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The process of research with adolescents should balance parental involvement and adolescent autonomy. The attendance of parents and peers at research study visits of girls participating in a 6-month study of topical microbicide acceptability is described, as well as the participants’ conversations with their parents.
Girls, 14 through 21 years, were recruited from previous studies (3%), advertisements (14%), clinics (17%), and recommendations by friends (66%) to participate. Girls under 18 years were required to have parental consent, but parents could provide verbal phone consent as long as a signed consent form was returned before participation.
The 208 participants were 41% African-American, 30% Hispanic, and 29% Caucasian. Girls averaged 18 years of age, and 95 (46%) were under 18. Seventeen percent of parents attended the first visit; all but one was with a daughter of less than 18 years. The mothers of older adolescents were less likely to attend the appointment with them. More Caucasian than African-American girls came with a mother. Parental attendance decreased at follow-up visits. Thirty-seven percent of girls brought a peer to the first visit; there were no age or race/ethnic differences. There was no relationship between attending with a parent or peer and talking to a parent about the study. Some adolescents obtained parental consent to participate in the study while keeping their sexual behaviors private.
Parental attendance at study visits may not be marker of parental involvement with the study. Creative ways for balancing concerns about confidentiality, promotion of autonomy, and adult involvement should be considered.
Adolescents should have the opportunity to participate in and benefit from research that is relevant to their health concerns, including studies on “sensitive subjects” such as sexually transmitted infections (STIs).1,2 Inclusion of adolescents in such studies is consistent with the Belmont Report principles of respect for person, justice, and beneficence. Further, girls should have the a part in decision-making, of whether or not to participate in studies and should be protected from exploitation and harm.3 Yet, because adolescence is the transitional stage from the dependency of childhood to the autonomy of adulthood, adult guidance in decision-making remains important.4 Parents and health care providers have a responsibility to help adolescents transition to adulthood by providing them opportunities to be autonomous and use their most advanced cognitive skills while making sure that this is done safely. This can be challenging because the maturation process is gradual and within any one adolescent and across individuals, there may be unevenness across areas of development based on experiences. Decisions as to how to balance parental involvement and adolescent autonomy will impact the practicalities of methods fro enhancing adolescents’ participation in research. In this manuscript, we describe our experience with parental and peer attendance at study visits and its’ relationship with parental communication about the study for adolescents participating in a microbicide acceptability study.
Adolescents (ages 14 through 21 years) were recruited to participate in a 6 month study of experiences of adolescent girls with a topical microbicide surrogate.5 Topical microbicides are products (gels/creams) which would be used intra-vaginally to protect against STIs and possibly pregnancy. Microbicides are currently in clinical development but the products used in this study were over the counter vaginal lubricants available in stores (a gel-filled applicator -Replens® Vaginal Moisturizer [Warner Wellcome, Morris Plains, NJ], and a suppository-Lubrin® Insert [Bradley Pharmaceuticals, Fairfield, NJ]).
Participants were recruited from previous studies (3%), advertisements (14%), clinics (17%), and through snowballing (66%). Snowball recruitment (i.e., having friends recommend other friends to the study) was included because a purpose of the primary study was to examine the influence of friends on microbicide attitudes and beliefs. In order to be in the study, the adolescent girls needed to have a history of penile-vaginal sexual intercourse at least once; however, they did not have to plan to have intercourse during the study period.
Those under 18 years were required to have parental consent to participate. Parents were given a brief description of the study with permission sought to talk to their daughter. The study was explained to the adolescents in detail. If the adolescent was under 18 years, this included explaining to the adolescent that although her sexual experience status would not be disclosed to her parents, her parents might assume she was sexually experienced, since the study consent form required her “to use a vaginal product in the context of romantic relationships” and that participants would “strongly be encouraged to use condoms if engaging in sexual activity.”
