Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00946517
• Other study ID #: IRB09-00224
• Status: Terminated
• Phase: N/A
• First received: July 24, 2009
• Last updated: May 14, 2015
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetics

• Aged 9 - 18 years

Exclusion Criteria:

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Questionnaires
Parenting and behavioral questionnaires

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting styles		Baseline	No
Secondary	Child behavior traits		Baseline	No
Secondary	Adherence to therapy		Baseline	No