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

This study has been completed.
Medical University of South Carolina
Information provided by (Responsible Party):
Deborah Ellis, Wayne State University Identifier:
First received: August 22, 2007
Last updated: March 29, 2016
Last verified: March 2016
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • adherence behaviors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • metabolic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • rates of diabetic complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • hospital utilization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • general family functioning [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • diabetes-specific family functioning [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • child behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • stress [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • patient-provider relationships [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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: TAU
standard medical care as usual

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.


Ages Eligible for Study:   10 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00519935

United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical University of South Carolina
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Deborah Ellis, Professor, Wayne State University Identifier: NCT00519935     History of Changes
Other Study ID Numbers: DK59067B (completed) 
Study First Received: August 22, 2007
Last Updated: March 29, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Insulin Dependent Diabetes Mellitus
family therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on October 20, 2016