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Family Management of Type 1 Diabetes in Children

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
family diabetes management intervention
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Juvenile-Onset, IDDM, Type 1 Diabetes Mellitus

Eligibility Criteria

108 Months - 174 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nemours Children's Clinic
  • Children's Memorial Hospital
  • Joslin Diabetes Center
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

family diabetes management intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

glycemic control
HbA1c
treatment adherence
Diabetes Self Management Profile

Secondary Outcome Measures

quality of life
PedsQL Diabetes

Full Information

First Posted
January 5, 2006
Last Updated
May 11, 2011
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00273286
Brief Title
Family Management of Type 1 Diabetes in Children
Official Title
Family Management of Childhood Diabetes Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Juvenile-Onset, IDDM, Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
family diabetes management intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
family diabetes management intervention
Intervention Description
a clinic-integrated, low intensity, multi-component behavioral intervention
Primary Outcome Measure Information:
Title
glycemic control
Description
HbA1c
Time Frame
1/2006-3/2009
Title
treatment adherence
Description
Diabetes Self Management Profile
Time Frame
1/2006-3/2009
Secondary Outcome Measure Information:
Title
quality of life
Description
PedsQL Diabetes
Time Frame
1/2006-3/2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
108 Months
Maximum Age & Unit of Time
174 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Simons-Morton, PhD
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-8426
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36250647
Citation
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.
Results Reference
derived
PubMed Identifier
26231856
Citation
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.
Results Reference
derived
PubMed Identifier
23339757
Citation
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.
Results Reference
derived
PubMed Identifier
22392172
Citation
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.
Results Reference
derived

Learn more about this trial

Family Management of Type 1 Diabetes in Children

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