Autism Spectrum DisorderASDNCT04811885
The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Cardiovascular Health, run by South East Technological University at 1 site in Ireland.
Trial summary
The aim of the questionnaire and semi structured interview was to understand how the Covid 19 pandemic has impacted the cardiovascular health, physical activity levels, sedentary behavior, sleep, anxiety levels and eating habits of children with ASD in comparison to before the pandemic. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Cardiovascular Health
- What is being tested?
- The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
- How many people
- 120 participants
- Where
- 1 siteIreland
- Study dates
- 14 Oct 2019to 14 Oct 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: child with ASD of school going age living in Ireland, UK and USA.
Who may be able to join
- children with ASD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism
The aim of the questionnaire and semi structured interview was to understand how the Covid 19 pandemic has impacted the cardiovascular health, physical activity levels, sedentary behavior, sleep, anxiety levels and eating habits of children with ASD in comparison to before the pandemic.
Read the detailed description
A questionnaire was designed and was available for completion on the colleges survey monkey account. The link for the questionnaire and an explanation of the purpose of the questionnaire was e-mailed to relevant Autism charities or groups within Ireland, the UK and the USA and the administrators of these group were requested to send the link for the questionnaire onto their members. The administrators of relevant social media sites such as Facebook Autism groups were contacted and asked for permission to share the link for the questionnaire to be circulated on their Facebook page.
The questionnaire was completed by parents of children with ASD and consisted of questions relating to them and their child. Within the questionnaire they were asked about their socio-economic background and about their ASD child's cardiovascular health, physical activity levels, sedentary behavior, eating habits and anxiety levels during the Covid 19 pandemic compared to normal life before the outbreak of the pandemic. The aim of the questionnaire was to understand how the Covid 19 pandemic has impacted the cardiovascular health, physical activity levels, sedentary behavior, sleep, anxiety levels and eating habits in comparison to before the pandemic.
The questionnaires was completed online through IT Carlow's survey monkey. Individual results were anonymous and results of the questionnaire were stored on a password protected computer. Participants completed a consent form that explained that participation in the survey was completely voluntary and they could withdraw at any stage if they wished to do so. If they did not wish to answer a question, was a prefer not to say option available and they could continue with the survey. Parents had an option at the end of the survey to enter their email address which allowed them to partake in any follow up questionnaire studies. The questionnaire was initially piloted and was amended as necessary based on the results of the pilot study.
The second aspect will of the study used qualitative design (semi-structured interviews, n=10) to gain deeper insights into the challenges and barriers to engaging children with autism in healthy lifestyle behaviours and the effects COVID 19 had on these challenges and barriers. Each interview was approximately 60 minutes in length. A semi-structured, qualitative interview schedule, which is attached below guided the interview process and was continually revised based on reflection and evolving conceptualisation. Written consent was sought from all participants. The consent form explained that participation in the interview was completely voluntary and they could withdraw at any stage if they wished to do so. If they did not wish to answer a question, they could decline and move on to the next question. The interview was initially piloted and was amended as necessary based on the results of the pilot study.
- Conditions
- Autism Spectrum Disorder, Cardiovascular Health
- Being tested
- The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum DisorderOther
Also called Questionnaire study, Interview study
The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
| Study group | Role | What they receive |
|---|---|---|
| child with ASD of school going age | Questionnaire complete by parent with children with ASD semi structure interview complete by parent with children Receives: Other: The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Covid-9 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
Questionnaire, interview
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start14 Oct 2019
- Primary completion14 Oct 2021 (estimated)
- Study completion14 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South East Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie White, South East Technological University
- Investigators
- Katie White, Principal investigator, South East Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811885
- Sponsor's protocol ID
- Institute Technology Carlow
- Acronym
- ASD
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism
- ClinicalTrials.gov ID
- NCT04811885
- Acronym / sponsor ID
- ASD / Institute Technology Carlow
- Conditions
- Autism Spectrum Disorder, Cardiovascular Health
- Keywords
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- South East Technological UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 14 Oct 2021 (estimated)
- Study completion
- 14 Oct 2021 (estimated)
- First posted
- 23 Mar 2021 (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 the questionnaire and semi structured interview was to understand how the Covid 19 pandemic has impacted the cardiovascular health, physical activity levels, sedentary behavior, sleep, anxiety levels and eating habits of children with ASD in comparison to before the pandemic.
Detailed description
A questionnaire was designed and was available for completion on the colleges survey monkey account. The link for the questionnaire and an explanation of the purpose of the questionnaire was e-mailed to relevant Autism charities or groups within Ireland, the UK and the USA and the administrators of these group were requested to send the link for the questionnaire onto their members. The administrators of relevant social media sites such as Facebook Autism groups were contacted and asked for permission to share the link for the questionnaire to be circulated on their Facebook page.
The questionnaire was completed by parents of children with ASD and consisted of questions relating to them and their child. Within the questionnaire they were asked about their socio-economic background and about their ASD child's cardiovascular health, physical activity levels, sedentary behavior, eating habits and anxiety levels during the Covid 19 pandemic compared to normal life before the outbreak of the pandemic. The aim of the questionnaire was to understand how the Covid 19 pandemic has impacted the cardiovascular health, physical activity levels, sedentary behavior, sleep, anxiety levels and eating habits in comparison to before the pandemic.
The questionnaires was completed online through IT Carlow's survey monkey. Individual results were anonymous and results of the questionnaire were stored on a password protected computer. Participants completed a consent form that explained that participation in the survey was completely voluntary and they could withdraw at any stage if they wished to do so. If they did not wish to answer a question, was a prefer not to say option available and they could continue with the survey. Parents had an option at the end of the survey to enter their email address which allowed them to partake in any follow up questionnaire studies. The questionnaire was initially piloted and was amended as necessary based on the results of the pilot study.
The second aspect will of the study used qualitative design (semi-structured interviews, n=10) to gain deeper insights into the challenges and barriers to engaging children with autism in healthy lifestyle behaviours and the effects COVID 19 had on these challenges and barriers. Each interview was approximately 60 minutes in length. A semi-structured, qualitative interview schedule, which is attached below guided the interview process and was continually revised based on reflection and evolving conceptualisation. Written consent was sought from all participants. The consent form explained that participation in the interview was completely voluntary and they could withdraw at any stage if they wished to do so. If they did not wish to answer a question, they could decline and move on to the next question. The interview was initially piloted and was amended as necessary based on the results of the pilot study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| child with ASD of school going age | – | Other: The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum DisorderQuestionnaire complete by parent with children with ASD semi structure interview complete by parent with children |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- child with ASD of school going age living in Ireland, UK and USA.
Key inclusion criteria (1 listed)
- children with ASD
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum DisorderAlso: Questionnaire study, Interview studyThe Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder | Other | child with ASD of school going age |
Primary outcome
The Effects of Covid-9 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
Time frame: 24 months
Questionnaire, interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Katie White principal investigator
South East Technological University
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 and Cardiovascular Health, run by South East Technological University at 1 site in Ireland.
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 1 inclusion and 1 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 24 Mar 2021. 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 Ireland. 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?
The Effects of Covid-9 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2021.