Family Management of Childhood Diabetes (Type 1)

Investigators:
Project staff:

• Tim Wysocki, PhD (Principal Investigator)
• Amanda Lochrie, PhD (Co-Investigator)
• Alex Taylor, MACP
• Amy Milkes, MA
• Jeanpaul Burnett, MPH (Research Specialists)
• Larry Fox, M.D. (Endocrinologist)

Background:

This is a research contract awarded by the Prevention Research Branch of the National Institutes of Health, National Institute of Child Health and Development. Principal Investigators from four clinical sites (Nemours; Joslin Diabetes Center in Boston; Children's Memorial Hospital in Chicago; Texas Children's Hospital in Houston) are collaborating with members of the NICHD Prevention Research Branch to design, implement, and analyze studies of psychological and behavioral interventions designed to prevent the deterioration in treatment adherence, metabolic control, and psychological adjustment that commonly occurs beginning in early adolescence for youths with diabetes. These interventions incorporate techniques such as behavior modification and motivational interviewing; parent-child training in effective communication and problem solving skills; provision of written behavior modification plans for common diabetes-related behavioral problems; and negotiation of a written family diabetes management plan specifying parent, child, and shared responsibilities. A total award of $1.42 million was made for the period of November 2003 through October 2008.

What Were Doing:

Beginning in late childhood and early adolescence, many youths with type 1 diabetes and their families begin to experience much more difficulty managing the diabetes successfully. Deterioration in treatment adherence, diabetic control, and psychological adjustment to diabetes is common. Once this negative cycle begins, it tends to continue into adulthood. Thus, it is important to find ways to prevent the early onset of this deterioration so that adolescents can maintain optimal health and adjustment over the long term. This project was funded by the National Institutes of Health to attack these problems.

A steering committee comprising staff of the NICHD Prevention Research Branch (Drs. Bruce Simons-Morton, Ron Iannotti and Tonja Nansel), the four principal investigators (Drs. Barbara Anderson, Lori Laffel, Jill Weissberg-Benchell, and Tim Wysocki) and the study coordinating center (Dr. Cheryl McDonnell) planned and has implemented a pilot and feasibility study. That study began at the four clinical sites (Houston, Chicago, Boston, and Jacksonville) in November of 2004 and enrolled a sample of 128 families, each of whom remain in the study for 6 months. Families were randomized to either remain in Standard Care or to receive a low-intensity clinic-based behavioral intervention designed to promote effective problem solving related to family management of diabetes. This pilot and feasibility study will conclude in the beginning of 2006, and results will be used to guide the development of a much larger randomized controlled trial that will be planned in detail for implementation in 2006-2008. Preliminary plans call for enrollment of a sample of 480 families in the larger trial, each of whom will be followed for 2 years. It is hoped that these studies will lead to more effective family management of type 1 diabetes during the transition to adolescence, a developmental period that is often very challenging for these patients, their parents, and their health care providers.

Some of What We've Found:

The pilot study will be completed in the Winter of 2006. Thus far, the pilot has confirmed the feasibility and acceptance of both the intervention and measurement protocols that were planned. Analyses of pilot study data will follow the completion of the study and will further guide the planning and implementation of the larger study beginning in early 2006.