Participants under 18 were allowed to bring in a witnessed signed consent form if a parent did not accompany them to the first research visit. The method for accomplishing this was that the research coordinator described the study over the phone to the parent. If the research coordinator had any concerns about whether the parent understood the study process, she then had an option of requiring parental attendance. Records were kept of whether the participants attended each of their research visits with a parent figure (“mother”) or a peer, but no records were kept regarding required parental attendance. Nevertheless, this was estimated to have occurred only once or twice across subject recruitment.
Girls had 3 face-to-face interviews at the hospital research center (intake, 3 and 6 months). The interviewer asked whether the adolescent had spoken to friends and to parents about the study. The girls also were called weekly to discuss their sexual experiences and product use over the prior week. At the 3-month visit, they were asked “Have you talked about the study or the product with your mother or parent figure or has your mother or parent figured asked you about the study?” If they said yes, they were asked, “Tell me what you told them regarding the study,” and if they said no, they were asked, “Why not?” For seven girls who missed the 3-month interview, we examined their responses to the same question at the 6-month interview.
We ran descriptive statistics on demographic information (age, race/ethnicity), whether subjects had talked to their parents about the study, and whether parents or peers attended each study visit. Further, we examined the extent to which age, race/ethnicity and study discussion with parents influenced parental attendance at each study visit. Race/ethnicity was categorized as African-American, Hispanic, and Non-Hispanic Caucasian/Other. Chi-square analyses were used to assess whether age and race/ethnicity were associated with having a mother come to a study visit. However, since only one girl over the age of 18 had a mother in attendance at any study visit, some analyses were confined to those less than 18 years of age.
To analyze girls’ qualitative responses regarding communication with their mothers about study participation,6 an investigator and a research coordinator independently identified whether responses indicated a belief that her mother thought she was a virgin and if she indicated that she talked to her mother about sexuality. It should be noted that the girls were asked about these two topics specifically; however, several girls spontaneously addressed them when asked about talking with their mother about the study. Discrepancies between the two coders were discussed and resolved by consensus.
A total of 208 girls were recruited into the study; 41% were African-American, 30% were Hispanic, and 29% were non-Hispanic Caucasian/other. They had a mean age of 18 years, and 95 participants (46%) were under the age of 18. One-hundred seventy-six females attended the 3-month visit, and of those, 79 (44%) were less than 18. There were 165 females who attended a 6-month visit; 78 (46%) of these were under 18. There was one girl over 18 whose mother attended the intake and 3-month. There were no differences between the number of girls who were under 18 and those 18 and older with regards to bringing a peer to intake. Therefore, for the quantitative analyses examining the relationship of age and race/ethnicity to parent/peer attendance, only those girls under 18 were included. The race/ethnicity for those girls under 18 was 50% African-American, 34% Hispanic, and 16% non-Hispanic Caucasian/other.
Thirty-four (36%) girls brought their mothers to the intake visit, 14 (18%) to the 3-month visit and 11 (14%) to the 6-month visit. Overall, 56 (59%) girls did not bring their mothers to any of the research visits, seven girls (7%) brought their mothers to all three visits, with the remaining girls bringing their mother to one (n= 26; 27%) or two (n = 6; 6%) visits. There were five mothers who attended later visits (four came to one, and one came to two visits) but did not attend the initial visit.
The percentage of parents attending the intake study visit by adolescent age is presented in Table 1. As age increased, the number of mothers who attended a visit declined significantly (χ2= 7.0, p <.01). In addition, a greater proportion of the non-Hispanic Caucasian/other girls came to the intake visit with a parent as compared to African-American girls (Table 2; χ2= 10.0, p <.01). This difference continued for the 3-month (χ2= 8.8, p =.01) and 6-month visits (χ2= 8.32, p <.02). Among African-Americans, only three girls came with a mother after the intake visit and none of these brought their mothers to all three visits.
