Neurocognitive indicators predict results of an informed-consent quiz among substance-dependent treatment seekers entering a randomized clinical trial.
OBJECTIVE
This study sought to determine the extent to which key aspects of a clinical trial's protocol were recalled by participants entering a clinical trial for alcohol and illicit substance-use treatment after standard informed-consent procedures, as well as to explore the possible relationships between recall, neuropsychological functioning, and substance-use outcomes.


METHODS
Before entering a randomized clinical trial testing the effectiveness of a computer-based training version of cognitive-behavioral therapy, 76 participants (55% male) meeting criteria for current substance dependence (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) completed a 14-item true/false quiz that assessed their comprehension of basic information provided in the consent form.


RESULTS
Only 15% of participants correctly answered all 14 consent quiz items. The percentage of correct recall was associated with measures of intelligence (r= .29, p = .01) and attention (r = -.26, p = .04). Quiz scores were also moderately associated with the amount of substance use during the treatment period (r = -.26, p = .03).


CONCLUSIONS
These findings highlight the importance of formally evaluating research participants' understanding of the informed-consent process, and they call to attention the potential utility of a brief neuropsychological screening to identify individuals in need of enhanced consent procedures, particularly within vulnerable populations, such as substance users.
Kiluk
Brian D
BD
Department of Psychiatry, Division of Substance Abuse, Yale University School of Medicine, 950 Campbell Avenue, 151D, West Haven, Connecticut 06516, USA. brian.kiluk@yale.edu
Nich
Charla
C
Carroll
Kathleen M
KM
D000328:Adult; D032882:Comprehension; D032962:Consent Forms; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D009483:Neuropsychological Tests; D018579:Patient Selection; D011237:Predictive Value of Tests; D019966:Substance-Related Disorders / Q000523:psychology* / Q000628:therapy