Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

This study has been terminated.
(PI left the institution)
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00946517
First received: July 24, 2009
Last updated: May 4, 2010
Last verified: July 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Endocrinology clinic patients

Criteria

Inclusion Criteria:

  • Type 1 diabetics
  • Aged 9 - 18 years

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014