Predicting adolescent asthma research participation decisions from a structural equations model of protocol factors

Abstract

Purpose: To examine similarities and differences in the process that parents and adolescents use to make decisions concerning participation in an asthma clinical trial. We hypothesized that a single conceptual model, tested through structural equations modeling, could explain adolescent assent and parent consent for adolescent research participation.

Methods: One hundred nine adolescents enrolled with at least one parent and received an asthma evaluation from a pediatric asthma specialist and then evaluated a hypothetical asthma research protocol. Family members independently evaluated the protocol and made research participation decisions.

Results: Perceived risk, benefit, and compensation were direct predictors of participation decisions for parents and adolescents. Adolescents perceived direct study benefit from the relationship with the physician, however parents did not. Parent decisions were most strongly associated with perceived risk, and parents associated discomfort with risk more strongly than did adolescents. Protocol procedures contributed to perceptions of benefit and discomfort for parents and adolescents.

Conclusions: Parent and adolescent research participation decisions are influenced by protocol variables in similar ways, although there are differences that account for disagreements within families. Findings may help investigators develop protocols that appeal to parents and adolescents and highlight issues of particular importance to address during the process of informed consent.

Figure 1

Unstandardized structural model of adolescent participation decision. Numbers in brackets are standard errors, B’s are unstandardized path coefficients, solid lines represent significant pathways and the dotted line represents a non significant pathway. Overall goodness of fit χ²(216) = 313.13, p < .001, RMSEA = .064, test of close fit (RMSEA < .05), p < .07. The model includes three correlated residuals (see Table 1).

Figure 2

Unstandardized structural model of parent participation decision. Numbers in brackets are standard errors, B’s are unstandardized path coefficients, solid lines represent significant pathways, and dotted lines represent non significant pathways. Overall goodness of fit χ²(217) = 305.22, p < .001, RMSEA = .061, test of close fit (RMSEA < .05), p < .13. The model includes two correlated residuals (see Table 1).