跳至主要内容
临床试验/NCT05652387
NCT05652387已完成不适用

Preparing for Parenthood: A Father Inclusive Model of Prenatal Care

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2021年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
216
试验地点
2
主要终点
Parenting Stress Index - Short Form

研究概览

简要总结

Young families need additional institutional support to help them meet the challenges of parenthood. Prenatal clinics are well situated to address some of their needs by expanding services to include fathers. The Father Inclusive Prenatal Care (FIPC) model is designed to prepare young men for the challenges of parenting by supporting the development of their relationship skills as part of routine prenatal healthcare. This approach involves assessing expectant fathers and mothers with a "parent prep-check" (PPC) to identify their needs and then offer services to address those needs and prepare them for parenthood. Services include: (1) parent education about how to understand and care for infants, and how to build secure parent-child bonds; (2) an evidence-based co-parenting program to strengthen and stabilize their family; and (3) educational and employment support designed to help young parents find and keep living wage jobs. The project will be implemented through several community based healthcare sites that are well positioned to engage young fathers through their prenatal clinics. To extend the reach and accessibility of the model, trainings and most services will be available online. As a result of participating in this project it is expected that young couples will have better co-parenting relationships and be better prepared to take care of their infants.

详细描述

Recruitment: This project will recruit/engage young expectant fathers using a multi-stage process. First, primary care providers (PCP) will ask their patients (17-25-year-old pregnant women) about the degree to which the father of her child will be participating in parenting and supporting their baby. If the mother anticipates the fathers' involvement, the provider will tell her about the Parent Prep-Checks (PPC), give her a brochure about describing that process (including incentives), and ask about connecting her with members of the research team in order to receive additional information. The research team members will establish father eligibility based upon age (18-29 years) and schedule time to meet with both parents.

The intake process - the Parent Prep Check - is a strategy for engaging young fathers and mothers in research and intervention activities. In addition to collecting useful baseline data, the PPC is designed to build a strong alliance between project staff and participants. For example, FIPC intake staff are trained to administer a semi-structured interview designed to help participants articulate their feelings about becoming parents, which most find to be an interesting and rewarding experience. Then to facilitate recruitment into the intervention, a motivational interviewing approach is used that (a) gives feedback to participants based on their self-reported data and (b) engages them in thinking about what services will help them get ready for parenthood. When fathers are given the chance to say what concerns them, they are more likely to be receptive to participating in programs that can address those concerns. Intake staff will then introduce expectant parents to a FIPC provider, who discusses the goals and benefits of the FIPC program. Emphasizing how FIPC programs address a parent's self-identified goals has been an effective way to engage and retain participants.

The most critical element in this process is the quality of communication between FIPC staff and the expectant mother and father. If done well, both parents will feel appreciated, supported, and respected. Another key factor is flexibility. FIPC staff are trained to be as accommodating as possible about scheduling appointments. Related to this, almost all FIPC services and research activities are available online to increase participant reach and accessibly.

Finally, fathers and mothers are told they will be reimbursed for their time. Incentivizing patients is not sustainable over the long run; however, it is deemed necessary to get a representative sample for this project. In years 4 and 5, incentives for services will be reduced as part of the sustainability plan. In past projects, this strategy has been effective in recruiting between 60 and 75% of eligible expectant fathers.

Staff at partner clinics and Rush program coordinators who will be trained on the FIPC program and research/evaluation data protocol will be responsible for recruiting the sample. The clinic staff will be asking eligible mothers if they think their partner (father of the baby) would be interested in participating. The FIPC program coordinators will be responsible for contacting fathers and recruiting them to participate after mothers share their contact information.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
17 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Women: pregnant woman
  • Men & women have to be willing to participate at baseline interview together

排除标准

  • Men & Women: Language other than Spanish or English and cognitive disability interfering with ability to understand the informed consent process.

结局指标

主要结局

Parenting Stress Index - Short Form

时间窗: At 6 months and 18 months post birth

Evaluates parents' perception of parenting-related stress

Self-efficacy for Parenting Task Index - Toddler-Short

时间窗: Time 3 - eighteen months post birth

Evaluates how capable parents feel of addressing their child's needs.

Julion Index of Paternal Involvement

时间窗: At 6 months and 18 months post birth

Measures how often fathers are involved with their children in a variety of activities

Brief Infant Toddler Social & Emotional Assessment (BITSEA)

时间窗: Time 3- eighteen months post birth

This form is used to measure infant social-emotional development

Perceived Maternal Parenting Self-Efficacy Tool

时间窗: Time 2 - six months post birth

Evaluates how confident parents feel taking care of their infant

Change in conflict in Adolescent Dating Relationship Inventory- Short Form

时间窗: Change from Baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth

Used to measure couple relationships and potential conflict.

Quality of Relationship Inventory

时间窗: At 6 months and 18 months post birth

Examines the quality of the relationship between co-parenting couples

次要结局

  • Maternal Health Outcome Assessment(Six months post birth)
  • Parent Health Questionnaire (PHQ9)(At 6 months and 18 months post birth)
  • Trait Emotional Intelligence Questionnaire(At 6 months and 18 months post birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验