QoL and Stress in Parents of Children With Developmental Disabilities and Chronic Disease

March 25, 2020 updated by: Ivana Kolcic, University of Split, School of Medicine

Quality of Life and Stress in Parents of Children With Developmental Disabilities and Chronic Disease

The aim of this cross-sectional study is to investigate the level of stress and quality of life in parents of children with developmental disabilities (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) and parents of children chronic diseases (diabetes mellitus type 1, epilepsy, asthma) compared to parents of healthy children.

The investigators will analyze the level of stress, quality of life, self-esteem, optimism, resilience, happiness, stigmatization, depression, anxiety, sleep quality, parenting challenges and some physiological indicators of the stress such as level of cortisol and heart rate variability. Also, the investigators will measure Advanced Glycation End products (AGEs) in the skin.

The investigators assume that parents of children with developmental disabilities and chronic diseases have higher level of stress and lower quality of life compared to the parents of healthy children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants will be parents of children with a pervasive developmental disorder (autistic spectrum disorder), Down syndrome, cerebral palsy, epilepsy, diabetes mellitus type 1, asthma, and parents of healthy children (without difficulty and chronic disease - control group).

The investigators will examine the level of stress and quality of life in parents of children with developmental and chronic illnesses, compared to parents of healthy children, adjusting for the effect of confounding factors.

Data collection will be conducted using the questionnaire to assess personal quality of life, family quality of life, general and parental stress levels. Additionally, potential confounding or mediating factors will be measured and taken into account: stress resilience, cohesion, self-esteem, optimism, perception of happiness, stigmatization, depression, anxiety, sleep quality and parenting challenges. Also, socio-demographics parameters, short medical history, lifestyle habits and the perception of life difficulties will be assessed. The questionnaire will be filled by paper-pencil method with anticipated duration of about 45 minutes.

The investigators will also measure several physiological indicators - salivary cortisol, heart rate variability, blood pressure and Advanced Glycation End products (AGEs).

Saliva will be taken in order to analyze the cortisol level, using Salivette Sarstedt REF 51.1534.500. Participants will be taken five saliva samples during the day because of the physiological variability of cortisol (first one around 22:00 hours, second right after waking up, then 15, 30 and 60 minutes after awaking). Each subject will receive detailed instructions on how to take saliva, with written instructions. Thirty minutes before sampling, the subjects has to restrain from eating, drinking, smoking or brushing teeth. In case of acute illness, inflammation or disease in the oral cavity, the sampling will be delayed. After taking the sample, tubes will be stored in the refrigerator. In the laboratory, the sample will be centrifuged for two minutes to remove saliva from cotton, and saliva samples will be frozen. Cortisol analysis will be done using ECLIA (Electrochemiluminous Absorption Method).

The electrocardiogram (ECG) will be recorded using the Medilog AR12 Plus Holter device, which will also be used to record heart rate variability (HRV) during 5 minutes. HRV will also be recorded using the Polar V800 (also during 5 minutes). Kubios software will be used for HRV analysis.

AGE Reader, a non-invasive device will be used for measuring the autofluorescence in the skin, reflecting the level of Advanced Glycation End products (AGEs).

Omrom M6 Comfort is an automatic device which will be used to measure blood pressure and pulse.

Anthropometric parameters will be measured (body weight, height, neck circumference, waist and hip circumference).

Statistical analysis will be carried out using statistical program MedCalc. Initial analysis of results will include analysis of the distribution of variables using the Kolmogorov-Smirnov test. If the distribution of numerical variables will be normal, parametric statistics will be applied. The confounding factors will be controlled by using appropriate statistical tests.

Participation of parents in this study is voluntary. If a parent decides to participate in this study, the code will be assigned. In that way, all data, measured parameters, and saliva samples will be encoded, and the personal data of the respondents will be completely invisible. It will not be possible to identity an individual parent. All researchers must and will be protecting confidentiality of data.

Study Type

Observational

Enrollment (Anticipated)

592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University Hospital Split
      • Split, Croatia, 23000
        • Ivana Kolcic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Parents of children with Down syndrome, pervasive developmental disorder (autistic spectrum disorder), cerebral palsy, epilepsy, diabetes type 1, asthma, and parents of healthy children (without difficulties and chronic diseases - control group).

