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Since children are a vulnerable population, ethical issues in the conduct of medication studies involving them are extremely important. We recently reported the results of a study that examined youths' and parents' attitudes about, and experiences with, participation in psychopharmacology treatment research.
There is much discussion in the scientific literature and in the press about participation in clinical treatment studies. Since children are a vulnerable population, ethical issues in the conduct of medication studies involving them are extremely important. The adequacy of informed consent, the parents' understanding of the risk/benefit ratio, and the use of placebo have been discussed extensively. However, there is little information about the experiences of the children participating in these studies or of their parents. We recently reported the results of a study that examined youths' and parents' attitudes about, and experiences with, participation in psychopharmacology treatment research.1
The aim of the study was to examine the attitudes and experiences of youths who participated in clinical treatment research and of their parents, both before and on completion of a treatment study. Ninety youths, ranging in age from 6 to 17 years, and their parents completed questionnaires. The youths had participated in one of the following studies: a double-blind placebo-controlled trial of antidepressants for the management of major depression or anxiety disorder; a double-blind placebo-controlled trial of anticonvulsants for the management of bipolar disorder; an open-label study of antidepressants for the management of depression; or an open-label study of an atypical antipsychotic for the management of Tourette syndrome. In general, the clinical treatment studies ranged in duration from 4 to 16 weeks.
Before participating in the study, parent and child completed a questionnaire that had items about reasons for enrolling in the study, the informed consent process, views about placebo (if applicable), and expectations about improvement and quality of care during the treatment study. Following completion of the study, parent and child completed another a questionnaire about clinical improvement, quality of care, study expectations, satisfaction with the study, best and worst parts of the study, and willingness to participate in a future study.
Youths' pretreatment attitudes
Children and adolescents reported that the main reason for participation in the clinical treatment research was for them to get help with their problems and to find out what was bothering them. With regard to the adequacy of the informed consent process, the percentage of youths who recalled that they had been told about consent issues were as follows: purpose of the study, 96%; procedures in the study, 94%; alternative treatment, 62%; and ability to withdraw from the study, 89%. The study participants' views of placebo were "good," 26%; "OK," 70%; and "bad," 4%. Regarding expectation of clinical improvement, 40% of the youths expected much improvement, 53% expected some, and 2% expected none.
Parents' prestudy attitudes
The parents stated that the main reason they wanted their child to participate in the clinical treatment study was to get treatment for their child and to find out about their child's problem. Regarding adequacy of informed consent, the percentage of parents who recalled that they were informed about consent issues were as follows: purpose of the study, 100%; procedures in the study, 100%; alternative treatment, 94%; and ability to withdraw their child from the study, 99%. With regard to parents' views of placebo, 31% had a positive view, 65% were neutral, and 4% viewed it as negative. Most parents expected clinical improvement from their child's participation in the study; 46% expected much improvement and 52% expected some improvement, whereas only 2% expected no improvement. The majority of parents expected the quality of care rendered in the trial to be good (97%) or acceptable (3%).
Youths' attitudes after study participation
Forty-nine percent of children and adolescents thought they got a lot better, 52% thought they got a little better, and 9% said they did not get better. The youths' own view of their improvement correlated with the clinician's assessment of their improvement. Most of the youths liked their treatment during the study (96%) and believed that the study had proceeded as they had expected (67%). Ninety-four percent said they were glad to have participated in the treatment study and 65% of the youths said they would participate in another clinical treatment study. Their views of their experiences in the study were independent of whether or not they improved clinically during the study. The youths reported that their clinical improvement and the study personnel were the 2 best parts of participation in the study. They reported the worst part about participating in the study was blood work (ie, phlebotomy).
Parents' attitudes after the study
Most parents believed that there was improvement in their child's condition; 51% reported much improvement and 43% noted some improvement, whereas only 6% found no improvement. The majority of parents believed that the quality of care rendered in the study was good (90%) and that the study proceeded as they had expected (96%). Ninety-nine percent of parents reported that they were glad their child had participated in the clinical treatment study. Regarding future participation in a study, 26% of parents said yes, 72% said maybe, and 2% said no. The parents reported that their child's clinical improvement and the study personnel were the best parts of their child's participation. Parents reported that the 2 worst aspects of their child's participation were the appointment schedule and the distance to the clinic.
This study demonstrated that the majority of the youths and their parents had a positive view about their experiences in participating in clinical treatment research, regardless of whether the child's psychiatric condition improved. This study does not support some concerns that have been raised about individuals participating in clinical trials solely for financial reasons. Only 1% of the parents reported that the main reason for participating in the study was that treatment was free, and only 2% of parents reported that financial reimbursement for clinic visits was the main reason for their child's participation.
Another concern raised in the literature has been with the use of placebo. In this study, very few of the parents or youths had a negative view of placebo. There was also no correlation between the severity of the child's illness and the parent's or the child's attitude about placebo.
In order to determine the safety and efficacy of medication treatment for children with psychiatric disorders, it is essential to continue to conduct treatment trials with children. As clinical treatment researchers, we are indebted to the children and adolescents who participate in these studies as well as the parents who allow their child's participation.
Dr Wagner is the Robert L. Stubblefield Professor in the department of psychiatry and behavioral sciences and director of child and adolescent psychiatry at the University of Texas Medical Branch at Galveston.
Reference:1. Wagner KD, Martinez M, Joiner T. Youths' and their parents' attitudes and experiences about participation in psychopharmacology treatment research. J Child Adolesc Psychopharmacol. 2006;16:298-307.