Computerized Screen for Adverse Events Associated with SSRI's in Youth

青少年与 SSRI 相关不良事件的计算机筛查

• 批准号: 7282699
• 负责人: Prudence Winslow Fisher
• 金额: $ 22.49万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-18 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7282699
• 关键词: Adolescent; Adverse event; Agreement; Antidepressive Agents; Area; Behavior; Boxing; Characteristics; Child; Childhood; Classification; Clinic; Clinical; Clinical Trials; Communities; Community Practice; Computers; Data; Development; Event; Exercise; Expert Opinion; Feeling suicidal; Foundations; Glossary; Goals; Intervention; Label; Medical; Mental Health; Methods; Monitor; Parents; Patients; Performance; Pharmaceutical Preparations; Physicians; Procedures; Reading; Recruitment Activity; Reporting; Research; Research Personnel; Research Project Grants; Respondent; Risk; Safety; Sampling; Screening procedure; Specificity; Standards of Weights and Measures; Symptoms; Technology; Testing; Thinking; Time; Training Support; United States Food and Drug Administration; Validation; Validity and Reliability; Videotape; Youth; base; computerized; depressive symptoms; experience; improved; instrument; programs; psychopharmacologic; satisfaction; sound; suicidal; suicidal risk; user-friendly

DESCRIPTION (provided by applicant): The recent controversy concerning the relationship between antidepressant medication and suicidal ideation and behavior has highlighted the need for better methods for standardized and systematic monitoring of adverse events associated with the use of such agents. The aim of this project is to develop better methods to systematically screen for and assess adverse events associated with the use of antidepressant medications with children and adolescents, including suicidal events and symptoms/behaviors thought to portend increased suicide risk. The methods to be developed are necessary for a planned R01 study to (1) evaluate the risks of antidepressant medications and (2) examine the impact of introducing a standardized safety monitoring procedure on clinical practice. Two methods will be developed: (1) A computerized screening instrument for adverse events experienced by children and adolescents who take SSRI's and other anti-depressant medications. The this instrument will: (a) have parent and youth versions (b) use sound technology so that the computer "reads" the questions, allowing use with those of limited reading ability, (c) yield an instant report that will indicate areas of possible concern and (d) be feasible to include in psychopharmacological research trials and busy community settings (2) A standard glossary of adverse events and materials (including videotapes) which can be used to systematically classify specific adverse events thought to be associated with treatment of depressive illness. The glossary will help improve the classification of adverse event reports The performance characteristics -- test-retest reliability, validity, feasibility, acceptability to clinicians and patients (and parents) - of the computerized AE screening instrument will be evaluated in 80 child and adolescent/parent pairs. Data from the study will be used to refine the screen and will serve as a foundation for the R01 application, which will be prepared during the second year of the project. A second long term goal of the research is to develop a user friendly, psychometrically sound assessment method that might be used in typical community settings to better monitor the safety of antidepressant medications with pediatric patients.

描述（由申请人提供）：最近关于抗抑郁药物与自杀意念和行为之间关系的争议强调了需要更好的方法来标准化和系统地监测与使用此类药物相关的不良事件。该项目的目的是开发更好的方法来系统地筛查和评估与儿童和青少年使用抗抑郁药物相关的不良事件，包括自杀事件和被认为预示自杀风险增加的症状/行为。所开发的方法对于计划的R 01研究是必要的，以（1）评价抗抑郁药物的风险和（2）检查引入标准化安全性监测程序对临床实践的影响。将开发两种方法：（1）一种计算机化的筛查工具，用于筛查服用SSRI和其他抗抑郁药物的儿童和青少年所经历的不良事件。该文书将：（a）让家长版和青少年版（B）使用声音技术，以便计算机“阅读”问题，允许阅读能力有限的人使用，（c）产生一份即时报告，指出可能关注的领域，（d）可纳入精神药理学研究试验和忙碌社区环境（2）不良事件和材料的标准词汇表（包括录像带），可用于系统分类被认为与抑郁症治疗相关的特定不良事件。该词汇表将有助于改善不良事件报告的分类。将在80对儿童和青少年/父母中评价计算机化AE筛查工具的性能特征--重测信度、效度、可行性、临床医生和患者（及父母）的可接受性。该研究的数据将用于优化筛选，并将作为R 01应用程序的基础，该应用程序将在项目的第二年进行准备。该研究的第二个长期目标是开发一种用户友好的，心理测量学上合理的评估方法，可用于典型的社区环境，以更好地监测儿科患者抗抑郁药物的安全性。