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
ACTRN12619001254189
Ethics application status
Approved
Date submitted
18/08/2019
Date registered
11/09/2019
Date last updated
10/06/2021
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the delivery of a Positive Behaviour Support Service to regional and remote children on the autism spectrum and their local support team via video-conferencing technology
Scientific title
Evaluation of the delivery of a Positive Behaviour Support Service to regional and remote children on the autism spectrum and their local support team via video-conferencing technology
Secondary ID [1] 299048 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 314064 0
Condition category
Condition code
Mental Health 312450 312450 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positive Behaviour support includes the following sequential process across the treatment program 1) functional assessment of behaviour (behaviour assessment interview and observation sessions conducted in-vivo, live via video link, or via presentation of video recording), 2) behaviour support planning (development of behaviour support plans), 3) implementation, and 4) monitoring.
These are outlined in detail below in accordance with a Proficient or Above Behaviour Support Practitioner under the NDIS Quality and Safeguards Commission Positive Behaviour Support Capability Framework 2019.

Functional Assessment
• Establish a developmental history
• Analyse any current or previous interventions including reactive strategies
• Consider physical or mental health problems, including the effect of medications and sleep
• Analyse other considerations such as a history of trauma, sensory processing, social and interpersonal history
• Analyse the relationship between the person and their environment
• Identify enablers and barriers to quality of life, including understanding the protective value of friendships and family, and their contribution to safety
• Identify barriers to intervention
• Lead an interdisciplinary assessment of complex behaviour
• Construct a model of understanding that explains the functions of behaviours
• Refer on when the requirements fall outside of the scope of behaviour support

Behaviour Support Planning
• Include strategies that remove conditions likely to promote behaviours of concern including:
o Environmental modifications
o Active engagement through structured and meaningful daily activities
• Include strategies for replacement behaviours
• Include preventative strategies such as relaxation, distraction and diversion
• Include reactive strategies when behaviours are not preventable
• Minimise or eliminate the use of restrictive practices
• Develop a behaviour support plan according to the literacy and communication needs of the target audience
• Develop a behaviour support plan that is compatible with the ability and resources of the implementers
• Develop a behaviour support plan that is supported by data that measures how accurately it is implemented
• Clearly articulate responsibilities and timeframes

Implementation
• Provide education and training to an interdisciplinary team
• Address barriers to implementation
• Identify the resilience, capacity and sustainability of implementers and make appropriate adjustments to a behaviour support plan to take these into consideration
• Provide implementers with information on ethical reactive strategies
• Provide implementers with information on risks and consequences of non-compliance with implementation
• Train implementers in escalation mechanism and emergency response plans
• Identify appropriate methods of feedback for those implementing a behaviour support plan
• Facilitate team building to enable successful implementation of a behaviour support plan
• Adjust a behaviour support plan as required
• Identify incident debriefing supports available to implementers
• Provide training on facilitating critical incident debriefing to appropriate members of the implementing team if required

Monitoring
• Support staff to collect ongoing data to evaluate the effectiveness of a behaviour support plan
• Provide information on how consistently staff are implementing a behaviour support plan that may be affecting evaluative data
• Support the person and other key people to contribute to a behaviour support plan’s evaluation and review meetings
• Use the person’s outcomes as performance indicators
• Ensure mechanisms are in place to collect and report on incident report data

The intervention is delivered in collaboration with the family and local support team. Structured interviews are conducted to gather information to inform the behaviour support plan. All team members are actively involved in the for face to face and via video for online). Family and local support team are trained in the delivery of the behaviour support strategies through modelling (online and face to face), and question and answer.

The support program will be administered in 2 hour weekly sessions for the first four weeks and then in 1 hour fortnightly sessions for the following 24 weeks.

The intervention will be administered by NDIS registered behaviour support practitioners (BSP). The BSP’s are a registered speech pathologist, occupational therapist, psychologist, or social worker and have additional training and experience in administering behaviour support program.

