- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273286
Family Management of Type 1 Diabetes in Children
May 11, 2011 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Family Management of Childhood Diabetes Study
This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deterioration in glycemic control, treatment adherence, and quality of life that commonly occur during late childhood and early adolescence in youth with type 1 diabetes.
The study will also examine mechanisms and processes that influence the effectiveness of family management of diabetes during this developmental period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to test the effectiveness of a practical, low-cost, low-intensity behavioral intervention that can be integrated directly into diabetes clinic routines.
The goal of the intervention is to prevent the deterioration in glycemic control, treatment adherence, and quality of life that often occur during the transition to adolescence in families of youth with type 1 diabetes.
Four-hundred and eighty families (120 from each of the four sites) will be randomly assigned by the coordinating center to intervention or standard care conditions.
Standard care will be the multidisciplinary management of type 1 diabetes as currently practiced at the clinical sites.
Randomization will be stratified by main versus recent-onset subgroup, age, and for the main subgroup, baseline glycosylated hemoglobin level.
Families will remain in their respective experimental conditions for 24 months.
A trained health advisor will be responsible for interactions with parents and patients prior to each diabetes clinic visit (preparation phase), at the time of the diabetes clinic visit (consolidation phase) and by phone, e-mail, etc. after the clinic visit (follow-up phase).
Using educational modules developed for the study, families will be engaged in problem identification and solving activities to foster improved disease management capabilities and improved parent-youth communication around and sharing of responsibility for diabetes management.
Families will be assessed at home three times and in the clinic four times over the course of the study.
Measures include parent, child, and family characteristics that may affect intervention effectiveness, targeted mediators, family interaction, management practices, and glycosylated hemoglobin (HbA1c).
Primary outcomes are diabetes management adherence and metabolic control; secondary outcomes are quality of life, health status, and psychosocial status.
Study Type
Interventional
Enrollment (Actual)
422
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207-8426
- Nemours Children's Clinic
-
-
Illinois
-
Chicago, Illinois, United States, 60614
- Children's Memorial Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Child Inclusion Criteria:
- Age 9.0 to <14.5.
- Type 1 diabetes diagnosis (diagnosed by ADA criteria) for a minimum of 1 year for the main subgroup or 3 months for the recent onset subgroup.
- Insulin dose greater than or equal to 0.5 u/kg/day for the main subgroup or 0.2 u/kg/day for the recent onset subgroup; with 2 or more daily injections or use of insulin pump.
- Most recent A1c is >6.0% and <13.0%; <12.0% for those diagnosed for less than 1 year.
- Willing to provide informed assent.
Parent/Family Environment Inclusion Criteria
- Child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected in next 2 years.
- The same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and at least 1 caregiver agrees to participate in all aspects of the protocol (single-parent families, blended families, and separated parents will be eligible).
- Home has telephone access.
- Child had at least 2 clinic visits within last 12 months.
- Parent and child willing to come to clinic every 3 months for duration (2 years) of study.
- If a family has more than one eligible child, all qualifying children who provide consent/assent will participate in assessment and intervention or control activities; however, only the oldest qualifying child will be included in statistical analyses.
Child Exclusion Criteria:
- Presence of a major chronic diseases (except well-controlled thyroid, asthma, celiac).
- Presence of a major visual/auditory impairments.
- Child is in a self-contained special education class throughout the school day.
- Record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. Current diagnosis of eating disorder. History of anti-psychotic medications for the past 6 months.
- Diagnosis of mental retardation.
- Unable to read and write English at 2nd grade level.
- Children who are currently enrolled in any intervention study are not eligible for enrollment. Those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. However, children who were in a standard care control group in an intervention study are eligible once they have completed all scheduled study follow-ups. Children cannot enroll in another intervention study during the course of this study. Enrollment of children who are currently participating in another observational study will be at the discretion of the site principal investigator.
Parent/Family Environment Exclusion Criteria
- Family has plans to re-locate out of area within the next 2 years of the study.
