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临床试验/NCT00198939
NCT00198939已完成1 期

Neurological Influences on Drug Prevention Intervention

University of Florida2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
330
试验地点
2
主要终点
Alcohol use abstinence and frequency

研究概览

简要总结

In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.

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
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 11 to 15 year old middle school students

排除标准

  • Acute suicidal, homicidal, psychotic ideation
  • Problem severity indicating outpatient or residential treatment

结局指标

主要结局

Alcohol use abstinence and frequency

时间窗: 3, 6, 9, 12, and 18 month Follow-up assement

Personal Experience Inventory (PEI) is a youth self-report drug use inventory that assesses the frequency and quantity of substance use and drug abuse risk factors, such as deviant behavior and peer drug use.

Marijuana use abstinence and frequency

时间窗: 3, 6, 9, 12, and 18 Month Follow-up Assessment

The Personal Experience Inventory (PEI) is a youth self-report drug use inventory that assesses the frequency and quantity of substance use and drug abuse risk factors, such as deviant behavior and peer drug use.

Other drug use abstinence and frequency

时间窗: 3, 6, 9, 12, 18 month Follow-up Assessment

The Adolescent Stage of Change Scale (ASCS) consists of items to measure youths' motivation to change drug use behavior. Urine will also be analyzed for the presence of drugs, such as cannabinoids, cocaine, opiates, amphetamine, methamphetamine, MDMA, benzodiazepines, and barbiturates using gas chromatography/mass spectrometry methods.

次要结局

  • Academic achievement(3,6,9,12, and 18 month assessment)
  • Family functioning(3,6,9,12, and 18 month follow-up assessment)
  • Learning Strategy Skill(3,6,9,12, and 18 month assessment)
  • Legal Involvement(3,6,9, 12, and 18 month follow-up assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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