Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,072
- 试验地点
- 1
- 主要终点
- Condom use self efficacy as measured by the Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5)
研究概览
简要总结
The objective of this research study is to evaluate a culturally tailored sexual and reproductive health intervention among American Indian (AI) youth. Specifically, the investigators aim to evaluate the impact of "Respecting the Circle of Life: Mind, Body and Spirit" on knowledge, attitude and behavioral outcomes associated with risk for unprotected sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the RCL intervention effectively reduces risky sexual behavior among AI adolescents (11-19 years old), with long term goals of reducing teen pregnancy and incidence/prevalence of STIs. The evaluation will focus on well-established intermediate outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI incidence.
详细描述
The investigators have the following research questions:
Confirmatory Research Question 1: Assess the effectiveness of the RCL intervention, compared to the control condition, on improving knowledge related to reproductive health, pregnancy, contraception and STIs. Outcome Measure 1: Knowledge Score (0-100%): Mean score on a 44-question reproductive and sexual health knowledge survey.
Confirmatory Research Question 2: Assess the effectiveness of the RCL intervention, compared to the control condition, on delaying initiation of sexual activity. Outcome Measure 2: Proportion of participants who report they have ever had sex.
Confirmatory Research Question 3: Assess effectiveness of the RCL intervention, compared to the control condition, on improving condom use self-efficacy. Outcome Measure 3: Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5).
Confirmatory Research Question 4: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing intention to use a condom at next sex.
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
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Indian ethnicity
- •Membership in the White Mountain Apache community. (Although the investigators anticipate the vast majority of participants will be White Mountain Apache tribal members, study participation is open to all American Indian individuals who live on the Fort Apache Indian Reservation or on/near the border).
- •Participants ages 11+ must have parent/legal guardian consent
- •Adult participants must sign written informed consent
排除标准
- •Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
- •Unwilling to be randomized
研究组 & 干预措施
RCL Intervention
Respecting the Circle of Life (RCL) includes peer-group & youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. RCL lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total RCL duration is 810-1,080 minutes over 3 months. All 8 days of the camp are "study days," in which RCL youth will receive one lesson each day. The investigators will evaluate RCL's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points.
干预措施: Respecting the Circle of Life (RCL) (Behavioral)
Control
The control program includes peer-group & youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. Control lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total control duration is 810-1,080 minutes over 3 months. All 8 days of the camp are "study days," in which control youth will receive one lesson each day. The investigators will evaluate the control program's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points.
干预措施: Control Program (Other)
结局指标
主要结局
Condom use self efficacy as measured by the Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5)
时间窗: 3-month, 9-month, 12-month, 24-month, 36-month
Mean difference in ability to correctly and consistently use condoms, between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention.
次要结局
- Knowledge of sexual and reproductive health as measured by the mean score on a 44-question reproductive and sexual health knowledge survey(3-month, 9-month, 12-month, 24-month, 36-month)
- Initiation of sexual activity as measured by the proportion of participants who report ever having sex(3-month, 9-month, 12-month, 24-month, 36-month)
- Condom use intention as measured by the proportion of participants who report they intend to use a condom at next sex(3-month, 9-month, 12-month, 24-month, 36-month)