Diabetes Mellitus, Insulin DependentNCT00372814
Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes
A study testing Intensive Home-Based Family Therapy and Supportive Telephone Calls in people with Diabetes Mellitus, Insulin Dependent, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Insulin Dependent
- What is being tested?
- Intensive Home-Based Family Therapy and Supportive Telephone Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jan 2011
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- moderate to severe mental retardation (unable to complete study measures)
- psychosis or current suicidal intent
- any medical diagnosis that alters standard diabetes care
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Adherence to IDDM Regimen in Urban Youth
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.
Read the detailed description
The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC.
The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of >8% and an average HbA1c of >8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.
- Conditions
- Diabetes Mellitus, Insulin Dependent
- Being tested
- Intensive Home-Based Family Therapy, Supportive Telephone Calls
- Keywords
- diabetes, regimen adherence, metabolic control, adolescents, family therapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Home-Based Family TherapyBehavioural
Also called Multisystemic Therapy, MST
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.
Supportive Telephone CallsBehavioural
Also called TS
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.
| Study group | Role | What they receive |
|---|---|---|
| Multisystemic Therapy (MST) | Experimental | Adolescents 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. Receives: Behavioral: Intensive Home-Based Family Therapy |
| Telephone Support Calls | Active comparator | Adolescents 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. Receives: Behavioral: Supportive Telephone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control: Hemoglobin A1c (HbA1c)
Retrospective measure of blood glucose control, encompasses the previous 2-3 months
Measured: treatment termination, 6-month follow up
Secondary outcomes (4)
BMI percentile
Body mass index (BMI) a value derived from the mass and height of an individual
Measured: treatment termination, 6-month follow up
Diabetes-Specific Family Functioning
Diabetes Family Responsibility Questionnaire (DFRQ), Parental Monitoring of Adolescent Diabetes Care (PMADC), Diabetes Social Support Questionnaire-Family (DSSQ-Family)
Measured: treatment termination, 6-month follow up
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: treatment termination, 6-month follow up
Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, 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: treatment termination, 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startMar 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Insulin DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Ellis, Ph.D., Wayne State University
- Investigators
- Deborah A. Ellis, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372814
- Sponsor's protocol ID
- DK59067B (completed)
- Other IDs
- R01DK059067
- Status last verified
- Jun 2017
- First submitted
- 5 Sep 2006
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22644587Carcone 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.
PubMed 25940767
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to IDDM Regimen in Urban Youth
- ClinicalTrials.gov ID
- NCT00372814
- Acronym / sponsor ID
- DK59067B (completed)
- Conditions
- Diabetes Mellitus, Insulin Dependent
- Keywords
- diabetes, regimen adherence, metabolic control, adolescents, family therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC.
The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of >8% and an average HbA1c of >8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisystemic Therapy (MST) | Experimental | Behavioral: Intensive Home-Based Family TherapyAdolescents 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 comparator | Behavioral: Supportive Telephone CallsAdolescents 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- moderate to severe mental retardation (unable to complete study measures)
- psychosis or current suicidal intent
- any medical diagnosis that alters standard diabetes care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Home-Based Family TherapyAlso: Multisystemic Therapy, MSTMultisystemic 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. | Behavioural | Multisystemic Therapy (MST) |
| Supportive Telephone CallsAlso: TSTelephone 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. | Behavioural | Telephone Support Calls |
Primary outcome
Metabolic Control: Hemoglobin A1c (HbA1c)
Time frame: treatment termination, 6-month follow up
Retrospective measure of blood glucose control, encompasses the previous 2-3 months
4 secondary outcomes
BMI percentile
Time frame: treatment termination, 6-month follow up
Diabetes-Specific Family Functioning
Time frame: treatment termination, 6-month follow up
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Time frame: treatment termination, 6-month follow up
Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, Glucose Meter Downloads
Time frame: treatment termination, 6-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Results publication: PubMed 22644587Ellis 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.
- Results publication: PubMed 25940767Carcone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A. Ellis, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Home-Based Family Therapy and Supportive Telephone Calls in people with Diabetes Mellitus, Insulin Dependent, 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 7 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: treatment termination, 6-month follow up). 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 NCT00372814, which also lists 2 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.