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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00519935
First received: August 22, 2007
Last updated: March 1, 2010
Last verified: March 2010
  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 (MST)

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 ]
  • metabolic control [ Time Frame: 2 years ]
  • rates of diabetic complications [ Time Frame: 2 years ]
  • hospital utilization [ Time Frame: 2 years ]
  • quality of life [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • general family functioning [ Time Frame: 2 years ]
  • diabetes-specific family functioning [ Time Frame: 2 years ]
  • child behavior [ Time Frame: 2 years ]
  • stress [ Time Frame: 2 years ]
  • patient-provider relationships [ Time Frame: 2 years ]

Enrollment: 127
Study Start Date: July 2001
Study Completion Date: March 2006
Intervention Details:
    Behavioral: Multisystemic Therapy (MST)

    MST is a family and community-based treatment model that draws upon social-ecological and family systems theories of behavior. Extra-familial systems, such as the health care system, school, work, peers, and even community and cultural institutions are seen as interconnected with the individual and his or her family. Problem behavior such as severe adherence problems may be a function of difficulty within or between any of these systems (e.g., family-health provider relations, family-school relations, child-peer relations).

    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.

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
Genders Eligible for Study:   Both
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
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
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00519935     History of Changes
Other Study ID Numbers: DK59067B (completed)
Study First Received: August 22, 2007
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014