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

NCT03602378 | Unknown

• 1 other identifier: 2181-198-03-04-18-0014
• Study Type: observational
• Target: 592
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  1 days

Secondary Outcomes (5)

• Family quality of life

  1 day

• Perceived Stress Scale

  1 day

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

  1 day

• Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children

  1 day

• Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children.

  1 day

Study Arms (3)

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; 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

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

Diagnostic Test: salivary cortisol; Device: Holter Medilog AR12 Plus; Device: Polar V800; Device: AGE reader

Interventions

salivary cortisol DIAGNOSTIC_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).

Parents of children with chronic disease; Parents of children with disability; Parents of healthy children

Holter Medilog AR12 Plus DEVICE

Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV

Parents of children with chronic disease; Parents of children with disability; Parents of healthy children

Polar V800 DEVICE

Polar V800 with sensor - during 5 minutes for measuring HRV

Also known as: Polar V800 with sensor

Parents of children with chronic disease; Parents of children with disability; Parents of healthy children

AGE reader DEVICE

for measuring Advanced Glycation End products (AGEs)

Also known as: Advanced glycation end products reader, AGEs reader

Parents of children with chronic disease; Parents of children with disability; Parents of healthy children

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• General Hospital Zadar: collaborator

Study Sites (2)

University Hospital Split

Split, 21000, Croatia

Location

Ivana Kolcic

Split, 23000, Croatia

Location

Related Publications (69)

• 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.

  PMID: 17882539 BACKGROUND

• Turner 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.

  PMID: 17683451 BACKGROUND

• Eaves 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.

  PMID: 15449513 BACKGROUND

• Bella 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.

  PMID: 21146316 BACKGROUND

• Stalder 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.

  PMID: 26563991 BACKGROUND

• Heart 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.

  PMID: 8737210 BACKGROUND

• Billman GE. Heart rate variability - a historical perspective. Front Physiol. 2011 Nov 29;2:86. doi: 10.3389/fphys.2011.00086. eCollection 2011.

  PMID: 22144961 BACKGROUND

• Baba 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.

  PMID: 25752657 BACKGROUND

• Karhula 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.

  PMID: 28692340 BACKGROUND

• Niu 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.

  PMID: 25900684 BACKGROUND

• Simon 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.

  PMID: 26330120 BACKGROUND

• Tu 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.

  PMID: 16716531 BACKGROUND

• Rogers 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.

  PMID: 27374760 BACKGROUND

• Orta 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.

  PMID: 28942465 BACKGROUND

• Wolfram 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.

  PMID: 21237574 BACKGROUND

• Hodgson NA, Granger DA. Collecting saliva and measuring salivary cortisol and alpha-amylase in frail community residing older adults via family caregivers. J Vis Exp. 2013 Dec 18;(82):e50815. doi: 10.3791/50815.

  PMID: 24378361 BACKGROUND

• Foody C, James JE, Leader G. Parenting stress, salivary biomarkers, and ambulatory blood pressure: a comparison between mothers and fathers of children with autism spectrum disorders. J Autism Dev Disord. 2015 Apr;45(4):1084-95. doi: 10.1007/s10803-014-2263-y.

  PMID: 25287900 BACKGROUND

• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

  PMID: 9626712 BACKGROUND

• Berry JO, Jones WH. The parental stress scale: Initial psychometric evidence. Journal of Social and Personal Relationships 1995;12:463-72

  BACKGROUND

• Bourke-Taylor H, Law M, Howie L, Pallant JF. Development of the Child's Challenging Behaviour Scale (CCBS) for mothers of school-aged children with disabilities. Child Care Health Dev. 2010 Jul;36(4):491-8. doi: 10.1111/j.1365-2214.2009.01055.x. Epub 2009 Dec 29.

  PMID: 20047597 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Crandal R. The measurement of self-esteem and related constructs, Pp. 80-82 in JP Robinson and PR Shaver (Eds), Measures of social psychological attitudes. Revised edition. Ann Arbor: ISR 1973.

  BACKGROUND

• Gosling SD, Rentfrow PJ, Swann WB. A very brief measure of the Big-Five personality domains. Journal of Research in personality 2003;37:504-28.

  BACKGROUND

• Hoffman L, Marquis J, Poston D, Summers JA, Turnbull A. Assessing Family Outcomes: Psychometric Evaluation of the Beach Center Family Quality of Life Scale. Journal of Marriage and Family 2006;68:1069-83.

  BACKGROUND

• Lupien SJ, Seguin F. How to measure stress in humans. Centre for Studies in Human Stress 2013.

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Lyubomirsky S, Lepper HS. A measure of subjective happiness: Preliminary reliability and construct validation. Social indicators research 1999;46:137-55.

  BACKGROUND

• Mak WWS, Cheung RYM. Affiliate Stigma Among Caregivers of People with Intellectual Disability or Mental Illness. J Appl Res Intellect Disabil 2008;21:532-45.

  BACKGROUND

• Poston D, Turnbull A, Park J, Mannan H, Marquis J, Wang M. Family quality of life: a qualitative inquiry. Ment Retard. 2003 Oct;41(5):313-28. doi: 10.1352/0047-6765(2003)412.0.CO;2.

  PMID: 12962536 BACKGROUND

• Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

  PMID: 18696313 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Tolan PH, Gorman-Smith D, Huesmann LR, Zelli A. Assessment of family relationship characteristics: A measure to explain risk for antisocial behavior and depression among urban youth. Psychological Assessment 1997;9:212.

  BACKGROUND

• Yaneva M, Mosnier-Pudar H, Dugue MA, Grabar S, Fulla Y, Bertagna X. Midnight salivary cortisol for the initial diagnosis of Cushing's syndrome of various causes. J Clin Endocrinol Metab. 2004 Jul;89(7):3345-51. doi: 10.1210/jc.2003-031790.

  PMID: 15240613 BACKGROUND

• El-Farhan N, Rees DA, Evans C. Measuring cortisol in serum, urine and saliva - are our assays good enough? Ann Clin Biochem. 2017 May;54(3):308-322. doi: 10.1177/0004563216687335. Epub 2017 Mar 16.

  PMID: 28068807 BACKGROUND

• Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. doi: 10.1016/0306-4530(94)90013-2.

  PMID: 8047637 BACKGROUND

• Heart 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. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Sammito S, Bockelmann I. Reference values for time- and frequency-domain heart rate variability measures. Heart Rhythm. 2016 Jun;13(6):1309-16. doi: 10.1016/j.hrthm.2016.02.006. Epub 2016 Feb 12.

  PMID: 26883166 BACKGROUND

• Nunan D, Sandercock GR, Brodie DA. A quantitative systematic review of normal values for short-term heart rate variability in healthy adults. Pacing Clin Electrophysiol. 2010 Nov;33(11):1407-17. doi: 10.1111/j.1540-8159.2010.02841.x.

  PMID: 20663071 BACKGROUND

• Giles D, Draper N, Neil W. Validity of the Polar V800 heart rate monitor to measure RR intervals at rest. Eur J Appl Physiol. 2016 Mar;116(3):563-71. doi: 10.1007/s00421-015-3303-9. Epub 2015 Dec 26.

  PMID: 26708360 BACKGROUND

• Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.

  PMID: 24054542 BACKGROUND

• Urfer-Maurer N, Ludyga S, Stalder T, Brand S, Holsboer-Trachsler E, Gerber M, Grob A, Weber P, Lemola S. Heart rate variability and salivary cortisol in very preterm children during school age. Psychoneuroendocrinology. 2018 Jan;87:27-34. doi: 10.1016/j.psyneuen.2017.10.004. Epub 2017 Oct 5.

  PMID: 29035709 BACKGROUND

• Hofmann B, Jacobs K, Navarrete Santos A, Wienke A, Silber RE, Simm A. Relationship between cardiac tissue glycation and skin autofluorescence in patients with coronary artery disease. Diabetes Metab. 2015 Nov;41(5):410-5. doi: 10.1016/j.diabet.2014.12.001. Epub 2014 Dec 29.

  PMID: 25553578 BACKGROUND

• de Vos LC, Lefrandt JD, Dullaart RP, Zeebregts CJ, Smit AJ. Advanced glycation end products: An emerging biomarker for adverse outcome in patients with peripheral artery disease. Atherosclerosis. 2016 Nov;254:291-299. doi: 10.1016/j.atherosclerosis.2016.10.012. Epub 2016 Oct 6.

  PMID: 27751506 BACKGROUND

• Grover-Paez F, Cardona-Munoz EG, Cardona-Muller D, Guzman-Saldivar VH, Rodriguez-De la Cerda M, Jimenez-Cazarez MB, Totsuka-Sutto SE, Alanis-Sanchez GA, Ramos-Becerra CG. Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population. Blood Press Monit. 2017 Dec;22(6):375-378. doi: 10.1097/MBP.0000000000000290.

  PMID: 28945665 BACKGROUND

• Verberk WJ, Kessels AG, Thien T. Blood pressure measurement method and inter-arm differences: a meta-analysis. Am J Hypertens. 2011 Nov;24(11):1201-8. doi: 10.1038/ajh.2011.125. Epub 2011 Jul 21.

  PMID: 21776035 BACKGROUND

• Ali BA, Abdelhakm AA, Abdelhameed MA, Tawfik NK. Quality of Life in Children with Type I Diabetes Mellitus (T1D) in Minia Governorate: Relationship with Mood and Family Attitudes. J Diabetes Metab 2017;8:5.

  BACKGROUND

• Andrade EM, Geha LM, Duran P, Suwwan R, Machado F, do Rosario MC. Quality of Life in Caregivers of ADHD Children and Diabetes Patients. Front Psychiatry. 2016 Jul 25;7:127. doi: 10.3389/fpsyt.2016.00127. eCollection 2016.

  PMID: 27504099 BACKGROUND

• Dardas LA, Ahmad MM. Quality of life among parents of children with autistic disorder: a sample from the Arab world. Res Dev Disabil. 2014 Feb;35(2):278-87. doi: 10.1016/j.ridd.2013.10.029. Epub 2013 Dec 4.

  PMID: 24316492 BACKGROUND

• Gagliano A, Lamberti M, Siracusano R, Ciuffo M, Boncoddo M, Maggio R, Rosina S, Cedro C, Germano E. A Comparison between Children with ADHD and Children with Epilepsy in Self-Esteem and Parental Stress Level. Clin Pract Epidemiol Ment Health. 2014 Dec 24;10:176-83. doi: 10.2174/1745017901410010176. eCollection 2014.

  PMID: 25614755 BACKGROUND

• Hullmann SE, Wolfe-Christensen C, Ryan JL, Fedele DA, Rambo PL, Chaney JM, Mullins LL. Parental overprotection, perceived child vulnerability, and parenting stress: a cross-illness comparison. J Clin Psychol Med Settings. 2010 Dec;17(4):357-65. doi: 10.1007/s10880-010-9213-4.

  PMID: 21086027 BACKGROUND

• Leung C, Tsang SK. The Chinese Parental Stress Scale: psychometric evidence using Rasch modeling on clinical and nonclinical samples. J Pers Assess. 2010 Jan;92(1):26-34. doi: 10.1080/00223890903379209.

  PMID: 20013453 BACKGROUND

• Manee F, Ateya Y, Rassafiani M. A Comparison of the Quality of Life of Arab Mothers of Children with and without Chronic Disabilities. Phys Occup Ther Pediatr. 2016 Aug;36(3):260-71. doi: 10.3109/01942638.2015.1076558. Epub 2015 Nov 13.

  PMID: 26566139 BACKGROUND

• Mugno D, Ruta L, D'Arrigo VG, Mazzone L. Impairment of quality of life in parents of children and adolescents with pervasive developmental disorder. Health Qual Life Outcomes. 2007 Apr 27;5:22. doi: 10.1186/1477-7525-5-22.

  PMID: 17466072 BACKGROUND

• Norizan A, Shamsuddin K. Predictors of parenting stress among Malaysian mothers of children with Down syndrome. J Intellect Disabil Res. 2010 Nov;54(11):992-1003. doi: 10.1111/j.1365-2788.2010.01324.x. Epub 2010 Sep 27.

  PMID: 20868445 BACKGROUND

• Phillips BA, Conners F, Curtner-Smith ME. Parenting children with down syndrome: An analysis of parenting styles, parenting dimensions, and parental stress. Res Dev Disabil. 2017 Sep;68:9-19. doi: 10.1016/j.ridd.2017.06.010. Epub 2017 Jul 7.

  PMID: 28692948 BACKGROUND

• Roncada C, Dias CP, Goecks S, Cidade SE, Pitrez PM. [Usefulness of the WHOQOL-BREF questionnaire in assessing the quality of life of parents of children with asthma]. Rev Paul Pediatr. 2015 Jul-Sep;33(3):268-74. doi: 10.1016/j.rpped.2015.01.007. Epub 2015 Jun 9.

  PMID: 26137868 BACKGROUND

• Semakina NV, Mikhailov VA, Bagaev VI. Assessing the quality of life of families of children with epilepsy. Obozrenie psikhiatrii i meditsinskoi psikhologii im VM Bekhtereva 2012:73-6.

  BACKGROUND

• Vadakedom SS, Antony JM, Padma BK, Mammen DS, Thankappan BP. Quality of life of mothers of children with Down syndrome. J Evol Med Dent Sci-JEMDS 2017;6:2939-42.

  BACKGROUND

• Wolf JM, Miller GE, Chen E. Parent psychological states predict changes in inflammatory markers in children with asthma and healthy children. Brain Behav Immun. 2008 May;22(4):433-41. doi: 10.1016/j.bbi.2007.10.016. Epub 2007 Dec 18.

  PMID: 18068332 BACKGROUND

• Epifanio MS, Genna V, Vitello MG, Roccella M, La Grutta S. Parenting stress and impact of illness in parents of children with coeliac disease. Pediatr Rep. 2013 Dec 19;5(4):e19. doi: 10.4081/pr.2013.e19. eCollection 2013.

  PMID: 24416498 BACKGROUND

• Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.

  PMID: 7815302 BACKGROUND

• Monteagudo C, Mariscal-Arcas M, Rivas A, Lorenzo-Tovar ML, Tur JA, Olea-Serrano F. Proposal of a Mediterranean Diet Serving Score. PLoS One. 2015 Jun 2;10(6):e0128594. doi: 10.1371/journal.pone.0128594. eCollection 2015.

  PMID: 26035442 BACKGROUND

• Bassett DR Jr. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1396. doi: 10.1249/01.MSS.0000078923.96621.1D. No abstract available.

  PMID: 12900695 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.

  PMID: 22401881 BACKGROUND

• Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.

  PMID: 18431116 BACKGROUND

• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

  PMID: 1798888 BACKGROUND

• Stelmach-Mardas M, Iqbal K, Mardas M, Kostrzewska M, Piorunek T. Clinical Utility of Berlin Questionnaire in Comparison to Polysomnography in Patients with Obstructive Sleep Apnea. Adv Exp Med Biol. 2017;980:51-57. doi: 10.1007/5584_2017_7.

  PMID: 28255917 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva samples

MeSH Terms

Conditions

Developmental Disabilities; Chronic Disease; Down Syndrome; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Cerebral Palsy; Diabetes Mellitus, Type 1; Epilepsy; Asthma; Sleep Initiation and Maintenance Disorders; Social Stigma; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• MARIJA LJUBICIC, RN, MSN

  General hospital Zadar, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

• IVANA KOLCIC, MD, PhD

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor in Epidemiology Centre for Global Health & Department of Public Health Medical School, University of Split

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 26, 2018
• Study Start: April 2, 2018
• Primary Completion: April 2, 2021
• Study Completion: May 2, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

CR (2)