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. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Endorsing active suicidality on intake survey;
prisoners;
infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;
inability to consent.
Trial design
Parallel
Treatments tested in this trial
Together in Parenting
BehavioralTogether 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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)
Secondary outcomes
Feasibility: recruitment
Percentage of participants who approached to participate who consent
Acceptability: System Usability Scale
8-item survey measuring perceived usability of digital products (score 0-100, with score \>68 reflecting above average usability)
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
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
Other outcomes
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.
Qualitative
One-on-one interviews with cohort of those randomized to intervention about their user experience and the program's strengths and limitations
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
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.
Sponsors and contacts
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