Description

Inclusion Criteria:

  • subject are parents between 20 and 50 years,
  • subject are parents of the child with developmental disability (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) or chronic disease (diabetes mellitus type 1, epilepsy, asthma) - the ages of the child between 4 and 12 years.

Exclusion Criteria:

  • severe psychiatry and severe chronic illnesses of parents
  • ischemic heart disease
  • cardiomyopathy
  • heart arrhythmia
  • malignant hypertension
  • diabetic neuropathy
  • transplantation of heart and other organs
  • tetraplegia
  • diseases of the hypothalamus and pituitary and adrenal gland
  • corticosteroid therapy
  • antiarrhythmic therapy
  • therapy of β-blockers
  • therapy of sedatives
  • therapy of anxiolytics
  • chemotherapy
  • night shift work
  • breastfeeding (active or completed within less 6 months)
  • pregnancy
  • diagnose of child less than 6 months
  • parents of children with other severe chronic or rare diseases such as malignant disease, haemophilia, phenylketonuria, neurofibromatosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parents of children with disability
parents of children with developmental disabilities (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy), age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader
Diagnostic test: salivary cortisol
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes).
Device: Holter Medilog AR12 Plus
Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
Device: Polar V800
Polar V800 with sensor - during 5 minutes for measuring HRV
Other Names:
  • Polar V800 with sensor
Device: AGE reader
for measuring Advanced Glycation End products (AGEs)
Other Names:
  • Advanced glycation end products reader
  • AGEs reader
Parents of children with chronic disease
parents of children chronic disease (diabetes mellitus type 1, epilepsy, asthma), age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader
Diagnostic test: salivary cortisol
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes).
Device: Holter Medilog AR12 Plus
Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
Device: Polar V800
Polar V800 with sensor - during 5 minutes for measuring HRV
Other Names:
  • Polar V800 with sensor
Device: AGE reader
for measuring Advanced Glycation End products (AGEs)
Other Names:
  • Advanced glycation end products reader
  • AGEs reader
Parents of healthy children
parents of healthy children, age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader
Diagnostic test: salivary cortisol
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes).
Device: Holter Medilog AR12 Plus
Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
Device: Polar V800
Polar V800 with sensor - during 5 minutes for measuring HRV
Other Names:
  • Polar V800 with sensor
Device: AGE reader
for measuring Advanced Glycation End products (AGEs)
Other Names:
  • Advanced glycation end products reader
  • AGEs reader

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in parents of children with developmental disability and chronic disease, and healthy children.
Time Frame: 1 day
Subjects will complete the questionnaires about quality of life. A total 26 item in the WHOQOL-BREF produces four domain scores: physical, psychological, social relationships and environment domain (Likert type scale ranging from 1- strongly disagree to 5 - strongly agree).
1 day
Stress in parents of children with developmental disability and chronic disease, and healthy children.
Time Frame: 1 days
Subjects will complete the questionnaires about parental stress. Parental Stress Scale consists of 18 item self report scale (Likert type scale ranging from 1-strongly disagree, 2-disagree, 3-undecided, 4-agree 5-strongly agree). Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood.
1 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family quality of life
Time Frame: 1 day
A total 25 items in FQOL scale keyed for five domains scores: family interaction, parenting, emotional well-being, physical / material well-being and disability-related support (Likert type scale satisfaction are rated on a 5-point scale, where 1- very dissatisfied, 3-neither satisfied nor dissatisfied, and 5-very satisfied). Scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
1 day
Perceived Stress Scale
Time Frame: 1 day
Perceived Stress Scale consists of 10 items (Likert type scale ranging from 0-never, 1-almost never, 2-sometimes,3-fairly often, 4-very often). Higher scores indicating greater levels of stress.
1 day
Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children.
Time Frame: 1 day
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes)).
1 day
Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children
Time Frame: 1 day
Holter Medilog AR12 Plus - electrocardiogram and Polar V800 with sensor - during 5 minutes
1 day
Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children.
Time Frame: 1 day
AGE reader for measuring advanced glycation end products. Higher results indicating greater cardiovascular risk.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Collaborators

General Hospital Zadar

Investigators

  • Principal Investigator: MARIJA LJUBICIC, RN, MSN, General hospital Zadar, Department of Pediatrics
  • Principal Investigator: IVANA KOLCIC, MD, PhD, University of Split, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Anticipated)

April 2, 2021

Study Completion (Anticipated)

May 2, 2021

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-198-03-04-18-0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Identified participants for outcome measures

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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