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临床试验/NCT04101565
NCT04101565已完成不适用

Feasibility, Acceptability, & Preliminary Efficacy of Text4Father for Improving Infant & Family Health

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年12月26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
120
试验地点
2
主要终点
Feasibility of Overall Recruitment

研究概览

简要总结

This study evaluates the feasibility, acceptability, and preliminary efficacy of Text4Father among first-time lower income fathers. Half of the participants will receive Text4Father - a text messaging educational program - from mid-pregnancy through 2 months of postnatal age, while the other half will receive usual care.

详细描述

Text4Father, a multi-modal text messaging program, is designed to increase first-time lower income fathers' knowledge, self-efficacy, and behavioral engagement on infant care and parenting. Text4Father consists of 48-weeks of twice weekly texts written at a 5th grade reading level. Texts include resource links and instructions to support behavior change (e.g., videos, infographics), starting mid-pregnancy and continuing through 2 months of postnatal age. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.

Usual maternity care does not involve expectant fathers in education. Further, while father engagement is widely advocated, few public health and clinical approaches aim to engage expectant fathers during the prenatal period and first months after birth - a critical window of opportunity that has been insufficiently leveraged to promote father engagement when fathers describe being unsure of father role.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Self-reported expectant father and pregnant partner (expectant mother)
  • Aged ≥18 years
  • In a romantic relationship and expect to continue to be in this relationship during the study period
  • Able to speak English
  • Lower socioeconomic status (SES) (e.g., high school/general education or vocational/trade school or less; or qualify for Medicaid/public insurance, WIC, SNAP, food stamps)
  • Access to necessary resources for participating in a technology-based intervention (i.e., cell phone) and willing/able to receive/send texts

排除标准

  • Individuals who are not able to provide informed consent.

结局指标

主要结局

Feasibility of Overall Recruitment

时间窗: At Baseline

Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures.

Feasibility of Overall Retention

时间窗: Follow-up (7 months)

Feasibility of retention will be assessed as the number of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age).

Intervention Usability as Assessed by the Usability Score

时间窗: Follow-up (7 months)

11 item self-report measure among participating intervention fathers with higher score indicating greater perceived usability of technology (text messaging program). This measure is scaled with range from 1 (low) to 4 (high). Mean of participant scale choice (1-4) is reported.

Intervention Acceptability as Assessed by the Acceptability Score

时间窗: Follow-up (7 months)

An 9 item self-report measure among participating intervention fathers with higher score indicating greater perceived acceptability of technology (text messaging program). This measure is scaled with range from 1 (low) to 4 (high). Mean of participant scale choice (1-4) is reported.

次要结局

  • Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC)(7 months (2 months post-birth))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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