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

Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Postpartum Depression Prevention Intervention

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Together in Parenting (TIP), a program of podcasts and online handouts meant to help prevent depression in fathers after a baby is born. It is for soon-to-be or new fathers. Researchers will learn whether the program is practical, whether fathers like it, and when it is best to offer it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak English.
  • Be older than 18.
  • Own a smartphone or have internet access at home.
  • You or your partner received or are receiving pregnancy care at a resident, nurse practitioner, or midwife clinic at the Obstetrics and Gynecologic Care Center at Women & Infants Hospital of Rhode Island, or are receiving an ultrasound at its Prenatal Diagnosis Center.
  • Plan to have the baby at Women & Infants Hospital of Rhode Island, or have already had the baby there.

Who can't join

  • Report having a current or past mental health condition, such as depression or anxiety.
  • Report current thoughts of suicide on the intake survey, or have a positive depression screen (MDS score of 13 or more) or anxiety screen (GAD-7 score of 8 or more) when joining.
  • Be a prisoner.
  • When joining, have a baby with a genetic condition, a major problem with how the body formed, or admission to a neonatal intensive care unit (NICU), which gives special care to newborns.
  • Be unable to give consent to take part.
  • Fathers may stay in the study if a new positive mental health screen or one of the listed baby health problems occurs after they join and are assigned to a study group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

RI