Thirty-eight percent of the girls came to the intake visit with a “peer” (boyfriend, relative, or friend). The percentage of girls who brought a peer to a visit did not change over time (30% at the 3-month visit and 40% at the 6-month visit) (see Table 3). Overall, 35 girls (37%) did not bring a peer to any of the visits. Eight (8%) brought a peer to all three visits, with the remaining girls bringing a peer to one (n= 37; 39%) or two (n = 15; 16%) of the visits. There were 38 peers who attended later visits (18 came to one, and 6 came to two) but did not attend the initial visit. The percentage that brought a peer did not differ by age or race/ethnicity.
Adolescents responded to a query about whether they spoke to their mothers about the study and why they spoke or did not speak to their mothers.6 Data regarding the relationship between participant age and talking to her mother about the study has been previously reported, and no relationship was found. 6 We extended this analysis to examine whether those girls whose parent attended the intake interview were more likely to report talking with their mothers about the study and if those who attended with a parent or a peer were more likely to talk with their mother. There was no relationship between attending with a parent (χ2 = 0.04; p = 0.84) or attending with a peer (χ2 = 0.02; p =.88) and the adolescent talking to a parent about the study.
We reviewed the girls’ answers for spontaneous information about whether the girls thought their mothers beliefs about their sexual experience. Some of the girls appeared to be talking about their sexual experience but their answers were vague and no follow-up query occurred. For example, one girl, age 16, said “I just don’t know. Cause I don’t think she cares to know and she’d be scared to find out even if she did know. ” Interestingly, this girl’s mother attended every study visit with her. However, there were three girls (two were over 18 and one under 18) who clearly indicated that their mothers still believed they were virgins, and none of the girls brought their mother to any appointments. One girl, age 19, said “My mom thinks I am a virgin, or she hopes I am, and she is in denial.” One girl, age 16, told her mother that sexual experience was not a requirement to be in the study, and she did not bring her mother to any appointments. Two girls under 18 and one girl over 18 indicated that their mothers did not believe they were currently having sexual intercourse, and both of those under 18 came with their mother.
As noted previously, 6 there were girls who reported that they did not talk to their mothers because of an impaired relationship but others were clear that there were certain topics which they did not discuss with their mothers. For example, a 19-year-old who therefore was not required to have parental consent said “she knows I’m in it [the study] but she don’t be asking me questions about it..We are cool and all but I don’t want her to know much about my business” and a 17-year--old said, “Don’t talk to them, I do, but not about stuff like that. I only talk to them about certain stuff.” A 16-year-old whose mother attended the first appointment with her stated, “we don’t talk about that kind of stuff.”
Researchers have a responsibility to ensure that all of the principles of the Belmont report are implemented. With regards to research on sexual health, this means that adolescents have the opportunity to participate in research while making sure that their status as a vulnerable population is respected.4 Participating in research also can provide an opportunity for adolescents to practice their increasing cognitive skills and autonomy. Efforts to address the developmental changes in the cognitive abilities of children and adolescents are evidenced by changes in IRB expectations for consenting throughout childhood. For example, similar to many IRBs, our institutional IRB requires verbal assent starting at age seven with the use of simple language, and at age 12 the subject is asked to sign assent on a regular informed consent form.
Both the requirement for parental consent and misunderstandings about the parental consent process can act as barriers to participation in some studies for some adolescents.7 If adolescents believe that participation in a study will lead to disclosure of sensitive information to their parents, then they may be less likely to participate in the study. 7 In this study, we were not able to evaluate those under 18 who could not participate because their mothers’ believed them to be virgins, but there were at least two older girls for whom parental consent might have posed a barrier to participation. Some girls were able to participate and obtain consent even if sexuality was a subject typically not discussed with their mothers. Previous literature has indicated that adolescents may feel more secure in the maintenance of privacy and confidentiality if they are able to come alone to an interview even when their parents have consented to their involvement. 7 Further research needs to explore how parents and adolescents manage privacy and involvement successfully; for example, at least one girl obtained consent, attended the first appointment with her mother, but clearly had a sense that her sexual decisions were private. We did not ask the parents what they thought they did knew about their daughters’ sexuality, it is possible that they were not in the level of “denial” that their daughters believed but that they chose not to have these conversations. Clearly, a better understanding of the relationship of adolescent-parent closeness, involvement in research decision-making, and maintenance of privacy or confidentiality is needed.
