An observational study in Developmental Disability, Chronic Disease and Down Syndrome, sponsored by University of Split, School of Medicine. Status unknown at 2 sites in Croatia. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University of Split, School of Medicine · Observational
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.
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.
This study's planned enrollment of 592 is above the median of 63 across 454 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Split, School of Medicine is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
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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).
Exclusion Criteria:
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 · Device: Holter Medilog AR12 Plus · Device: Polar V800 · Device: AGE reader
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 · Device: Holter Medilog AR12 Plus · Device: Polar V800 · Device: AGE reader
parents of healthy children, age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader
Diagnostic Test: salivary cortisol · Device: Holter Medilog AR12 Plus · Device: Polar V800 · Device: AGE reader
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes).
Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
Polar V800 with sensor - during 5 minutes for measuring HRV
Also known as: Polar V800 with sensor
for measuring Advanced Glycation End products (AGEs)
Also known as: Advanced glycation end products reader, AGEs reader
Quality of life in parents of children with developmental disability and chronic disease, and healthy children.
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).
Time frame: 1 day
Stress in parents of children with developmental disability and chronic disease, and healthy children.
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.
Time frame: 1 days
Family quality of life
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).
Time frame: 1 day
Perceived Stress Scale
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.
Time frame: 1 day
Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children.
5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes)).
Time frame: 1 day
Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children
Holter Medilog AR12 Plus - electrocardiogram and Polar V800 with sensor - during 5 minutes
Time frame: 1 day
Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children.
AGE reader for measuring advanced glycation end products. Higher results indicating greater cardiovascular risk.
Time frame: 1 day
Plan to share: Undecided — Identified participants for outcome measures
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Split, School of Medicine