Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression (TIP RCT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Anxiety; Paternal Postpartum Depression
• Intervention / Treatment: Behavioral: Together in Parenting

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Nunez, MS; Phone Number: 401-274-1122; Email: snunez@wihri.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: Treatment As Usual (routine care); Routine care will be provided to those randomized to this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 postpartum depression prevention intervention	Client Satisfaction Questionnaire (8 item survey assessing satisfaction; scores range from 8-32 with higher scores indicating greater satisfaction)	3 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: recruitment	Percentage of participants who approached to participate who consent	Prior to randomization
Acceptability: System Usability Scale	8-item survey measuring perceived usability of digital products (score 0-100, with score >68 reflecting above average usability)	3 months postpartum
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	Six or twelve weeks postpartum
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	Six or twelve weeks postpartum
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.	Six or twelve weeks postpartum
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)	Six or twelve weeks postpartum
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.	12 weeks postpartum
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.	3 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative	One-on-one interviews with cohort of those randomized to intervention about their user experience and the program's strengths and limitations	3 months postpartum
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	Six or twelve weeks postpartum
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.	12 weeks postpartum
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	Six or twelve weeks postpartum
New paternal diagnosis of psychiatric condition	Initiation of antidepressant or other psychotropic medication during study period by the father	From randomization until three months postpartum
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	Three months postpartum

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: paternal postpartum depression; paternal postpartum anxiety; maternal postpartum depression; postpartum perceived stress; maternal postpartum anxiety; dyadic adjustment
• Other Study ID Numbers: 2277329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: For three years after study period
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No