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The Effects of Exercise in Anxiety in Children With ASD

Primary Purpose

Autism Spectrum Disorder, Anxiety, Behavior

Status

Unknown status

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Anxiety, Exercise, Behaviour

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Diagnosis of autism spectrum disorder

Exclusion Criteria:

Any medical condition which excludes the child from partaking in exercise

Sites / Locations

Sharon KinsellaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise effects on anxiety

Arm Description

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.

Outcomes

Primary Outcome Measures

Anxiety

Changes in anxiety levels of the children will be assessed using the Anxiety Scale for Children -ASD.

Behaviour

Changes in the behaviour of the children will be assessed using the Nisingor Child Behaviour Rating Form

Secondary Outcome Measures

Fitness level

The modified Eurofit test will be used to assess the fitness levels of children

Full Information

NCT ID

NCT03860389

First Posted

February 12, 2019

Last Updated

February 28, 2019

Sponsor

Institute of Technology, Carlow

Collaborators

University of Reading

1. Study Identification

Unique Protocol Identification Number

NCT03860389

Brief Title

The Effects of Exercise in Anxiety in Children With ASD

Official Title

The Effects of a School Based Exercise Programme on Behaviour and Anxiety in Children With ASD

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 7, 2019 (Actual)

Primary Completion Date

June 24, 2019 (Anticipated)

Study Completion Date

December 16, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Technology, Carlow

Collaborators

University of Reading

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Anxiety, Behavior

Keywords

Autism, Anxiety, Exercise, Behaviour

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise effects on anxiety

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

Anxiety

Description

Changes in anxiety levels of the children will be assessed using the Anxiety Scale for Children -ASD.

Time Frame

Change from baseline at Week 8 and Week 16

Title

Behaviour

Description

Changes in the behaviour of the children will be assessed using the Nisingor Child Behaviour Rating Form

Time Frame

Change from baseline at Week 8 and Week 16

Secondary Outcome Measure Information:

Title

Fitness level

Description

The modified Eurofit test will be used to assess the fitness levels of children

Time Frame

Change from baseline at Week 8 and Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of autism spectrum disorder Exclusion Criteria: Any medical condition which excludes the child from partaking in exercise

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sharon Kinsella, PhD.

Phone

+353599175515

sharon.kinsella@itcarlow.ie

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Carey, BSc.

mariec1995@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Kinsella, PhD

Organizational Affiliation

IT Carlow

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sharon Kinsella

City

Carlow

State/Province

Co. Carlow

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sharon Kinsella, PhD.

Phone

+353 599175515

sharon.kinsella@itcarlow.ie

First Name & Middle Initial & Last Name & Degree

Marie Carey, BSc

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Effects of Exercise in Anxiety in Children With ASD

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