Type I DiabetesNCT00340639
Management of Type 1 Diabetes Among Adolescents
An observational study of Type I Diabetes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Type I Diabetes
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2003to 2 Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects for this study will include 135 male and female youth with diabetes age 10-16 and a parent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Type I Diabetes
- Keywords
- Adherence, Chronic Illness, Adolescent, Family, Self-Regulation
- Medical subject headings
- Diabetes Mellitus, Type 1, Chronic Disease, Self-Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start28 Jan 2003
- Study completion2 Nov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340639
- Sponsor's protocol ID
- 999903088
- Other IDs
- 03-CH-N088
- Status last verified
- 2 Nov 2006
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Anderson B, Ho J, Brackett J, Finkelstein D, Laffel L. Parental involvement in diabetes management tasks: relationships to blood glucose monitoring adherence and metabolic control in young adolescents with insulin-dependent diabetes mellitus. J Pediatr. 1997 Feb;130(2):257-65. doi: 10.1016/s0022-3476(97)70352-4.
PubMed 9042129
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Influences on Management of Type I Diabetes
- ClinicalTrials.gov ID
- NCT00340639
- Acronym / sponsor ID
- 999903088
- Conditions
- Type I Diabetes
- Keywords
- Adherence, Chronic Illness, Adolescent, Family, Self-Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 28 Jan 2003
- Study completion
- 2 Nov 2006
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects for this study will include 135 male and female youth with diabetes age 10-16 and a parent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9042129Anderson B, Ho J, Brackett J, Finkelstein D, Laffel L. Parental involvement in diabetes management tasks: relationships to blood glucose monitoring adherence and metabolic control in young adolescents with insulin-dependent diabetes mellitus. J Pediatr. 1997 Feb;130(2):257-65. doi: 10.1016/s0022-3476(97)70352-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type I Diabetes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.