Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes
Adherence to IDDM Regimen in Urban Youth
2 other identifiers
interventional
146
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 7, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 2, 2017
June 1, 2017
3.8 years
September 5, 2006
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Control: Hemoglobin A1c (HbA1c)
Retrospective measure of blood glucose control, encompasses the previous 2-3 months
treatment termination, 6-month follow up
Secondary Outcomes (4)
BMI percentile
treatment termination, 6-month follow up
Diabetes-Specific Family Functioning
treatment termination, 6-month follow up
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
treatment termination, 6-month follow up
Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, Glucose Meter Downloads
treatment termination, 6-month follow up
Study Arms (2)
Multisystemic Therapy (MST)
EXPERIMENTALAdolescents 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.
Telephone Support Calls
ACTIVE COMPARATORAdolescents 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- moderate to severe mental retardation (unable to complete study measures)
- psychosis or current suicidal intent
- any medical diagnosis that alters standard diabetes care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Related Publications (2)
Ellis DA, Naar-King S, Chen X, Moltz K, Cunningham PB, Idalski-Carcone A. Multisystemic therapy compared to telephone support for youth with poorly controlled diabetes: findings from a randomized controlled trial. Ann Behav Med. 2012 Oct;44(2):207-15. doi: 10.1007/s12160-012-9378-1.
PMID: 22644587RESULTCarcone AI, Ellis DA, Chen X, Naar S, Cunningham PB, Moltz K. Multisystemic Therapy Improves the Patient-Provider Relationship in Families of Adolescents with Poorly Controlled Insulin Dependent Diabetes. J Clin Psychol Med Settings. 2015 Sep;22(2-3):169-78. doi: 10.1007/s10880-015-9422-y.
PMID: 25940767RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A. Ellis, Ph.D.
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 7, 2006
Study Start
March 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
June 2, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share