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

Type 1 Diabetes Clinical Trial

Official title:

Diabetes Distress,Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010528
• Other study ID #: DIS-PSY-PAR-T1D-2013
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: February 12, 2014
• Start date: December 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Slovenia	Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency (ARRS)

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	family hardiness	FHI (Family Hardiness Index)	1 month	No
Other	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	No
Primary	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	No
Secondary	psychosocial characteristics	STAIX (State Trait Anxiety Inventory), PANAS (The Positive And Negative Affect Schedule), SWLS (Satisfaction With Life Scale), RQ (Relationship Questionnaire)	1 month	No