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

<p dir="ltr">Objective</p><p dir="ltr">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</p><p dir="ltr">Methods</p><p dir="ltr">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.</p><p dir="ltr">Results</p><p dir="ltr">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.</p><p dir="ltr">Conclusions</p><p dir="ltr">The TRECA DMQ is a useful tool for evaluating research participation decisions in older children, as well as parents and guardians.</p><p dir="ltr">Practice implications</p><p dir="ltr">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.</p>