Clinical trial NCT03602378: QoL and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
Official title: Quality of Life and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Developmental Disability
Chronic Disease
Down Syndrome
Autism Spectrum Disorder
Pervasive Developmental Disorder
Cerebral Palsy
Diabetes Mellitus, Type 1
Epilepsy
Asthma
Stress
Keywords: 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
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
Collaborators: name: General Hospital Zadar
First posted: 2018-07-26
Enrollment: 592
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life in parents of children with developmental disability and chronic disease, and healthy children.
timeFrame: 1 day
measure: Stress in parents of children with developmental disability and chronic disease, and healthy children.
timeFrame: 1 days
Secondary outcomes:
measure: Family quality of life
timeFrame: 1 day
measure: Perceived Stress Scale
timeFrame: 1 day
measure: Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children.
timeFrame: 1 day
measure: Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children
timeFrame: 1 day
measure: Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children.
timeFrame: 1 day
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital Split
city: Split
country: Croatia
facility: Ivana Kolcic
Study officials:
affiliation: General hospital Zadar, Department of Pediatrics
name: MARIJA LJUBICIC, RN, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Split, School of Medicine
name: IVANA KOLCIC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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