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临床试验/NCT02700035
NCT02700035已完成不适用

A Randomized Control Trial (RCT) of a Family-Centered Ojibwe Substance Abuse Prevention

University of Nebraska Lincoln0 个研究点目标入组 705 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
705
主要终点
Change in Illicit Drug Use

研究概览

简要总结

This study will complete a multisite randomized controlled trial (RCT) of a family-centered alcohol and drug prevention program for Anishinabe (Ojibwe) pre-adolescents in 3rd or 4th grade (Fall 2017) or who are age 8-10 years on June 1, 2017. The 14 week program includes cultural lessons to strengthen family interactions, decrease substance use, teach parenting skills, increase social skills, improve refusal skills, and teach coping mechanisms for adolescents and parents. Session are expected to last around 3-hours, including a meal, youth and parent breakout sessions, and group based discussions. Parents and adolescents will participate in a pre-test before the program begins and a series of post-tests after the program ends.

详细描述

Investigators will implement a multisite randomized controlled trial (RCT) of a family-centered alcohol and drug prevention program for Anishinabe (Ojibwe) pre-adolescents in 3rd or 4th grade (Fall 2017) or who are age 8-10 years on June 1, 2017. to assess its efficacy for delaying and/or preventing adolescent onset of alcohol and drug use. This unique project will empirically address cultural challenges for RCTs involving AI cultures by evaluating contamination and informal diffusion in AI communities and extended families. AI values of sharing and community benefits clash with Western RCT methods of withholding benefits from control groups vs. treatment groups. Although risks of informal community dissemination and control group contamination are widely acknowledged challenges for AI RCTs, the degree to which this actually occurs and the potential impact has never been assessed. Rather, efforts are made to suppress and minimize AI values that result in informal dissemination and contamination, or the potential effects are simply ignored. This research will address these challenges by attempting to measure and control for them. The intent-to-treat study design will allow us to use question routing aimed at identifying content sharing among treatment and control adolescents and their treatment and control group parents. Moreover, the project will also use question routes to investigate potential contamination via extended family members who have contact with both the treatment and control families. Investigators will then assess potential impact of measured contamination on observed intervention effects.

At the completion of the study, Investigators will work with community research partners to develop a plan to sustain the prevention program. A sustainability plan is part of our model for developing and implementing culturally specific evidence-based prevention programs. Communities have readiness for sustainability due to familiarity and the popularity of BZDDD. We will work through community advisory boards (named Prevention Research Councils or PRCs) to place the program within schools, health services, and social services agencies. The project will leave behind comprehensive facilitator manuals in addition to a videotaped training program to facilitate ongoing training. In addition, the program has recently been adapted to a virtual program in response to COVID-19. The investigative team has a proven track record of sustainability in prior adaptions of BZDDD.

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
8 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Youth who self-Identified as American Indian (between the ages of 8-10)
  • Adult Guardians of participating youth (aged 18 or older)

排除标准

  • Youth who did not self-identify as American Indian
  • Youth under the age of 8 years old
  • Youth over the age of 11 years old.

结局指标

主要结局

Change in Illicit Drug Use

时间窗: Pre-Test Baseline, 15 Week, 6 Month

Frequency of use of illicit drug use

Change in Cigarette Use

时间窗: Pre-Test Baseline, 15 Week, 6 Month

Frequency of use of cigarettes

Change in Alcohol Use

时间窗: Pre-Test Baseline, 15 Week, 6 Month

Frequency of use of alcohol

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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A Family-Centered Ojibwe Substance Abuse Prevention | 临床试验