Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adherence to IDDM Regimen in Urban Youth

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Multisystemic Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a current hemoglobin A1c(HbA1c) of >8.0% an average HbA1c of >8.0% during the past year diagnosed with Type 1 diabetes for at least one year reside in the metro Detroit tri-county area Exclusion Criteria: severe mental impairment/thought disorder non-English speaking patient/parent co-morbid major medical condition such as cystic fibrosis

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multisystemic Therapy<br>In-home, intensive family therapy | Behavioral: Multisystemic Therapy<br>* 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.<br>* Other names: MST;|
| No Intervention: Standard Medical Care (TAU)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control: Hemoglobin A1c (HbA1c) | Retrospective measure of blood glucose control, encompasses the previous 2-3 months | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads | 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. | 2 years | 
| DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ) | The number of patient visits to acute care settings represents a significant health care cost in this high-risk population. | 2 years | 
| Quality of life | 44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Dependent Diabetes Mellitus, family therapy, adolescents