Autism Spectrum DisorderNCT05422261
The Relationship Between Parents' Fatigue and Quality of Life
An observational study of Autism Spectrum Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
By comparing them to a healthy control group, this study aims to investigate the relationship between the participation of children with autism spectrum disorder (ASD) in home, school, and community environments and their parents' fatigue, depression, and quality of life, as well as the child's quality of life. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 May 2023
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with diagnosed Autism Spectrum Disorder and their health peers and their families
Who may be able to join
- Diagnosis of Autism Spectrum Disorder and their parents
- Aged at 2-17 years.
- To be the native language Turkish
- Ages at 2-18 years.
- Not having any psychiatric or neurological diagnosis.
- To be the native language Turkish.
Who cannot join
- Diagnosis of other neurologic disorder such as epilepsy, diabetes, congenital heart disease, brain trauma
- Not to accept to attend the study
- Not agree to participate the study.
- To have received medical treatment for any neuropsychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Parents' Fatigue and Quality of Life, and the Quality of Life and Participation of Children With Autism Spectrum Disorder
By comparing them to a healthy control group, this study aims to investigate the relationship between the participation of children with autism spectrum disorder (ASD) in home, school, and community environments and their parents' fatigue, depression, and quality of life, as well as the child's quality of life. There is no study that investigators are aware of that looks into the relationship between the fatigue and quality of life of parents of children with ASD and the quality of life and participation of children with ASD. This study hypothesizes that parents of children with ASD experience more fatigue and have a lower health-related quality of life than parents of healthy children.
Read the detailed description
ASD is a neurodevelopmental disorder characterized by difficulties with social communication, limited and repetitive activities, and sensory sensitivity. The social, emotional, and behavioral issues that children with ASD face are a source of concern for their parents. Mental health issues such as stress, depression, and anxiety are common in these households. According to studies, mothers of children with ASD experience more stress and depression than mothers of children without ASD or mothers of children with other chronic disorders. Another aspect of having an ASD child that has an influence on health is fatigue. In terms of the health of parents of children with ASD, fatigue is often overlooked in study and practice. One of the study was investigated at the fatigue levels of 50 mothers of children with ASD who were between the ages of 2 and 5. Compared to mothers of healthy children, mothers of children with ASD reported higher fatigue, stress, worry, and depressive symptoms.
Participation in daily activities is critical for all children's healthy development, whether or not they have a disability. Participating in activities allows children to express themselves, find purpose, and improve their health. Exclusion and loneliness can arise from a child's inability to participate in normal childhood activities. This circumstance has a number of harmful consequences for the child. According to research, children with ASD participate in their home, school, and community surroundings at a considerably lower rate than their healthy peers, and this difference grows over time.
There is no study in the literature that examines the association between children with ASD's participation in home, school, and community environments, their parents' fatigue level, and the child's quality of life. As a result, the purpose of this research is to look at the relationship between ASD children's participation in home, school, and community settings and their parents' fatigue, depression, and quality of life, as well as the child's quality of life, by comparing them to a healthy control group.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Quality of life, Participation, Depression
- Medical subject headings
- Autism Spectrum Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Children with Autism Spectrum Disorder and their parents | |
| Control Group | Health children and their parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of fatigue
Fatigue Impact Scale is a multidimensional scale that measures the physical, cognitive, and social effects of fatigue. It consists of 40 items divided into 10 cognitive, 10 physical, and 20 social subscales. Each question is scored on a five-point Likert scale from 0 (no problem) to 4 (extreme problem). The maximum score is 160.
Measured: baseline
Evaluation of fatigue severity
The Fatigue Severity Scale is one of the most commonly used scales to assess fatigue. There are nine questions. Each question is scored on a seven-point Likert scale from one to seven. The mean of nine questions is the scale value.The minimum score is 1 and maximum score is 7. Higher scores indicate more severe fatigue. Although there is no recommendation, it is usually considered that fatigue severity above 4 points is significant.
Measured: Baseline
Evaluation of Quality of Life of children
Quality of Life in Autism Questionnaire-Parent Version is divided into 2 parts (A and B). Part A consists of 28 questions that assess parents' perceptions of their own life quality. Each question is scored on a five-point Likert scale from one (not at all) to five (very much). Part B assesses parents' perceptions of the severity of their child's autism-related difficulties with 20 questions. Each question is scored on a five-point Likert scale from one (not much of a problem for me) to five (very much of a problem for me). Higher scores indicate that a child's autism-related difficulties cause fewer problems for parents. The scale produces a score ranging from minimum 48 to maximum 240 score.
Measured: Baseline
Secondary outcomes (3)
Evaluation of health
Nottingham Health Profile assesses the physical, emotional, and health problems perceived by a person. It consists of 6 different subcategories such as energy, pain, physical mobility, sleep, emotional reactions, and social isolation, with 38 items. Nottingham Health Profile examines the current state of health, and the answers are binary (yes/no).The overall value is calculated by multiplying the intensity of the questions by the positive answer to each one. Minimum score is 0 and maximum score is 100.
Measured: Baseline
Evaluation of depression
Beck Depression Inventory assesses characteristic attitudes and depression symptoms with 21 self-reported items. It takes about 10 minutes to finish the assessment. It is intended for people aged 13 and up. Beck Depression Inventory includes 21 questions. For each question, the lowest score is 0 and the maximum score is 3. The total score of all answers is evaluated as follows 0 to 9 points: "minimal depressive symptoms", 10 to 16 points: "mild depressive symptoms", 17 to 29 points: "moderate depressive symptoms", 20 to 63 points: "severe depressive symptoms".
Measured: Baseline
Evaluation of participation
Participation and Environment- Children and Youth is a parent-reported questionnaire to assess participation and environmental factors in the home, at school, and within community settings. The participation sections included 10 activities in the home setting, five activities in the school setting and 10 in the community setting. For each activity, parents are asked to determine the participation frequency (how frequently has the child participated with eight options: daily to never); participation involvement (how involved the child is while participating in the activity rated on a five-point scale: very involved to minimally involved); and whether change is desired (do the parents want to see change in the child's participation in this type of activity: no or yes, with five different types of change). The minimum score is 0 and the maximum score is 100.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Feb 2023
- Primary completion16 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422261
- Sponsor's protocol ID
- 2019/288
- Status last verified
- May 2023
- First submitted
- 14 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be presented in the journal
Publications
Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
PubMed 24413388Lecavalier L, Leone S, Wiltz J. The impact of behaviour problems on caregiver stress in young people with autism spectrum disorders. J Intellect Disabil Res. 2006 Mar;50(Pt 3):172-83. doi: 10.1111/j.1365-2788.2005.00732.x.
PubMed 16430729Cohrs AC, Leslie DL. Depression in Parents of Children Diagnosed with Autism Spectrum Disorder: A Claims-Based Analysis. J Autism Dev Disord. 2017 May;47(5):1416-1422. doi: 10.1007/s10803-017-3063-y.
PubMed 28214978Hayes SA, Watson SL. The impact of parenting stress: a meta-analysis of studies comparing the experience of parenting stress in parents of children with and without autism spectrum disorder. J Autism Dev Disord. 2013 Mar;43(3):629-42. doi: 10.1007/s10803-012-1604-y.
PubMed 22790429Higgins DJ, Bailey SR, Pearce JC. Factors associated with functioning style and coping strategies of families with a child with an autism spectrum disorder. Autism. 2005 May;9(2):125-37. doi: 10.1177/1362361305051403.
PubMed 15857858Giallo R, Wood CE, Jellett R, Porter R. Fatigue, wellbeing and parental self-efficacy in mothers of children with an autism spectrum disorder. Autism. 2013 Jul;17(4):465-80. doi: 10.1177/1362361311416830. Epub 2011 Jul 25.
PubMed 21788255Seymour M, Wood C, Giallo R, Jellett R. Fatigue, stress and coping in mothers of children with an autism spectrum disorder. J Autism Dev Disord. 2013 Jul;43(7):1547-54. doi: 10.1007/s10803-012-1701-y.
PubMed 23124359King G, Law M, King S, Rosenbaum P, Kertoy MK, Young NL. A conceptual model of the factors affecting the recreation and leisure participation of children with disabilities. Phys Occup Ther Pediatr. 2003;23(1):63-90.
