Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes
Condition: Diabetes Mellitus, Insulin Dependent
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Intensive Home-Based Family Therapy; Supportive Telephone Calls
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Multisystemic Therapy, MST; TS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; regimen adherence; metabolic control; adolescents; family therapy