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临床试验/NCT04451031
NCT04451031已完成不适用

Evaluation of the Impact of Linking Families and Teens (LiFT) Curriculum

Philliber Research & Evaluation0 个研究点目标入组 888 人开始时间: 2016年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
888
主要终点
No sex or safe sex at last intercourse

研究概览

简要总结

To test a new curriculum designed by Planned Parenthood of the Great Northwest and Hawaiian Islands (PPGNHI). The Linking Families and teens (LiFT) curriculum is an innovative program designed for families in rural communities, with the goal of reducing unplanned teen pregnancies by increasing family connectedness and increasing youth's self-efficacy, knowledge, and skills related to sexual health.

详细描述

LiFT is a two-module curriculum workshop for youth and their parenting adults. Topics for youth include communication skills, condom use, and skill building to access sexual healthcare resources. For parenting adults, topics include building a climate of trust and open communication with youth about sexual health.

Trained and certified facilitators delivered each 2.5 hour module. Sites could choose to deliver the modules in one or two sessions. Youth and parents participated in simultaneous but separate programming in community locations such as schools or health care settings. Youth and parenting adults also received participant guides that encouraged communication between them. Facilitators encouraged youth and parenting adults to opt-in to receive weekly texts that offer additional resources and suggestions for fun ways families can communicate; these continued for 12 weeks after the workshop. Parenting adults received a phone call from the facilitator 3 to 5 weeks after the workshop to reinforce the skills learned during the program.

Community partners (schools, health care settings, or other community organizations) assisted with recruiting interested dyads of youth and parenting adults from their client base and the community. Each site held a kickoff event or individual meeting or meetings describing the LiFT program in detail.

Over the course of three years, the program was offered 57 times across five cohorts. The program took place in rural communities across nine states; Alaska, California, Hawaii, Idaho, Mississippi, New York, Oregon, Utah, and Washington. The study enrolled 886 dyads for participation.

The LiFT study was a cluster randomized controlled trial. Dyads of youth and their parenting adults were randomly assigned to participate in the intervention or comparison group. Siblings were randomly assigned together within the same condition. At kick-off events or through individual meetings, program staff obtained parental consent and student assent and administered baseline surveys. After receiving consent, assent, and baseline surveys, the research team conducted the random assignment of dyads and informed the site of the results. Program implementation occurred within two weeks of recruitment and baseline data collection.

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
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Youth must be 13 to 19 years old
  • •Youth must live in a rural community that has teen pregnancy rates higher than the national average.
  • •Youth must be accompanied by a parenting adult who agrees to participate in the program. The parenting adult does not need to be the youth's biological parent.

排除标准

  • •Lack of parental consent
  • •Lack of youth assent

研究组 & 干预措施

LiFT Program

Experimental

LiFT is a two-module curriculum workshop for youth and their parenting adults. Topics for youth include communication skills, condom use, and skill building to access sexual healthcare resources. For parenting adults, topics include building a climate of trust and open communication with youth about sexual health. Trained and certified facilitators deliver each 2.5 hour module over one or two sessions. Youth and parents participated in simultaneous but separate programming in community locations such as schools or health care settings. They received participant guides that encourage communication between them. They could opt-in to receive 12 weekly texts that offered additional resources. Parenting adults received a phone call from the facilitator a month after the workshop to reinforce the skills learned during the program.

干预措施: LiFT Program (Behavioral)

Comparison Group

No Intervention

The comparison group received business as usual. The youth and parents enrolled in the study could receive the existing services available within the broader community, which may have included sexual education delivered in the local school system. Study staff collected data throughout the study to track access to other TPP programming offered at the study sites.

结局指标

主要结局

No sex or safe sex at last intercourse

时间窗: 1 year from baseline

This is a computed dichotomous variable (based on a single survey item - "The last time you had vaginal sex, which of these methods of birth control did you or your partner use?") comprised of youth who reported using any of the following: condom, birth control pills, the shot, the patch, the ring, IUD, implant, or never having vaginal sex as Yes (1) and youth who reported either none, not sure, or other (e.g., withdrawal) as No (0).

次要结局

  • No sex or safe sex at last intercourse(3 months from baseline)
  • Perceived competence in pregnancy prevention scale(3 months from baseline)
  • Parent child communication about sexuality and pregnancy prevention scale(3 months from baseline)

研究者

发起方
Philliber Research & Evaluation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sally Brown

Senior Research Associate

Philliber Research & Evaluation

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