Development and validation of a new tool to assess quality of decision-making by older children and parents about research participation.

Abstract

Effective decision-making is crucial for children and young people's trial participation, but specific tools to measure it are lacking. The TRECA (TRials Engagement in Children and Adolescents) Decision-Making Questionnaire (DMQ) was developed to fill this gap and has been evaluated for reliability and validity METHODS: We created the TRECA Decision-Making Questionnaire, based on similar measures for adults, and recruited participants through seven Studies-Within-a-Trial (SWATs). Participants were randomly assigned to receive trial information either as a printed Participant Information Sheet or Multimedia Information, or both, and asked to complete the DMQ. We calculated item completion rates, item-remainder statistics and Cronbach's Alpha, and conducted factor analysis. 549 participants (433 parents/guardians, 116 older children) completed a DMQ. It had high completion rates and internal consistency (Alpha = 0.88 for parents/guardians and 0.84 for older children) and moderate to high inter-item correlations. The DMQ had a single factor accounting for 53 % of variance. The TRECA DMQ is a useful tool for evaluating research participation decisions in older children, as well as parents and guardians. Our study suggests that the TRECA DMQ can be used to assess the quality of decision-making about trials in parents, guardians and older children.