The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy (MST) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.
The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC. The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of \>8% and an average HbA1c of \>8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
146
Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.
Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.
Children's Hospital of Michigan
Detroit, Michigan, United States
Metabolic Control: Hemoglobin A1c (HbA1c)
Retrospective measure of blood glucose control, encompasses the previous 2-3 months
Time frame: treatment termination, 6-month follow up
BMI percentile
Body mass index (BMI) a value derived from the mass and height of an individual
Time frame: treatment termination, 6-month follow up
Diabetes-Specific Family Functioning
Diabetes Family Responsibility Questionnaire (DFRQ), Parental Monitoring of Adolescent Diabetes Care (PMADC), Diabetes Social Support Questionnaire-Family (DSSQ-Family)
Time frame: treatment termination, 6-month follow up
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.
Time frame: treatment termination, 6-month follow up
Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, 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.
Time frame: treatment termination, 6-month follow up
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