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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multisystemic Therapy
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin Dependent Diabetes Mellitus, family therapy, adolescents

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multisystemic Therapy

Standard Medical Care (TAU)

Arm Description

In-home, intensive family therapy

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
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)
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Quality of life
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.

Full Information

First Posted
August 22, 2007
Last Updated
May 31, 2017
Sponsor
Wayne State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00519935
Brief Title
Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control
Official Title
Adherence to IDDM Regimen in Urban Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Insulin Dependent Diabetes Mellitus, family therapy, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multisystemic Therapy
Arm Type
Experimental
Arm Description
In-home, intensive family therapy
Arm Title
Standard Medical Care (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multisystemic Therapy
Other Intervention Name(s)
MST
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic Control: Hemoglobin A1c (HbA1c)
Description
Retrospective measure of blood glucose control, encompasses the previous 2-3 months
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
Description
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.
Time Frame
2 years
Title
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Description
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Time Frame
2 years
Title
Quality of life
Description
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A. Ellis, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvie Naar-King, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen O. Frey, Ph.D.
Organizational Affiliation
Children's Hospital of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15983308
Citation
Ellis DA, Frey MA, Naar-King S, Templin T, Cunningham P, Cakan N. Use of multisystemic therapy to improve regimen adherence among adolescents with type 1 diabetes in chronic poor metabolic control: a randomized controlled trial. Diabetes Care. 2005 Jul;28(7):1604-10. doi: 10.2337/diacare.28.7.1604.
Results Reference
result
PubMed Identifier
16322140
Citation
Ellis DA, Frey MA, Naar-King S, Templin T, Cunningham PB, Cakan N. The effects of multisystemic therapy on diabetes stress among adolescents with chronically poorly controlled type 1 diabetes: findings from a randomized, controlled trial. Pediatrics. 2005 Dec;116(6):e826-32. doi: 10.1542/peds.2005-0638.
Results Reference
result
PubMed Identifier
16260435
Citation
Ellis DA, Naar-King S, Frey M, Templin T, Rowland M, Cakan N. Multisystemic treatment of poorly controlled type 1 diabetes: effects on medical resource utilization. J Pediatr Psychol. 2005 Dec;30(8):656-66. doi: 10.1093/jpepsy/jsi052. Epub 2005 Mar 3.
Results Reference
result
PubMed Identifier
16881786
Citation
Naar-King S, Podolski CL, Ellis DA, Frey MA, Templin T. Social ecological model of illness management in high-risk youths with type 1 diabetes. J Consult Clin Psychol. 2006 Aug;74(4):785-9. doi: 10.1037/0022-006X.74.4.785.
Results Reference
result
PubMed Identifier
16322274
Citation
Naar-King S, Idalski A, Ellis D, Frey M, Templin T, Cunningham PB, Cakan N. Gender differences in adherence and metabolic control in urban youth with poorly controlled type 1 diabetes: the mediating role of mental health symptoms. J Pediatr Psychol. 2006 Sep;31(8):793-802. doi: 10.1093/jpepsy/jsj090. Epub 2005 Dec 1.
Results Reference
result
PubMed Identifier
17295576
Citation
Ellis DA, Templin T, Naar-King S, Frey MA, Cunningham PB, Podolski CL, Cakan N. Multisystemic therapy for adolescents with poorly controlled type I diabetes: Stability of treatment effects in a randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):168-74. doi: 10.1037/0022-006X.75.1.168.
Results Reference
result
PubMed Identifier
16675714
Citation
Ellis DA, Yopp J, Templin T, Naar-King S, Frey MA, Cunningham PB, Idalski A, Niec LN. Family mediators and moderators of treatment outcomes among youths with poorly controlled type 1 diabetes: results from a randomized controlled trial. J Pediatr Psychol. 2007 Mar;32(2):194-205. doi: 10.1093/jpepsy/jsj116. Epub 2006 May 4.
Results Reference
result
PubMed Identifier
17659062
Citation
Cakan N, Ellis DA, Templin T, Frey M, Naar-King S. The effects of weight status on treatment outcomes in a randomized clinical trial of multisystemic therapy for adolescents with type 1 diabetes and chronically poor metabolic control. Pediatr Diabetes. 2007 Aug;8(4):206-13. doi: 10.1111/j.1399-5448.2007.00273.x.
Results Reference
result
PubMed Identifier
18566340
Citation
Ellis D, Naar-King S, Templin T, Frey M, Cunningham P, Sheidow A, Cakan N, Idalski A. Multisystemic therapy for adolescents with poorly controlled type 1 diabetes: reduced diabetic ketoacidosis admissions and related costs over 24 months. Diabetes Care. 2008 Sep;31(9):1746-7. doi: 10.2337/dc07-2094. Epub 2008 Jun 19.
Results Reference
derived

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

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