Study objective
To understand parent/adolescent attitudes towards parental involvement (PI) 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 to 17 years; 62% female; 72% Hispanic) and their parents.
Interventions
None
Main outcome measures
The interview included demographics, sexual history, family environment (subscales of the Family Environment Scale (FES)), which was associated with attitudes about parental involvement.
Results
Factor analysis of the parental involvement scale yielded two factors: LEARN, reflecting gaining knowledge about study test results/behaviors (4 items) and PROCEDURE, reflecting enrollment/permissions (4 items). Adolescents endorsed significantly fewer items on both 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-religious emphasis in their family had lower PROCEDURE scores; there were no significant predictors for parents in the multivariate analyses.
Conclusions
Parents wanted greater involvement in the research process than adolescents. Recruitment/retention may be enhanced by managing these differing expectations.