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Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

This study has been terminated.
(PI left the institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946517
First Posted: July 27, 2009
Last Update Posted: May 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nationwide Children's Hospital
  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

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Parenting styles [ Time Frame: Baseline ]

Secondary Outcome Measures:
  • Child behavior traits [ Time Frame: Baseline ]
  • Adherence to therapy [ Time Frame: Baseline ]

Enrollment: 20
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Endocrinology clinic patients
Criteria

Inclusion Criteria:

  • Type 1 diabetics
  • Aged 9 - 18 years

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946517


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
  More Information

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00946517     History of Changes
Other Study ID Numbers: IRB09-00224
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: May 15, 2015
Last Verified: May 2015

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