PubMed 12703385Simpson K, Adams D, Bruck S, Keen D. Investigating the participation of children on the autism spectrum across home, school, and community: A longitudinal study. Child Care Health Dev. 2019 Sep;45(5):681-687. doi: 10.1111/cch.12679. Epub 2019 May 20.
PubMed 31041826Egilson ST, Jakobsdottir G, Olafsdottir LB. Parent perspectives on home participation of high-functioning children with autism spectrum disorder compared with a matched group of children without autism spectrum disorder. Autism. 2018 Jul;22(5):560-570. doi: 10.1177/1362361316685555. Epub 2017 Apr 21.
PubMed 28429605Taheri A, Perry A, Minnes P. Examining the social participation of children and adolescents with Intellectual Disabilities and Autism Spectrum Disorder in relation to peers. J Intellect Disabil Res. 2016 May;60(5):435-43. doi: 10.1111/jir.12289.
PubMed 27120987
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Parents' Fatigue and Quality of Life, and the Quality of Life and Participation of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05422261
- Acronym / sponsor ID
- 2019/288
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Quality of life, Participation, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 16 Jun 2022 (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.
By comparing them to a healthy control group, this study aims to investigate the relationship between the participation of children with autism spectrum disorder (ASD) in home, school, and community environments and their parents' fatigue, depression, and quality of life, as well as the child's quality of life. There is no study that investigators are aware of that looks into the relationship between the fatigue and quality of life of parents of children with ASD and the quality of life and participation of children with ASD. This study hypothesizes that parents of children with ASD experience more fatigue and have a lower health-related quality of life than parents of healthy children.
Detailed description
ASD is a neurodevelopmental disorder characterized by difficulties with social communication, limited and repetitive activities, and sensory sensitivity. The social, emotional, and behavioral issues that children with ASD face are a source of concern for their parents. Mental health issues such as stress, depression, and anxiety are common in these households. According to studies, mothers of children with ASD experience more stress and depression than mothers of children without ASD or mothers of children with other chronic disorders. Another aspect of having an ASD child that has an influence on health is fatigue. In terms of the health of parents of children with ASD, fatigue is often overlooked in study and practice. One of the study was investigated at the fatigue levels of 50 mothers of children with ASD who were between the ages of 2 and 5. Compared to mothers of healthy children, mothers of children with ASD reported higher fatigue, stress, worry, and depressive symptoms.
Participation in daily activities is critical for all children's healthy development, whether or not they have a disability. Participating in activities allows children to express themselves, find purpose, and improve their health. Exclusion and loneliness can arise from a child's inability to participate in normal childhood activities. This circumstance has a number of harmful consequences for the child. According to research, children with ASD participate in their home, school, and community surroundings at a considerably lower rate than their healthy peers, and this difference grows over time.
There is no study in the literature that examines the association between children with ASD's participation in home, school, and community environments, their parents' fatigue level, and the child's quality of life. As a result, the purpose of this research is to look at the relationship between ASD children's participation in home, school, and community settings and their parents' fatigue, depression, and quality of life, as well as the child's quality of life, by comparing them to a healthy control group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –Children with Autism Spectrum Disorder and their parents |
| Control Group | – | –Health children and their parents |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with diagnosed Autism Spectrum Disorder and their health peers and their families
Key inclusion criteria (6 listed)
- Diagnosis of Autism Spectrum Disorder and their parents
- Aged at 2-17 years.
- To be the native language Turkish
- Ages at 2-18 years.
- Not having any psychiatric or neurological diagnosis.
Key exclusion criteria (4 listed)
- Diagnosis of other neurologic disorder such as epilepsy, diabetes, congenital heart disease, brain trauma
- Not to accept to attend the study
- Not agree to participate the study.
- To have received medical treatment for any neuropsychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of fatigue
Time frame: baseline
Fatigue Impact Scale is a multidimensional scale that measures the physical, cognitive, and social effects of fatigue. It consists of 40 items divided into 10 cognitive, 10 physical, and 20 social subscales. Each question is scored on a five-point Likert scale from 0 (no problem) to 4 (extreme problem). The maximum score is 160.
