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临床试验/NCT03858803
NCT03858803已完成不适用

Improving the Reproductive Health of Families

Portland State University2 个研究点 分布在 1 个国家目标入组 945 人开始时间: 2019年4月22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
945
试验地点
2
主要终点
Changes in Parent Use of Positive Reinforcement Scale (Youth)

研究概览

简要总结

This research will assess the effectiveness of a parent- and an adolescent- intervention in lowering risk of STIs, HIV, and unintended pregnancies among Batswana youth.

详细描述

Youth in Botswana face extraordinary challenges as they transition through adolescence. High rates of teen pregnancy force girls to drop out of school after which few resume their education. Sexually transmitted infections (STIs) are prevalent and the country has the 3rd highest Human Immunodeficiency Virus (HIV) prevalence in the world, with incidence increasing rapidly among adolescents 15-19, peaking at 40.2% HIV seroprevalence at ages 30-34. Traditional methods for sex education through village initiation schools are no longer available and parents are not comfortable with discussions addressing reproductive health within the family. As a result, adolescents have no conduit to educate them about healthy sexual development. This study will recruit 456 families, ½ with a male and ½ with a female adolescent. Families will be randomized to one of three intervention arms. Parents will participate in Families Matter 2! (FM2) and adolescents in Living as a Safer Teen (LAST), both evidence-based interventions that were adapted and pilot tested in Botswana during an earlier R34 award. In Arm 1, the parent will participate in FM2 immediately and the youth will participate in LAST six months later. In Arm 2, both the parent and youth will participant in their respective interventions simultaneously. In Arm 3, the comparison condition, participants will be offered the interventions immediately after the final assessment. Each adolescent and parent will complete assessments in English or Setswana at baseline, post-intervention, and 6- and 12-month follow-ups. Results from a pilot trial of the adapted interventions suggest that these interventions may result in improved family communications, child management skills, knowledge of sexual development, more favorable attitudes toward contraception, less tolerance for intergenerational transactional sex, greater rejection of gender violence, and lower rates of sexual risk behavior by both parents and adolescents. It is further anticipated that youths who are abstinent upon entering the intervention will delay sexual debut to a greater extent than youth in the comparison arm. This proposed study addresses the highest priority in Botswana's current national strategic plan: preventing early pregnancy, STIs and HIV in adolescents. If the proposed randomized controlled trial (RCT) provides strong evidence of effectiveness, the investigators will work with the Ministries of Education, Health, Youth & Culture and the Office of the President to disseminate the intervention throughout Botswana.

研究设计

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

入排标准

年龄范围
13 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent 13-18 in or near Gaborone Botswana and parent/guardian

排除标准

  • 未提供

结局指标

主要结局

Changes in Parent Use of Positive Reinforcement Scale (Youth)

时间窗: 6 month

Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents

Changes in Frequency of Unprotected Intercourse (Youth)

时间窗: 6 month

Self-reported frequency of unprotected intercourse occasions in past 3 months.

Changes on Family Communication Scale (Youth)

时间窗: 6 month

Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency

Changes in Reproductive Health Knowledge Test Scores (Youth)

时间窗: 6 month

Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.

Changes in Condom Barriers Scale(Youth)

时间窗: 6 month

Total score range 0 - 140; Higher scores reflect greater perceived barriers to condom use. No subscales

Change in Attitudes Toward Transactional Sex Scale (Youth)

时间窗: 6 month

Total score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex

Change in Number of Sex Partners (Youth)

时间窗: 6 months

Change in self-reported numbers of sex partners in past two months

Changes on Parental Responsiveness Scale (Youth)

时间窗: 6 month

Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness

Changes in Scores on the Condom Attitudes Scale (Youth)

时间窗: 6 month

Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use

Changes in Scores on Self Efficacy Beliefs Scale (Youth)

时间窗: 6 month

Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs

Changes in Parental Monitoring Scale (Youth)

时间窗: 6 month

Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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