Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control

Wayne State University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Multisystemic Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00519935

R01DK059067 (U.S. NIH Grant/Contract)

DK59067A (completed)

Details and patient eligibility

About

The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.

Full description

Substantial data exists to demonstrate that improving metabolic control in persons with Type 1 diabetes mellitus (T1DM) can delay the onset of diabetes complications and reverse some existing complications as well. Unfortunately, those adolescents with T1DM who are at highest risk for diabetes complications are often the most resistant to hospital based care and traditional education/ supportive interventions. They are also faced with multiple barriers to improved metabolic control, which may include lack of knowledge about diabetes, family disorganization and disengagement, high levels of stress and an unhealthy lifestyle. Multisystemic Therapy (MST), a flexible and home-based therapeutic intervention originally designed for use with mental health populations, seems to be a promising approach to providing diabetic adolescents with the ability to engage in consistent and attentive illness management.

The study recruited a sample of 127 adolescents in poor metabolic control and randomly assigned them to either the treatment intervention, MST plus standard medical care, or standard medical care alone. Families randomized to MST received intensive, home-based family therapy for approximately six months. Families completed data collection at baseline and then again at 7, 12 18 and 24 months after study entry.

Enrollment: 127 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a current hemoglobin A1c(HbA1c) of >8.0%
• an average HbA1c of >8.0% during the past year
• diagnosed with Type 1 diabetes for at least one year
• reside in the metro Detroit tri-county area

Exclusion criteria

• severe mental impairment/thought disorder
• non-English speaking patient/parent
• co-morbid major medical condition such as cystic fibrosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

Multisystemic Therapy

Experimental group

Description:

In-home, intensive family therapy

Treatment:

Behavioral: Multisystemic Therapy

Standard Medical Care (TAU)

No Intervention group

Description:

Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.