and supporting information can contact the study team and engage with the study PI, who will facilitate data transfer as word documents, excel files, or STATA databases as indicated.

Locations

US (1)