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

May 31, 2017 updated by: Deborah Ellis, Ph.D., Wayne State University

Adherence to IDDM Regimen in Urban Youth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multisystemic Therapy
In-home, intensive family therapy
Behavioral: Multisystemic Therapy
MST is an individualized approach that begins with a comprehensive, multi-informant assessment that allows for the development of treatment goals and interventions that are individually tailored for each family. Therapists draw upon a menu of evidenced-based interventions that include cognitive-behavioral therapy, parent training and behavioral family systems therapy.
Other Names:
  • MST
No Intervention: Standard Medical Care (TAU)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
Time Frame: 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.
2 years
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Time Frame: 2 years
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
2 years
Quality of life
Time Frame: 2 years
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Deborah A. Ellis, Ph.D., Wayne State University
  • Principal Investigator: Maureen O. Frey, Ph.D., Children's Hospital of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK59067A (completed)
  • R01DK059067 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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