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

Completed

Conditions

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 Type

Observational

Enrollment

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Child Health and Human Development (NICHD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 28, 2003

Primary Completion

December 7, 2022

Study Completion

November 2, 2006

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

November 2, 2006

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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