Developmental DisabilityNCT03602378
QoL and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
An observational study of Developmental Disability and Chronic Disease, run by University of Split, School of Medicine at 2 sites in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability, Chronic Disease, Down Syndrome
- What is being tested?
- salivary cortisol, Holter Medilog AR12 Plus and Polar V800
- Type of treatment
- Medical device
- How many people
- 592 participants
- Where
- 2 sitesCroatia
- Study dates
- 2 Apr 2018to 2 May 2021
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- severe psychiatry and severe chronic illnesses of parents
- ischemic heart disease
- cardiomyopathy
- heart arrhythmia
- malignant hypertension
- diabetic neuropathy
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
University Hospital Split
Split, 21000
Ivana Kolcic
Split, 23000
About this study
Official title: 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.
Read the 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.
- Conditions
- Developmental Disability, Chronic Disease, Down Syndrome, Autism Spectrum Disorder, Pervasive Developmental Disorder, Cerebral Palsy
- Being tested
- salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader
- 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
- Medical subject headings
- Developmental Disabilities, Chronic Disease, Down Syndrome, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Cerebral Palsy, Diabetes Mellitus, Type 1, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary cortisolDiagnostic test
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 PlusDevice
Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
Polar V800Device
Also called Polar V800 with sensor
Polar V800 with sensor - during 5 minutes for measuring HRV
AGE readerDevice
Also called Advanced glycation end products reader, AGEs reader
for measuring Advanced Glycation End products (AGEs)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: salivary cortisol; Device: Holter Medilog AR12 Plus; Device: Polar V800; Device: AGE 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 Receives: Diagnostic Test: salivary cortisol; Device: Holter Medilog AR12 Plus; Device: Polar V800; Device: AGE reader | |
| Parents of healthy children | parents of healthy children, age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader Receives: Diagnostic Test: salivary cortisol; Device: Holter Medilog AR12 Plus; Device: Polar V800; Device: AGE reader |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 days
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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)).
Measured: 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
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 Apr 2018
- Primary completion2 Apr 2021 (estimated)
- Study completion2 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital Zadar
- Responsible party
- Principal investigator, Ivana Kolcic, University of Split, School of Medicine
- Investigators
- MARIJA LJUBICIC, RN, MSN, Principal investigator, General hospital Zadar, Department of PediatricsIVANA KOLCIC, MD, PhD, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602378
- Sponsor's protocol ID
- 2181-198-03-04-18-0014
- Status last verified
- Mar 2020
- First submitted
- 4 Jun 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Identified participants for outcome measures
Publications
Kleinman JM, Robins DL, Ventola PE, Pandey J, Boorstein HC, Esser EL, Wilson LB, Rosenthal MA, Sutera S, Verbalis AD, Barton M, Hodgson S, Green J, Dumont-Mathieu T, Volkmar F, Chawarska K, Klin A, Fein D. The modified checklist for autism in toddlers: a follow-up study investigating the early detection of autism spectrum disorders. J Autism Dev Disord. 2008 May;38(5):827-39. doi: 10.1007/s10803-007-0450-9.
PubMed 17882539Turner LM, Stone WL. Variability in outcome for children with an ASD diagnosis at age 2. J Child Psychol Psychiatry. 2007 Aug;48(8):793-802. doi: 10.1111/j.1469-7610.2007.01744.x.
PubMed 17683451Eaves LC, Ho HH. The very early identification of autism: outcome to age 4 1/2-5. J Autism Dev Disord. 2004 Aug;34(4):367-78. doi: 10.1023/b:jadd.0000037414.33270.a8.
PubMed 15449513Bella GP, Garcia MC, Spadari-Bratfisch RC. Salivary cortisol, stress, and health in primary caregivers (mothers) of children with cerebral palsy. Psychoneuroendocrinology. 2011 Jul;36(6):834-42. doi: 10.1016/j.psyneuen.2010.11.005. Epub 2010 Dec 10.
PubMed 21146316Stalder T, Kirschbaum C, Kudielka BM, Adam EK, Pruessner JC, Wust S, Dockray S, Smyth N, Evans P, Hellhammer DH, Miller R, Wetherell MA, Lupien SJ, Clow A. Assessment of the cortisol awakening response: Expert consensus guidelines. Psychoneuroendocrinology. 2016 Jan;63:414-32. doi: 10.1016/j.psyneuen.2015.10.010. Epub 2015 Oct 20.
PubMed 26563991Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
PubMed 8737210Billman GE. Heart rate variability - a historical perspective. Front Physiol. 2011 Nov 29;2:86. doi: 10.3389/fphys.2011.00086. eCollection 2011.
PubMed 22144961Baba M, Ohkura M, Koga K, Nishiuchi K, Herrera LR, Matsuse R, Inoue T. Analysis of salivary cortisol levels to determine the association between depression level and differences in circadian rhythms of shift-working nurses. J Occup Health. 2015;57(3):237-44. doi: 10.1539/joh.14-0079-OA. Epub 2015 Mar 6.
