Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

This study has been terminated.
(PI left the institution)
Information provided by (Responsible Party):
Nationwide Children's Hospital Identifier:
First received: July 24, 2009
Last updated: May 14, 2015
Last verified: May 2015
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
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parents or caregivers of type 1 diabetics
Other: Questionnaires
Parenting and behavioral questionnaires
Type 1 diabetics
Other: Questionnaires
Parenting and behavioral questionnaires


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

Inclusion Criteria:

  • Type 1 diabetics
  • Aged 9 - 18 years

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00946517

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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 Identifier: NCT00946517     History of Changes
Other Study ID Numbers: IRB09-00224 
Study First Received: July 24, 2009
Last Updated: May 14, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases processed this record on May 01, 2016