Evaluation of an Optimized Intervention to Prevent Early Substance Use Among American Indian Youth: Examination of Expanded Impacts on Youth and Parents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- Lifetime cigarette use
研究概览
简要总结
Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains reservation community, creating a program optimized for American Indian families, Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong). This study will test the effectiveness of TG for delaying the onset of substance use among young adolescents. In response to requests from participating families and community partners to help address suicide risk among their youth, and based on preliminary evidence that the program may impact risk behaviors beyond substance use, the study will also test suicide risk outcomes among youth. Finally, in recognition of the potential for reciprocal influence on the adults participating in the program with their children, capitalizing on their motivation to make concomitant positive changes in their own lives, the current study will also examine effects on adult substance use. In summary, this study will test the effectiveness of TG for reducing risk for: (1) substance use among youth; (2) suicide risk among youth; and (3) substance abuse among adults.
详细描述
Study design overview
All 13 middle schools on the reservation will participate in this study by providing space for program groups to meet in the evenings and allowing recruitment activities at school events. A total of 480 families will be recruited into 6 cohorts across two years (spring, summer and fall). In each community, families with a child 10-12 years of age will be recruited to participate in the study. Half of recruited families will be randomly assigned to receive the Thiwáhe Gluwáš'akapi (TG) substance use prevention program and half to the comparison group, which will receive the Woyute Waśte (WW) healthy eating and exercise program. Randomization will be explained to families as part of the recruitment and consent process. Given the potential for contamination across groups with this design, the investigators will carefully examine outcomes across groups and statistically control for contamination effects as necessary. Alternative designs, including randomization at the school/community level, were rejected due to greater concerns about cross-community variability.
Recruitment and retention strategies
Schools (e.g., registration, family nights, parent-teacher conferences, holiday events) will be the main points of recruitment but additional advertising and promotion will take place at community events such as powwows, health fairs, and basketball tournaments. Written materials about the program will be distributed, along with promotional items (e.g., water bottles, magnets, and lanyards with the project name and logo). The investigators will also advertise on local community radio, which has wide reach on the reservation. Because TG has been implemented at 12 of the 13 middle schools on the reservation as a part of the adaptation study and has been well received by both families and school staff, the investigators often have inquiries about opportunities for future participation, and anticipate a positive response to recruitment efforts.
Facilitators will call families weekly to touch base with them and remind them about upcoming sessions. The investigators provide meals to families at the start of each program session, giving them opportunities to connect with other families and facilitators, fostering relationships, and making it easier for busy families to get to the sessions. Child care and transportation will be provided, as needed.
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
- 10 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Youth participants:
- •10-12 years old on the date of the first program session
- •Attending school on the reservation
- •Must enroll with an eligible adult
- •Adult participants:
- •At least 18 years old
- •Must enroll with an eligible child
- •Must play a significant parenting role for the child enrolled in the study, as a parent, grandparent, other relative, legal guardian, or other household member.
排除标准
- •Prisoners
- •Decisionally-challenged adults
研究组 & 干预措施
Thiwáhe Gluwáš'akapi
Weeks 1-7: Weekly in-person 2.5 hour family sessions 30 minute family meal 1 hour separate youth and adult sessions
1 hour family session
干预措施: Thiwáhe Gluwáš'akapi (Behavioral)
Woyute Waśte
Respect for community and cultural values regarding research protocols precluded use of a randomized controlled design with a control group receiving no intervention, so we identified a cost-effective comparison condition program to offer value to study participants. A focus on healthy eating and exercise was of interest to community partners and not expected to directly confound the primary outcomes of the TG program (substance use and suicide risk).
Week 1 in-person 2.5 hour family session 30 minute family meal 2 hour interactive family session (3 stations) Weeks 2-7: text messages with program content and questions
干预措施: Woyute Waśte (Behavioral)
结局指标
主要结局
Lifetime cigarette use
时间窗: Change from baseline to 36 months after intervention
Percentage reporting lifetime cigarette use (measured at baseline, post-test, and 6 month intervals for 36 months)
Past month usual quantity of alcohol use [adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of usual quantity of alcohol use in past month (# drinks, measured at baseline, post-test, and 6 month intervals for 36 months)
Alcohol intoxication initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported alcohol intoxication
Lifetime use of cough syrup (without parental permission) [youth only]
时间窗: Change from baseline to 36 months after intervention
Percentage reporting use of cough syrup (without parental permission) (measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of any alcohol use
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month alcohol use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of consumption of 4+ (for females) or 5+ (for males) alcoholic drinks at one time
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month alcohol consumption of 4+ drinks (for females) or 5+ (for males) (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of intoxication
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month alcohol intoxication (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime use of electronic vapor products
时间窗: Change from baseline to 36 months after intervention
Percentage reporting use of electronic vapor products (measured at baseline, post-test, and 6 month intervals for 36 months)
Chewing tobacco initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported chewing tobacco use
Prescription pain medicine use (non-medical) initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported non-medical prescription pain medicine use
Alcohol initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported alcohol use
Cough syrup use initiation (without parental permission) [youth only]
时间窗: Up to 16 years of age
Age of first reported non-medical cough syrup use
Cigarette initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported cigarette use
Past month frequency of inhalant use
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month inhalant use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Percentage reporting non-medical use of prescription pain medicine (measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month non-medical prescription pain medicine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Cocaine use initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported cocaine use
Lifetime alcohol intoxication
时间窗: Change from baseline to 36 months after intervention
Percentage reporting lifetime alcohol intoxication (measured at baseline, post-test, and 6 month intervals for 36 months)
Electronic vapor products initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported electronic vapor product use
Lifetime inhalant use
时间窗: Change from baseline to 36 months after intervention
Percentage reporting inhalant use (measured at baseline, post-test, and 6 month intervals for 36 months)
Inhalant use initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported inhalant use
Lifetime alcohol use
时间窗: Change from baseline to 36 months after intervention
Percentage reporting lifetime alcohol use (measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of use of cough syrup without parental permission [youth only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month use of cough syrup without parental permission (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month quantity of use of cough syrup without parental permission [youth only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of quantity of past month cough syrup used without parental permission (1 or 2 teaspoons (0); ¼ of the bottle (1); ½ of the bottle (2); One whole bottle (3); More than one bottle (4); measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime marijuana use
时间窗: Change from baseline to 36 months after intervention
Percentage reporting lifetime marijuana use (measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of cigarette use
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month cigarette use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of chewing tobacco use
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month chewing tobacco use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime methamphetamine use [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Percentage methamphetamine use (measured at baseline, post-test, and 6 month intervals for 36 months)
Methamphetamine use initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported methamphetamine use
Lifetime suicidal ideation [youth only]
时间窗: Change from baseline to 36 months after intervention
Youth Risk Behavior Survey, middle school version, adapted to lifetime (ever seriously thought about suicide, ever made a plan, ever attempted); scored 0 to 3.
