Trial Review

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
ACTRN12623000716662p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Addressing Quality of Life on Challenging Behaviour in Adults with Intellectual or Developmental Disability
Scientific title
Active Support as an Antecedent Intervention for Challenging Behaviour in Adults with Intellectual or Developmental Disability
Secondary ID [1] 309602 0
None
Universal Trial Number (UTN)
U1111-1293-2184
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Challenging behaviour 329915 0
Intellectual Disability 330509 0
Developmental Disability 330510 0
Condition category
Condition code
Neurological 326824 326824 0 0
Other neurological disorders
Mental Health 327289 327289 0 0
Autistic spectrum disorders
Human Genetics and Inherited Disorders 327292 327292 0 0
Other human genetics and inherited disorders
Human Genetics and Inherited Disorders 327301 327301 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to explore the effects of Active Support staff training strategies on engagement and challenging behaviour (aggressive, self-injurious, destructive or significantly disruptive behaviours) in adults with Intellectual or Developmental Disabilities (IDD) and high support needs.

Key Active Support strategies that are theoretically aligned with reducing the likelihood of challenging behaviours will be taught to support staff in residential living settings. These will include:
1) Planning activities
2) Provision of choice
3) Providing appropriate levels of support to the adult with IDD to engage in a chosen activity
4) Providing positive social attention during engagement

Training will be delivered face-to-face by the researcher in line with following features of a Behaviour Skills Training protocol:
a) Short PowerPoints
b) Written information
c) Verbal explanations
d) Demonstrations
e) Roleplay
f) Feedback

There will be approximately seven, 40-minute, one-on-one training sessions per staff member. They will be scheduled for convenience over approximately 2-3 weeks. The training phase will continue until the staff member has completed 7 training sessions, and staff are able to use all the strategies with 100% fidelity. Fidelity will be checked in a role play context in sessions 4 and 5. Targeted booster sessions will be used if needed.

The fidelity of training delivery will also be monitored by an additional researcher for at least 30% of training sessions.

The intervention observation phase will occur immediately after staff have completed the 2-3 week training phase. Timing will vary in terms of participants beginning the intervention phase due to the staggered delivery of concurrent multiple baseline design. It is expected that participants will begin the intervention phase between 1-6 weeks after beginning the baseline phase.


Intervention code [1] 326025 0
Behaviour
Comparator / control treatment
No control group. As per single case design, each participant will act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 334675 0
Challenging Behaviour, measured through direct assessment and the Challenging Behaviour Interview (CBI; Oliver et al., 2003)
Timepoint [1] 334675 0
Direct assessment of challenging behaviour will occur during every baseline observation (5-30 data points) and every intervention observation phase (5-30 data points).

Baseline observation sessions will begin for all participants after pre-assessments and trial-based functional analyses have been conducted (approximately 2-4 weeks after study commences).


The CBI will be administered as a pre and post-intervention assessment. Pre-intervention assessment will occur upon the commencement of the study, prior to trial based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after the intervention has begun.

Primary outcome [2] 334676 0
Resident meaningful engagement will be measured through direct assessment (observation)
Timepoint [2] 334676 0
Direct assessment of meaningful engagement will occur during every baseline observation (5-30 data points) and every intervention observation phase (5-30 data points).

Baseline observation sessions will begin for all participants after pre-assessments and trial-based functional analyses have been conducted (approximately 2-4 weeks after the study commences).

Pre-intervention assessment will occur upon the commencement of the study, prior to trial-based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after the intervention has begun
Primary outcome [3] 334677 0
Staff fidelity of Active Support strategies using direct assessment (observation).
Timepoint [3] 334677 0
Fidelity probes will be conducted in session 4 and session 5 of the staff training phase (approximately week 2 of training
Secondary outcome [1] 421630 0
Staff social validity, measured through the Treatment Acceptability Rating Form- Revised (TARF-R; Reimers et al., 1991).
Timepoint [1] 421630 0
The TARF-R will be administered as a pre and post-intervention assessment. Pre-intervention assessment will occur upon the commencement of the study, prior to trial based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after the intervention has begun.
Secondary outcome [2] 421631 0
Changes in staff perception of choice available to the resident they support, measured using the Choice Questionnaire (CQ; Stancliffe & Parmenter, 1999)
Timepoint [2] 421631 0
The CQ will be administered as a pre and post-intervention assessment. Pre-intervention assessment will occur upon the commencement of the study, prior to trial based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after the intervention has begun.
Secondary outcome [3] 423378 0
Changes in staff perception of support needs of the resident they support. Measured using the Supports Intensity Scale- Adult (SIS-A; Thompson et al., 2015)
Timepoint [3] 423378 0
The CQ will be administered as a pre and post-intervention assessment. Pre-intervention assessment will occur upon the commencement of the study, prior to trial based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after the intervention has begun.
Secondary outcome [4] 423551 0
Social validity of AS strategies for resident participants measured through behavioural indices of happiness vs. unhappiness, Specific indices of happiness vs. unhappiness will be individualised for the current study and will reflect each participant's characteristics.
Timepoint [4] 423551 0
These will be measured through probes in baseline (5-20 data points) and intervention phases (5-20 data points).

Baseline observation sessions will begin for all participants after pre-assessments and trial-based functional analyses have been conducted (approximately 2-4 weeks after study commences).

Pre-intervention assessment will occur upon the commencement of the study, prior to trial-based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after intervention observations have begun
Secondary outcome [5] 423552 0
Social validity of Active Support (AS) strategies for resident participants measured through behavioural indices of interest vs. disinterest. Specific indices of interest vs. disinterest will be individualised for the current study and will reflect each participant's characteristics.
Timepoint [5] 423552 0
These will be measured through probes in baseline (5-20 data points) and intervention phases (5-20 data points).

