- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340639
Management of Type 1 Diabetes Among Adolescents
Developmental Influences on Management of Type I Diabetes
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Child Health and Human Development (NICHD)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION/EXCLUSION CRITERIA:
Subjects for this study will include 135 male and female youth with diabetes age 10-16 and a parent.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999903088
- 03-CH-N088
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type I Diabetes
-
Hadassah Medical OrganizationOramed Pharmaceutical Inc.CompletedBrittle Type I Diabetes MellitusIsrael
-
Nemours Children's ClinicThrasher Research FundCompleted
-
HealthPartners InstituteInternational Diabetes Center at Park Nicollet; Park Nicollet Foundation; Melrose...TerminatedEating Disorder | Type I Diabetes Mellitus Without ComplicationUnited States
-
Nationwide Children's HospitalTerminated
-
Eunice Kennedy Shriver National Institute of Child...CompletedType I DiabetesUnited States
-
Ohio State UniversityNatreon, Inc.Completed
-
National Institute of Diabetes and Digestive and...CompletedType I DiabetesUnited States
-
Hompesch, Marcus, M.D.Profil Institute for Clinical Research, Inc.Unknown
-
Diatranz Otsuka LimitedCompleted
-
Migal Galilee Research InstituteZiv Medical CenterUnknownType I DiabetesIsrael