对美国印第安青年和青少年预防怀孕项目的严格评估：一项随机对照试验的研究方案

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.

作者信息

Tingey Lauren, Chambers Rachel, Goklish Novalene, Larzelere Francene, Lee Angelita, Suttle Rosemarie, Rosenstock Summer, Lake Kristin, Barlow Allison

机构信息

Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.

Johns Hopkins Center for American Indian Health, 308 Kuper St, Whiteriver, AZ, 85941, USA.

出版信息

Trials. 2017 Feb 27;18(1):89. doi: 10.1186/s13063-017-1842-6.

DOI:10.1186/s13063-017-1842-6

PMID:28241775

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5330144/

Abstract

BACKGROUND

American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens.

METHODS

The proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants.

DISCUSSION

Currently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents.

TRIAL REGISTRATION

Clinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.

摘要

背景

美国印第安青少年的青少年怀孕率和青少年重复生育率在美国处于最高水平之一。物质使用是无保护性行为的一个重要风险因素，并且美国印第安青少年在所有美国种族群体中与物质使用相关的发病率和死亡率最高。尽管存在这些差异，但目前还没有针对美国印第安青少年进行严格评估的、基于证据的预防怀孕项目。

方法

拟进行的研究是一项随机对照试验，以测试与一个美国印第安社区合作开发的综合性性与生殖健康项目的效果。参与者将是年龄在11 - 19岁的美国印第安青少年及其父母或信任的成年人，随机分为接受对照条件或名为“尊重生命之环：身心与精神”的干预措施。干预措施包括在夏季篮球训练营期间向自行选择的同伴群体讲授的八节课，以及在训练营结束后3个月内同时向青少年及其父母/信任的成年人讲授的一节课。所有课程均由来自参与项目的美国印第安社区的经过培训的社区卫生工作者授课。青少年及其父母/信任的成年人参与者将在干预结束后的基线、3个月、9个月、12个月、24个月和36个月完成评估。主要结局变量是性/生殖健康知识、首次性行为、使用避孕套的自我效能感以及与干预组和对照组参与者从基线到干预后相比下次性行为时使用避孕套的意愿。选定的主要结局适用于所有研究参与者。