NCT00519935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

4.7 years

First QC Date

August 22, 2007

Last Update Submit

May 31, 2017

Conditions

Type 1 Diabetes

Keywords

Insulin Dependent Diabetes Mellitusfamily therapyadolescents

Outcome Measures

Primary Outcomes (1)

  • Metabolic Control: Hemoglobin A1c (HbA1c)

    Retrospective measure of blood glucose control, encompasses the previous 2-3 months

    2 years

Secondary Outcomes (3)

  • Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads

    2 years

  • DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)

    2 years

  • Quality of life

    2 years

Study Arms (2)

Multisystemic Therapy

EXPERIMENTAL

In-home, intensive family therapy

Behavioral: Multisystemic Therapy

Standard Medical Care (TAU)

NO INTERVENTION

Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.

Interventions

Multisystemic TherapyBEHAVIORAL

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.

Also known as: MST
Multisystemic Therapy

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • severe mental impairment/thought disorder
  • non-English speaking patient/parent
  • co-morbid major medical condition such as cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Related Publications (9)

  • 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.

    PMID: 15983308RESULT

  • 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.

    PMID: 16322140RESULT

  • 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.

    PMID: 16260435RESULT

  • 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.

    PMID: 16881786RESULT

  • 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.

    PMID: 16322274RESULT

  • 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.

    PMID: 17295576RESULT

  • 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.

    PMID: 16675714RESULT

  • 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.

    PMID: 17659062RESULT

  • 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.

    PMID: 18566340DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Deborah A. Ellis, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Sylvie Naar-King, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Maureen O. Frey, Ph.D.

    Children's Hospital of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

July 1, 2001

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

June 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)