Research knowledge among parents of children participating in a randomized clinical trial.
OBJECTIVE
Parental permission is required for child research, but parents' understanding of research aims and procedures has not been well documented. Parental research knowledge was assessed during a clinical trial in autism.


METHODS
Parents of 101 children (age 5-17 years) with autism participating in a placebo-controlled trial of risperidone were given a questionnaire at the end of the study.


RESULTS
Of the 95 parents completing the questionnaire, 99% knew of possible placebo assignment and that testing the medication efficacy was the main purpose of the investigators; 96% to 98% knew that research involved both risks and potential benefits, identified the study medication, and knew of their right to withdraw at any time; 90% to 95% knew of the medication's main side effects; 87% reported having been informed of possible alternatives to research participation; and 72% were aware that treatment was randomly assigned (whereas 27% reported that treatment was chosen based on individual needs to ensure best care). Parents with a college degree were more likely to recognize the random nature of treatment assignment.


CONCLUSIONS
Overall, parents were highly knowledgeable of the main research components. About one fourth, however, seemed unaware that treatment was randomly determined and not personalized, suggesting that therapeutic misconception may affect some otherwise well-informed parents.
Vitiello
Benedetto
B
Child and Adolescent Treatment and Preventive Intervention Research Branch, National Institute of Mental Health, Bethesda, MD 20892-9633, USA. bvitiell@mail.nih.gov
Aman
Michael G
MG
Scahill
Lawrence
L
McCracken
James T
JT
McDougle
Christopher J
CJ
Tierney
Elaine
E
Davies
Mark
M
Arnold
L Eugene
LE
D000293:Adolescent; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001294:Attitude to Health; D001321:Autistic Disorder / Q000523:psychology*; D002648:Child; D002675:Child, Preschool; D003071:Cognition; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy* / Q000209:etiology*; D010290:Parents; D010358:Patient Participation; D010541:Permissiveness; D016032:Randomized Controlled Trials as Topic; D018967:Risperidone / Q000627:therapeutic use*; D016728:Self-Injurious Behavior / Q000188:drug therapy* / Q000209:etiology*
D014150:Antipsychotic Agents; D018967:Risperidone