Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Mental Health Intervention, For Fathers With Anxiety or Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility of Together in Parenting as a paternal mental health intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participant will be randomized to routine care vs a digital intervention, so they will not be masked. However, those providing clinical care to participants, the entire investigative team (aside from the research assistant who enrolls randomized participants to the intervention) will be blinded, including the outcomes assessors and data analytic team.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ,
- •planned delivery or status post delivery at WIHRI.
- •self-reported history of depression/anxiety or active depression/anxiety or screen positive on GAD-7 (8 or higher) or MDS (13 or higher)
排除标准
- •Endorsing active suicidality on intake survey;
- •infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;
- •inability to consent.
研究组 & 干预措施
Together in Parenting (intervention)
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.
干预措施: Together in Parenting (Behavioral)
Treatment As Usual (routine care)
Routine care will be provided to those randomized to this group
结局指标
主要结局
Feasibility of Together in Parenting as a paternal mental health intervention
时间窗: From randomization until 3 months postpartum
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
时间窗: 3 months postpartum
Client Satisfaction Questionnaire (8 item survey assessing satisfaction; scores range from 8-32 with higher scores indicating greater satisfaction)
次要结局
- Feasibility: recruitment(Prior to randomization)
- Acceptability: System Usability Scale(3 months postpartum)
- Paternal postpartum depressive symptoms(Six or twelve weeks postpartum)
- Paternal postpartum anxiety symptoms(Six or twelve weeks postpartum)
- Paternal postpartum perceived stress(Six or twelve weeks postpartum)
- Paternal positive screens for mood disorders(Six or twelve weeks postpartum)
- Maternal postpartum stress(12 weeks postpartum)
