Stepped Pharmacotherapy for Aggressive Youth with ADHD

患有多动症的攻击性青少年的阶梯式药物治疗

• 批准号: 6851430
• 负责人: Joseph C Blader
• 金额: $ 15.08万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-19 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6851430
• 关键词: aggression; anticonvulsants; attention deficit disorder; behavioral /social science research tag; central nervous system stimulants; child rearing; clinical research; clinical trials; combination chemotherapy; conduct disorder; dextroamphetamine; family genetics; human subject; impulsive behavior; interview; mental disorder chemotherapy; methylphenidate; middle childhood (6-11); mood disorders; patient oriented research; psychopharmacology; psychotherapy; questionnaires; valproate

DESCRIPTION (provided by applicant): The goal of this Mentored Patient-Oriented Research Career Development Award is to promote the candidate's progress toward an independent scientific career focused on treatment strategies for youth with severe disruptive disorders. Didactics and apprenticeship in interventions research skills in Year 1 will prepare the candidate to initiate a study of stepped pharmacotherapy for aggressive youth with attention-deficit/hyperactivity disorder (ADHD). This study, conducted in Years 2, 3 and part of 4, will a) provide the candidate with supervised experience in controlled treatment research, and b) address the critical need for rigorous trials to examine if combined medication approaches improve outcomes over monotherapy in this patient group. Childhood aggressive behavior most often develops alongside other disruptive disorder symptoms, which are highly comorbid with ADHD. Stimulant medication is first-line treatment for ADHD. Yet, for many children receiving stimulant treatment, aggressive behavior and affective instability remain significant impairments, leading clinicians to layer additional medications in efforts to diminish aggressive dyscontrol. However, the lack of evidence to support any medication combination strategy for these children is a great concern. The proposed study will first optimize open stimulant treatment for aggressive children 6- 12 years old with ADHD and a comorbid disruptive disorder. Children whose ADHD symptoms benefit from stimulant treatment but whose aggression persists will be randomly assigned to the mood stabilizer divalproex sodium or placebo during an 8-week double-blind trial while their stimulant treatment continues. All families will receive structured psychosocial treatment. The study will furnish preliminary data to enable a full-scale efficacy study, supported through an R01 to be submitted in Year 4. Further training activities throughout the award period will equip the candidate with research skills and provide experience in the areas of: a) intervention trial design and statistics, b) development and adoption in clinical settings of treatment strategies, including combined medication and psychosocial treatment, and c) assessment, including observational and laboratory approaches to outcome and mediator measurement. Mentors (N. Schooler, P. Jensen, V. Kafantaris) and consultants (including H. Abikoff, P. Frick, C. Grillon, J. Halperin, J. Kane, D. Kolko, S. Pliszka) will provide expert training and supervision. The proposed program will therefore culminate in the awardee's competence as a well-rounded clinical scientist focused on the complex treatment needs of youth with severe behavior disorders.

描述（由申请人提供）：这一受过指导患者的研究职业发展奖的目的是促进候选人的进步，朝着专注于严重破坏性疾病青年的治疗策略的独立科学职业。第1年的干预研究技能的教学和学徒制将为候选人做好准备，以对患有注意力缺陷/多动症障碍（ADHD）的激进青年进行阶梯性药物治疗。这项研究在第2、3和4年的一部分中进行，将为a）为候选人提供受控治疗研究的监督经验，b）解决了严格的试验的关键需求，以检查该患者组中是否有合并的药物方法改善了对单一疗法的结果。儿童攻击行为通常与其他破坏性疾病症状一起发展，这些症状与多动症高度合并。刺激性药物是多动症的一线治疗。然而，对于许多接受刺激性治疗的儿童，侵略性行为和情感不稳定仍然是重大障碍，导致临床医生对减少攻击性障碍障碍的努力进行了额外的药物分层。但是，缺乏支持这些孩子的任何药物组合策略的证据是一个很大的问题。拟议的研究将首先优化6至12岁患有多动症和合并症颠覆性疾病的侵略性儿童的开放式刺激治疗。在为期8周的双盲试验中，在刺激性的双盲试验中，他们的侵略性持续的刺激性治疗中受益但其侵略性持续的儿童将随机分配给情绪稳定剂Divalproex钠或安慰剂。所有家庭都将接受结构化的社会心理治疗。这项研究将提供初步数据，以实现通过R01支持的全尺度效能研究，并在第4年中提交。在整个奖励期间的进一步培训活动将使候选人具备研究技能，并在以下方面提供研究技能，a）干预试验设计和统计数据，b）在包括临床治疗策略和精神疾病的临床环境中的发展和采用，包括临床和C），以及CASSICAIL COSCOCIAL COSCIAL COPIACTIAL和CESSICAL COSCOCIAL COPIACIAL和CESSICAL COSCOCIAL COPICAL COMPITION，以及）。中介测量。导师（N. Schooler，P。Jensen，V。Kafantaris）和顾问（包括H. Abikoff，P。Frick，C。Grillon，J。Halperin，J。Kane，J。Kane，D。Kolko，S。Pliszka）将提供专家培训和监督。因此，拟议的计划将以全面的临床科学家为重点，重点介绍了严重行为障碍青年的复杂治疗需求。