Implementation data will be collected at regular intervals by the Behaviour Support Practitioner via the Implementation checklist. The Implementation checklist is part of the Behaviour Support Intervention Program and outlines strategies that are to be implemented by participant families and local support team members as informed by the Behaviour Support protocol. Behaviour Support Practitioners record the progress on the Implementation checklist in their case notes.
Adherence to/attendance in treatment sessions will be monitored through the participant case notes.
Participants will be assigned to the intervention or control based on distance. Participants who reside more than 50km from any Aspect Behaviour Support Practitioner will be assigned to the intervention group.
Intervention code [1] 315320 0
Behaviour
Comparator / control treatment
Control: Positive Behaviour Support delivered via in-person, face to face services.
This treatment will be run the same as the treatment condition.

The support program will be administered in 2 hour weekly sessions for the first four weeks and then in 1 hour fortnightly sessions for the following 24 weeks.

The intervention will be administered by NDIS registered behaviour support practitioners (BSP). The BSP’s are a registered speech pathologist, occupational therapist, psychologist, or social worker and have additional training and experience in administering behaviour support program.

Implementation data will be collected at regular intervals by the Behaviour Support Practitioner via the Implementation checklist. The Implementation checklist is part of the Behaviour Support Intervention Program and outlines strategies that are to be implemented by participant families and local support team members as informed by the Behaviour Support protocol. Behaviour Support Practitioners record the progress on the Implementation checklist in their case notes.
Adherence to/attendance in treatment sessions will be monitored through the participant case notes.
Control group
Active

Outcomes
Primary outcome [1] 321099 0
The perceived acceptability of the tele-PBS service will be measured using semi-structured post-intervention interviews.
Data will be transcribed and entered into nVivo for qualitative analysis. The lead investigator will start by reading through the entire data set to understand the full breadth of the data. Preliminary analysis will follow, which will involve reading through the data to search for a broad set of categories (open coding). Using a constant comparative approach, sections of the text will be identified under each category. The lead investigator will then explore the relationships within and between categories and group these to form several central themes (axial coding). Finally, the lead investigator will analyse and sort the themes and categories to develop a story that will connect the entire data set (selective coding).
A summary of the themes and categories will be sent to participants (member checking) to provide additional comments or feedback. The rigour and trustworthiness of the data will be enhanced using a data analysis check performed a secondary researcher on 20% of the transcripts.
Timepoint [1] 321099 0
2 weeks post-intervention
Primary outcome [2] 321211 0
Perceived effectiveness of a tele-PBS service
2. The perceived effectiveness of the tele-PBS service will be measured using semi-structured post-intervention interviews.
Data will be transcribed and entered into nVivo for qualitative analysis. The lead investigator will start by reading through the entire data set to understand the full breadth of the data. Preliminary analysis will follow, which will involve reading through the data to search for a broad set of categories (open coding). Using a constant comparative approach, sections of the text will be identified under each category. The lead investigator will then explore the relationships within and between categories and group these to form several central themes (axial coding). Finally, the lead investigator will analyse and sort the themes and categories to develop a story that will connect the entire data set (selective coding).
A summary of the themes and categories will be sent to participants (member checking) to provide additional comments or feedback. The rigour and trustworthiness of the data will be enhanced using a data analysis check performed a secondary researcher on 20% of the transcripts.
Timepoint [2] 321211 0
2 weeks post-intervention
Secondary outcome [1] 373986 0
Changes in child’s well-being and health-related quality of life. (Physical Well-being, Emotional Well-being, Self-esteem, Family, Social Contacts, School)
Outcome measure: The KINDL Quality of Life Questionnaire [Ravens-Sieberer & Bullinger, (1998)
Timepoint [1] 373986 0
There will be two time points:
1. Pre-intervention
2. 2 weeks post-intervention
Secondary outcome [2] 373987 0
Changes in parent empowerment and efficacy (efficacy to parent - level of parental confidence and positive feelings, and efficacy to connect - the degree to which parents feel empowered to access support and to participate in social or other activities that promote positive parenting)
Outcome measure: Parent Empowerment and Efficacy Measure. (Freiberg, Homel, & Branch, 2014)
Timepoint [2] 373987 0
There will be two time points:
1. Pre-intervention
2. 2 weeks post-intervention
Secondary outcome [3] 373988 0
Changes in the ratings on behaviour typology, frequency, management difficulty, and severity.
Outcome measure: Checklist of Challenging Behaviour. (Harris, Humphries & Thompson, 1994) .
This is a composite secondary outcome
Timepoint [3] 373988 0
There will be two time points:
1. Pre-intervention
2. 2 weeks post-intervention
Secondary outcome [4] 373989 0
Assessment of behaviour support plans for treatment fidelity.
Outcome measure: Behaviour Support Plan Quality Evaluation tool (BSP-QEII). (Webber, McVilly, Fester, & Zazelis, 2011)
Timepoint [4] 373989 0
Collected within one week of completion of the behaviour support program as part of the program. Time will vary.

