Clinical trial NCT00519935: Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control
Official title: Adherence to IDDM Regimen in Urban Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Insulin Dependent Diabetes Mellitus
family therapy
adolescents
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Medical University of South Carolina
First posted: 2007-08-23
Enrollment: 127
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Metabolic Control: Hemoglobin A1c (HbA1c)
timeFrame: 2 years
Secondary outcomes:
measure: Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
timeFrame: 2 years
measure: DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah A. Ellis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Sylvie Naar-King, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Michigan
name: Maureen O. Frey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.