Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

NCT ID: NCT00946517

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-05-31

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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

Parents

Parents or caregivers of type 1 diabetics

Questionnaires

Intervention Type: OTHER

Parenting and behavioral questionnaires

Child

Type 1 diabetics

Questionnaires

Intervention Type: OTHER

Parenting and behavioral questionnaires

Interventions

Questionnaires

Parenting and behavioral questionnaires

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 1 diabetics
• Aged 9 - 18 years

Exclusion Criteria

• None

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana S Hardin, MD

Role: PRINCIPAL_INVESTIGATOR

The Research Institute at Nationwide Children's Hospital, The Ohio State University

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IRB09-00224

Identifier Type: -

Identifier Source: org_study_id