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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 ,

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Together in Parenting

    Behavioral

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Together in Parenting (intervention)Experimental treatment 1 intervention
Group B: Treatment As Usual (routine care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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)

Time frame
3 months postpartum

Secondary outcomes

1

Feasibility: recruitment

Percentage of participants who approached to participate who consent

Time frame
Prior to randomization
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

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