CClinicalTrials.gg
RecruitingNCT07594743TIP RCTUpdated Jul 13, 2026

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

An interventional study of Together in Parenting in Paternal Postpartum Depression and Postpartum Anxiety, sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Paternal Postpartum Depression
  • Postpartum Anxiety

Keywords

  • paternal postpartum depression
  • paternal postpartum anxiety
  • maternal postpartum depression
  • postpartum perceived stress
  • maternal postpartum anxiety
  • dyadic adjustment
03

In context

Lead sponsor

Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study 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.

    Behavioral: Together in Parenting

  • No intervention
    Treatment As Usual (routine care)

    Routine care will be provided to those randomized to this group

Interventions

  • BehavioralTogether 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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 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)

    Time frame: 3 months postpartum

Secondary outcomes

  1. Feasibility: recruitment

    Percentage of participants who approached to participate who consent

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 3 months postpartum

Other outcomes

  1. Qualitative

    One-on-one interviews with cohort of those randomized to intervention about their user experience and the program's strengths and limitations

    Time frame: 3 months postpartum

  2. Paternal dyadic adjustment

    Paternal scores on Dyadic Adjustment Scale, a 7-time survey measuring relationship satisfaction, decision-making, and cohesion. Scores range from 0-35, with higher scores indicating higher adjustment

    Time frame: Six or twelve weeks postpartum

  3. Paternal parenting self-confidence

    Paternal 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.

    Time frame: 12 weeks postpartum

  4. Paternal loneliness

    Paternal scores on UCLA Loneliness Scale, a 20-item survey measuring loneliness. The score range is 20-80, with higher scores indicating greater loneliness

    Time frame: Six or twelve weeks postpartum

  5. New paternal diagnosis of psychiatric condition

    Initiation of antidepressant or other psychotropic medication during study period by the father

    Time frame: From randomization until three months postpartum

  6. Maternal dyadic adjustment

    Maternal scores on Dyadic Adjustment Scale, a 7-time survey measuring relationship satisfaction, decision-making, and cohesion. Scores range from 0-35, with higher scores indicating higher adjustment

    Time frame: Three months postpartum

07

Study locations

1 of 1 sites recruiting
  • Women & Infants Hospital of Rhode Island
    Providence, Rhode Island 02903, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Icf, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07594743
Lead sponsor
Women and Infants Hospital of Rhode Island
Responsible party
Adam Lewkowitz (Assistant Professor, Women and Infants Hospital of Rhode Island) — Principal investigator
First posted
May 19, 2026
Start date
Jul 7, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion