Status:
COMPLETED
Family Management of Childhood Diabetes Study
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes
Type 1 Diabetes
Eligibility:
All Genders
9-70 years
Phase:
PHASE1
Brief Summary
This study will test the effectiveness of a practical, low-cost, problem-solving method called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this teaching and suppor...
Detailed Description
This protocol describes a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deteriora...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - CHILD CRITERIA:
- Age 9.0 to 14.5
- Type I diabetes diagnosis (diagnosed by ADA criteria) for a minimum of 1 year requiring insulin treatment
- Insulin dose greater than or equal to 0.5 u/kg/day
- Mean A1c over last 8 months is less than 13.0%
- No major chronic diseases (except well-controlled thyroid, asthma)
- No major visual/auditory impairments
- Child is not in self-contained special education class throughout the school day
- No DSM-IV diagnosis of bipolar, addiction, psychosis, or eating disorder documented in existing medical chart. No record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. No history of anti-psychotic medications for the past 6 months.
- No diagnosis of mental retardation.
- Literate (reading, writing) in English/Spanish at 2nd grade level
- Willing to provide informed assent
- Children who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. Children cannot enroll in another study during the course of this study. 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 or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
- PARENT/FAMILY ENVIRONMENT CRITERIA:
- Child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected to next 2 years.
- The same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and a single adult, who has primary responsibility for the child's diabetes care and monitoring, agrees to participate in all aspects of the protocol (single-parent families, blended families and separated parents will be eligible).
- Family has no plan to re-locate out of area within the next 2 years of the study.
- Home has telephone access
- Primary parent is not currently undergoing treatment for substance abuse.
- Primary parent has not been hospitalized in past 6 months for mental disorder.
- Primary caretaker has no history of psychosis.
- Child had at least 2 clinic visits within last 12 months
- Parent and child wiling to come to clinic every 3 months for duration (2 years) of study.
- Families who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. Families cannot enroll in another study during the course of this study. 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 month are also ineligible to participate. However, families who were in a standard care control group in an intervention study or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
- 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.
Exclusion
Key Trial Info
Start Date :
November 8 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2009
Estimated Enrollment :
1298 Patients enrolled
Trial Details
Trial ID
NCT00340938
Start Date
November 8 2004
End Date
August 20 2009
Last Update
December 17 2019
Active Locations (3)
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1
Childrens Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614-3394
2
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
3
Texas Children's Hospital
Houston, Texas, United States, 77030