Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-04-10 @ 8:28 AM
Study NCT ID:
NCT02010528
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D
Sponsor:
University Medical Centre Ljubljana
Organization:
Study Overview
Official Title:
Diabetes Distress,Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: