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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Multisystemic Therapy

• Registration Number: NCT00519935
• Lead Sponsor: Wayne State University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multisystemic Therapy	Multisystemic Therapy	In-home, intensive family therapy

Primary Outcome Measures

Name	Time	Method
Metabolic Control: Hemoglobin A1c (HbA1c)	2 years	Retrospective measure of blood glucose control, encompasses the previous 2-3 months

Secondary Outcome Measures

Name	Time	Method
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads	2 years	The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control.
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)	2 years	The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Quality of life	2 years	44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.

Trial Locations

Locations (1)

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States