Vitiello Benedetto, Aman Michael G, Scahill Lawrence, McCracken James T, McDougle Christopher J, Tierney Elaine, Davies Mark, Arnold L Eugene
Child and Adolescent Treatment and Preventive Intervention Research Branch, National Institute of Mental Health, Bethesda, MD 20892-9633, USA.
J Am Acad Child Adolesc Psychiatry. 2005 Feb;44(2):145-9. doi: 10.1097/00004583-200502000-00006.
Parental permission is required for child research, but parents' understanding of research aims and procedures has not been well documented. Parental research knowledge was assessed during a clinical trial in autism.
Parents of 101 children (age 5-17 years) with autism participating in a placebo-controlled trial of risperidone were given a questionnaire at the end of the study.
Of the 95 parents completing the questionnaire, 99% knew of possible placebo assignment and that testing the medication efficacy was the main purpose of the investigators; 96% to 98% knew that research involved both risks and potential benefits, identified the study medication, and knew of their right to withdraw at any time; 90% to 95% knew of the medication's main side effects; 87% reported having been informed of possible alternatives to research participation; and 72% were aware that treatment was randomly assigned (whereas 27% reported that treatment was chosen based on individual needs to ensure best care). Parents with a college degree were more likely to recognize the random nature of treatment assignment.
Overall, parents were highly knowledgeable of the main research components. About one fourth, however, seemed unaware that treatment was randomly determined and not personalized, suggesting that therapeutic misconception may affect some otherwise well-informed parents.
儿童研究需要获得家长的许可，但家长对研究目的和程序的理解尚未得到充分记录。在一项针对自闭症的临床试验中对家长的研究知识进行了评估。
101名年龄在5至17岁之间的自闭症儿童的家长参与了一项关于利培酮的安慰剂对照试验，在研究结束时向他们发放了问卷。
在完成问卷的95位家长中，99%知道可能会进行安慰剂分配，并且知道测试药物疗效是研究人员的主要目的；96%至98%知道研究既有风险也有潜在益处，能识别研究药物，并且知道他们有随时退出的权利；90%至95%知道药物的主要副作用；87%报告称已被告知参与研究可能的替代方案；72%知道治疗是随机分配的（而27%报告称治疗是根据个体需求选择以确保最佳护理）。拥有大学学位的家长更有可能认识到治疗分配的随机性。
总体而言，家长对主要研究内容了解程度很高。然而，约四分之一的家长似乎未意识到治疗是随机确定的而非个性化的，这表明治疗性误解可能会影响一些在其他方面了解情况的家长。