Baseline observation sessions will begin for all participants after pre-assessments and trial-based functional analyses have been conducted (approximately 2-4 weeks after study commences).

Pre-intervention assessment will occur upon the commencement of the study, prior to trial-based-functional analyses and baseline observations. Post-intervention assessment will occur approximately 2-weeks after intervention observations have begun

Eligibility
Key inclusion criteria
Dyads consisting of one resident participant and one respective staff member

Resident participants:

(a) adults 18 years or older
(b) have a diagnosis of IDD and high levels of support need to be identified through the Supports Intensity Scale- Adult (SIS-A; Thompson et al., 2015)
(c) living in a residential care setting
(d) engaging in challenging behaviour that is negatively impacting the quality of life of the individual according to the Challenging Behaviour Interview (CBI; Oliver et al., 2003)
(e) not be currently receiving a formal behavioural intervention in addition to the organisations behaviour management plan.

Staff participants:
(a) regularly working with a resident that meets the above criteria
(b) expecting to continue working with this resident at least for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the resident is actively receiving a formal behavioural intervention at the time of recruitment, they will be excluded from the study as a) intervention strategies may have the potential for conflict, b) changes in residents’ behaviour will not be clearly attributable to the current study or the formal behaviour intervention, posing challenges for both parties. However, given long waitlists for behaviour intervention services in New Zealand, participants may be on the waitlist for services and will not be discouraged from seeking these services participation.

Staff members will be excluded if they are expecting to leave their role working with the resident during the study's duration. This will maximise the likelihood of the intervention having full effect.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable. All participants will experience the same conditions,.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single-case design. All participants will experience the same intervention (individualised to unique characteristics). Data will be analysed on an individual basis.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Visual analysis with statistical analysis where appropriate e.g., Tau-U

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
Date of last participant enrolment
Anticipated
24/07/2023
Actual
Date of last data collection
Anticipated
20/12/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25432 0
New Zealand
State/province [1] 25432 0
Wellington region

Funding & Sponsors
Funding source category [1] 313964 0
University
Name [1] 313964 0
Te Herenga Waka, Victoria University of Wellington
Country [1] 313964 0
New Zealand
Funding source category [2] 313965 0
Charities/Societies/Foundations
Name [2] 313965 0
American Association on Intellectual and Developmental Disabilities
Country [2] 313965 0
United States of America
Primary sponsor type
Individual
Name
Sophia Kennedy
Address
Te Herenga Waka, Victoria University of Wellington, Kelburn Campus.

WR15 112, 15 Waiteata Road, Kelburn, Wellington, 6012
Country
New Zealand
Secondary sponsor category [1] 315886 0
Individual
Name [1] 315886 0
Dr Amarie Carnett
Address [1] 315886 0
Te Herenga Waka, Victoria University of Wellington, PO Box 600, Wellington, 6140, New Zealand
Country [1] 315886 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312952 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 312952 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 312952 0
New Zealand
Date submitted for ethics approval [1] 312952 0
09/06/2023
Approval date [1] 312952 0
Ethics approval number [1] 312952 0

Summary
Brief summary
The study aims to understand whether Active Support a quality-of-life staff training programme has the potential for preventing challenging behaviour (e.g., aggression, self-injury and destructive behaviour) in adults with IDD living in residential living settings. The study will involve training support staff in Active Support aligned strategies that are anticipated to prevent challenging behaviours. These strategies will include staff planning for activities, providing choices, supporting residents to engage in chosen activities and providing positive social attention. The researcher will observe the effects of the training on staff and the residents they support. The study will seek to understand whether the strategies are more effective for some individuals than others and will use some behavioural assessments and questionnaires to understand the individual characteristics of residents. Social validity data will also be gathered to understand how the strategies are perceived and experienced by both staff and residents.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 126458 0
Miss Sophia Kennedy
Address 126458 0
Te Herenga Waka, Victoria University of Wellington
WR15, 112, 15 Waiteata Road, Kelburn, Wellington, 6012
Country 126458 0
New Zealand
Phone 126458 0
+64 223628572
Fax 126458 0
Email 126458 0
[email protected]
Contact person for public queries
Name 126459 0
Sophia Kennedy
Address 126459 0
Te Herenga Waka, Victoria University of Wellington
WR15, 112, 15 Waiteata Road, Kelburn, Wellington, 6012
Country 126459 0
New Zealand
Phone 126459 0
+64 223628572
Fax 126459 0
Email 126459 0
[email protected]
Contact person for scientific queries
Name 126460 0
Sophia Kennedy
Address 126460 0
Te Herenga Waka, Victoria University of Wellington
WR15, 112, 15 Waiteata Road, Kelburn, Wellington, 6012
Country 126460 0
New Zealand
Phone 126460 0
+64 223628572
Fax 126460 0
Email 126460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
As per single-case design, individual participant data will be the default presentation of data from the current study.

This will include behaviours of participants and results from assessments /questionnaires. These will be presented in a non-identifiable format.
When will data be available (start and end dates)?
This data will be available when the studies are published in the researcher's thesis, and in other publications. Approximately 2025. There will be no end date for the availability of data.
Available to whom?
These will be available to anyone who has access to the relevant academic journals.
Available for what types of analyses?
Data will be freely available in publications.
How or where can data be obtained?
These will be available to anyone who has access to the relevant academic journals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19106Ethical approval    This will be attached when received from the Healt... [More Details]



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.