Evaluation of fatigue severity
Time frame: Baseline
The Fatigue Severity Scale is one of the most commonly used scales to assess fatigue. There are nine questions. Each question is scored on a seven-point Likert scale from one to seven. The mean of nine questions is the scale value.The minimum score is 1 and maximum score is 7. Higher scores indicate more severe fatigue. Although there is no recommendation, it is usually considered that fatigue severity above 4 points is significant.
Evaluation of Quality of Life of children
Time frame: Baseline
Quality of Life in Autism Questionnaire-Parent Version is divided into 2 parts (A and B). Part A consists of 28 questions that assess parents' perceptions of their own life quality. Each question is scored on a five-point Likert scale from one (not at all) to five (very much). Part B assesses parents' perceptions of the severity of their child's autism-related difficulties with 20 questions. Each question is scored on a five-point Likert scale from one (not much of a problem for me) to five (very much of a problem for me). Higher scores indicate that a child's autism-related difficulties cause fewer problems for parents. The scale produces a score ranging from minimum 48 to maximum 240 score.
3 secondary outcomes
Evaluation of health
Time frame: Baseline
Evaluation of depression
Time frame: Baseline
Evaluation of participation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 24413388Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
- Results publication: PubMed 16430729Lecavalier L, Leone S, Wiltz J. The impact of behaviour problems on caregiver stress in young people with autism spectrum disorders. J Intellect Disabil Res. 2006 Mar;50(Pt 3):172-83. doi: 10.1111/j.1365-2788.2005.00732.x.
- Results publication: PubMed 28214978Cohrs AC, Leslie DL. Depression in Parents of Children Diagnosed with Autism Spectrum Disorder: A Claims-Based Analysis. J Autism Dev Disord. 2017 May;47(5):1416-1422. doi: 10.1007/s10803-017-3063-y.
- Results publication: PubMed 22790429Hayes SA, Watson SL. The impact of parenting stress: a meta-analysis of studies comparing the experience of parenting stress in parents of children with and without autism spectrum disorder. J Autism Dev Disord. 2013 Mar;43(3):629-42. doi: 10.1007/s10803-012-1604-y.
- Results publication: PubMed 15857858Higgins DJ, Bailey SR, Pearce JC. Factors associated with functioning style and coping strategies of families with a child with an autism spectrum disorder. Autism. 2005 May;9(2):125-37. doi: 10.1177/1362361305051403.
- Results publication: PubMed 21788255Giallo R, Wood CE, Jellett R, Porter R. Fatigue, wellbeing and parental self-efficacy in mothers of children with an autism spectrum disorder. Autism. 2013 Jul;17(4):465-80. doi: 10.1177/1362361311416830. Epub 2011 Jul 25.
- Results publication: PubMed 23124359Seymour M, Wood C, Giallo R, Jellett R. Fatigue, stress and coping in mothers of children with an autism spectrum disorder. J Autism Dev Disord. 2013 Jul;43(7):1547-54. doi: 10.1007/s10803-012-1701-y.
- Results publication: PubMed 12703385King G, Law M, King S, Rosenbaum P, Kertoy MK, Young NL. A conceptual model of the factors affecting the recreation and leisure participation of children with disabilities. Phys Occup Ther Pediatr. 2003;23(1):63-90.
- Results publication: PubMed 31041826Simpson K, Adams D, Bruck S, Keen D. Investigating the participation of children on the autism spectrum across home, school, and community: A longitudinal study. Child Care Health Dev. 2019 Sep;45(5):681-687. doi: 10.1111/cch.12679. Epub 2019 May 20.
- Results publication: PubMed 28429605Egilson ST, Jakobsdottir G, Olafsdottir LB. Parent perspectives on home participation of high-functioning children with autism spectrum disorder compared with a matched group of children without autism spectrum disorder. Autism. 2018 Jul;22(5):560-570. doi: 10.1177/1362361316685555. Epub 2017 Apr 21.
- Results publication: PubMed 27120987Taheri A, Perry A, Minnes P. Examining the social participation of children and adolescents with Intellectual Disabilities and Autism Spectrum Disorder in relation to peers. J Intellect Disabil Res. 2016 May;60(5):435-43. doi: 10.1111/jir.12289.
- Individual participant dataSharing planned: No. Results will be presented in the journal
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of fatigue (time frame: baseline). The study lists 3 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 NCT05422261, which also lists 11 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 1 Jun 2023.