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Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372814
First Posted: September 7, 2006
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Deborah Ellis, Ph.D., Wayne State University
  Purpose
The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy (MST) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.

Condition Intervention
Diabetes Mellitus, Insulin Dependent Behavioral: Intensive Home-Based Family Therapy Behavioral: Supportive Telephone Calls

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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: treatment termination, 6-month follow up ]
    Retrospective measure of blood glucose control, encompasses the previous 2-3 months


Secondary Outcome Measures:
  • BMI percentile [ Time Frame: treatment termination, 6-month follow up ]
    Body mass index (BMI) a value derived from the mass and height of an individual

  • Diabetes-Specific Family Functioning [ Time Frame: treatment termination, 6-month follow up ]
    Diabetes Family Responsibility Questionnaire (DFRQ), Parental Monitoring of Adolescent Diabetes Care (PMADC), Diabetes Social Support Questionnaire-Family (DSSQ-Family)

  • DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ) [ Time Frame: treatment termination, 6-month follow up ]
    The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.

  • Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, Glucose Meter Downloads [ Time Frame: treatment termination, 6-month follow up ]
    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.


Enrollment: 146
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multisystemic Therapy (MST)
Adolescents receiving MST will receive Intensive Home-Based Family Therapy which will consist of home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their daily diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.
Behavioral: Intensive Home-Based Family Therapy
Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.
Other Name: Multisystemic Therapy, MST
Active Comparator: Telephone Support Calls
Adolescents receiving Supportive Telephone Calls (TS) will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.
Behavioral: Supportive Telephone Calls
Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.
Other Name: TS

Detailed Description:

The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC.

The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of >8% and an average HbA1c of >8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • insulin dependent Type 1 or Type 2 diabetes
  • diagnosed with diabetes ≥ 1 year
  • current HbA1c ≥ 8%
  • average HbA1c ≥ 8% over the past year
  • aged 10 -17
  • patient of Children's Hospital of Michigan Diabetes Clinic
  • lives within 30 miles of Children's Hospital of Michigan

Exclusion Criteria:

  • moderate to severe mental retardation (unable to complete study measures)
  • psychosis or current suicidal intent
  • any medical diagnosis that alters standard diabetes care
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372814


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)
Investigators
Principal Investigator: Deborah A. Ellis, Ph.D. Wayne State University
  More Information

Publications:
Responsible Party: Deborah Ellis, Ph.D., Professor of Pediatrics, Wayne State University
ClinicalTrials.gov Identifier: NCT00372814     History of Changes
Other Study ID Numbers: DK59067B (completed)
R01DK059067 ( U.S. NIH Grant/Contract )
First Submitted: September 5, 2006
First Posted: September 7, 2006
Last Update Posted: June 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Deborah Ellis, Ph.D., Wayne State University:
diabetes
regimen adherence
metabolic control
adolescents
family therapy

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