Autism Spectrum DisorderNCT03860389
The Effects of Exercise in Anxiety in Children With ASD
A study testing Exercise in people with Autism Spectrum Disorder and Anxiety, run by South East Technological University at 1 site in Ireland.
Trial summary
This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. 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, Anxiety, Behavior
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 7 Jan 2019to 16 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of autism spectrum disorder
Who cannot join
- Any medical condition which excludes the child from partaking in exercise
Trial locations and contacts
1 site in 1 country.
Marie Carey, BSc. contact
Ireland1 site, 1 recruiting
- Recruiting
Sharon Kinsella
Carlow, Co. Carlow
Sharon Kinsella, PhD., +353 599175515, sharon.kinsella@itcarlow.ie
Marie Carey, BSc
About this study
Official title: The Effects of a School Based Exercise Programme on Behaviour and Anxiety in Children With ASD
This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.
Read the detailed description
This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. Local special autism schools and primary and secondary schools with specialised classes for children with autism will be approached to participate in the project. The age profile of the children will be 4-18 yrs of age and they will have mild-severe levels of autism. The exercise programme will delivered 3 times per week in the schools over periods of 8-16 weeks dependent on the severity of autism within the children.
Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in anxiety levels and behaviour as a result of the exercise programme.
- Conditions
- Autism Spectrum Disorder, Anxiety, Behavior
- Being tested
- Exercise
- Keywords
- Autism, Anxiety, Exercise, Behaviour
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Behavior, Autistic Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
An exercise programme will be delivered in the school for a period of up to 16 weeks. Exercise classes will take place 3 times a week and will be of 60 minutes duration.
| Study group | Role | What they receive |
|---|---|---|
| Exercise effects on anxiety | Experimental | An exercise programme will be administered 3 times a week for up to an 16 week period of time in a school setting. Each exercise class will last 60 minutes. The exercise classes will involve aspects of fundamental movement skills and will be fun for the students to participate in. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Changes in anxiety levels of the children will be assessed using the Anxiety Scale for Children -ASD.
Measured: Change from baseline at Week 8 and Week 16
Behaviour
Changes in the behaviour of the children will be assessed using the Nisingor Child Behaviour Rating Form
Measured: Change from baseline at Week 8 and Week 16
Secondary outcomes (1)
Fitness level
The modified Eurofit test will be used to assess the fitness levels of children
Measured: Change from baseline at Week 8 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start7 Jan 2019
- Primary completion24 Jun 2019 (estimated)
- Study completion16 Dec 2019 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South East Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading
- Responsible party
- Sponsor
- Investigators
- Sharon Kinsella, PhD, Principal investigator, IT Carlow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860389
- Sponsor's protocol ID
- ASD1
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a School Based Exercise Programme on Behaviour and Anxiety in Children With ASD
- ClinicalTrials.gov ID
- NCT03860389
- Acronym / sponsor ID
- ASD1
- Conditions
- Autism Spectrum Disorder, Anxiety, Behavior
- Keywords
- Autism, Anxiety, Exercise, Behaviour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South East Technological UniversityUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 24 Jun 2019 (estimated)
- Study completion
- 16 Dec 2019 (estimated)
- First posted
- 1 Mar 2019 (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.
This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.
Detailed description
This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. Local special autism schools and primary and secondary schools with specialised classes for children with autism will be approached to participate in the project. The age profile of the children will be 4-18 yrs of age and they will have mild-severe levels of autism. The exercise programme will delivered 3 times per week in the schools over periods of 8-16 weeks dependent on the severity of autism within the children.
Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in anxiety levels and behaviour as a result of the exercise programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise effects on anxiety | Experimental | Other: ExerciseAn exercise programme will be administered 3 times a week for up to an 16 week period of time in a school setting. Each exercise class will last 60 minutes. The exercise classes will involve aspects of fundamental movement skills and will be fun for the students to participate in. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of autism spectrum disorder
Key exclusion criteria (1 listed)
- Any medical condition which excludes the child from partaking in exercise
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 |
|---|---|---|
| ExerciseAn exercise programme will be delivered in the school for a period of up to 16 weeks. Exercise classes will take place 3 times a week and will be of 60 minutes duration. | Other | Exercise effects on anxiety |
Primary outcome
Anxiety
Time frame: Change from baseline at Week 8 and Week 16
Changes in anxiety levels of the children will be assessed using the Anxiety Scale for Children -ASD.
Behaviour
Time frame: Change from baseline at Week 8 and Week 16
Changes in the behaviour of the children will be assessed using the Nisingor Child Behaviour Rating Form
1 secondary outcome
Fitness level
Time frame: Change from baseline at Week 8 and Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- 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.
Marie Carey, BSc. contact
Sharon Kinsella, PhD principal investigator
IT Carlow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Autism Spectrum Disorder and Anxiety, 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 1 Mar 2019. 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?
Contact Sharon Kinsella, PhD. (+353599175515, sharon.kinsella@itcarlow.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Change from baseline at Week 8 and Week 16). The study lists 2 primary outcomes in all. 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 1 Mar 2019.