In addition, if consent requires the parent to physically attend the appointment, it may be a practical barrier to participation. We did not inquire as to why parents made the decision they did about attendance, and there could have been a range of reasons including access to transportation, time demands and ability to take time off from work, perceptions of the safety of the location, or perceptions of the daughters’ needs for supervision. Given the fact that attendance by mothers was higher at intake, it may be that mothers initially wanted to give guidance and assure safety, and once they established that their daughters were safe and in “good hands,” they no longer felt a need to attend.
Attendance by the mother decreased by age, but even when their adolescents were 14 years, some mothers did not attend. We found race/ethnic differences in attendance by mothers which could not be explained by age differences. Since there were no differences in talking with mothers by race/ethnicity, 6 this can not be presumed to be a difference in parental involvement, rather in the manifestation of that involvement. Thus, further studies should explore cultural differences in promoting autonomy and managing supervision.
In addition to the practical barriers that could limit participation, there is the importance of supporting increasing behavioral autonomy. Behavioral autonomy refers to the adolescent’s ability to make her own decisions and follow through with them.1 This is in contrast to value autonomy, which refers to the ability to resist pressure from others and make decisions based on a set of principles which define right from wrong. The third type of independence is emotional autonomy which refers to decreased emotional dependence but does not suggest that adolescents do not remain close to their parents. These different types of independence were clearly seen in the adolescents’ descriptions of selective sharing of information even in close relationships and the lack of relationship between sharing information and attending the appointments. Legal independence and the capacity to make an independent decision and follow-through should not be mistaken for parental involvement. It has long been established that even older adolescents rely on their parents for health care decision-making. In fact, most adolescents expect their parents to be part of their health care decisions.8–10 Even college students believe parental views are important. 9 Further, parents and teens often have the same attitudes regarding health care decision-making,11–12 even if they did not talk about their choices before making a decision. 13
Consistent with a difference in being behaviorally independent versus being emotionally independent, there was no relationship between girls whose parents attended the first appointment and whether they reported that they had a conversation about the study with their parent. The absence of a relationship between attending the appointment with a peer and talking to the parents is consistent with the literature that peers do not replace parents but rather serve as an additional system of support.
Our interpretations of our experience are limited by the fact that we did not design this study to examine issues associated with parental attendance and parental involvement. Thus, there is much we do not know regarding how parents in this study made their decisions to attend study visits. We did not note what kind of “peer” attended with the adolescent and the reasons a peer attended. Finally, we only know about conversations with mothers for those adolescent who attended a later visit. For the girls who did not attend a 3-month or 6-month visit, we do not have information on their conversation with mothers. Future research studies might consider including adding questions and collect data on why mom and peers decided to attend or not attend study visits.
The results support the need to consider creative ways to balance adolescent’s autonomy and protection from harm. Physical attendance at a study visit should not be considered a marker of parental involvement. This may be particularly true for studies of sensitive subjects in which there may be increased concern by the adolescent regarding protection of their confidentiality.
Sources of support: Support was received from the National Institute of Child Health and Human Development (R01 HD4015101) and the National Institutes of Allergy and Infectious Diseases (U19 A161972, and N01 A150042) of the National Institutes of Health. Studies were conducted on the General Clinical Research Center (GCRC) at the University of Texas Medical Branch at Galveston. The GCRC is funded by a grant (M01 RR 00073) from the National Center for Research Resources, NIH, USPHS.
The authors wish to thank The Teen Health Center, Inc and Galveston College for helping with recruitment, Beth Auslander, Elissa Brown, Stephanie Ramos, Jennifer K. Oakes, E. Alexandra Zubowicz and Melissa Loza for their support in data collection and data management, Paul A. Succop for his statistical advice, and all of the adolescents for their participation in this research study.
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