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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00519935 |
The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.
Condition | Intervention |
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Type 1 Diabetes |
Behavioral: Multisystemic Therapy (MST) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Adherence to IDDM Regimen in Urban Youth |
Enrollment: | 127 |
Study Start Date: | July 2001 |
Study Completion Date: | March 2006 |
MST is a family and community-based treatment model that draws upon social-ecological and family systems theories of behavior. Extra-familial systems, such as the health care system, school, work, peers, and even community and cultural institutions are seen as interconnected with the individual and his or her family. Problem behavior such as severe adherence problems may be a function of difficulty within or between any of these systems (e.g., family-health provider relations, family-school relations, child-peer relations).
MST is an individualized approach that begins with a comprehensive, multi-informant assessment that allows for the development of treatment goals and interventions that are individually tailored for each family. Therapists draw upon a menu of evidenced-based interventions that include cognitive-behavioral therapy, parent training and behavioral family systems therapy.
Substantial data exists to demonstrate that improving metabolic control in persons with Type 1 diabetes mellitus (T1DM) can delay the onset of diabetes complications and reverse some existing complications as well. Unfortunately, those adolescents with T1DM who are at highest risk for diabetes complications are often the most resistant to hospital based care and traditional education/ supportive interventions. They are also faced with multiple barriers to improved metabolic control, which may include lack of knowledge about diabetes, family disorganization and disengagement, high levels of stress and an unhealthy lifestyle. Multisystemic Therapy (MST), a flexible and home-based therapeutic intervention originally designed for use with mental health populations, seems to be a promising approach to providing diabetic adolescents with the ability to engage in consistent and attentive illness management.
The study recruited a sample of 127 adolescents in poor metabolic control and randomly assigned them to either the treatment intervention, MST plus standard medical care, or standard medical care alone. Families randomized to MST received intensive, home-based family therapy for approximately six months. Families completed data collection at baseline and then again at 7, 12 18 and 24 months after study entry.
Ages Eligible for Study: | 10 Years to 16 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Children's Hospital of Michigan | |
Detroit, Michigan, United States, 48201 |
Principal Investigator: | Deborah A. Ellis, Ph.D. | Wayne State University |
Principal Investigator: | Sylvie Naar-King, Ph.D. | Wayne State University |
Principal Investigator: | Maureen O. Frey, Ph.D. | Children's Hospital of Michigan |
Study ID Numbers: | DK59067B |
Study First Received: | August 22, 2007 |
Last Updated: | September 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00519935 |
Health Authority: | United States: Federal Government |
Insulin Dependent Diabetes Mellitus family therapy adolescents |
Morphine Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |