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Paternal Postpartum DepressionTIP RCTNCT07594743

Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression

A study testing Together in Parenting in people with Paternal Postpartum Depression and Postpartum Anxiety, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Together in Parenting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
7 Jul 2026to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • prisoners;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stephanie Nunez, MS contact

401-274-1122

snunez@wihri.org

United States1 site, 1 recruiting
  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02903

    Stephanie Nunez, BS, 401-274-1122, snunez@wihri.org

    Recruiting

Other trials in United States

About this study

Official title: Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Postpartum Depression Prevention Intervention

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.

Read the detailed description

Postpartum depression (PPD) PPD affects 10-15% of women and 8-10% of men. Despite the similar prevalence, the United States Preventive Services Task Force (USPSTF) endorses psychotherapy approaches to prevent PPD for mothers, but no stand-alone preventive interventions specifically targeting paternal PPD exist. Primary paternal PPD prevention is crucial because paternal PPD is underdiagnosed and undertreated. It is hard to identify fathers who have PPD because PPD symptoms affect fathers differently than mothers due to cultural conceptions of masculinity, leading to the risk that fathers do not recognize their symptoms as PPD and engage in avoidant or numbing behavior instead of PPD treatment. Even if they recognize their PPD, men are less likely than women to pursue help due to the stigma of mental health care, resulting in delays in PTD diagnosis and treatment. Furthermore, the American Psychological Association recommends altering depression treatment to patient demographics because the efficacy of psychological interventions varies by patient factors. Since there is no psychotherapy for paternal PPD, the most common non-pharmacological treatment strategy for paternal PPD is to provide fathers with maternal PPD therapy, which likely reduces its effectiveness. Fathers' lack of awareness and aversion to treatment leads to untreated PPD, which drastically increases risk of PPD for mothers and impaired cognitive development for children. Given the barriers fathers face being diagnosed with PPD and the lack of tailored treatment, a targeted intervention for fathers that effectively prevents paternal PPD is urgently needed to prevent maternal PPD and decrease the risk of profound intergenerational consequences for fathers, mothers, and infants.

Interpersonal therapy (IPT) is an evidence-based psychotherapy approach for depression that views relationship attachments, effective communication, and disruption in social support as intimately linked with psychological symptoms. In 2019, the USPSTF's maternal PPD statement indicated IPT prevents maternal PPD. IPT may be even more suitable for paternal PPD prevention: fathers have been shown to prefer psychology over pharmacotherapy for PPD. In fact, IPT-based counseling has mechanistic plausibility to prevent paternal PPD: by helping fathers improve communication within their relationships, change expectations about those relationships, and/or build or better utilize an extended social support network, IPT can help fathers develop the interpersonal support needed to deal with the crises precipitating depressive symptoms (birth or infant care).

Online interventions reduce the stigma associated with mental health care, are widely utilized by men, and reduce depressive symptoms. Online peripartum mental health care effectively prevents and treats maternal PPD. Though there are currently no ongoing studies examining the effect of online IPT for paternal PPD prevention, online IPT will be accessible to most fathers: In the US, 90% of adults own a smartphone and 80% have home broadband internet. Also, unlike current IPT-based maternal PPD prevention interventions, which require trained providers for intervention fidelity, online IPT could be disseminated without impacting intervention fidelity.

Together in Parenting (TIP) is a novel online paternal postpartum depression (PPD) prevention intervention that utilizes interpersonal-therapy-based strategies to reduce interparental conflicts and increase social support in the newborn period, thereby preventing PPD among fathers. An iterative end-user centered design process allowed qualitative interviews with 25 fathers at high-risk of paternal PPD-as defined by the fact that their partners attended prenatal care at the clinic for federally insured pregnant people-to transform TIP's appearance and features. Specifically, TIP was originally conceptualized as a smartphone application but has evolved iteratively from feedback from target end-users during the qualitative interviews to become a scripted audio- and video-recorded podcast, mimicking friends casually discussing parenting and relationships. Each of the 12 podcasts, referred to as lessons on the website, range between 8 to 15 minutes (most are less than 11 minutes) and include a digital handout to encourage participant engagement with the progressive IPT-based curriculum. There are also 10 digital handouts to encourage engagement. TIP is hosted on a password-protected website. User-specific log-ins allow TIP to contain an embedded analytic platform to monitor duration of use and modules accessed as well as responses to digital handouts.

The proposed study is a pilot randomized control trial that aims to examine the feasibility, acceptability, and preliminary estimates of effects of TIP (intervention) when compared to routine care (control). Ultimately, the goal is to use TIP to prevent PPD among fathers at high-risk for the condition due to those with structural or personal risk factors.

For this pilot study, the primary purpose will not be to determine TIP's efficacy at PPD prevention but to demonstrate the feasibility and acceptability of TIP as a digital intervention among fathers with newly born infants at high risk of PPD. The dual primary outcome for this study will be feasibility and acceptability. In order to obtain a preliminary estimate of effect for TIP on PPD outcomes to support a future efficacy trial, the proposed pilot study will also assess clinically meaningful perinatal mental health outcomes (depression and anxiety) and mediators (dyadic adjustment, stress, loneliness, and parenting confidence). These metrics will be collected at multiple time points after randomization to allow for longitudinal assessment of symptom trajectories postpartum as well as pre/post-intervention analyses comparing scores at randomization to those at various postpartum intervals. The effect of TIP on maternal well-being will be examined by having mothers complete some psychometric at study completion. Lastly, the most effective timing of intervention delivery will be determined using a mixed-methods approach nested within the proposed pilot randomized trial.

Being tested
Together in Parenting
Keywords
paternal postpartum depression, paternal postpartum anxiety, maternal postpartum depression, postpartum perceived stress, maternal postpartum anxiety, dyadic adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Together in ParentingBehavioural

    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.

Study groups in NCT07594743
Study groupRoleWhat they receive
Together in Parenting (intervention)ExperimentalPassword 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.
Receives: Behavioral: Together in Parenting
Treatment As Usual (routine care)No interventionRoutine care will be provided to those randomized to this group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From randomization until 3 months postpartum

  2. Acceptability of Together in Parenting as paternal postpartum depression prevention intervention

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

    Measured: 3 months postpartum

Secondary outcomes (8)
  1. Feasibility: recruitment

    Percentage of participants who approached to participate who consent

    Measured: Prior to randomization

  2. Acceptability: System Usability Scale

    8-item survey measuring perceived usability of digital products (score 0-100, with score >68 reflecting above average usability)

    Measured: 3 months postpartum

  3. Paternal postpartum depressive symptoms

    Masculine Depressive Scale: 13-item score designed specifically for men to assess symptoms of depression. The score ranges from 0-39 and screening positive is a score of 13 or higher

    Measured: Six or twelve weeks postpartum

  4. Paternal postpartum anxiety symptoms

    Generalized anxiety disorder-7: 7-item self-reported anxiety symptoms. The score range from 0-21, with higher scores indicating greater severity

    Measured: Six or twelve weeks postpartum

  5. Paternal postpartum perceived stress

    Perceived Stress Scale-4: 4-item self-report on stress symptoms. The score range is 0-16, with higher scores denoting higher stress.

    Measured: Six or twelve weeks postpartum

  6. Paternal positive screens for mood disorders

    Paternal screening positive for postpartum depression or anxiety (i.e,, masculine depression score of 13 or higher and/or generalized anxiety disorder-7 score of 10 or higher)

    Measured: Six or twelve weeks postpartum

  7. Maternal postpartum stress

    Maternal scores on the perceived Stress Scale-4: 4-item self-report on stress symptoms. The score range is 0-16, with higher scores denoting higher stress.

    Measured: 12 weeks postpartum

  8. Maternal parenting self-confidence

    Maternal scores on Parenting Sense of Self-Confidence-Revised score: 16-item survey assessing parenting competence and satisfaction. The score range is 16-96, with higher scores (especially 74 or higher) suggesting high competence and satisfaction.

    Measured: 3 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start7 Jul 2026
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07594743
Sponsor's protocol ID
2277329
Acronym
TIP RCT
Status last verified
Jul 2026
First submitted
24 Apr 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After the primary study is published, IPD that has been deidentified will be shared with any investigator who is interested and contacts the study PI

Questions about this trial

What is this clinical trial studying?

A study testing Together in Parenting in people with Paternal Postpartum Depression and Postpartum Anxiety, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephanie Nunez, MS (401-274-1122, snunez@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Together in Parenting as a paternal mental health intervention (time frame: From randomization until 3 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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