A multisite trial of a clinic-integrated intervention for promoting family management of pediatric type 1 diabetes: feasibility and design

Nansel, T. R.; Anderson, B. J.; Laffel, L. M.; Simons-Morton, B. G.; Weissberg-Benchell, J.; Wysocki, T.; Iannotti, R. J.; Holmbeck, G. N.; Hood, K. K.; Lochrie, A. S.

Pediatr Diabetes. 2008 Aug 30; 10(2):105-15


The feasibility of a family-based clinic-integrated behavioral intervention to improve family management of type 1 diabetes was evaluated. In each of four clinical sites, 30-32 families (a total of 122) were randomized to intervention or usual care comparison groups. The WE*CAN intervention, based on family problem-solving methods, was delivered during three routine clinic visits by trained 'Health Advisors'. Of eligible families across the four sites, 83% agreed to participate, of whom 96% completed the baseline, mid-term, and postintervention assessments. Families participated in an average of 2.85 intervention sessions over an 8-month period. The intervention was integrated into the clinic setting without impairing clinic flow and was implemented with fidelity and consistency across sites by trained non-professionals. The findings provide evidence of the feasibility of conducting a multisite trial to evaluate the effects of a clinic-integrated problem-solving intervention to improve family management. Many lessons were learned that provide guidance for recruitment, measurement, and intervention for the larger clinical trial.

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