Together in Parenting / Postpartum Anxiety / Paternal Postpartum Depression · Interventional Study

Feasibility and Acceptability of a Novel Digital Intervention For Perinatal Men Who Have Depression or Anxiety

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned feasibility and acceptability trial of a digital interpersonal-therapy-based intervention (Together in Parenting) for perinatal men with depression or anxiety symptoms. The study is registered but not yet recruiting and has not reported results. It is designed to generate preliminary effect estimates to support a future efficacy trial.

What was studied

Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Paternal Postpartum Depression, Postpartum Anxiety; age from 18 Years. Intervention: Together in Parenting (intervention). Compared with: Treatment As Usual (routine care) — No Intervention. n = 45. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study addresses a significant gap: paternal postpartum depression occurs at rates comparable to maternal PPD but few targeted interventions exist. Results on feasibility and acceptability are needed before a larger efficacy trial can be justified.

Plain-language summary

This is a trial registry record for a planned feasibility and acceptability study with no results reported; the design and population are appropriate for hypothesis generation only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Feasibility of Together in Parenting as a paternal mental health intervention (assessed at From randomization until 3 months postpartum); Acceptability of Together in Parenting as paternal mental health intervention (assessed at 3 months postpartum)

DesignInterventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationPaternal Postpartum Depression, Postpartum Anxiety; age from 18 Years

Sample size45

InterventionTogether in Parenting (intervention)

ComparatorTreatment As Usual (routine care) — No Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment45

Primary outcome measure 1Feasibility of Together in Parenting as a paternal mental health intervention, from randomization until 3 months postpartum

Primary outcome measure 2Acceptability of Together in Parenting as paternal mental health intervention, 3 months postpartum

Proportion ineligible for prior pilot due to depression or anxiety symptoms20%

Clinical bottom line

Caveats

This is a registry record only; no results have been reported.
Recruitment has not yet begun (status: NOT_YET_RECRUITING).
No control group or comparator arm is described in the registry record.
Blinding and allocation methods are not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional design specified; randomization mentioned but allocation method not detailed.

Directness

moderate

Directly targets perinatal men with depression or anxiety; primary outcomes are feasibility and acceptability.

Consistency

insufficient

No results reported; comparison to other interventions not described in registry record.

Risk of bias

insufficient

Blinding, allocation concealment, and outcome assessment methods not stated in registry record.

Sample adequacy

limited

Planned enrollment 45 participants; feasibility study size appropriate for design but limited for efficacy inference.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07742566). This is a study registration, not published results. Lead sponsor: Women and Infants Hospital of Rhode Island. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 45 participants (ESTIMATED). Conditions: Paternal Postpartum Depression, Postpartum Anxiety. Interventions: BEHAVIORAL: Together in Parenting. Primary outcome measures: Feasibility of Together in Parenting as a paternal mental health intervention , From randomization until 3 months postpartum; Acceptability of Together in Parenting as paternal mental health intervention , 3 months postpartum. Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Together in ParentingPostpartum AnxietyNCT07742566Women and Infants Hospital of Rhode IslandPaternal Postpartum Depression