Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT02010528
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-12
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
parental diabetes-related distress	1 month	To examine associations between diabetes-related distress - diabetes burden (Problem Areas In Diabetes-Parent (PAID-P) questionnaire), fear of hypoglycemia (Hypoglycemia Fear Survey-Parent (HFS-P) questionnaire, Hypoglycemia Fear Survey- Parents of Young Children (HFS-PYC) questionnaire)

Secondary Outcome Measures

Name	Time	Method
psychosocial characteristics	1 month	STAIX (State Trait Anxiety Inventory), PANAS (The Positive And Negative Affect Schedule), SWLS (Satisfaction With Life Scale), RQ (Relationship Questionnaire)

Trial Locations

Locations (1)

Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL; 🇸🇮 Ljubljana, Slovenia