- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04811885
The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder (ASD)
The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Lenister
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Carlow, Lenister, Ireland
- Institute of Technology Carlow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- children with ASD
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
child with ASD of school going age
Questionnaire complete by parent with children with ASD semi structure interview complete by parent with children
|
The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effects of Covid-9 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
Time Frame: 24 months
|
Questionnaire, interview
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katie White, Institute of Technology, Carlow
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurodevelopmental Disorders
- COVID-19
- Autistic Disorder
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
Other Study ID Numbers
- Institute Technology Carlow
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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