Adolescent and Parental Attitudes About STI Prevention Trial Participation

描述(申请人提供)：贝尔蒙特报告的“正义”概念意味着青少年应该参与性传播感染的研究，因为他们的感染率很高。然而，他们也是一个“弱势”群体，这意味着他们应该受益于父母的指导，而不会在决策过程中受到不适当的影响。了解父母和青少年在参与意愿(WTP)方面的不一致有助于制定策略，以确保双方都对最终决定感到满意。决策受发展特征的影响，因此，考虑到青春期的快速变化，随着时间的推移也会发生变化。局部杀微生物剂的安全性试验将是检查WTP的背景，允许适用于其他试验类型。具体目标：1)在性传播感染预防研究的背景下，描述发展特征(认知和相关经验、父母教养方式和家庭变量)与WTP、对隐私的态度和父母的影响以及不和谐之间的关系；2)描述发展特征(认知和相关经验、父母教养方式和家庭关系)随时间的变化与WTP和对隐私的态度和父母影响的态度之间的关系；以及在STI预防研究的背景下，描述WTP中的不和谐；3)描述青少年与父母对不和谐的管理，因为它涉及对试验显著方面的感知，以及青少年与父母的互动方式，因为它涉及对参与的最终决定的不和谐和满意度。方法：采用多层次策略，从初级保健诊所招募14-17岁男女青少年及其家长。将在决策的所有阶段获得关于不参与的数据，以便收集关于通常不会参与研究的父母和青少年的信息。假设性临床试验的使用允许对不愿参与试验的家庭进行评估。家长和青少年将由两名不同的面试者同时进行采访，然后完成联合采访，并将采访录制下来，用于互动的编码。为了评估发展变化的影响，参与者将在一年后重新接受采访。结果：这些信息将用于制定和评估干预措施，旨在为青少年提供机会，使他们有机会在父母的指导下参加研究，并拥有自主作出决定的权利。

DESCRIPTION (provided by applicant): The Belmont Report's concept of "justice" means adolescents should participate in studies regarding sexually transmitted infections, given their high rates of infection. Yet they are also a "vulnerable" population, which means they should benefit from parental guidance without being inappropriately influenced in their decision-making. Understanding parent-adolescent discordance about willingness to participate (WTP) helps develop strategies to insure that both are comfortable with the final decision. Decision-making is influenced by developmental characteristics, thus, given the rapid changes during adolescence there will be changes over time. A safety trial of topical microbicides will be the context in which to examine WTP, allowing for applicability to other trial types. Specific Aims: 1) Describe the relationship between developmental characteristics (cognition and relevant experience, parenting and family variables) and WTP, attitudes towards privacy and parental influence, and discordance in the context of a study of STI prevention; 2) Describe the relationship between changes in developmental characteristics (cognition and relevant experience, parenting and family relationships) over time and WTP and attitudes towards privacy and parental influence, and discordance in WTP in the context of a study of STI prevention; 3) Describe adolescent-parent management of discordance as it relates to perceptions of the salient aspects of the trial and adolescent-parent interactional style as it relates to discordance and satisfaction with the final decision regarding participation. Methods: A multi-level strategy will be used to recruit 14-17 year old male and female adolescents and parents from primary care clinics. Data about non-participation will be obtained at all stages of decision-making in order to collect information about parents and adolescents who would normally not participate in research. The use of a hypothetical clinical trial allows for assessment of families who would not participate in trials. Parents and adolescents will be interviewed simultaneously by two different interviewers, and then complete a joint interview, which will be videotaped for coding of the interaction. To evaluate the impact of developmental change, participants will be re-interviewed one year later. Outcomes: This information will be used to develop and evaluate interventions designed to provide adolescents the opportunity to participate in studies with as much guidance as needed from parents and the autonomy to make their own decision.