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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Type 1 diabetes; Parents or caregivers of children and adolescents with type 1 diabetes
Controls; Parents or caregivers of children and adolescents without diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
parental diabetes-related distress	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)	1 month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
family hardiness	FHI (Family Hardiness Index)	1 month
objective measures	parent daily involvement in child's diabetes management; frequency of blood glucose monitoring; parent general satisfaction with glycemic control; child's HbA1c level; child's experience of severe hypoglycemia	1 month

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: Slovenian Research Agency (ARRS)
• Investigators: Study Chair: Tadej Battelino, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes related distress, children, T1D, family hardiness, psychological well-being
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DIS-PSY-PAR-T1D-2013