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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical University of South Carolina
Information provided by (Responsible Party):
Deborah Ellis, Ph.D., Wayne State University
ClinicalTrials.gov Identifier:
NCT00519935
First received: August 22, 2007
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Type 1 Diabetes Behavioral: Multisystemic Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence to IDDM Regimen in Urban Youth

Resource links provided by NLM:


Further study details as provided by Deborah Ellis, Ph.D., Wayne State University:

Primary Outcome Measures:
  • Metabolic Control: Hemoglobin A1c (HbA1c) [ Time Frame: 2 years ]
    Retrospective measure of blood glucose control, encompasses the previous 2-3 months


Secondary Outcome Measures:
  • 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.

  • 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.

  • Quality of life [ Time Frame: 2 years ]
    44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.


Enrollment: 127
Study Start Date: July 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519935

Locations
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical University of South Carolina
Investigators
Principal Investigator: Deborah A. Ellis, Ph.D. Wayne State University
Principal Investigator: Sylvie Naar-King, Ph.D. Wayne State University
Principal Investigator: Maureen O. Frey, Ph.D. Children's Hospital of Michigan
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah Ellis, Ph.D., Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00519935     History of Changes
Other Study ID Numbers: DK59067A (completed)
R01DK059067 ( U.S. NIH Grant/Contract )
Study First Received: August 22, 2007
Last Updated: May 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Deborah Ellis, Ph.D., Wayne State University:
Insulin Dependent Diabetes Mellitus
family therapy
adolescents

ClinicalTrials.gov processed this record on September 21, 2017