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临床试验/NCT01910701
NCT01910701已完成不适用

Extension Study of the Family Spirit Program

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Increase in score on parenting self-efficacy scale

研究概览

简要总结

The aim of the proposed research is to implement and evaluate a follow-up study of the impact of the Family Spirit family strengthening program among a high-risk sample of Apache mothers and their children. The Family Spirit intervention is a 52-session home-visiting curriculum administered by American Indian paraprofessionals to young mothers from 28 weeks gestation through the child's first 3 years of life. In a series of pilot studies and a recently completed randomized controlled trial, the Family Spirit intervention has been found to positively impact several maternal, parenting and child outcomes up through three years postpartum. In the proposed study, the investigators will implement the Family Spirit intervention to young mothers (12-20 years at conception), with revisions to several assessment measures and to the curriculum such that the substance abuse prevention curriculum modules will be taught earlier than in the original study.

详细描述

This is a single group pre-post study designed to evaluate the impact of a home visiting intervention in improving parenting self-efficacy and a number of other maternal and child health and behavioral outcomes among a sample of young mothers, including maternal substance use. The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase. All sessions are designed to be taught at the participant's home, but they may also occur at another location chosen by the participant (e.g. study office, vehicle). Outcome data will be collected at Baseline and at 2 months, 6 months, 12 months, 24 months and 36 months postpartum.

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
12 Years 至 20 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant American Indian female less than or equal to 32 weeks gestation.
  • Reside within 60 miles of Whiteriver Indian Health Service unit.
  • Age 12-20 years of age at time of conception

排除标准

  • Completed previous randomized controlled trial of Family Spirit
  • ≤11 years old or ≥21 years old at time of conception of index pregnancy.

研究组 & 干预措施

Family Spirit Intervention

Experimental

The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.

干预措施: Family Spirit (Behavioral)

结局指标

主要结局

Increase in score on parenting self-efficacy scale

时间窗: 24 months postpartum

次要结局

  • Improved prenatal and infant medical care practices(24 months postpartum)
  • Reduction in emergency department visits due to childhood injuries(24 months postpartum)
  • Improved school readiness scores(24 months postpartum)
  • Improved score on family economic self-sufficiency scale(24 months postpartum)
  • Increased referrals for community resources(24 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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