Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12617001290381
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
6/09/2017
Date last updated
7/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting the proprioceptive system to improve behaviours for children with Autism Spectrum Disorder (ASD)
Scientific title
The ‘Hidden Sense’: Targeting the proprioceptive system to improve behaviours for children with Autism Spectrum Disorder (ASD)
Secondary ID [1] 292782 0
Nil known
Universal Trial Number (UTN)
U1111-1201-5056
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism spectrum disorder 304585 0
sensory over-responsiveness 304586 0
Condition category
Condition code
Mental Health 303917 303917 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The A-B-A design will be used in this study: a baseline phase (2 weeks), the intervention phase (5 weeks) and post-intervention (or return-to-baseline) phase (2 weeks). Before the baseline phase, the researcher and parent will identify a target undesirable behaviour (that is a result of sensory over-resposiveness) from a sensory domain of Sensory Profile - 2nd edition. In the baseline phase, the parent will rate their child’s target undesirable behaviour using a visual analogue scale (See 'Methods of VAS rating' attachment in original ANZCTR record) at the conclusion of each day for 2 weeks. After the 5-week intervention phase, the post-intervention phase will involve the parent ceasing proprioceptive activities (intervention) and continuing to score the target behaviour daily at the conclusion of each day for 2 weeks.
The intervention phase includes a sensory-based intervention. The intervention has been developed to reflect real world occupational therapy with an aim of being easily embedded into regular routines, with minimal additional demands for participants. Furthermore, each participant is able to work towards an outcome meaningful to them. Each child has their own target behaviour that is measured using the visual analogue scale and their own set of proprioceptive activities that work for their family. On the first day of the intervention phase the researcher, who is an experienced and practising occupational therapist, will visit the parents and child, to provide a 1-hour instruction session that includes education, programming, modelling.
Education will involve the researcher (occupational therapist) explaining the fundamentals of sensory over-responsiveness to parents and how to be responsive through understanding the signs of over-responsiveness and triggers for the child’s target behaviour. The researcher will work with the parent to develop a program of activities that primarily provide proprioceptive input to the body. These activities will be those that can easily be implemented by the parent in the home environment and in the child’s established routine, typically embedded within play or jobs around the house. Please see the attached parent handout that will be used in the instruction session. The recommended activities do not involve expensive equipment or specialised training to administer. However, the researcher will model how to engage the child in these activities and how to perform the activities correctly in order to provide proprioceptive input.
After the instruction and during the intervention phase, the parent will then facilitate the chosen proprioceptive activities to the child in daily life when triggers of the child’s target behaviour are present or when they observe the child showing signs of over-responsiveness. The parent will facilitate the activities for 10-15 minutes each time, or until a positive change is shown in the child’s face and body language. The researcher will visit the home once each week during the intervention phase, which takes approximately 30 minutes, to follow up and provide further guidance to the parents.
Intervention code [1] 299022 0
Treatment: Other
Intervention code [2] 299023 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303251 0
Change in undesirable behaviours measured by a Visual Analogue Scale
Timepoint [1] 303251 0
The single case study design is used in the current study, which requires ongoing monitoring to effectively track individual outcomes. Thus the outcomes will be measured daily during the 2-week baseline and 5-week intervention.
Secondary outcome [1] 338371 0
Change in undesirable behaviours measured by a Visual Analogue Scale
Timepoint [1] 338371 0
The outcomes will be measured daily for 2 weeks after intervention.

Eligibility
Key inclusion criteria
Children have a diagnosis of ASD. While ASD is commonly paired with a mild cognitive impairment and/or mental health conditions, children with a diagnosis of mild global developmental delay (GDD), mild intellectual disability (ID), mild anxiety and/or ADHD will be eligible for the study. Parents and children will be required to reside in South Eastern Sydney. Due to practical reasons, parents will be required to speak fluent English.
Minimum age
3 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with co- morbidities (e.g., physical disabilities, moderate-profound cognitive impairments, severe mental health disorders) will not be eligible for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is not a RCT study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to the single case design (SCD) using the child as their own control, they yield robust findings with a small number of participants. Furthermore, standards for SCD research recommend at least three replications, or three participants, are required to establish a causal relationship between proprioceptive input and improving undesirable behaviour for children with ASD. Therefore, five families will be recruited for the study.
Data analysis will involve visual analysis of the VAS results for each participant. As with SCD research, each child is his/her own control, and therefore, each child’s data will be analysed individually. The visual analysis will aim to find a causal relationship between the intervention and the child’s undesirable behaviour, and the strength of this relationships, then generate a hypothesis about the relationship.
The first step in the visual analysis will be establishing a projected level of baseline data, that is, determining whether the target undesirable behaviour is steady, increasing, decreasing or adopting another pattern over the 2 weeks prior to intervention. Next, the data within each child’s intervention and post-intervention phase will be examined to establish the within-phase patterns. The data from each phase will then be compared visually to the data in the adjacent phase (baseline to intervention and intervention to post-intervention). The final step will include integrating the information from each phase to establish preliminary evidence of a causal relationship.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2017
Actual
17/09/2017
Date of last participant enrolment
Anticipated
28/05/2018
Actual
24/09/2017
Date of last data collection
Anticipated
31/07/2018
Actual
19/11/2017
Sample size
Target
5
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297413 0
Self funded/Unfunded
Name [1] 297413 0
Country [1] 297413 0
Primary sponsor type
Individual
Name
Yu-Wei Chen
Address
Faculty of Health Sciences, The University of Sydney
75 East St Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 296406 0
None
Name [1] 296406 0
Address [1] 296406 0
Country [1] 296406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298518 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 298518 0
Ethics committee country [1] 298518 0
Australia
Date submitted for ethics approval [1] 298518 0
24/07/2017
Approval date [1] 298518 0
29/08/2017
Ethics approval number [1] 298518 0
2017/667

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2002 2002 0 0
/AnzctrAttachments/373569-Protocol_TMPHEC13837522648201783016351.pdf (Protocol)
Attachments [2] 2003 2003 0 0
/AnzctrAttachments/373569-Approval letter.pdf (Ethics approval)
Attachments [3] 2004 2004 0 0
/AnzctrAttachments/373569-PISfinal.pdf (Participant information/consent)
Attachments [4] 2005 2005 0 0
/AnzctrAttachments/373569-ParticipantInformationStatementChild.pdf (Participant information/consent)
Attachments [5] 2006 2006 0 0
/AnzctrAttachments/373569-ParticipantConsentForm.pdf (Participant information/consent)
Attachments [6] 2015 2015 0 0
/AnzctrAttachments/373569-Methods of VAS rating.pdf (Supplementary information)

Contacts
Principal investigator
Name 77334 0
Dr Yu-Wei Chen
Address 77334 0
75 East St Lidcombe NSW 2141
Faculty of Health Sciences, The University of Sydney
Country 77334 0
Australia
Phone 77334 0
+61 2 9351 9798
Fax 77334 0
Email 77334 0
[email protected]
Contact person for public queries
Name 77335 0
Yu-Wei Chen
Address 77335 0
75 East St Lidcombe NSW 2141
Faculty of Health Sciences, The University of Sydney
Country 77335 0
Australia
Phone 77335 0
+61 2 9351 9798
Fax 77335 0
Email 77335 0
[email protected]
Contact person for scientific queries
Name 77336 0
Yu-Wei Chen
Address 77336 0
75 East St Lidcombe NSW 2141
Faculty of Health Sciences, The University of Sydney
Country 77336 0
Australia
Phone 77336 0
+61 2 9351 9798
Fax 77336 0
Email 77336 0
[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
No additional documents have been identified.