NCT02010528

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. 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. 2.mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

December 9, 2013

Last Update Submit

February 12, 2014

Conditions

Type 1 Diabetes

Keywords

Diabetes related distress, children, T1D, family hardiness, psychological well-being

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • psychosocial characteristics

    1 month

Other Outcomes (2)

  • family hardiness

    1 month

  • objective measures

    1 month

Study Arms (2)

Type 1 diabetes

Parents or caregivers of children and adolescents with type 1 diabetes

Controls

Parents or caregivers of children and adolescents without diabetes

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPersonal SatisfactionBehavior

Study Officials

  • Tadej Battelino

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

SL(1)