Clinical trial NCT00372814: Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes
Official title: Adherence to IDDM Regimen in Urban Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Insulin Dependent
Keywords: diabetes
regimen adherence
metabolic control
adolescents
family therapy
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-09-07
Enrollment: 146
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Control: Hemoglobin A1c (HbA1c)
timeFrame: treatment termination, 6-month follow up
Secondary outcomes:
measure: BMI percentile
timeFrame: treatment termination, 6-month follow up
measure: Diabetes-Specific Family Functioning
timeFrame: treatment termination, 6-month follow up
measure: DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
timeFrame: treatment termination, 6-month follow up
measure: Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, Glucose Meter Downloads
timeFrame: treatment termination, 6-month follow up
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah A. Ellis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis DA, Naar-King S, Chen X, Moltz K, Cunningham PB, Idalski-Carcone A. Multisystemic therapy compared to telephone support for youth with poorly controlled diabetes: findings from a randomized controlled trial. Ann Behav Med. 2012 Oct;44(2):207-15. doi: 10.1007/s12160-012-9378-1.
citation: Carcone AI, Ellis DA, Chen X, Naar S, Cunningham PB, Moltz K. Multisystemic Therapy Improves the Patient-Provider Relationship in Families of Adolescents with Poorly Controlled Insulin Dependent Diabetes. J Clin Psychol Med Settings. 2015 Sep;22(2-3):169-78. doi: 10.1007/s10880-015-9422-y.