PubMed 25752657Karhula K, Harma M, Sallinen M, Lindholm H, Hirvonen A, Elovainio M, Kivimaki M, Vahtera J, Puttonen S. Salivary cortisol and alpha-amylase: Is there consistency between psychosocial stress test and burdensome work shifts? J Occup Environ Hyg. 2017 Dec;14(12):1003-1010. doi: 10.1080/15459624.2017.1350786.
PubMed 28692340Niu SF, Chung MH, Chu H, Tsai JC, Lin CC, Liao YM, Ou KL, O'Brien AP, Chou KR. Differences in cortisol profiles and circadian adjustment time between nurses working night shifts and regular day shifts: A prospective longitudinal study. Int J Nurs Stud. 2015 Jul;52(7):1193-201. doi: 10.1016/j.ijnurstu.2015.04.001. Epub 2015 Apr 8.
PubMed 25900684Simon CD, Adam EK, McKinney CO, Krohn JB, Shalowitz MU. Breastfeeding, Bed-Sharing, and Maternal Cortisol. Clin Pediatr (Phila). 2016 May;55(5):470-8. doi: 10.1177/0009922815601981. Epub 2015 Sep 1.
PubMed 26330120Tu MT, Lupien SJ, Walker CD. Diurnal salivary cortisol levels in postpartum mothers as a function of infant feeding choice and parity. Psychoneuroendocrinology. 2006 Aug;31(7):812-24. doi: 10.1016/j.psyneuen.2006.03.006. Epub 2006 May 23.
PubMed 16716531Rogers SL, Hughes BA, Tomlinson JW, Blissett J. Cortisol metabolism, postnatal depression and weight changes in the first 12 months postpartum. Clin Endocrinol (Oxf). 2016 Dec;85(6):881-890. doi: 10.1111/cen.13150. Epub 2016 Aug 11.
PubMed 27374760Orta OR, Gelaye B, Bain PA, Williams MA. The association between maternal cortisol and depression during pregnancy, a systematic review. Arch Womens Ment Health. 2018 Feb;21(1):43-53. doi: 10.1007/s00737-017-0777-y. Epub 2017 Sep 24.
PubMed 28942465Wolfram M, Bellingrath S, Kudielka BM. The cortisol awakening response (CAR) across the female menstrual cycle. Psychoneuroendocrinology. 2011 Jul;36(6):905-12. doi: 10.1016/j.psyneuen.2010.12.006. Epub 2011 Jan 14.
PubMed 21237574
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
- ClinicalTrials.gov ID
- NCT03602378
- Acronym / sponsor ID
- 2181-198-03-04-18-0014
- Conditions
- Developmental Disability, Chronic Disease, Down Syndrome, Autism Spectrum Disorder, Pervasive Developmental Disorder, Cerebral Palsy
- Keywords
- Parents, Quality of life, Stress, Children with developmental disability, Children with chronic disease, Cortisol, Heart rate variability, Advanced glycation end products
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- General Hospital Zadar
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 2 Apr 2021 (estimated)
- Study completion
- 2 May 2021 (estimated)
- First posted
- 26 Jul 2018 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parents of children with disability | – | Diagnostic Test: salivary cortisol, Device: Holter Medilog AR12 Plus, Device: Polar V800, Device: AGE readerparents 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 |
| Parents of children with chronic disease | – | Diagnostic Test: salivary cortisol, Device: Holter Medilog AR12 Plus, Device: Polar V800, Device: AGE readerparents of children chronic disease (diabetes mellitus type 1, epilepsy, asthma), age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader |
| Parents of healthy children | – | Diagnostic Test: salivary cortisol, Device: Holter Medilog AR12 Plus, Device: Polar V800, Device: AGE readerparents of healthy children, age 20-50, salivary cortisol, Holter Medilog AR12 Plus, Polar V800, AGE reader |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- severe psychiatry and severe chronic illnesses of parents
- ischemic heart disease
- cardiomyopathy
- heart arrhythmia
- malignant hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salivary cortisol5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes). | Diagnostic test | Parents of children with chronic disease, Parents of children with disability, Parents of healthy children |
| Holter Medilog AR12 PlusHolter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV | Device | Parents of children with chronic disease, Parents of children with disability, Parents of healthy children |
| Polar V800Also: Polar V800 with sensorPolar V800 with sensor - during 5 minutes for measuring HRV | Device | Parents of children with chronic disease, Parents of children with disability, Parents of healthy children |
| AGE readerAlso: Advanced glycation end products reader, AGEs readerfor measuring Advanced Glycation End products (AGEs) | Device | Parents of children with chronic disease, Parents of children with disability, Parents of healthy children |
Primary outcome
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).
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.
