The Effects of Exercise in Anxiety in Children With ASD

February 28, 2019 updated by: Institute of Technology, Carlow

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Co. Carlow
      • Carlow, Co. Carlow, Ireland
        • Recruiting
        • Sharon Kinsella
        • Contact:
        • Sub-Investigator:
          • Marie Carey, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of autism spectrum disorder

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise effects on anxiety
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at Week 8 and Week 16
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
Change from baseline at Week 8 and Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitness level
Time Frame: Change from baseline at Week 8 and Week 16
The modified Eurofit test will be used to assess the fitness levels of children
Change from baseline at Week 8 and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Technology, Carlow

Collaborators

University of Reading

Investigators

  • Principal Investigator: Sharon Kinsella, PhD, IT Carlow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Anticipated)

June 24, 2019

Study Completion (Anticipated)

December 16, 2019

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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