TY - JOUR
T1 - Adolescent and Parent Willingness to Participate in Microbicide Safety Studies
AU - Catallozzi, Marina
AU - de Roche, Ariel M.
AU - Hu, Mei Chen
AU - Breitkopf, Carmen Radecki
AU - Chang, Jane
AU - Ipp, Lisa S.
AU - Francis, Jenny K.R.
AU - Rosenthal, Susan L.
N1 - Publisher Copyright:
© 2016 North American Society for Pediatric and Adolescent Gynecology
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Study Objective To understand adolescents’ and parents’ willingness to participate (WTP) in a hypothetical phase I prevention study of sexually transmitted infections, discordance within adolescent-parent dyads, and expectations of each other during decision-making. Design and Setting Adolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes. Participants Adolescents (14-17 years old) and their parents (n = 301 dyads) participated. Interventions None. Main Outcome Measures Individual interviews at baseline assessed WTP on a 6-level Likert scale. WTP was dichotomized (willing/unwilling) to assess discordance. Results WTP was reported by 60% (182 of 301) of adolescents and 52% (156 of 300) of parents. In bivariate analyses, older adolescent age, sexual experience, and less involvement of parents in research processes were associated with higher level of WTP for adolescents; only sexual experience remained in the multivariable analysis. For parents, older adolescent age, perceived adolescent sexual experience, and conversations about sexual health were significant; only conversations remained. Dyadic discordance (44%, 132 of 300) was more likely in dyads in which the parent reported previous research experience, and less likely when parents reported higher family expressiveness. Adolescents (83%, 248 of 299) and parents (88%, 263 of 300) thought that the other would have similar views, influence their decision (adolescents 66%, 199 of 300; parents 75%, 224 of 300), and listen (adolescents 90%, 270 of 300; parents 96%, 287 of 300). There were no relationships between these perceptions and discordance. Conclusion Inclusion of adolescents in phase I clinical trials is necessary to ensure that new methods are safe, effective, and acceptable for them. Because these trials currently require parental consent, strategies that manage adolescent-parent discordance and support adolescent independence and parental guidance are critically needed.
AB - Study Objective To understand adolescents’ and parents’ willingness to participate (WTP) in a hypothetical phase I prevention study of sexually transmitted infections, discordance within adolescent-parent dyads, and expectations of each other during decision-making. Design and Setting Adolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes. Participants Adolescents (14-17 years old) and their parents (n = 301 dyads) participated. Interventions None. Main Outcome Measures Individual interviews at baseline assessed WTP on a 6-level Likert scale. WTP was dichotomized (willing/unwilling) to assess discordance. Results WTP was reported by 60% (182 of 301) of adolescents and 52% (156 of 300) of parents. In bivariate analyses, older adolescent age, sexual experience, and less involvement of parents in research processes were associated with higher level of WTP for adolescents; only sexual experience remained in the multivariable analysis. For parents, older adolescent age, perceived adolescent sexual experience, and conversations about sexual health were significant; only conversations remained. Dyadic discordance (44%, 132 of 300) was more likely in dyads in which the parent reported previous research experience, and less likely when parents reported higher family expressiveness. Adolescents (83%, 248 of 299) and parents (88%, 263 of 300) thought that the other would have similar views, influence their decision (adolescents 66%, 199 of 300; parents 75%, 224 of 300), and listen (adolescents 90%, 270 of 300; parents 96%, 287 of 300). There were no relationships between these perceptions and discordance. Conclusion Inclusion of adolescents in phase I clinical trials is necessary to ensure that new methods are safe, effective, and acceptable for them. Because these trials currently require parental consent, strategies that manage adolescent-parent discordance and support adolescent independence and parental guidance are critically needed.
KW - Adolescent research participation
KW - Clinical trials
KW - Sexually transmitted infections
KW - Topical microbicides
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U2 - 10.1016/j.jpag.2016.06.009
DO - 10.1016/j.jpag.2016.06.009
M3 - Article
C2 - 27381236
AN - SCOPUS:84992390653
SN - 1083-3188
VL - 30
SP - 82
EP - 87
JO - Journal of pediatric and adolescent gynecology
JF - Journal of pediatric and adolescent gynecology
IS - 1
ER -