Past month frequency of methamphetamine use [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month methamphetamine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime heroin use [adults only]
时间窗: Change from baseline to 36 months after intervention
Percentage heroin use (measured at baseline, post-test, and 6 month intervals for 36 months)
Heroin use initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported heroin use
Marijuana initiation
时间窗: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported marijuana use
Past month frequency of marijuana use
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month marijuana use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of electronic vapor product use
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month electronic vapor product use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime chewing tobacco use
时间窗: Change from baseline to 36 months after intervention
Percentage reporting chewing tobacco use (measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime frequency of prescription pain medicine use without a prescription or other than as prescribed [adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime non-medical pain medicine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of cocaine use [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month cocaine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime frequency of methamphetamine use [adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime methamphetamine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month suicidal ideation [youth only]
时间窗: Change from baseline to 36 months after intervention
Youth Risk Behavior Survey items adapted to past month time frame; Middle school version for youth up to age 12 (scored 0-3); High school version for youth aged 13+ (scored 0-8).
Lifetime cocaine use [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Percentage cocaine use (measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of heroin use [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of past month heroin use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime frequency of cocaine use [adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime cocaine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime frequency of heroin use [youth aged 13+ and adults only]
时间窗: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime heroin use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
次要结局
- Family conflict [youth reports](Change from baseline to 36 months after intervention)
- Family expressiveness [youth reports](Change from baseline to 36 months after intervention)
- General parent-child communication [youth reports](Change from baseline to 36 months after intervention)
- Parental monitoring [youth reports](Change from baseline to 36 months after intervention)
- Children's Hope Scale [youth only](Change from baseline to 36 months after intervention)
- Past week depression [youth only](Change from baseline to 36 months after intervention)
- Family expressiveness [adult reports](Change from baseline to 36 months after intervention)
- Substance use resistance skills [youth only](Change from baseline to 36 months after intervention)
- Antisocial behavior [youth only](Change from baseline to 36 months after intervention)
- Use of family meetings [adult reports only](Change from baseline to 36 months after intervention)
- Parent warmth [adult reports](Change from baseline to 36 months after intervention)
- Parent negative affect [youth reports](Change from baseline to 36 months after intervention)
- Parental structure/rule setting [youth reports](Change from baseline to 36 months after intervention)
- Parental support of autonomy [youth report only](Change from baseline to 36 months after intervention)
- Parent rules about substance use [youth and adult reports](Change from baseline to 36 months after intervention)
- Parent communication about alcohol and drugs [youth and adult reports](Change from baseline to 36 months after intervention)
- Substance use attitudes [youth only](Change from baseline to 36 months after intervention)
- Substance use norms [youth only](Change from baseline to 36 months after intervention)
- Awareness of Connectedness scale (adapted) [youth only](Change from baseline to 36 months after intervention)
- General parent-child communication [adult reports](Change from baseline to 36 months after intervention)
- Parent warmth [youth reports](Change from baseline to 36 months after intervention)
- Parental use of discipline [adult report only](Change from baseline to 36 months after intervention)
- Support for parenting [adult report only](Change from baseline to 36 months after intervention)
- Association with deviant peers [youth only](Change from baseline to 36 months after intervention)
- Parental structure/rule setting [adult reports](Change from baseline to 36 months after intervention)
- Parenting self-efficacy [adult report only](Change from baseline to 36 months after intervention)
- Substance use patterns (use of substances around children) [adults only](Change from baseline to 36 months after intervention)
- Family cohesion [adult reports](Change from baseline to 36 months after intervention)
- Family cohesion [youth reports](Change from baseline to 36 months after intervention)
- Family conflict [adult reports](Change from baseline to 36 months after intervention)
- Parent negative affect [adult reports](Change from baseline to 36 months after intervention)
- Parental anger management [adult report only](Change from baseline to 36 months after intervention)