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NCT Number: NCT02010528

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

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. parental diabetes-related distress

    Time frame: 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 outcomes

  1. psychosocial characteristics

    Time frame: 1 month

    STAIX (State Trait Anxiety Inventory), PANAS (The Positive And Negative Affect Schedule), SWLS (Satisfaction With Life Scale), RQ (Relationship Questionnaire)

Other outcomes

  1. family hardiness

    Time frame: 1 month

    FHI (Family Hardiness Index)

  2. objective measures

    Time frame: 1 month

    • 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Slovenian Research Agency (ARRS)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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