MULTISITE MULTIMODALITY TREATMENT STUDY OF ADHD/ADD

ADHD/ADD 的多部位多模式治疗研究

• 批准号: 2249780
• 负责人: JAMES M SWANSON
• 金额: $ 75.5万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1997-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2249780
• 关键词: academic achievement; amphetamines; attention deficit disorder; behavior modification; behavior test; central nervous system stimulants; child behavior; cognitive behavior therapy; cooperative study; dosage; elementary school; family structure /dynamics; family therapy; human subject; human therapy evaluation; interpersonal relations; interview; mental disorder chemotherapy; mental disorder diagnosis; methylphenidate; middle childhood (6-11); parent offspring interaction; pediatric pharmacology; peer group; problem solving; psychometrics; questionnaires; social behavior

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).

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（n=125）。 我们预计对200个项目进行全面评估 个人，其中将包括结构化面试，并确认 DSM-IV 对 170 名个人进行 ADHD 诊断，这些人将作为 科目。 将根据童年共病的存在情况来形成亚组 失调。 这 170 名受试者将接受双盲、剂量 2 种兴奋剂药物（哌甲酯和 d-）的反应评估 安非他明），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 个对兴奋剂有反应的 ADHD 将被随机分配到 5 个治疗组中的 1 个：社区 治疗（COM，n+30），结构化药物（MED，n=30），MED 加学校- 基于干预（MED+SCH，n=30），MED+SCH 加家长培训 （MED+SCH+PAR，n=30），以及 MED+SCH+PAR 加上定制的多模式治疗 从 Satterfield 菜单中选择（MED+SCH+PAR+SAT，n=30）。 如果这是 在 5 个地点重复，这将产生 150 名受试者的小组规模 5个治疗组中的每一个。 将实施为期 2 年的治疗方案。 我们预计每年 10% 损耗率，因此在治疗后 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）。 将采取两种结果措施来评估效果 治疗。 首先，我们将使用 IOWA 和 SNAP 家长和教师评级 进行扩展以获得 I/O 和 A/D 行为以及 ADHD 的季度评估 症状学记录短期效果和治疗进展。 其次，我们将每年进行一次全面评估，以衡量初始、 维护和 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 样本量将为我们提供足够的统计能力来评估影响 多模式治疗（MED+SCH+PAR+SAT）的效果优于 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，就最常见的情况而言 社会心理（PAR）和新兴的心理教育治疗（SCH）。