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Type 1 DiabetesNCT00519935

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

A study testing Multisystemic Therapy in people with Type 1 Diabetes, run by Wayne State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 16 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Multisystemic Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteUnited States
Study dates
Jul 2001to Mar 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Adherence to IDDM Regimen in Urban Youth

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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Multisystemic Therapy
Keywords
Insulin Dependent Diabetes Mellitus, family therapy, adolescents
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multisystemic TherapyBehavioural

    Also called MST

    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.

Study groups in NCT00519935
Study groupRoleWhat they receive
Multisystemic TherapyExperimentalIn-home, intensive family therapy
Receives: Behavioral: Multisystemic Therapy
Standard Medical Care (TAU)No interventionStandard 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic Control: Hemoglobin A1c (HbA1c)

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

    Measured: 2 years

Secondary outcomes (3)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. Quality of life

    44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2007 (estimated)
  2. Study startJul 2001
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00519935
Sponsor's protocol ID
DK59067A (completed)
Other IDs
R01DK059067
Status last verified
May 2017
First submitted
22 Aug 2007
Last updated
2 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15983308

  • 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.

    PubMed 16322140

  • 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.

    PubMed 16260435

  • 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.

    PubMed 16881786

  • 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.

    PubMed 16322274

  • 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.

    PubMed 17295576

  • 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.

    PubMed 16675714

  • 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.

    PubMed 17659062

  • 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.

    PubMed 18566340

Questions about this trial

What is this clinical trial studying?

A study testing Multisystemic Therapy in people with Type 1 Diabetes, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Control: Hemoglobin A1c (HbA1c) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00519935, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.

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