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

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Abstract
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.