- Participating caretaker is currently undergoing treatment for substance abuse.
- Participating caretaker has been hospitalized in past 6 months for mental disorder.
- Participating caretaker has history of psychosis.
- Families who are currently enrolled in any intervention study are not eligible for enrollment. Those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. However, families who were in a standard care control group in an intervention study are eligible once they have completed all scheduled study follow-ups. Families cannot enroll in another intervention study during the course of this study. Enrollment of families who are currently participating in another observational study will be at the discretion of the site principal investigator.
The family must reside within 90 miles (one-way) of the clinic (main or satellite), or agree to meet at a mutually agreed upon closer location for conduct of the home assessment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: family diabetes management intervention
A trained health advisor will be responsible for interactions with parents and patients prior to each diabetes clinic visit (Preparation Phase), at the time of the diabetes clinic visit (Consolidation Phase) and by phone, e-mail, etc. after the clinic visit (Follow-up Phase).
Using educational modules developed for the study, families will be engaged in problem identification and solving activities to improve shared parent-youth responsibility for diabetes management and foster increased adolescent's independent management capabilities.
|
a clinic-integrated, low intensity, multi-component behavioral intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycemic control
Time Frame: 1/2006-3/2009
|
HbA1c
|
1/2006-3/2009
|
treatment adherence
Time Frame: 1/2006-3/2009
|
Diabetes Self Management Profile
|
1/2006-3/2009
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: 1/2006-3/2009
|
PedsQL Diabetes
|
1/2006-3/2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bruce Simons-Morton, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Temmen CD, Lu R, Gee BT, Chen Z, Nansel TR. Latent classifications of parental involvement in diabetes management for youth with type 1 diabetes: A randomized clinical trial. Pediatr Diabetes. 2022 Nov;23(7):1133-1142. doi: 10.1111/pedi.13397. Epub 2022 Aug 19.
- Nansel TR, Thomas DM, Liu A. Efficacy of a Behavioral Intervention for Pediatric Type 1 Diabetes Across Income. Am J Prev Med. 2015 Dec;49(6):930-4. doi: 10.1016/j.amepre.2015.05.006. Epub 2015 Jul 29.
- Nansel TR, Lipsky LM, Iannotti RJ. Cross-sectional and longitudinal relationships of body mass index with glycemic control in children and adolescents with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2013 Apr;100(1):126-32. doi: 10.1016/j.diabres.2012.12.025. Epub 2013 Jan 20.
- Nansel TR, Iannotti RJ, Liu A. Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Pediatrics. 2012 Apr;129(4):e866-73. doi: 10.1542/peds.2011-2858. Epub 2012 Mar 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
January 5, 2006
First Submitted That Met QC Criteria
January 5, 2006
First Posted (Estimate)
January 9, 2006
Study Record Updates
Last Update Posted (Estimate)
May 13, 2011
Last Update Submitted That Met QC Criteria
May 11, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMOD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 1
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on family diabetes management intervention
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
University of ArkansasPatient-Centered Outcomes Research InstituteActive, not recruitingDiabetes Mellitus, Type 2United States
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingType 2 DiabetesUnited States
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPreDiabetes | Type 2 Diabetes | Obesity, Childhood | Overweight and Obesity | Lifestyle, Healthy | Overweight, ChildhoodUnited States
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Yale UniversityNational Institute of Nursing Research (NINR); Beijing Ditan Hospital; Shanghai...Completed
-
University of California, Los AngelesStanford University; University of Colorado, BoulderCompletedBipolar Disorder | Major Depressive DisorderUnited States
-
Arizona State UniversityHand Therapy PartnersCompletedDiabetes Mellitus, Type 2 | Diabetes MellitusUnited States
-
University of Texas Southwestern Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedType 2 Diabetes | Major Depressive DisorderUnited States
-
University of Massachusetts, WorcesterCompletedType 2 Diabetes | Glycemic ControlUnited States