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

Type 1 Diabetes Clinical Trial

Official title:

Adherence to IDDM Regimen in Urban Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519935
• Other study ID #: DK59067A (completed)
• Secondary ID: R01DK059067
• Status: Completed
• Phase: N/A
• First received: August 22, 2007
• Last updated: May 31, 2017
• Start date: July 2001
• Est. completion date: March 2006

Study information

• Verified date: May 2017
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. 20 — View 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 — View 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 — View 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. Epub 2005 Mar 3. — View 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 — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control: Hemoglobin A1c (HbA1c)	Retrospective measure of blood glucose control, encompasses the previous 2-3 months	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	Quality of life	44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.	2 years