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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00273286 |
This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deterioration in glycemic control, treatment adherence, and quality of life that commonly occur during late childhood and early adolescence in youth with type 1 diabetes. The study will also examine mechanisms and processes that influence the effectiveness of family management of diabetes during this developmental period.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Behavioral: Family problem solving |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Family Management of Childhood Diabetes Study |
Estimated Enrollment: | 480 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | August 2008 |
The purpose of this study is to test the effectiveness of a practical, low-cost, low-intensity behavioral intervention that can be integrated directly into diabetes clinic routines. The goal of the intervention is to prevent the deterioration in glycemic control, treatment adherence, and quality of life that often occur during the transition to adolescence in families of youth with type 1 diabetes. Four-hundred and eighty families (120 from each of the four sites) will be randomly assigned by the coordinating center to intervention or standard care conditions. Standard care will be the multidisciplinary management of type 1 diabetes as currently practiced at the clinical sites. Randomization will be stratified by main versus recent-onset subgroup, age, and for the main subgroup, baseline glycosylated hemoglobin level. Families will remain in their respective experimental conditions for 24 months. A trained health advisor will be responsible for interactions with parents and patients prior to each diabetes clinic visit (preparation phase), at the time of the diabetes clinic visit (consolidation phase) and by phone, e-mail, etc. after the clinic visit (follow-up phase). Using educational modules developed for the study, families will be engaged in problem identification and solving activities to foster improved disease management capabilities and improved parent-youth communication around and sharing of responsibility for diabetes management. Families will be assessed at home three times and in the clinic four times over the course of the study. Measures include parent, child, and family characteristics that may affect intervention effectiveness, targeted mediators, family interaction, management practices, and glycosylated hemoglobin (HbA1c). Primary outcomes are diabetes management adherence and metabolic control; secondary outcomes are quality of life, health status, and psychosocial status.
Ages Eligible for Study: | 108 Months to 174 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Child Inclusion Criteria:
Parent/Family Environment Inclusion Criteria
Child Exclusion Criteria:
Parent/Family Environment Exclusion Criteria
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207-8426 | |
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Bruce Simons-Morton, PhD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Study ID Numbers: | FMOD |
Study First Received: | January 5, 2006 |
Last Updated: | February 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00273286 History of Changes |
Health Authority: | United States: Federal Government |
Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Juvenile-Onset IDDM Type 1 Diabetes Mellitus |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |