P4.101 Adolescents’ And their parents’ attitudes over time about parental involvement in clinical research

Introduction Adolescent participation in reproductive health clinical trials requires balancing adolescent autonomy and parental involvement. Previous work indicated that adolescents and parents viewed parental involvement as having two aspects, learning information (e.g., test results, risk behaviours) and involvement in the process (e.g. accompanying them to the appointment). Methods Adolescents (ages 14 to 17 years) and their parents were enrolled in a longitudinal study assessing willingness to participate in a hypothetical microbicide clinical trial. They were asked at baseline and at one year follow-up to respond yes/no to 9 items regarding parental involvement. At baseline, one item “asking details about the study” was subsequently dropped from analyses. Results The adolescents (n=254) were 69% Hispanic, 65% female, and had a mean age at baseline of 15.5 years. Factor analysis for follow-up data indicated a different factor structure. In order to understand the change, adolescent and parent data were factor analysed separately. The adolescents’ factor structure indicated that all of the items loaded on one factor, with the exception of the two items regarding getting permission from parents to participate in studies. The factor structure for those that were under 18 remained different from the factor structure at baseline, implying that being a legal adult was not the cause of the change. For the parents, the factors remained fairly similar to the baseline factor structure. Conclusion The findings suggest that although the structure of parental attitudes about involvement in research may be stable over a year’s time; adolescents may over time view parental permission as a separate concept from the general role of parents in research. This view was not related to adolescents obtaining legal status to self-consent. Understanding of why/how attitudes about parental involvement change or stay stable over time may help investigators manage expectations. Support: National Institutes of Health (R01HD067287); National Centre for Advancing Translational Sciences, National Institutes of Health (UL1 TR000040, UL1 TR000457)