Given our experience in developing and testing coping skills training (CST) programs for adolescents with type 1 diabetes (DM) and the need to develop and test such programs with children younger than adolescence, we propose to conduct a clinical trial to determine: (1) whether the effects of CST seen in adolescents with DM can be generalized to children (age 8-12) with DM by conducting a randomized clinical trial designed to examine whether CST will improve metabolic control (Hemoglobin A1c/HbA1c) and adaptation (depression, self-efficacy, quality of life, family behaviors in the children; well-being, coping, family adaptability in the parents); (2) whether the improved metabolic control (HbA1c) and adaptation (depression, self-efficacy, quality of life) associated with CST in our initial study can be maintained over four years of follow-up; and (3) finally, because so little is known about the costs of care to provide intensive diabetes management to a general population of youth with diabetes, we will determine the costs of care provided to children and adolescents implementing intensive therapy regimens, the incremental costs of CST, and we will relate these costs to incremental changes in metabolic control and quality of life. To achieve aim 1, we will enroll 100 children (age 8-12) with DM and one of their parents and randomly assign them to one of two groups: intensive therapy with CST or intensive therapy with education. CST consists of a series of small group efforts designed to help youth cope with the management of their disease. Both groups will received intensive DM management from an established team of providers. Data will be collected pre and post intervention and at 3, 6, and 12 months following using HbA1c, Self-Efficacy for Diabetes Scale, Children's Depression Inventory, Issues in Coping with IDDM-Child, and Diabetes Quality of Life: Youth, Diabetes Family Behavior Scale for the children and the Beck Depression Inventory, Issues in Coping with IDDM-parent, and FACES II Scales in the parents. To meet aims 2 and 3, we will continue to follow the 80 youth with diabetes enrolled in our initial trial, collecting data every 6 months using the Self-Efficacy for Diabetes Scale, Children's Depression Inventory, Issues in Coping with IDDM, and the Diabetes Quality of Life: Youth Scales. It is expected that this important and timely study will yield valuable information to help other youth manage this devastating disease, and thereby decrease the potential for these children and youth to develop long-term physical and psycho-social complications.
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