MULTISITE MULTIMODALITY TREATMENT STUDY OF ADHD/ADD

我们建议筛选250名潜在参与者(或5个地点的1,250名)。 我们将使用两个来源：医疗转介(n=125)和小学 学生125人。我们预计将对200人进行全面评估 个人，其中将包括一次结构化的面试，并确认 DSM-IV对170例ADHD的诊断 研究对象。亚组将根据存在的共病童年而形成 精神错乱。这170名受试者将被给予双盲剂量 2种刺激性药物(哌醋甲酯和D-羟色胺)的疗效评价 安非他命)，我们预计10%的人会拒绝或表现出 不良反应。这将留下大约150种兴奋剂反应 ADHD将随机分配到5个治疗组中的一个：社区 治疗(COM，n+30)，结构化药物(MED，n=30)，MED加学校- 基础干预(MED+SCH，n=30)，MED+SCH+家长培训 (MED+SCH+PAR，n=30)和MED+SCH+PAR加个体化综合治疗 从Satterfield菜单中选择(MED+SCH+PAR+SAT，n=30)。如果这是 在5个站点上复制，这将产生150个受试者的小组规模 5个治疗组各1个。 将实施为期两年的治疗方案。我们预计每年会有10%的增长 流失率，所以在治疗后3年的随访中，我们预计 每组保留约22名受试者(或5个地点的110名受试者)。 将采取两种类型的结果衡量标准来评估 治疗。首先，我们将使用爱荷华州和SNAP的家长和教师评级 扩展以获得对I/O和A/D行为以及ADHD的季度评估 症状学记录治疗的短期效果和进展。 第二，我们将每年进行一次全面的评估，以衡量初始， 维护，以及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。我们的 样本量将使我们有足够的统计能力来评估影响 综合治疗(MED+SCH+PAR+SAT)的效果超过 单独用药(MED)。我们的嵌套设计将允许我们拆卸 多通道效应，如果应该出现的话，在最常见的方面 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).