ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000598280

Ethics application status

Approved

Date submitted

14/01/2018

Date registered

18/04/2018

Date last updated

14/09/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Assessment of motor, psychological and social abilities of children with autism

Scientific title

Evaluation of deflections of gravity center, and other motor parameters in children with Autism Spectrum Disorder (ASD) as well as assessing the level of parental stress, the risk of burnout syndrome and other psychological assessment of people related to children with ASD.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1207-6115

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism Spectrum Disorder

Parental Stress

Depression

Burnout syndrome

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Ear

Normal ear development and function

Mental Health

Depression

Physical Medicine / Rehabilitation

Physiotherapy

Public Health

Health promotion/education

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Before the tests, each child will undergo a consultation with a child psychiatrist.
Physiotherapeutic assessment of children with the autism spectrum in fields;
-Biomechanical assessment of the child's gait parameters, postural stability, sensomotoric integration. Duration time: 1 h.
-Assessment of the child's motor skills. Duration time: 1 h.
-Diagnosis of auditory attention - 'Tomatis audiometric test'. Duration time: 0,5 h.
Psychological assessment of teachers working with ASD children. Duration time: 0,5 h.
Psychological assessment of parents of children with ASD. Duration time: 0,5 h.
Assessment of public awareness of symptoms of autism. Duration time: 0,5 h.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early Detection / Screening

Comparator / control treatment

Control group will undergo same assessment as exposed group. Which mean;
Physiotherapeutic assessment of normal developing children.
Psychological assessment of teachers working with normal developing children.
Psychological assessment of parents of normal developing children.

Control group

Active

Outcomes

Primary outcome [1]

Composite biomechanical assessment of the child's gait parameters. Determined by the measurement of forces and pressures under the feet and the time-space parameters of walking. It will be used pedobarographic platform Footscan (RSscan International, 2m x 0.4m x 0.02m, with 16384 sensors) with footscan 7 gait 2nd generation.

Timepoint [1]

Participants will be assessed one time at baseline assessment (1h each patient).

Primary outcome [2]

Psychological assessment of teachers working with ASD children.
Determined by standardised questionnaire Link Burnout Questionnaire, The scale of man at work.
The result of this test is assessed by key answers.

Timepoint [2]

Participants will be assessed one time at baseline assessment (0,5h each patient).

Primary outcome [3]

Psychological assessment of parents of children with ASD.
Determined by standardised questionnaire Flexibility and Cohesion Evaluation Scales, The Oxford Happiness Questionnaire, Beck's Depression Inventory.
The result of this test is assessed by key answers.

Timepoint [3]

Participants will be assessed one time at baseline assessment (0,5h each patient).

Secondary outcome [1]

Primary outcome: Diagnosis of auditory attention - 'Tomatis audiometric test'

Timepoint [1]

Participants will be assessed one time at baseline assessment (0,5h each patient).

Secondary outcome [2]

Primary outcome: Assessment of public awareness of symptoms of autism.
Determined by standardised questionnaire 'KCAHW' (Knowledge about childhood autism among health workers).
The result of this test is assessed by key answers.

Timepoint [2]

Participants will be assessed one time at baseline assessment (0,5h each patient).

Secondary outcome [3]

Primary outcome: Sensomotoric integration- determined by The Southern California Sensory Integration Tests and Sensory Profile test.

Timepoint [3]

Primary timepoint: Participants will be assessed one time at baseline assessment (1h each patient).

Eligibility

Key inclusion criteria

For children in study group;
-autism diagnosis
-pre-school age (from 2 years to 10 years).

Assessment of parents in study group - the inclusion criteria will be the possession of a child from the autism spectrum. In the control group - having a healthy child.

In the assessment of teachers in the study group - teacher's who work with autistic children and in the control colony- teacher's work with healthy children.

In the assessment of autism knowledge - all ex. medical, psychological students.

