Viewing Study NCT00519935



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00519935
Status: COMPLETED
Last Update Posted: 2017-06-02
First Post: 2007-08-22

Brief Title: Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control
Sponsor: Wayne State University
Organization: Wayne State University

Study Overview

Official Title: Adherence to IDDM Regimen in Urban Youth
Status: COMPLETED
Status Verified Date: 2017-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01DK059067 NIH None httpsreporternihgovquickSearchR01DK059067