COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

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. Identifier: NCT00946517
Recruitment Status : Terminated (PI left the institution)
First Posted : July 27, 2009
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):
Nationwide Children's Hospital

Brief Summary:
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 or disease Intervention/treatment
Type 1 Diabetes Other: Questionnaires

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Parents or caregivers of type 1 diabetics
Other: Questionnaires
Parenting and behavioral questionnaires

Type 1 diabetics
Other: Questionnaires
Parenting and behavioral questionnaires

Primary Outcome Measures :
  1. Parenting styles [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Child behavior traits [ Time Frame: Baseline ]
  2. Adherence to therapy [ Time Frame: Baseline ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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

Inclusion Criteria:

  • Type 1 diabetics
  • Aged 9 - 18 years

Exclusion Criteria:

  • None

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 identifier (NCT number): NCT00946517

Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Layout table for investigator information
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
Layout table for additonal information
Responsible Party: Nationwide Children's Hospital Identifier: NCT00946517    
Other Study ID Numbers: IRB09-00224
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases