Factors that influence parental attitudes toward enrollment in type 1 diabetes trials

Abstract

Aims: To assess parental attitudes towards type 1 diabetes clinical trials (T1DCTs) and factors that impact willingness to enroll their children with and without diabetes.

Methods: A cross-sectional survey of parents of children with type 1 diabetes was administered at an academic clinic and a diabetes educational event.

Results: Survey response rate was 36%. Of 166 participating parents, 76% were aware of T1DCTs. More parents reported willingness to enroll children with diabetes (47%) than unaffected children (36%). Only 18% recalled being asked to enroll their children, and of these, 60% agreed to enroll at least some of those times. Less than 30% were comfortable with placebos. Factors predicting willingness to enroll children with diabetes included healthcare provider trust, comfort with consent by proxy, low fear of child being a "guinea pig," and comfort with placebo. Factors predicting willingness to enroll unaffected children were provider trust, comfort with consent by proxy, comfort with placebo, and perceived ease of understanding T1DCT information.

Conclusions: Parents report moderate willingness to enroll children in T1DCTs. Willingness is diminished by common trial methodologies. Although most parents recalled receiving trial-related information, significantly fewer recalled being asked to participate. Efforts to optimize effective communication around identified areas of parental concern may increase T1DCT participation.

Figure 1. Parental responses to items probing factors that may influence decision to enroll a child in type 1 diabetes clinical trials (T1DCTs).

Parents were asked: “There are lots of things that might affect a parent/guardian's decision to enroll a child in clinical trials. How much would the following influence your decision to enroll a child in a type 1 diabetes clinical trial?” Shapes correspond to endorsed degree of influence on a five-point Likert scale: black square  =  not at all, black circle  =  a little, white triangle  =  some, white circle  =  a great deal, white square  =  completely. The X-axis represents proportion of parents endorsing a specific level of influence.

Figure 2. Parental responses to items probing comfort with various clinical trial protocols.

Parents were asked: “We would like to know more about how specific tasks that may be part of a Type 1 diabetes clinical trial may influence your decision to enroll your child. How comfortable would you feel if your child were asked to do the following?” Shapes correspond to self-described comfort score on a five-point Likert scale: black square  =  not at all, black circle  =  a little, white triangle  =  some, white circle  =  a great deal, white square  =  completely. The X-axis represents proportion of parents endorsing a specific comfort score. “All Respondents” indicates protocol-specific comfort breakdown for all parents; “Willing to Enroll” indicates protocol-specific comfort breakdown for parents who endorsed they were “completely” or “a great deal” willing to enroll a child with diabetes; “Not Willing to Enroll” indicates protocol-specific comfort breakdown for parents who endorsed they were “not at all” or “a little” willing to enroll a child with diabetes. Breakdown for reponses depending on willingness to enroll an unaffected child are not shown as results are similar. Green box highlights tasks with which >60% of all parents were “a great deal” or “completely” comfortable. The purple box highlights tasks with which <30% of all parents were “a great deal” or “completely” comfortable. Comfort with all protocols surveyed had a statistically significant positive correlation with both willingness to enroll a child with diabetes and a non-affected child (r = 0.23–0.6). This effect can be appreciated above by the larger green and much smaller purple box among parents who reported willingness to enroll their children in T1DCTs.