Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340639
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Management of Type 1 Diabetes Among Adolescents
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Developmental Influences on Management of Type I Diabetes
Status:
COMPLETED
Status Verified Date:
2006-11-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 1-year study will explore the influences of family and peers on how diabetic adolescents manage their disease focusing on adolescent developmental transitions The management of diabetes is a complex process involving daily self-care activities problem-solving and decision-making It is particularly challenging during adolescence when youth are experiencing physiological social and psychological changes and coming under increasing peer influence and decreasing parental supervision Although it is expected that the responsibility for diabetes management will gradually shift from the parent to the child during adolescence research indicates that many children may be given responsibility for managing their illness too early without adequate parental monitoring Specifically this study will examine the following issues
The relationship of peers parents and school support to successful diabetes management
The influence of the adolescents self-image and personal goals on diabetes management
The influence of the adolescents and parents attitudes capability and environment on the balance of responsibility for diabetes management
Children between 10 and 16 years of age receiving treatment for diabetes type 1 at Georgetown University Medical Centers pediatric diabetes clinic may be eligible for this study The children must have been diagnosed with diabetes at least 1 year before entering the study and must require insulin treatment One parent of each child will also participate in the study
Children and their parents will complete the following procedures
Home Interviews Parents and children will complete two at-home face-to-face interviews 6 months apart At each interview children will answer questions about their responsibility for and adherence to their diabetes management treatment outcome expectations optimism self-esteem self-consciousness personal goals social support perceived barriers to diabetes management family routine and family conflict their parents involvement in their diabetes management and parenting style Parents will evaluate their childs ability to manage his or her diabetes level of maturity self-esteem and transition of responsibility their family routine and family conflict parent-child communication their parenting goals and their involvement in and responsibility for their childs diabetes management Three days after the 6-month interview a randomly selected group of parents and children will complete a brief additional telephone interview covering some of the same issues
Telephone Interview At 12 months parents and children will complete a telephone interview that will include questions about adherence to diabetes management and the responsibility of parents and children for diabetes management
The relationship of peers parents and school support to successful diabetes management
The influence of the adolescents self-image and personal goals on diabetes management
The influence of the adolescents and parents attitudes capability and environment on the balance of responsibility for diabetes management
Children between 10 and 16 years of age receiving treatment for diabetes type 1 at Georgetown University Medical Centers pediatric diabetes clinic may be eligible for this study The children must have been diagnosed with diabetes at least 1 year before entering the study and must require insulin treatment One parent of each child will also participate in the study
Children and their parents will complete the following procedures
Home Interviews Parents and children will complete two at-home face-to-face interviews 6 months apart At each interview children will answer questions about their responsibility for and adherence to their diabetes management treatment outcome expectations optimism self-esteem self-consciousness personal goals social support perceived barriers to diabetes management family routine and family conflict their parents involvement in their diabetes management and parenting style Parents will evaluate their childs ability to manage his or her diabetes level of maturity self-esteem and transition of responsibility their family routine and family conflict parent-child communication their parenting goals and their involvement in and responsibility for their childs diabetes management Three days after the 6-month interview a randomly selected group of parents and children will complete a brief additional telephone interview covering some of the same issues
Telephone Interview At 12 months parents and children will complete a telephone interview that will include questions about adherence to diabetes management and the responsibility of parents and children for diabetes management
Detailed Description:
Management of diabetes is a complex process involving the conduct of daily self-care activities problem-solving and decision-making It is particularly challenging during adolescence when youth are experiencing a variety of physiological social and psychological changes at the same time that they are taking increased responsibility for their own diabetes care This study examines the influence of family social and adolescent developmental transitions Over the course of 12 months a sample of 135 parent-child dyads will provide information on individual efficacy maturity family and social support attitudes toward diabetes management and diabetes management behaviors One goal of this pilot study is to identify factors that predict the adherence of individual youth and parents during this transition period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-CH-N088 | None | None | None |