MULTISITE MULTIMODALITY TREATMENT STUDY OF ADHD/ADD

我们建议筛选250名潜在参与者（或5个研究中心的1，250名）。 我们将使用两个来源：医疗转诊（n=125）和小学 学生（n=125）。 我们预计将对200个国家进行全面评估， 个人，其中将包括结构化面试，并确认 DSM-IV诊断为ADHD的170名个体将以以下身份进入研究： 科目 将根据是否存在共病儿童形成亚组 紊乱 这170例受试者将接受双盲给药， 2种兴奋剂药物（哌甲酯和d- 安非他明），我们预计10%将拒绝或表现出 不良反应 这将使大约150名对兴奋剂敏感的人 ADHD被随机分配到5个治疗组之一：社区 治疗（COM，n+30）、结构性药物治疗（MED，n=30）、MED+学校- 基于干预（MED+SCH，n=30），MED+SCH加家长培训 (MED+SCH+PAR，n=30）和MED+SCH+PAR+定制多模式治疗 从Satterfield菜单中选择（MED+SCH+PAR+SAT，n=30）。 如果这是 在5个研究中心重复，这将产生150名受试者的组规模， 5个治疗组中的每一个。 将实施为期2年的治疗方案。 我们希望每年有10%的 因此，在治疗后3年的随访中，我们预计 每组保留约22例受试者（或5个研究中心的110例受试者）。 将采用两种类型的结局指标来评估 治疗。 首先，我们将使用爱荷华州和SNAP家长和教师评级 量表，以获得I/O和A/D行为和ADHD的季度评估 病理学记录短期效果和治疗进展。 第二，我们将每年进行一次全面评估，以衡量初始， 维持，并在5个领域的长期影响：家庭行为，学校 行为、学校表现、同伴地位和家庭功能。 我们 样本量将使我们有足够的统计能力来评估影响 多模式治疗（MED+SCH+PAR+SAT）的效果， 单独用药（MED）。 我们的嵌套设计将允许我们拆除 多模态效应，如果出现的话，就最常见的 心理社会（PAR）和新兴的心理教育治疗（SCH）。

We propose to screen 250 potential participants (or 1,250 across 5 sites). We will use two sources: medical referrals (n=125) and elementary school students (n=125). We expect to perform a comprehensive assessment of 200 individuals, which will include a structured interview, and to confirm a DSM-IV diagnosis of ADHD in 170 individuals who will enter the study as subjects. Subgroups will be formed based on presence of comorbid childhood disorders. These 170 subjects will be offered a double-blind, dose response assessment of 2 stimulant medications (methylphenidate and d- amphetamine), and we anticipate that 10% will either refuse or manifest an adverse response. This will leave approximately 150 stimulant-responsive ADHD to be randomly assigned to 1 of 5 treatment groups: Community Treatment (COM, n+30), Structured Medication (MED, n=30), MED plus School- Based intervention (MED+SCH, n=30), MED+SCH plus Parent Training (MED+SCH+PAR, n=30), and MED+SCH+PAR plus tailored multimodality treatment selected from the Satterfield menu (MED+SCH+PAR+SAT, n=30). If this were duplicated across 5 sites, this would yield a group size of 150 subjects in each of the 5 treatment groups. A 2 year treatment protocol will be implemented. We expect a 10% yearly attrition rate, so at the follow-up 3 years after treatment we expect to retain about 22 subjects (or 110 subjects across 5 sites) in each group. Two types of outcome measures will be taken to evaluate effects of treatments. First, we will use the IOWA and SNAP parent and teacher rating scales to obtain quarterly assessments of I/O and A/D behavior and ADHD symptomology to document short-term effects and progress in treatment. Second, we will perform a full assessment yearly to measure initial, maintenance, and long-term effects in 5 areas: home behavior, school behavior, school performance, peer status, and family functioning. Our sample size will give us adequate statistical power to evaluate the impact of multimodality treatment (MED+SCH+PAR+SAT) over and above the effect of medication alone (MED). Our nested design will allow us to dismantle the multimodality effect, if one should emerge, in terms of the most common psychosocial (PAR) and an emerging psychoeducational treatment (SCH).