Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes

Wayne State University

Status: Completed

Conditions: Diabetes Mellitus, Insulin Dependent

Treatments: Behavioral: Supportive Telephone Calls; Behavioral: Intensive Home-Based Family Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00372814

DK59067B (completed)

R01DK059067 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Multisystemic Therapy (MST)

Experimental group

Description:

Adolescents receiving MST will receive Intensive Home-Based Family Therapy which will consist of 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 daily diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.

Treatment:

Behavioral: Intensive Home-Based Family Therapy

Telephone Support Calls

Active Comparator group

Description:

Adolescents receiving Supportive Telephone Calls (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.

Treatment:

Behavioral: Supportive Telephone Calls