Trials / Completed
CompletedNCT02010528
Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D
Diabetes Distress,Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With Type 1 Diabetes
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- University Medical Centre Ljubljana · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Accepted
Summary
Parents have an important role in child's diabetes management. Many studies show that parental psychological stress and family dynamics are associated with parental diabetes-related distress and treatment outcomes among children and adolescents with type 1 diabetes. The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life, positive and negative affect and adult attachment relationship pattern), family hardiness and characteristics of children with type 1 diabetes in a sample of mothers and fathers of children and adolescents with type 1 diabetes of ages up to 18 years. In this study it is hypothesized that: 1. greater parental fear of hypoglycemia and diabetes-related burden are associated with lower family hardiness and worse psychological well-being parents and higher HbA1c levels in children and adolescents with type 1 diabetes; 2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers. 3. parents of children and adolescents with type 1diabetes will report greater anxiety, lower psychological well-being and family hardiness comparing to parents of children without diabetes. Standardized and validated questionnaires will be used to determine: parental fear of hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being, adult attachment relationship pattern and family hardiness. The investigators will also measure parent daily involvement in child's diabetes management, frequency of blood glucose monitoring and parent general satisfaction with glycemic control. Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode will also be obtained. These measures will be correlated with other research variables.
Conditions
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2013-12-12
- Last updated
- 2014-02-13
Locations
1 site across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT02010528. Inclusion in this directory is not an endorsement.