Adolescents' and Parents' Attitudes Toward Adolescent Clinical Trial Participation: Changes Over One Year.

Little is known about how adolescents' and parents' thoughts about participation in clinical trials change over time. In this study, adolescent (14-17 years)-parent dyads were asked about willingness to participate in a hypothetical reproductive health study. A year later, they were asked how their thoughts about the study had changed. Qualitative responses were coded and analyzed using framework analysis. Thirty-two percent of adolescents and 18% of parents reported changes in thoughts; reasons included general changes in perception, clearer understanding, new knowledge or experiences, increased maturity/age of adolescents, and changes in participants independent of the study. Adolescents and parents may benefit from learning about studies multiple times, and investigators should account for development and new experiences to optimize adolescent research enrollment.

Adolescent-Parent Dyadic Retention in an Interview Study and Changes in Willingness to Participate in a Hypothetical Microbicide Safety Study.

STUDY OBJECTIVE: In this study we describe adolescent and parent retention and changes in willingness to participate (WTP) in research among adolescents, parents, and adolescent-parent dyads. DESIGN AND SETTING: Adolescent-parent dyads were recruited to participate in a longitudinal study to assess research participation attitudes using simultaneous individual interviews of the adolescent and parent with a return visit 1 year later using the same interview. PARTICIPANTS: Adolescents (14-17 years old) and their parents. INTERVENTIONS: None. MAIN OUTCOME MEASURES: The relationship between participant characteristics and dyad retention was assessed. WTP was measured on a Likert scale and dichotomized (willing/unwilling) to assess changes in WTP attitudes over time for adolescents, parents, and dyads. RESULTS: Eighty-three percent of the 300 dyads were retained. Dyads in which there was successful contact with the parent before follow-up were more likely to be retained (odds ratio, 4.88; 95% confidence interval, 2.57-9.26). For adolescents at baseline, 59% were willing to participate and 55% were willing to participate at follow-up (McNemar S = 0.91; P = .34). For parents at baseline, 51% were willing to participate and 57% were willing to participate at follow-up (McNemar S = 5.12; P = .02). For dyads at baseline, 57% were concordant (in either direction) and 70% of dyads were concordant at follow-up (McNemar S = 10.56; P = .001). CONCLUSION: Over 1 year, parent contact might positively influence successful adolescent retention. Parents become more willing to let their adolescents participate over time, with dyads becoming more concordant about research participation.

Management of Adolescent-Parent Dyads' Discordance for Willingness to Participate in a Reproductive Health Clinical Trial.

The objective of this study is to understand the resolution of discordance between adolescent-parent dyads about participation in research. Adolescent (14-17 years) and parent dyads were recruited from NYC pediatric clinics to assess attitudes toward research participation. A subset of dyads participated in videotaped discussions about participation in a hypothetical study. Videos from dyads that held strongly discordant opinions about participation ( n = 30) were content-coded and analyzed using a thematic framework approach. Strategies used to resolve discordance included asserting authority, granting autonomy, or recognizing inaccurate assumptions using a variety of communication behaviors. Missed opportunities to enroll initially discordant dyads may be avoided by allowing time for adolescents and parents to elicit information, clarify a situation, or convince the other.

Adolescent-Parent Dyad Descriptions of the Decision to Start the HPV Vaccine Series.

STUDY OBJECTIVE: To examine how adolescent-parent dyads describe decision-making regarding initiation of the human papillomavirus (HPV) vaccine series, specifically who they viewed as making the final decision. DESIGN: Semistructured interviews with adolescent-parent dyads were audio-recorded and transcribed. Responses to the question: "How did you make a decision about whether or not to receive the HPV vaccine series?" were content-coded for each individual member of the dyad. SETTING: Adolescent medicine clinics of 2 large urban medical centers and through snowball sampling. PARTICIPANTS: Adolescents 14-17 years of age and a parent (N = 262). Qualitative analyses were conducted for those who agreed that they were offered and started the HPV vaccine series (n = 109). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Descriptions of the decision-making included 1 person (adolescent or parent) making the decision or joint decision-making by the adolescent and parent together. RESULTS: More than half of the dyads did not agree on who made the decision to start the vaccine. Most adolescents and parents described a similar account about when they were offered the HPV vaccine, although the interpretation of the event in terms of the decision-maker might have differed. More than half of adolescents and parents individually mentioned the health care provider in their description of the HPV vaccine decision-making process even though they were not queried about the role of the provider. CONCLUSION: Understanding the range of descriptions of these dyads is helpful to guide interventions to promote vaccine uptake in a manner that balances provider expertise, adolescent autonomy, and parental involvement.