5 secondary outcomes
Family quality of life
Time frame: 1 day
Perceived Stress Scale
Time frame: 1 day
Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children.
Time frame: 1 day
Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children
Time frame: 1 day
Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 17882539Kleinman JM, Robins DL, Ventola PE, Pandey J, Boorstein HC, Esser EL, Wilson LB, Rosenthal MA, Sutera S, Verbalis AD, Barton M, Hodgson S, Green J, Dumont-Mathieu T, Volkmar F, Chawarska K, Klin A, Fein D. The modified checklist for autism in toddlers: a follow-up study investigating the early detection of autism spectrum disorders. J Autism Dev Disord. 2008 May;38(5):827-39. doi: 10.1007/s10803-007-0450-9.
- Background: PubMed 17683451Turner LM, Stone WL. Variability in outcome for children with an ASD diagnosis at age 2. J Child Psychol Psychiatry. 2007 Aug;48(8):793-802. doi: 10.1111/j.1469-7610.2007.01744.x.
- Background: PubMed 15449513Eaves LC, Ho HH. The very early identification of autism: outcome to age 4 1/2-5. J Autism Dev Disord. 2004 Aug;34(4):367-78. doi: 10.1023/b:jadd.0000037414.33270.a8.
- Background: PubMed 21146316Bella GP, Garcia MC, Spadari-Bratfisch RC. Salivary cortisol, stress, and health in primary caregivers (mothers) of children with cerebral palsy. Psychoneuroendocrinology. 2011 Jul;36(6):834-42. doi: 10.1016/j.psyneuen.2010.11.005. Epub 2010 Dec 10.
- Background: PubMed 26563991Stalder T, Kirschbaum C, Kudielka BM, Adam EK, Pruessner JC, Wust S, Dockray S, Smyth N, Evans P, Hellhammer DH, Miller R, Wetherell MA, Lupien SJ, Clow A. Assessment of the cortisol awakening response: Expert consensus guidelines. Psychoneuroendocrinology. 2016 Jan;63:414-32. doi: 10.1016/j.psyneuen.2015.10.010. Epub 2015 Oct 20.
- Background: PubMed 8737210Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
- Background: PubMed 22144961Billman GE. Heart rate variability - a historical perspective. Front Physiol. 2011 Nov 29;2:86. doi: 10.3389/fphys.2011.00086. eCollection 2011.
- Background: PubMed 25752657Baba M, Ohkura M, Koga K, Nishiuchi K, Herrera LR, Matsuse R, Inoue T. Analysis of salivary cortisol levels to determine the association between depression level and differences in circadian rhythms of shift-working nurses. J Occup Health. 2015;57(3):237-44. doi: 10.1539/joh.14-0079-OA. Epub 2015 Mar 6.
- Background: PubMed 28692340Karhula K, Harma M, Sallinen M, Lindholm H, Hirvonen A, Elovainio M, Kivimaki M, Vahtera J, Puttonen S. Salivary cortisol and alpha-amylase: Is there consistency between psychosocial stress test and burdensome work shifts? J Occup Environ Hyg. 2017 Dec;14(12):1003-1010. doi: 10.1080/15459624.2017.1350786.
- Background: PubMed 25900684Niu SF, Chung MH, Chu H, Tsai JC, Lin CC, Liao YM, Ou KL, O'Brien AP, Chou KR. Differences in cortisol profiles and circadian adjustment time between nurses working night shifts and regular day shifts: A prospective longitudinal study. Int J Nurs Stud. 2015 Jul;52(7):1193-201. doi: 10.1016/j.ijnurstu.2015.04.001. Epub 2015 Apr 8.
- Background: PubMed 26330120Simon CD, Adam EK, McKinney CO, Krohn JB, Shalowitz MU. Breastfeeding, Bed-Sharing, and Maternal Cortisol. Clin Pediatr (Phila). 2016 May;55(5):470-8. doi: 10.1177/0009922815601981. Epub 2015 Sep 1.
- Background: PubMed 16716531Tu MT, Lupien SJ, Walker CD. Diurnal salivary cortisol levels in postpartum mothers as a function of infant feeding choice and parity. Psychoneuroendocrinology. 2006 Aug;31(7):812-24. doi: 10.1016/j.psyneuen.2006.03.006. Epub 2006 May 23.
- Individual participant dataSharing planned: Undecided. Identified participants for outcome measures
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Autism Spectrum Disorder
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"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
MARIJA LJUBICIC, RN, MSN principal investigator
General hospital Zadar, Department of Pediatrics
IVANA KOLCIC, MD, PhD principal investigator
University of Split, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Disability and Chronic Disease, run by University of Split, School of Medicine at 2 sites in Croatia.
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 20 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. 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?
Results are not available in the source record.
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?
Quality of life in parents of children with developmental disability and chronic disease, and healthy children. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602378, which also lists 69 linked publications.
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 26 Mar 2020.