Eligibility
Key inclusion criteria
There will be four groups of participants.
• Children and young persons (4-17 years) who are clients of Autism Spectrum Australia (see below for inclusion and exclusion criteria)
• Caregivers of the child participant
• Support team members (Allied health staff and community support workers) of the child participant
• Aspect PBS Practitioners

Participants inclusion criteria:
•Aged 4-17 years
•Diagnosed with an Autism Spectrum Disorder
•Reside in regional or remote areas of Australia for the Tele-PBS group only (and for an interim period while face to face services are impacted by physical isolation, Tele-PBS participants can be in any location)
•Access to technology, either computer or device with adequate local internet (testing available)
•Have a local caregiver and/or support worker who are willing to actively participate in the service with their child/client
•Presenting with behaviours of concern
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child participants exclusion criteria:
Participants will be excluded if they are in need of intensive support that is outside of the scope of the Aspect PBS Practitioner). This includes support requiring:
•medical intervention including prescription of medications and management of chronic disease
•psychiatric treatment
•assistive equipment including fitting of wheelchairs, scooters, walkers, canes, crutches, prosthetic devices, and orthotic devices, to enhance their mobility.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: The current research is a preliminary study based on a convenience sample rather than a population based sample. A power analysis was not conducted for the current study as there was no single outcome measure for the study to be used for comparison with previous studies.

Quantitative data analysis (Quality of Life and Parent Empowerment and Efficacy):
Data will be entered into Statistical Package for Social Sciences (SPSS) for analysis. A paired- samples t-test will be conducted to measure for change from pre- to post-program.

Qualitative Interviews
Data will be transcribed and entered into nVivo for qualitative analysis. The lead investigator will start by reading through the entire data set to understand the full breadth of the data. Preliminary analysis will follow, which will involve reading through the data to search for a broad set of categories (open coding). Using a constant comparative approach, sections of the text will be identified under each category. The lead investigator will then explore the relationships within and between categories and group these to form several central themes (axial coding). Finally, the lead investigator will analyse and sort the themes and categories to develop a story that will connect the entire data set (selective coding).
A summary of the themes and categories will be sent to participants (member checking) to provide additional comments or feedback. The rigour and trustworthiness of the data will be enhanced using a data analysis check performed a secondary researcher on 20% of the transcripts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
13/11/2019
Date of last participant enrolment
Anticipated
31/07/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
30
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303584 0
Charities/Societies/Foundations
Name [1] 303584 0
Autism Spectrum Australia
Country [1] 303584 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Autism Spectrum Australia
Address
Autism Spectrum Australia
PO Box 361
Forestville
NSW 2087
Country
Australia
Secondary sponsor category [1] 303668 0
None
Name [1] 303668 0
Address [1] 303668 0
Country [1] 303668 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304112 0
University of Sydney HREC
Ethics committee address [1] 304112 0
Ethics committee country [1] 304112 0
Australia
Date submitted for ethics approval [1] 304112 0
30/04/2019
Approval date [1] 304112 0
14/05/2019
Ethics approval number [1] 304112 0
2019/403

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95850 0
Mrs Genevieve Johnsson
Address 95850 0
Autism Spectrum Australia
PO Box 361
Forestville
NSW 2087
Country 95850 0
Australia
Phone 95850 0
+61 400503489
Fax 95850 0
Email 95850 0
[email protected]
Contact person for public queries
Name 95851 0
Genevieve Johnsson
Address 95851 0
Autism Spectrum Australia
PO Box 361
Forestville
NSW 2087
Country 95851 0
Australia
Phone 95851 0
+61 400503489
Fax 95851 0
Email 95851 0
[email protected]
Contact person for scientific queries
Name 95852 0
Genevieve Johnsson
Address 95852 0
Autism Spectrum Australia
PO Box 361
Forestville
NSW 2087
Country 95852 0
Australia
Phone 95852 0
+61 400503489
Fax 95852 0
Email 95852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.