Status:
COMPLETED
Family Management of Type 1 Diabetes in Children
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
108-174 years
Phase:
PHASE2
Brief Summary
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...
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 in...
Eligibility Criteria
Inclusion
- Child
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00273286
Start Date
January 1 2006
End Date
March 1 2009
Last Update
May 13 2011
Active Locations (4)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207-8426
2
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
3
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
4
Texas Children's Hospital
Houston, Texas, United States, 77030