Minimum age

2 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

-age over pre- school childrens,
-disability of the movement which may prevent participation in biomechanical tests,
-deafness confirmed by a medical diagnosis.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Research will be covered;
- 30 pre-school children diagnosed with ASD
- 30 healthy neurotypical children
- 30 parents of children with ASD
- 30 parents of neurotypical children
- 30 teachers working with children with ASD
- 30 teachers working with healthy children,
- 200 students (medical, pedagogical, psychological and other studies)
- 200 representatives of medical professions.
In total- sample size- 580
-Body composition analysis. All patients will be checking one time with 'TANITA DC-360 S' system.
-Biomechanical analysis with RSscan International 2m x 0.4m x 0.02m, with 16384 sensors and footscan 7 gait 2nd generation system.The measurement will be performed without shoes using the midgait method.
-Postural stability.The balancing test will be carried out using the Footscan platform with the Footscan Balance 7.7 2nd Generation System with a sampling rate of 100 Hz.
-Assessment of sensory disorders. Sensory Child Profile and South California Sensory Integration Tests.
-A diagnosis of auditory attention will be made using the Tomatis method.
-Teachers will be check by; ‘The scale of a man at work’ and ‘LBQ Burnout Questionnaire’
-Parents with children with ASD are will be check by; Family Assessment Scale.
-Medical Professions and students will be check with ‘KCAHW- Knowledge about Childhood Autism among Health Workers'

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

7/12/2017

Date of last participant enrolment

Anticipated

30/09/2018

Actual

Date of last data collection

Anticipated

30/09/2018

Actual

Sample size

Target

580

Accrual to date

100

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Poznan Univeristy of Medical Sciences

Address [1]

ul. Fredry 10
61-701 Poznan
POLAND

Country [1]

Poland

Primary sponsor type

University

Name

Poznan Univeristy of Medical Sciences

Address

ul. Fredry 10
61-701 Poznan
POLAND

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics Committee of the Poznan Univeristy of Medical Sciences

Ethics committee address [1]

ul. Bukowska 70, pok A204
60-812 Poznan

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

07/12/2017

Ethics approval number [1]

1223/17

Summary

Brief summary

Autism spectrum disorder (ASD) is a heterogeneous group of neurodevelopmental disorders, beginning in early childhood and characterized by limited, repetitive patterns of behaviour, interests, and activities as well as deficits in communication and social interactions.
Functioning of people with autism spectrum disorders to a large extent depends on early diagnosis and multidisciplinary therapeutic intervention. Therefore do not underestimate any disturbing symptoms in health or the behaviour of a small child. Therefore an individually adapted therapeutic process becomes extremely important, including psychological and pedagogical interactions but also involving interventions aimed at supporting the child's movement system. So far no therapeutic guidelines have been developed covering overall development support. In the motor skills area of a child with ASD is often overlooked. Meanwhile physiotherapeutic work can become an important factor of disturbed children as well as psychological and pedagogical therapy may become the golden standard in the rehabilitation of these children.
An important role in the overall support process is played by parents, teachers and medical staff who surround people with autism spectrum disorder. Awareness of the dangers that may stand in the way of the child should constantly be extended with appropriate educational programs. Nevertheless, it is equally important to pay attention to the emotional state of a family of the disabled child. 
Parents of children with autism spectrum are at high risk of burnout syndrome which results if from heavy burdens related to childcare. 
Teachers working with children with ASD due to their duties are also in group risk of burnout syndrome. This risk is characteristic of people working in professions related to helping.
As part of those study, pre-school children with a diagnosis of autism and healthy children will be examined in terms of the functioning of the human motion system. In addition, the psychological assessment will cover parents of these children, as well as teachers. Also, it is planned to examine the level of social awareness of autism as an element aimed at accelerating the diagnosis of developmental disorders from the autism spectrum in Poland.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Piotr Poniewierski

Address

Klinika Reumatologii i Rehabilitacji
ul. 28 Czerwca 1956 r. 135/147
61-545 Poznan

Country

Poland

Phone

+48 508729490

Fax

[email protected]

Contact person for public queries

Name

Piotr Poniewierski

Address

Klinika Reumatologii i Rehabilitacji
ul. 28 Czerwca 1956 r. 135/147
61-545 Poznan

Country

Poland

Phone

+48 508729490

Fax

[email protected]

Contact person for scientific queries

Name

Piotr Poniewierski

Address

Klinika Reumatologii i Rehabilitacji
ul. 28 Czerwca 1956 r. 135/147
61-545 Poznan

Country

Poland

Phone

+48 508729490

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	The estimation of the functioning of families with ASD children	2019	https://doi.org/10.3934/publichealth.2019.4.587

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically