Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes
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Purpose
This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. The investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. The investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. The investigators will also obtain objective measures of therapy adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. These measures will be correlated with our other findings.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Other: Questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Prospective |
| Official Title: | Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes |
- Parenting styles [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Child behavior traits [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Adherence to therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Parents
Parents or caregivers of type 1 diabetics
|
Other: Questionnaires
Parenting and behavioral questionnaires
|
|
Child
Type 1 diabetics
|
Other: Questionnaires
Parenting and behavioral questionnaires
|
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Endocrinology clinic patients
Inclusion Criteria:
- Type 1 diabetics
- Aged 9 - 18 years
Exclusion Criteria:
- None
Contacts and Locations| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| Principal Investigator: | Dana S Hardin, MD | The Research Institute at Nationwide Children's Hospital, The Ohio State University |
More Information
No publications provided
| Responsible Party: | Dana S. Hardin, MD, The Research Institute at Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00946517 History of Changes |
| Other Study ID Numbers: | IRB09-00224 |
| Study First Received: | July 24, 2009 |
| Last Updated: | May 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013