Type 1 DiabetesNCT02010528
Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D
An observational study of Type 1 Diabetes, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 300 participants
- Where
- 1 siteSlovenia
- Study dates
- Dec 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Parents or caregivers of children and adolescents with T1D of ages up to 18 years
- Minimal 1 year duration of Type 1 diabetes
Who cannot join
- Parents or caregivers of children and adolescents with T1D of ages over 18 years
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
Ljubljana, 1000
About this study
Official title: 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.
Read more
In this study it is hypothesized that:
- 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;
- mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers.
- 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.
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes related distress, children, T1D, family hardiness, psychological well-being
- Medical subject headings
- Diabetes Mellitus, Type 1, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (1)
psychosocial characteristics
STAIX (State Trait Anxiety Inventory), PANAS (The Positive And Negative Affect Schedule), SWLS (Satisfaction With Life Scale), RQ (Relationship Questionnaire)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency (ARRS)
- Responsible party
- Principal investigator, Tadej Battelino, University Medical Centre Ljubljana
- Investigators
- Tadej Battelino, Study chair, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010528
- Sponsor's protocol ID
- DIS-PSY-PAR-T1D-2013
- Status last verified
- Feb 2014
- First submitted
- 9 Dec 2013
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Distress,Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02010528
- Acronym / sponsor ID
- DIS-PSY-PAR-T1D-2013
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes related distress, children, T1D, family hardiness, psychological well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency (ARRS)
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | –Parents or caregivers of children and adolescents with type 1 diabetes |
| Controls | – | –Parents or caregivers of children and adolescents without diabetes |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- Parents or caregivers of children and adolescents with T1D of ages up to 18 years
- Minimal 1 year duration of Type 1 diabetes
Key exclusion criteria (1 listed)
- Parents or caregivers of children and adolescents with T1D of ages over 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
psychosocial characteristics
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadej Battelino study chair
Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parental diabetes-related distress (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.