title: Adolescent and Parent Willingness to Participate in Microbicide Safety Studies.
abstract: 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.
  
  
  METHODS
  Adolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes.
  
  
  METHODS
  Adolescents (14-17 years old) and their parents (n = 301 dyads) participated.
  
  
  METHODS
  None.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatrics, Columbia University Medical Center-College of Physicians and Surgeons, New York, New York; New York-Presbyterian Hospital, New York, New York; Heilbrunn Department of Population & Family Health, Columbia University Medical Center-Mailman School of Public Health, New York, New York. Electronic address: mc2840@cumc.columbia.edu.
authors.forename: Marina
authors.initials: M
authors.lastname: Catallozzi
authors.affiliation: Department of Pediatrics, Columbia University Medical Center-College of Physicians and Surgeons, New York, New York.
authors.forename: Ariel M
authors.initials: AM
authors.lastname: de Roche
authors.affiliation: Department of Psychiatry, Columbia University Medical Center-College of Physicians and Surgeons, New York, New York.
authors.forename: Mei-Chen
authors.initials: MC
authors.lastname: Hu
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Carmen Radecki
authors.initials: CR
authors.lastname: Breitkopf
authors.affiliation: Department of Pediatrics, Weill Cornell Medical College, New York, New York.
authors.forename: Jane
authors.initials: J
authors.lastname: Chang
authors.affiliation: Department of Pediatrics, Weill Cornell Medical College, New York, New York.
authors.forename: Lisa S
authors.initials: LS
authors.lastname: Ipp
authors.affiliation: Department of Pediatrics, Columbia University Medical Center-College of Physicians and Surgeons, New York, New York; New York-Presbyterian Hospital, New York, New York.
authors.forename: Jenny K R
authors.initials: JKR
authors.lastname: Francis
authors.affiliation: Department of Pediatrics, Columbia University Medical Center-College of Physicians and Surgeons, New York, New York; New York-Presbyterian Hospital, New York, New York; Department of Psychiatry, Columbia University Medical Center-College of Physicians and Surgeons, New York, New York.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Rosenthal
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D000328:Adult; D000890:Anti-Infective Agents; D001294:Attitude to Health; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology*; D003142:Communication; D003657:Decision Making; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D015999:Multivariate Analysis; D010287:Parent-Child Relations; D033282:Parental Consent; D010290:Parents / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*; D012725:Sexual Behavior; D012749:Sexually Transmitted Diseases / Q000517:prevention & control / Q000523:psychology*
chemical_list: D000890:Anti-Infective Agents
keywords: Adolescent research participation; Clinical trials; Sexually transmitted infections; Topical microbicides