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临床试验/NCT03590132
NCT03590132已完成4 期

A Dual Inoculation Approach to Alcohol Prevention Among African American Youth

University of Georgia0 个研究点目标入组 472 人开始时间: 2012年12月10日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
472
主要终点
Alcohol use in past 3 months (single item)

研究概览

简要总结

The most common approach to preventing alcohol use involves providing a well-designed program in preadolescence just prior to or upon entering middle school. This approach does not have long-lasting effects or address the risk factors that lead many youth to use alcohol in high school. This study tested a strategy that compares offering effective programs at the transition to middle school and the transition to high school with only offering a program at either one of the transitions or no programs at all.

详细描述

Alcohol use is a leading cause of morbidity and mortality among high school students. Annually, underage drinking leads to more than 3,000 deaths and 2.6 million other harmful events, resulting in $5.4 billion in medical costs, $14.9 billion in work loss and other resource costs, and $41.6 billion in lost quality of life. This public health crisis has engendered considerable attention from prevention scientists, who have specified guidelines for the development of primary prevention programs and the timing of their implementation. The present research is based on critical limitations in the prevailing model for implementing primary prevention for alcohol use. This model focuses on delaying alcohol use onset among youth who begin use in middle school (ages 11-14). Based on studies that linked early use to a high-risk behavioral trajectory in adolescence, prevention scientists translated data on risk and protective processes for early-onset alcohol use into primary prevention programs for youth to be implemented during or just prior to the transition to adolescence. This model has informed numerous randomized prevention trials and investigations of prevention implementation. An unquestioned premise of this model involves the adequacy of a single preadolescent "inoculation" of prevention programming to protect youth into the high school years.

The proposed trial addresses empirical and theoretical limitations to the preadolescent/single inoculation paradigm. First, inclusive reviews reveal that primary prevention programs implemented in early adolescence fail to achieve robust, long-term results. Second, studies of alcohol use trajectories reveal patterns of onset in high school with rapid escalation that culminate in high levels of alcohol use. Third, in the prevailing paradigm, targeting early adolescent risk processes is assumed to be sufficient to equip youth for the novel risk processes they will encounter in high school. In contrast, this study investigates the proposition that achievement of public health impact requires a "dual-inoculation" prevention strategy, one that addresses both onset in early adolescence and mid-adolescence and provides developmentally tailored curricula at each transition.

Based on longitudinal studies with rural African American families that documented the changing context of alcohol use risk and protective processes from late childhood through adolescence, scientists at the Center for Family Research developed a series of developmentally appropriate, family-centered preventive interventions that have proven efficacious in in preventing alcohol use: the Strong African American Families (SAAF) program for youth age 10-12 and the SAAF-Teen program for youth age 14-16. These programs afford a unique opportunity to test dual-inoculation hypotheses. Unlike medical inoculations of a vaccine, it is not appropriate to give the same inoculation to an 11-year-old that one gives a 14-year-old. Rather, each preventive inoculation must be tailored to address the most salient risk and protective processes at particular developmental transitions.

This study will recruit a sample of 460 African American families into a four-arm randomized prevention trial and evaluate the differential alcohol prevention effects of (a) a dual inoculation of prevention (youth receive SAAF at age 11 and SAAF-Teen at age 14) compared with (b) receipt of a preadolescent inoculation (SAAF at age 11), (c) receipt of a mid-adolescent inoculation (SAAF-Teen at age 14), or (d) a minimal contact control.

Specific efficacy aims are to:

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Neither the interventionists or the assessors were given information on participants' treatment group; however there is only partial masking for providers given that attendance in the program suggests some information on experimental group.

入排标准

年龄范围
11 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • self reported African American
  • 5th grade

排除标准

  • unable to attend a family-centered prevention intervention due to incapacitation of youth
  • unable to attend a family-centered prevention intervention due to incapacitation of youth

研究组 & 干预措施

SAAF

Experimental

participants in this arm receive the SAAF intervention at age 11-12.

干预措施: Strong African American Families Program (Behavioral)

SAAF-T

Experimental

participants in this arm receive the SAAF-Teen intervention at age 14-15.

干预措施: Strong African American Families--Teen Program (Behavioral)

SAAF SAAF-T

Experimental

participants in this arm receive SAAF at age 11-12 and later receive SAAF-Teen at age 14-15

干预措施: Strong African American Families Program (Behavioral)

SAAF SAAF-T

Experimental

participants in this arm receive SAAF at age 11-12 and later receive SAAF-Teen at age 14-15

干预措施: Strong African American Families--Teen Program (Behavioral)

Control

No Intervention

These participants receive no interventions.

结局指标

主要结局

Alcohol use in past 3 months (single item)

时间窗: 3 months

Youth complete this single item from Monitoring the Future Study assessing the frequency of alcohol use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher response numbers indicate a worse outcome (more alcohol use).

Frequency of cannabis use in the past 3 months (single item)

时间窗: 3 months

Single item from Monitoring the Future Study assessing frequency of marijuana use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher responses indicate a worse outcome (more marijuana use in the past 3 months).

Monitoring the Future: Total substance use (summative index of use of alcohol, cannabis, and nicotine)

时间窗: 3 months

Youth complete 3 single items from the Monitoring the Future study indexing the frequency of their use of alcohol, cannabis, and nicotine in past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times) for each item. The three items are summed yielding a scale ranging from 0-18. Higher response numbers indicate a worse outcome (more substance use).

次要结局

  • Center for Epidemiological studies-Depression scale(Past 7 days)
  • The National Survey of Adolescents Conduct Problems Subscale(past 3 months)
  • Center for Epidemiological Studies-Depression Scale-Child Version(past 7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steve Kogan

Professor

University of Georgia

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