A comprehensive intervention to treat emerging drug-using populations

2.1 简介：鉴于物质使用可能改变大脑发育，儿童是研究的关键人群。药物使用障碍是一种儿科疾病，儿童应得到与青少年和成人同样的关注。该项目将检查前瞻性地从接受药物治疗的儿童中收集的去识别化数据，以告知提供者如何在美国治疗儿童。 2011年，美国国务院国际麻醉品和执法事务局（INL）支持联合国毒品和犯罪问题办公室（UNODC）制定和实施一项干预措施，重点是减少药物使用和改善儿童的结局。首席研究员 Hendree Jones 博士制定了治疗儿童（4-17 岁）药物滥用的方案。接受早期版本的“停止使用麻醉品：儿童干预促进发展”(SUN CHILD) 干预治疗的 700 名儿童的结果表明，从基线到治疗后评估，儿童表现出一致的显着下降（所有 p<0.001），但在精神障碍、焦虑相关情绪障碍、社交问题和生活质量提高方面的随访中仍保持进步。设计：本研究由 NIDA 支持的部分将在美国接收和分析一项平行、两组、随机对照试验的去识别化数据，其中使用物质（大麻、溶剂或阿片类药物作为主要使用药物）的 7-12 岁儿童进入住院治疗，随机接受 SUN CHILD 干预（n=272：204 名男孩和 68 名女孩）或常规护理（n=272： 204 名男孩和 68 名女孩），分配治疗的男女比例为 3:1，代表了该人群物质使用的大致流行率。结果评估工具将在基线、治疗后以及治疗后 1、3、6 和 12 个月的随访中进行管理。直接比较干预条件将开始回答有关减少大麻、溶剂和阿片类药物以及其他物质使用和改善儿童福祉的功效的关键问题。目的：主要目的是确定 SUN CHILD 状况相对于常规护理状况在多大程度上显示出两个主要结局：(a) 平均治疗持续时间更长，以及 (b) 在治疗后以及治疗后 1、3、6 和 12 个月的随访过程中精神活性物质的平均使用量大幅减少；对于六项次要结局，治疗后以及治疗后 1、3、6 和 12 个月的随访时，平均 (c) HIV 危险行为、(d) 精神障碍、(e) 焦虑相关情绪障碍、(f) 社会问题、(g) 创伤后应激症状均值显着降低，平均 (h) 生活质量显着提高。辅助目标包括了解 SUN CHILD 对 (1) 女孩和男孩、(2) 年幼儿童与年龄较大儿童的不同有效程度，以及 (3) 检查 SUN CHILD 对以大麻、溶剂或阿片类药物为主要选择药物的儿童的相对疗效。目标： 近端：根据上述结果确定 SUN CHILD 干预措施的有效性。远端：制定有效的干预措施来阻止儿童滥用药物。

2.1 Introduction: Children are a critical population to study given the potential for changed brain development due to substance use. Substance use disorders are a pediatric disease and children deserve the same attention as adolescents and adults. This project will examine prospectively collected de-identified data from children receiving drug treatment to inform providers how children can be treated in the USA. In 2011, the Bureau of International Narcotics and Law Enforcement Affairs (INL) of the US Department of State supported the United Nations Office on Drugs and Crime (UNODC) in the development and implementation of an intervention focused on reducing substance use and improving outcomes for children. Dr. Hendree Jones, PI developed the protocols to treat substance use in children (ages 4-17). Results from the 700+ children treated with this early version of our Stopping Use of Narcotics: CHild Intervention to Lift Development (SUN CHILD) intervention indicated that children showed a consistent pattern of significant (all ps<.001) decreases from baseline to post-treatment assessment, with gains maintaining at follow-up in psychiatric disturbance, anxiety-related emotional disorders, social problems, and increases in quality of life. Design: The NIDA-supported part of this study will be to receive and analyze in the USA, the de-identified data from a parallel, two-group, randomized controlled trial in which substance-using (cannabis, solvents, or opioids as the primary drug of use) children 7-12 years of age entering residential treatment randomized to receive either the SUN CHILD intervention (n=272: 204 boys and 68 girls), or usual care (n=272: 204 boys and 68 girls), with the 3:1 male:female ratio of assignment to treatment representing the approximate prevalence of substance use in this population. Outcome assessment instruments will be administered at baseline, post-treatment, and 1-, 3-, 6-, and 12-month post-treatment follow-up. Directly comparing intervention conditions will begin to answer critical questions about the efficacy of reducing cannabis, solvent, and opioid use as well as other substance use and improving the well-being of children. Aims: The main aim is to determine the extent to which the SUN CHILD condition, relative to the usual care condition, shows for the two primary outcomes, (a) longer mean duration of treatment, and (b) greater reductions in mean use of psychoactive substances over the course of post-treatment and 1-, 3-, 6-, and 12-months post-treatment follow-up; and, for the six secondary outcomes, greater reductions in mean (c) HIV risk behaviors, (d) psychiatric disturbance, (e) anxiety-related emotional disorders, (f) social problems, (g) post-traumatic stress symptoms, and larger increases in mean (h) quality of life at post-treatment and 1-, 3-, 6-, and 12-months post-treatment follow-up. The ancillary aim includes understanding the extent to which SUN CHILD is differentially efficacious for (1) girls and boys, (2) younger children v. older children, and (3) examining the relative efficacy of SUN CHILD in children for whom cannabis, solvents, or opioids is the primary drug of choice. Goals: Proximal: To determine the efficacy of the SUN CHILD intervention in terms of the above noted outcomes. Distal: To develop an efficacious intervention to stop substance use among children.