Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 6/3/2017 |
| Start Date: | March 2007 |
| End Date: | January 2011 |
Adherence to IDDM Regimen in Urban Youth
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.
(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.
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.
Inclusion Criteria:
- insulin dependent Type 1 or Type 2 diabetes
- diagnosed with diabetes ≥ 1 year
- current HbA1c ≥ 8%
- average HbA1c ≥ 8% over the past year
- aged 10 -17
- patient of Children's Hospital of Michigan Diabetes Clinic
- lives within 30 miles of Children's Hospital of Michigan
Exclusion Criteria:
- moderate to severe mental retardation (unable to complete study measures)
- psychosis or current suicidal intent
- any medical diagnosis that alters standard diabetes care
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