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

Sponsor
University of Split, School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT03602378
Collaborator
General Hospital Zadar (Other)
592
Enrollment
2
Locations
37
Anticipated Duration (Months)
296
Patients Per Site
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: salivary cortisol
  • Device: Holter Medilog AR12 Plus
  • Device: Polar V800
  • Device: AGE reader

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 Design

Study Type:
Observational
Anticipated Enrollment :
592 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Quality of Life and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
Actual Study Start Date :
Apr 2, 2018
Anticipated Primary Completion Date :
Apr 2, 2021
Anticipated Study Completion Date :
May 2, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life in parents of children with developmental disability and chronic disease, and healthy children. [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).

    2. Stress in parents of children with developmental disability and chronic disease, and healthy children. [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.

    Secondary Outcome Measures

    1. Family quality of life [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).

    2. Perceived Stress Scale [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.

    3. Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children. [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)).

    4. Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children [1 day]

      Holter Medilog AR12 Plus - electrocardiogram and Polar V800 with sensor - during 5 minutes

    5. Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children. [1 day]

      AGE reader for measuring advanced glycation end products. Higher results indicating greater cardiovascular risk.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Split Split Croatia 21000
    2 Ivana Kolcic Split Croatia 23000

    Sponsors and Collaborators

    • University of Split, School of Medicine
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ivana Kolcic, MD, PhD, Associate Professor in Epidemiology Centre for Global Health & Department of Public Health Medical School, University of Split, University of Split, School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03602378
    Other Study ID Numbers:
    • 2181-198-03-04-18-0014
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Mar 26, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ivana Kolcic, MD, PhD, Associate Professor in Epidemiology Centre for Global Health & Department of Public Health Medical School, University of Split, University of Split, School of Medicine
    Parents
    Quality of life
    Stress
    Children with developmental disability
    Children with chronic disease
    Cortisol
    Heart rate variability
    Advanced glycation end products
    Sleep quality
    Family cohesion
    Stigma
    Resilience
    Anxiety
    Depression
    Self Esteem
    Additional relevant MeSH terms:
    Cerebral Palsy
    Down Syndrome
    Diabetes Mellitus, Type 1
    Disease
    Chronic Disease
    Autism Spectrum Disorder
    Developmental Disabilities
    Hydrocortisone

    Study Results

    No Results Posted as of Mar 26, 2020