Capacity to consent to research among adolescent-parent dyads in Rakai, Uganda

Capacity to consent to research among adolescent-parent dyads in Rakai, Uganda
Philip Kreniske, Susie Hoffman, William Ddaaki, Neema Nakyanjo, Esther Spindler, Charles Ssekyewa, Dauda Isabirye, Rosette Nakubulwa, Nabakka Proscovia, Lee Daniel, Nao Haba, Mahlet Maru, Julia Thompson, Ivy S. Chen, Fred Nalugoda, Robert Ssekubugu, Tom Lutalo, Mary A. Ott, John S. Santelli
The Journal of Pediatrics, 17 November 2022
Abstract
Objectives
To assess the cognitive capacity of early, middle, and late adolescents, and their parents or guardians to provide informed consent to a population-based cohort study.
Study design
Adolescent-parent/guardian dyads including 40 early (N = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study (RCCS), an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient (ICC) was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t-test and score differences between parent/guardian and adolescent dyads using two-sided paired t-tests.
Results
Early adolescents (mean score, 95% confidence interval (CI)) (28.8, 27.1-30.5) scored significantly lower (p<.01) than middle/late adolescents (32.4, 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference=-0.2, 95% CI=-1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference=3.0, 95% CI=1.2-4.8).
Conclusions
The capacity of adolescents of different ages and in diverse settings to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches.