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

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ClinicalTrials.gov Identifier: NCT03602378
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
General Hospital Zadar
Information provided by (Responsible Party):
Ivana Kolcic, University of Split, School of Medicine

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
Developmental Disability Chronic Disease Down Syndrome Autism Spectrum Disorder Pervasive Developmental Disorder Cerebral Palsy Diabetes Mellitus, Type 1 Epilepsy Asthma Stress Diagnostic Test: salivary cortisol Device: Holter Medilog AR12 Plus Device: Polar V800 Device: AGE reader

  Show Detailed Description

Study Type : Observational
Estimated 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 : April 2, 2018
Estimated Primary Completion Date : April 2, 2019
Estimated Study Completion Date : May 2, 2019


Group/Cohort 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 Name: 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 Name: 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 Name: Polar V800 with sensor

Device: AGE reader
for measuring Advanced Glycation End products (AGEs)
Other Names:
  • Advanced glycation end products reader
  • AGEs reader




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Family quality of life [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 1 day ]
    AGE reader for measuring advanced glycation end products. Higher results indicating greater cardiovascular risk.


Biospecimen Retention:   Samples Without DNA
saliva samples


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602378


Locations
Croatia
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

Publications:
Berry JO, Jones WH. The parental stress scale: Initial psychometric evidence. Journal of Social and Personal Relationships 1995;12:463-72
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.
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.
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.
Lupien SJ, Seguin F. How to measure stress in humans. Centre for Studies in Human Stress 2013.
Lyubomirsky S, Lepper HS. A measure of subjective happiness: Preliminary reliability and construct validation. Social indicators research 1999;46:137-55.
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.
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.
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.
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.
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.

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     History of Changes
Other Study ID Numbers: 2181-198-03-04-18-0014
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Identified participants for outcome measures

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ivana Kolcic, 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:
Disease
Diabetes Mellitus
Cerebral Palsy
Autism Spectrum Disorder
Diabetes Mellitus, Type 1
Chronic Disease
Down Syndrome
Developmental Disabilities
Child Development Disorders, Pervasive
Autistic Disorder
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn