Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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
ACTRN12624000365561p
Ethics application status
Submitted, not yet approved
Date submitted
4/03/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Decision Making for Problematic Behavior
Scientific title
Testing the Utility of an Intervention Decision-Making Tool for Challenging behaviour Maintained by the Access to Tangibles in People with Disability
Secondary ID [1] 311642 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disability 333113 0
Cognitive impairment 333274 0
Condition category
Condition code
Mental Health 329798 329798 0 0
Learning disabilities
Neurological 329799 329799 0 0
Dementias
Human Genetics and Inherited Disorders 329800 329800 0 0
Other human genetics and inherited disorders
Neurological 329801 329801 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: Development of decision-making tool

Part 1 will involve developing a decision-making tool for clinicians for selecting appropriate and effective interventions for problematic behaviour maintained by access to tangible items. We will do this by a) conducting a meta-analysis of the empirical literature and b) surveying behavioural practitioners. We will deliver the survey to behavioural practitioners electronically and it will take approximately 30 minutes to complete.
We will provide eight client scenarios based on literature and the investigators' experience, asking them to decide which intervention best suits each example. We will also ask them to consider additional factors, e.g., client characteristics, the setting, and practical limitations such as time and resources. We will provide a list of interventions, ask them to rank the top three for each scenario. Based on survey responses and synthesis with the literature, we will create a step-by-step guide on client characteristics, goals, and the intervention that aligns with these. This will include a decision tree based on the expert-suggested and empirically-tested interventions. This tool will ask yes/no questions that lead clinicians to a new question or a potential treatment option for challenging behaviour maintained by access to tangibles. Part 1 will be complete when we have received at least 30 responses to the survey. Adherence to Part 1 will be measured by the number of surveys returned.

Part 2: Testing the use of the decision-making tool.

Part 2 will commence approximately 2 weeks after Part 1 is complete. Part 2, we will recruit 3-9 participants with cognitive impairment. Participants could be people with dementia, brain injury, learning disability, intellectual disability and may be a child or an adult. The factor they will all have in common is that they engage in behaviour that is thought to be maintained by access to a preferred tangible item. They represent a client group that behavioural practitioners are likely to encounter in their clinical work.

Assessment:

1. Descriptive assessment: Interview the client (if appropriate) and caregivers/ support staff to understand the challenging behaviour and conditions under which it is likely to occur. We will use an array of assessment tools, including open-ended functional assessment interviews, and the Functional Assessment Screening Tool (FAST). These interviews will take between 30 min and 60 min per participant.
2. We will then conduct direct observations of the behaviour (at times informed by the descriptive assessment data). These are baseline sessions (please see outcome measures). We will record the behaviour, in addition to variables that may be related (e.g., provision of tangible item by staff, attention, time of day etc). These sessions will be approximately 30 minutes, and there will be one to four sessions conducted with each participant (no more than two sessions a day). The number of sessions will be determined through data-based decision making of the repeated measures data. We will analyse the data after every session, looking specifically at variability and richness of the data (e.g., stability of occurrence of problematic behaviour). The more variable the data, the more likely we are to conduct another session (up to the maximum number). These sessions will be conducted over approximately 4 weeks. These sessions will occur in where the person lives (i.e., the care home) or attends school. Procedural integrity will be measured in approximately 30% of sessions by a second observer. They will record integrity (adherence) based on a task analysis (a list of the investigator behaviours in which we will engage in each session).
3. Experimental functional analysis: This assessment is used to empirically-demonstrate the function of a problematic behaviour. (Iwata et al., 1982/1994) This will involve 3-10 sessions, each lasting 5 to 15 minutes. In each session, the way in which we react to the problematic behaviour will change. In the first condition, we will ignore any instances of the behaviour, then in the following condition we will provide attention (the type of attention (positive or negative) will depend on the individual's learning history and how the staff normally react- this will be individually tailored and defined for each participant). In the third condition, we will give frequent attention whether the individual engages in the behaviour or not, and in the fourth session, we will present a task or instruction (again, this will be individually defined based on what the individual is usually asked to do) and will remove the demand if the behaviour occurs. In the fifth and final condition, we will provide an item contingent on problematic behaviour. Each session will comprise each of the five conditions. The condition in which the most problematic behaviour occurs indicates the likely function. We expect that all of our participants will engage in the most behaviour in the fifth condition, confirming their behaviour to be maintained to access to a tangible item. The number of sessions will be determined through data-based decision making of the repeated measures data. We will analyse the data after every session, looking specifically at variability and richness of the data (e.g., stability of responding). The more variable the data, the more likely we are to conduct another session (up to the maximum number of 10). Procedural integrity will be measured in approximately 30% of sessions by a second observer. They will record integrity (adherence) based on a task analysis (a list of the investigator behaviours in which we will engage in each session).

Intervention:

We will use an alternating treatments design under which we will alternate applying two interventions to the problematic behaviour to allow for a comparison of effectiveness. In some sessions, we will implement the intervention suggested by the decision-making tool and in the other sessions, we will implement the ‘universal intervention' suggested by the literature. The 'universal intervention' will be noncontingent reinforcement (NCR) and was chosen because it is the most common reported intervention in the empirical literature. NCR involves giving the participant access to the desired item at set time intervals (e.g., 5 minutes), regardless of their behaviour, therefore removing the 'need' for the behaviour. Which intervention (i.e., that selected by the tool or NCR) will be delivered in each session will be determined using a random number generator. 10 minutes prior to beginning the intervention phase, the clinician will use the tool to decide which intervention will be compared to NCR for the rest of the intervention comparison.

