OBJECTIVE: To evaluate perceived benefits and barriers to pediatric clinical trials participation to improve decision-making and enhance recruitment and retention among minority youth with chronic health conditions (sickle cell disease, asthma) and their caregivers. METHODS: A questionnaire was developed based on the social ecological model using input from medical experts and community-based public health organizations. Parallel caregiver, adolescent/young adult (AYA; 16-39 years old), and child (8-15 years old) versions were field tested. Patients and caregivers completed the questionnaire, which included demographic items, perceived life stress and social desirability measures. RESULTS: Exploratory factor analysis rendered a four-factor solution for the caregiver version (direct treatment benefit, mistrust of research/researchers, trust in healthcare team to engage in safe research, and opportunity cost) and the AYA version (mistrust/no direct benefit, safety, direct treatment benefit/practical considerations, and social support for research). Factor structures differed for SCD and asthma caregivers; results were equivocal for the child version. Summated subscales were not significantly associated with patient demographics or social desirability, but significant correlations with perceived life stress and prior participation in research were identified. CONCLUSIONS: While the factor structure should be confirmed with larger samples, findings indicate potential benefit, perceived harm due to mistrust of researchers, and logistics are primary factors in decision-making about participation in pediatric clinical trials. By addressing these benefits/barriers through adjustments to recruitment and informed consent procedures, researchers may address misperceptions of research, improve decision-making, and increase recruitment and retention particularly for ethnic minority children with chronic health conditions.
OBJECTIVE: To evaluate perceived benefits and barriers to pediatric clinical trials participation to improve decision-making and enhance recruitment and retention among minority youth with chronic health conditions (sickle cell disease, asthma) and their caregivers. METHODS: A questionnaire was developed based on the social ecological model using input from medical experts and community-based public health organizations. Parallel caregiver, adolescent/young adult (AYA; 16-39 years old), and child (8-15 years old) versions were field tested. Patients and caregivers completed the questionnaire, which included demographic items, perceived life stress and social desirability measures. RESULTS: Exploratory factor analysis rendered a four-factor solution for the caregiver version (direct treatment benefit, mistrust of research/researchers, trust in healthcare team to engage in safe research, and opportunity cost) and the AYA version (mistrust/no direct benefit, safety, direct treatment benefit/practical considerations, and social support for research). Factor structures differed for SCD and asthma caregivers; results were equivocal for the child version. Summated subscales were not significantly associated with patient demographics or social desirability, but significant correlations with perceived life stress and prior participation in research were identified. CONCLUSIONS: While the factor structure should be confirmed with larger samples, findings indicate potential benefit, perceived harm due to mistrust of researchers, and logistics are primary factors in decision-making about participation in pediatric clinical trials. By addressing these benefits/barriers through adjustments to recruitment and informed consent procedures, researchers may address misperceptions of research, improve decision-making, and increase recruitment and retention particularly for ethnic minority children with chronic health conditions.
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