Adolescent and Parent Willingness to Participate in Microbicide Safety Studies.

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.

Parents' and Adolescents' Attitudes about Parental Involvement in Clinical Research.

STUDY OBJECTIVE: To understand parent and adolescent attitudes toward parental involvement during clinical trials and factors related to those attitudes. DESIGN: As part of a study on willingness to participate in a hypothetical microbicide study, adolescents and their parents were interviewed separately. SETTING: Adolescent medicine clinics in New York City. PARTICIPANTS: There were 301 dyads of adolescents (ages 14-17 years; 62% female; 72% Hispanic) and their parents. INTERVENTIONS: None. MAIN OUTCOME MEASURES: The interview included questions on demographic characteristics, sexual history, and family environment (subscales of the Family Environment Scale) that were associated with attitudes about parental involvement. RESULTS: Factor analysis of the parental involvement scale yielded 2 factors: LEARN, reflecting gaining knowledge about study test results and behaviors (4 items) and PROCEDURE, reflecting enrollment and permissions (4 items). Adolescents endorsed significantly fewer items on the LEARN scale and the PROCEDURE scale indicating that adolescents believed in less parental involvement. There was no significant concordance between adolescents and their own parents on the LEARN scale and the PROCEDURE scale. In final multivariate models predicting attitudes, adolescents who were female and had sexual contact beyond kissing, and non-Hispanic parents had lower LEARN scores. Adolescents who were older, had previous research experience, and reported less moral or religious emphasis in their family had lower PROCEDURE scores; there were no significant predictors for parents in the multivariate analyses. CONCLUSION: Parents wanted greater involvement in the research process than adolescents. Recruitment and retention might be enhanced by managing these differing expectations.

Adolescents and Their Parents Differ on Descriptions of a Reproductive Health Study.

STUDY OBJECTIVE: To understand how adolescents and parents describe a sexually transmitted infection prevention study to a friend. DESIGN: Adolescents and parents participating in a study about willingness to participate in a hypothetical microbicide clinical trial were interviewed separately and asked to describe the clinical trial to a friend. Qualitative responses were written down verbatim and coded using a thematic framework analysis. SETTING: Adolescent medicine clinics in New York City. PARTICIPANTS: The participants consisted of adolescents, 14-17 years old, and a parent (n = 301 dyads) who spoke English or Spanish. Most adolescents (72%) identified as Hispanic and 65% reported minimal sexual experience (ie, nothing more than kissing). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Qualitative responses were content coded for: (1) overall approach; (2) opinion rendered; and (3) details mentioned using thematic framework. The relationship of demographic characteristics, sexual history, and recruitment method to how adolescents and/or parents described the study was evaluated. RESULTS: Adolescents (n = 293) differed from parents (n = 298) in their overall approach to describing the study (P < .01) with more adolescents than parents providing a "purpose with detail" (54% adolescents vs 31% parents) and less providing a "commentary" description (6% adolescents vs 28% parents). Fewer adolescents (25% of n = 301) provided an opinion compared with parents (75% of n = 301; P < .01). A greater proportion of adolescents (70% adolescents, n = 206; vs 48% parents, n = 144) provided a detail (P < .01). Adolescents provided a greater number of details than parents (P < .01). CONCLUSION: Adolescents in this sample were more focused on the details of the study. Parents were focused on their impression of the study. Adolescents and parents might need to be approached differently about reproductive health studies.