Type 1 Diabetes
Conditions
Keywords
Insulin Dependent Diabetes Mellitus, family therapy, adolescents
Brief summary
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
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.
Interventions
BEHAVIORALMultisystemic 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical University of South Carolina
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Control: Hemoglobin A1c (HbA1c) | 2 years | Retrospective measure of blood glucose control, encompasses the previous 2-3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads | 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) | 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 | 2 years | 44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents. |
Countries
United States
Outcome results
None listed