Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control
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|ClinicalTrials.gov Identifier: NCT00519935|
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: Multisystemic Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adherence to IDDM Regimen in Urban Youth|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
Experimental: Multisystemic Therapy
In-home, intensive family therapy
Behavioral: Multisystemic Therapy
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.
Other Name: MST
No Intervention: Standard Medical Care (TAU)
Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.
- Metabolic Control: Hemoglobin A1c (HbA1c) [ Time Frame: 2 years ]Retrospective measure of blood glucose control, encompasses the previous 2-3 months
- Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads [ Time Frame: 2 years ]The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control.
- DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ) [ Time Frame: 2 years ]The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
- Quality of life [ Time Frame: 2 years ]44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519935
|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|