An interventional study of Together in Parenting in Paternal Postpartum Depression and Postpartum Anxiety, sponsored by Women and Infants Hospital of Rhode Island. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Treatment
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.
Postpartum depression (PPD) PPD affects 8-10% of men, and paternal anxiety affects up to 15% of men. Paternal mental health symptoms are often underdiagnosed and undertreated. It is hard to identify fathers who have mental health symptoms due to cultural conceptions of masculinity, leading to the risk that fathers do not recognize their symptoms as mental health symptoms and engage in avoidant or numbing behavior instead of appropriate treatment. Even if they recognize their mental health symptoms, men are less likely than women to pursue help due to the stigma of mental health care, resulting in delays in diagnosis and treatment. 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 treats mental health symptoms and prevents worsening of these symptoms is urgently needed to 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). It is also important to note that IPT has been shown to be an effective treatment for both anxiety and depression.
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 or treatment, 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 mental health 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 intervention that utilizes interpersonal-therapy-based strategies to reduce interparental conflicts and increase social support in the newborn period, thereby improve mental health symptoms 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.
Thus, a pilot feasibility study is being conducted that examines the feasibility, acceptability, and preliminary estimates of effects of TIP as a paternal mental health program when compared to routine care (NCT07594743). During screening for eligibility, 20% of those screened cannot participate in this trial because they either endorse having depression or anxiety or screen positive for symptoms of depression or anxiety on baseline psychometric surveys. Given IPT can be used to treat these mental health symptoms, a second small feasibility and acceptability study is now being proposed to examine whether TIP can improve mental health symptoms among fathers with depression or anxiety.
For this pilot study, the primary purpose will not be to determine TIP's efficacy at improving paternal mental health symptoms but to demonstrate the feasibility and acceptability of TIP as a digital intervention among fathers with newly born infants and who have mental health symptoms. 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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 45 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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
Routine care will be provided to those randomized to this group
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.
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
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)
Time frame: 3 months postpartum
Feasibility: recruitment
Percentage of participants who approached to participate who consent
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 3 months postpartum
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
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
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
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
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
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
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, Statistical analysis plan, Informed consent form, 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.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Women and Infants Hospital of Rhode Island