Follow-up of the PATS Sample

描述（由申请人提供）：这六个网站的后续申请要求资助一项为期五年的研究哌甲酯（MPH）的安全性在儿童谁最初招募和随机进入学龄前注意力缺陷/多动障碍（ADHD）治疗研究（PATS）。我们建议继续我们的多中心合作，以便对学龄前（3-5岁）被诊断患有ADHD的儿童进行系统的随访研究，并参加最初的学龄前儿童ADHD治疗研究（PATS），以确定哌甲酯的安全性和有效性。我们估计，在约300名符合参与计划准则的儿童中，约有200名可接受跟进。拟议的后续研究将在这些儿童5-9岁时对其进行评估。它将设在纽约州立精神病学研究所（NYSPI）、杜克大学、约翰霍普金斯大学（JHU）、纽约大学（NYU）、加州大学洛杉矶分校（UCLA）和加州大学欧文分校（UCI）。 目的1是解决MPH的早期治疗是否与任何负面的身体（身高和体重增长率降低），认知或行为（例如，睡眠障碍、抽搐）影响。目的2是确定随着儿童年龄的增长，哌甲酯剂量-反应关系的连续性，包括其减少ADHD症状，减少合并症症状和改善整体功能的能力。目标3是确定儿童的初始诊断和治疗状况以及治疗反应对五年随访期间接受的服务类型的影响程度。目的4是确定在3-5岁时进入研究的ADHD诊断和其他合并症在后续发展中的稳定性

DESCRIPTION (provided by applicant): This six-site follow-up application requests funding for a five year study of the safety of methylphenidate (MPH) in children who had been originally recruited and randomized into the preschool Attention-Deficit / Hyperactivity Disorder (ADHD) treatment study (PATS). We propose to continue our multisite collaboration in order to conduct a systematic follow-up study of the children who were diagnosed with ADHD in preschool years (ages 3-5 years) and participated in the original Preschoolers with ADHD Treatment Study (PATS) to determine the safety and efficacy of methylphenidate. We estimate that of the about 300 children meeting PATS entry criteria, about 200 will be available for follow-up. The proposed follow-up study will assess these children as they turn 5-9 years of age. It will be based at the New York State Psychiatric Institute (NYSPI), Duke University, Johns Hopkins University (JHU), New York University (NYU), University of California at Los Angeles (UCLA), and University of California at Irvine (UCI). Aim 1 is to address whether early treatment with MPH is associated with emergence of any negative physical (decreased height and weight growth rates), cognitive, or behavioral (e.g., sleep disturbance, tics) effects. Aim 2 is to determine the continuity of dose-response relationships for methylphenidate as the child grows older, including its ability to decrease ADHD symptoms, decrease symptoms from comorbidities, and improve overall functioning. Aim 3 is to ascertain the extent to which the children's initial diagnostic and treatment status and treatment response impact on type of services received during the five-year follow-up period. Aim 4 is to determine the stability of the ADHD diagnosis and other comorbidities made for study entry at age 3-5 years across subsequent development