NCT03860389

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

February 12, 2019

Last Update Submit

February 28, 2019

Conditions

Autism Spectrum DisorderAnxietyBehavior

Keywords

AutismAnxietyExerciseBehaviour

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Fitness level

    Change from baseline at Week 8 and Week 16

Study Arms (1)

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.

Other: Exercise

Interventions

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.

Exercise effects on anxiety

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of autism spectrum disorder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharon Kinsella

Carlow, Co. Carlow, Ireland

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAnxiety DisordersBehaviorAutistic DisorderMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sharon Kinsella, PhD

    IT Carlow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Kinsella, PhD.

CONTACT

+353599175515sharon.kinsella@itcarlow.ie

Marie Carey, BSc.

CONTACT

mariec1995@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 1, 2019

Study Start

January 7, 2019

Primary Completion

June 24, 2019

Study Completion

December 16, 2019

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

IE(1)