Management of Type 1 Diabetes Among Adolescents

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340639
First received: June 19, 2006
Last updated: March 5, 2008
Last verified: November 2006
  Purpose

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 adolescent's self-image and personal goals on diabetes management;
  • The influence of the adolescent's 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 Center's 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 child's 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 child's 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.


Condition
Type I Diabetes

Study Type: Observational
Official Title: Developmental Influences on Management of Type I Diabetes

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 240
Study Start Date: January 2003
Estimated Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION/EXCLUSION CRITERIA:

Subjects for this study will include 135 male and female youth with diabetes age 10-16 and a parent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340639

Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340639     History of Changes
Other Study ID Numbers: 999903088, 03-CH-N088
Study First Received: June 19, 2006
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adherence
Chronic Illness
Adolescent
Family
Self-Regulation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014