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.
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
- Conditions the study is for
- Paternal Postpartum Depression, Postpartum Anxiety
- What is being tested?
- Together in Parenting
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
Stephanie Nunez, BS, 401-274-1122, snunez@wihri.org
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.
- Conditions
- Paternal Postpartum Depression, Postpartum Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Together in Parenting |
| Treatment As Usual (routine care) | No intervention | Routine 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.
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
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)
Feasibility: recruitment
Percentage of participants who approached to participate who consent
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
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.
- First posted19 May 2026
- Study start7 Jul 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paternal Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lewkowitz, Women and Infants Hospital of Rhode Island
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Postpartum Depression Prevention Intervention
- ClinicalTrials.gov ID
- NCT07594743
- Acronym / sponsor ID
- TIP RCT / 2277329
- Conditions
- Paternal Postpartum Depression, Postpartum Anxiety
- Keywords
- paternal postpartum depression, paternal postpartum anxiety, maternal postpartum depression, postpartum perceived stress, maternal postpartum anxiety, dyadic adjustment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Together in Parenting (intervention) | Experimental | Behavioral: Together in ParentingPassword 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. |
| Treatment As Usual (routine care) | No intervention | –Routine care will be provided to those randomized to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Together in ParentingTogether 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. | Behavioural | Together in Parenting (intervention) |
Primary outcome
Feasibility of Together in Parenting as a paternal mental health intervention
Time frame: From randomization until 3 months postpartum
Percentage of participants who view at least 6 of the 12 audio and video podcasts
Acceptability of Together in Parenting as paternal postpartum depression prevention intervention
Time frame: 3 months postpartum
Client Satisfaction Questionnaire (8 item survey assessing satisfaction; scores range from 8-32 with higher scores indicating greater satisfaction)
8 secondary outcomes
Feasibility: recruitment
Time frame: Prior to randomization
Acceptability: System Usability Scale
Time frame: 3 months postpartum
Paternal postpartum depressive symptoms
Time frame: Six or twelve weeks postpartum
Paternal postpartum anxiety symptoms
Time frame: Six or twelve weeks postpartum
Paternal postpartum perceived stress
Time frame: Six or twelve weeks postpartum
Paternal positive screens for mood disorders
Time frame: Six or twelve weeks postpartum
Maternal postpartum stress
Time frame: 12 weeks postpartum
Maternal parenting self-confidence
Time frame: 3 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: 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
Related trials for Paternal Postpartum Depression
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Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life in a Resource-Limited Environment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.