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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Behavior: Family problem solving	Phase II

Further study details as provided by National Institute of Child Health and Human Development (NICHD):

Primary Outcomes: glycemic control; treatment adherence
Secondary Outcomes: quality of life; psychological adjustment; acute complications
Expected Total Enrollment:  480

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.

Ages Eligible for Study:  9 Years   -   15 Years,  Genders Eligible for Study:  Both

Criteria

Child Inclusion Criteria:

• Age 9.0 to <15.0.
• 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 0.3 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%.
• 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 principle 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 principle investigator.

Please refer to this study by ClinicalTrials.gov identifier  NCT00273286

Florida
      Nemours Children''''s Clinic, Jacksonville,  Florida,  32207-8426,  United States
Illinois
      Children''''s Memorial Hospital, Chicago,  Illinois,  60614,  United States
Massachusetts
      Joslin Diabetes Center, Boston,  Massachusetts,  02215,  United States
Texas
      Texas Children''''s Hospital, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Bruce Simons-Morton, PhD,  Principal Investigator,  National Institute of Child Health and Human Development (NICHD)   

Study ID Numbers:  FMOD
Last Updated:  January 6, 2006
Record first received:  January 5, 2006
ClinicalTrials.gov Identifier:  NCT00273286
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10