NICHD Investigators: Tonja R. Nansel, Ph.D; Bruce Simons-Morton, EdD; Ronald Iannotti, Ph.D.
Collaborating Sites and Principal Investigators:
Joslin Diabetes Center in Boston, Massachusetts; Lori Laffel, MD MPH, PI
Nemours Children's Clinic in Jacksonville, Florida; Tim Wysocki, PhD, PI
Texas Children's Hospital in Houston, Texas; Barbara Anderson, PhD, PI
Children's Memorial Hospital in Chicago, Illinois; Jill Weissberg-Benchell, PhD, PI
Data Coordinating Center:
James Bell Associates, Arlington, Virginia; Cheryl McDonnell, PhD, PI
Successful management of diabetes in youth is heavily dependent upon family adaptation to the affective, behavioral, and cognitive demands imposed by the disease. During pre- and early adolescence, transition in responsibility for diabetes management, along with normal physiological and psychological developmental changes creates an especially challenging situation. Although many youths and parents negotiate this transition effectively, it is also a period when many other youths take costly, self-destructive paths that result in preventable health care costs and psychological suffering in the short-term and accelerated onset and progression of long-term complications of the disease. Studies suggest that poor adaptation to diabetes during adolescence is likely to persist into early adulthood, accelerating the risks of long-term medical complications.
Research to date suggests that adherence, quality of life, and glycemic control could be enhanced if behavioral interventions were routinely implemented as part of standard care. Yet there are many barriers to the translation of these interventions into routine clinical practice, including cost, access, third-party coverage, availability of qualified clinicians, convenience, social stigma, and other such variables. A multi-component behavioral intervention that integrates psychological principles into medical management of diabetes is likely to enhance family management of diabetes during early adolescence in a practical, cost-effective, and lasting manner.
- Determine the effect of intervention on glycemic control and treatment adherence (primary),
- Determine the effect of intervention on instrumental mediators (i.e., at both dyadic/family and individual levels) compared with standard care;
- Examine cross-sectional and longitudinal patterns among dyadic, family, child, and parent characteristics and the maintenance of effective family management of diabetes during the transition to early adolescence; and
- Evaluate the cost-effectiveness and acceptance of the intervention among children, parents, and health care professionals.
The study employs a randomized experimental design in which youth-parent dyads attending one of four clinical sites are stratified by degree of glycemic control and randomized to receive either standard care or a clinic-integrated behavioral intervention. The intervention is based on both individual and family-system theoretical perspectives, including social cognitive theory, self-regulation, and authoritative parenting. It is designed to provide experiential training for families in the use of a problem-solving approach to promote improved parent-child teamwork and more effective problem-solving skills for diabetes management. The intervention is designed to be applicable to the broad population of youth with diabetes and their families, flexibly implemented and tailored to the varying needs of families, and delivered at a low intensity over time to meet the changing needs and roles of families during the period in which responsibility for diabetes management typically undergoes transition. A combination of in-person assessments, telephone assessments, and in-clinic data collection will be utilized to assess glycemic control, adherence, quality of life, psychological status, and hypothesized mediators of these outcomes.
Unique aspects of the study include the following:
- It is the largest to date, and the first multi-site study, to test the efficacy of behavioral interventions for improving adherence, glycemic control, and quality of life in youth with type 1 diabetes;
- It is based on the concept that small changes across the distribution of risk factor may have a greater public health impact than individual or high-risk approaches and, as such, is designed to address the population of youth with diabetes;
- The sample is large enough to test intervention moderator effects including baseline level of glycemic control, socio-economic status, and family functioning;
- Four clinical sites are participating, two of which have substantial low socio-economic status and minority populations.
DESPR Collaborators
· Denise L. Haynie, Ph.D., M.P.H.
Selected Publications
Nansel TR, Anderson BJ, Laffel LMB, Simons-Morton B, Weissberg-Benchell J, Wysocki T, Iannotti RJ, Holmbeck G, Hood KK, & Lochrie AS, for the Family Management of Diabetes Steering Committee. (In press). A multi-site trial of a clinic-integrated intervention for promoting family management of childhood diabetes: feasibility and design. Pediatric Diabetes.
Nansel TR, Rovner A, Haynie DL, Iannotti RJ, Simons-Morton B, Wysocki T, Anderson B, Weissberg-Benchell J, & Laffel L. (In press). Development and validation of the Collaborative Parent Involvement scale. Journal of Pediatric Psychology.
Mehta S, Volkening L, Laffel L, & Nansel TR, for the Family Management of Diabetes Steering Committee. (In press). Dietary behaviors predict glycemic control in youth with type 1 diabetes. Diabetes Care.
=
