Clinical trial NCT02010528: Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D
Official title: Diabetes Distress,Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Diabetes related distress, children, T1D, family hardiness, psychological well-being
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency (ARRS)
First posted: 2013-12-12
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children that have diabetes in Slovenia are controlled at the Dept. of Pediatric Endocrinology, Diabetes \& Metabolism, University Children's Hospital, UMCL and the population will be taken from here

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.


Eligibility criteria: Inclusion Criteria:

* Parents or caregivers of children and adolescents with T1D of ages up to 18 years
* Minimal 1 year duration of Type 1 diabetes

Exclusion Criteria:

* Parents or caregivers of children and adolescents with T1D of ages over 18 years

Primary outcomes:
measure: parental diabetes-related distress
timeFrame: 1 month
Secondary outcomes:
measure: psychosocial characteristics
timeFrame: 1 month
Other outcomes:
measure: family hardiness
timeFrame: 1 month
measure: objective measures
timeFrame: 1 month
Locations:
city: Ljubljana
country: Slovenia
facility: Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
Study officials:
affiliation: Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
name: Tadej Battelino
role: STUDY_CHAIR
References: