A comprehensive intervention to treat emerging drug-using populations

2.1导言：儿童是一个关键的研究人群，因为物质使用可能会改变大脑发育。物质使用障碍是一种儿科疾病，儿童应该得到与青少年和成年人同样的关注。该项目将检查从接受药物治疗的儿童中收集的前瞻性识别数据，以向提供者提供在美国如何治疗儿童的信息。2011年，美国国务院国际麻醉品和执法事务局支持联合国毒品和犯罪问题办公室(毒品和犯罪问题办公室)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结果。PI的Hendree Jones博士开发了治疗儿童(4-17岁)药物使用的方案。从我们的早期版本的停止使用毒品：儿童干预促进发展(SUN CHILD)干预治疗的700名儿童的结果显示，儿童显示出从基线到治疗后评估的显著下降的一致模式，在精神障碍、焦虑相关的情绪障碍、社交问题和生活质量的提高方面的后续进展保持不变。设计：NIDA支持的这项研究将在美国接收和分析一项平行的两组随机对照试验的未确定数据，在该试验中，7-12岁的使用药物(大麻、溶剂或阿片类药物)的儿童进入住宅治疗，随机接受太阳儿童干预(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，代表该人群中药物使用的大致流行情况。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。直接比较干预条件将开始回答有关减少大麻、溶剂和阿片类药物使用以及其他物质使用和改善儿童福祉的有效性的关键问题。目的：主要目的是确定相对于通常的护理条件，太阳儿童状况在多大程度上表现出两个主要结果：(A)平均治疗时间延长，以及(B)在治疗后和治疗后1、3、6和12个月的随访中，精神活性物质的平均使用量大幅减少；对于六个次要结果，(C)艾滋病毒危险行为，(D)精神障碍，(E)与焦虑相关的情绪障碍，(F)社会问题，(G)创伤后应激症状，以及(H)治疗后和治疗后1、3、6和12个月的随访，平均生活质量有较大幅度的下降。辅助目标包括了解SUN CHILD对(1)女孩和男孩、(2)年龄较小的儿童和年龄较大的儿童的不同疗效的程度，以及(3)检查SUN CHILD在大麻、溶剂或阿片类药物是主要选择的儿童中的相对疗效。目标：近期：根据上述结果，确定SUN儿童干预的效果。远端：开发一种有效的干预措施，以停止儿童中的药物使用。

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.