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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03860389
Other study ID # ASD1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date December 16, 2019

Study information

Verified date February 2019
Source Institute of Technology, Carlow
Contact Sharon Kinsella, PhD.
Phone +353599175515
Email sharon.kinsella@itcarlow.ie
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 16, 2019
Est. primary completion date June 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- Diagnosis of autism spectrum disorder

Exclusion Criteria:

- Any medical condition which excludes the child from partaking in exercise

Study Design


Intervention

Other:
Exercise
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.

Locations

Country Name City State
Ireland Sharon Kinsella Carlow Co. Carlow

Sponsors (2)

Lead Sponsor Collaborator
Institute of Technology, Carlow University of Reading

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety Changes in anxiety levels of the children will be assessed using the Anxiety Scale for Children -ASD. Change from baseline at Week 8 and Week 16
Primary Behaviour Changes in the behaviour of the children will be assessed using the Nisingor Child Behaviour Rating Form Change from baseline at Week 8 and Week 16
Secondary Fitness level The modified Eurofit test will be used to assess the fitness levels of children Change from baseline at Week 8 and Week 16
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