Interventions suggested by the tool will fall under two categories: (1) Access-Related Interventions and (2) Functional communication training. Examples of access-related interventions are free access to the desired items at all times and differential reinforcement. Differential reinforcement involves providing reinforcement (reward) for desired behaviour while reducing reward for challenging behaviours. For example, the person will have more time to engage with their preferred tangible item for desired behaviour compared to less time when engaging in challenging behaviour. Functional communication training interventions involve teaching new skills to our participants to receive the item they desire, e.g., verbally asking, exchanging a picture or visual, or sign language. Each participant will receive the intervention the tool suggests and therefore may all receive a different intervention to be compared with NCR.

We will implement the Intervention in the client's natural environment, such as school, home, or rehabilitation centre. The number of sessions will be individualised to the participant, depending on the behaviour of concern, skills learned, progress, participant availability etc. There will be a maximum of 30 sessions. The number of sessions will be determined through data-based decision making of the repeated measures data. We will analyse the data after every session, looking specifically at variability and richness of the data (e.g., stability of responding). The more variable the data, the more likely we are to conduct another session (up to the maximum number of 10). Procedural integrity will be measured in approximately 30% of sessions by a second observer. They will record integrity (adherence) based on a task analysis (a list of the investigator behaviours in which we will engage in each session). Sessions will be 30 min to 60 min in duration.

This phase will finish when the behaviour has reduced to an acceptable level under one or both interventions (as determined with each participant and their support people / whanau; for example, an acceptable behaviour change might be a reduction in rate of behaviour to less than 1 occurrence per hour) or when the maximum number of sessions (30) has been implemented (this mirrors clinical practice). We will ask the support person who cares for the participant to complete social valid survey. This participant will accompany the researcher and participant for at least one session of each of the two compared intervention so that they can observe and therefore comment on each. In the survey, we will ask which intervention they think was the most appropriate, meaningful, and effective. Support people will provide feedback but will not implement the intervention.

We will implement follow-up sessions one month and three months following the conclusion of the intervention comparison. Follow-up sessions will involve observing the participant without any intervention to determine whether the behaviour change achieved during the intervention remains. These sessions will be between 30 min and 60 min.

Overall, Part 2 will be approximately 9 months for each participant.

Part 3. Feedback and usefulness survey

We will ask behavioural practitioners to complete a follow-up survey (this part will commence when Part 2 is completed). This survey will take approximately 30 minutes to complete. Some may have completed Part 1 and some may not have; we will not be attempting to match responses within a respondent. We will provide four case studies (different but equivalent to those in the survey in Part 1) and ask the respondent to determine the best intervention by using the decision-making tool. We will ask about its utility, comprehensiveness. We will also ask for feedback regarding the tool, i.e., do they like it and find it useful? This will allow the final version of the tool to be developed. Part 3 will be complete when we have received at least 30 responses to the survey. Adherence to Part 3 will be measured by the number of surveys returned.

Participants will proceed to each subsequent phase immediately following completion of the previous part.
Intervention code [1] 328118 0
Behaviour
Comparator / control treatment
The baseline will serve as the control condition. In this small-N design, each participant serves as their own control, and is exposed to all conditions.
Control group
Active

Outcomes
Primary outcome [1] 337581 0
Indices of affect (including facial expression, vocalisations, body language). Behaviours to be operationally defined for each participant. This is a composite outcome; all indices of affect will be assessed together.
Timepoint [1] 337581 0
Repeated measures - data collected in every baseline, functional analysis, and intervention session
Primary outcome [2] 337582 0
Problematic behaviour to be operationally defined for each participant (e.g., biting, shouting, swearing). This is a composite outcome; all problematic behaviours will be assessed together.
Timepoint [2] 337582 0
Repeated measures - data collected in every baseline, functional analysis, and intervention session
Secondary outcome [1] 432374 0
Acceptability of intervention (carers)
Timepoint [1] 432374 0
After carers have observed at least one session of each type of intervention.
Secondary outcome [2] 432375 0
Information about how clinicians make decisions for intervention selection
Timepoint [2] 432375 0
Prior to intervention sessions in Phase 2, after at least two participants have completed Phase 2.

Eligibility
Key inclusion criteria
a) People with a disability (intellectual, learning, dementia, brain injury). Independently diagnosed prior to the study.
b) A professional carer / staff member for each person with a disability
c) Behavioural practitioners working with people whose behaviour is maintained by access to tangibles (Phases 1 and 3; survey only)

We also do not have a criterion for specific diagnosis (e.g., type of dementia, learning disability). We are not seeking to make broad generalisations about people with a specific diagnosis, but start to understand some of the factors that should be considered in how to choose an appropriate intervention. As such, and due to our small-N design approach, we are not seeking an homogenous sample.

What all participants will have in common is that they engage in behaviour thought to be maintained by access to tangibles. If we discover that their behaviour is maintained by something other than access to tangibles during the experimental functional analysis, we will exit them from the study with recommendations for intervention.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Behaviour-analytic approaches will be employed. The majority of the data will be collected by direct observational measurement of behaviours and environmental variables, operationally defined, and collected via pen-and-paper methods (e.g., Johnson & Pennypacker, 2009; Sharp, Mudford, & Elliffe, 2015). Experimental control will be demonstrated with small-N designs, which do not require statistical analyses. In a small-N design, each participant serves as their own control, and is exposed to all conditions. Comparisons of behaviour are made within a participant rather than across participants and we conduct repeated measures of our behaviour of interest (i.e., we measure behaviour throughout each session and phase rather than just pre- and post-intervention). We will use visual inspection of graphed data (based on baseline logic; Kazdin, 1982), a common method of data analysis employed in most of behaviour-analytic research. This involves tracking data visually on graphs, and making data-based decisions during the study. Under this approach, small samples can be highly informative. A key component of small-N design is that we publish our methods in detail (principle of technological). This enables replication; as a field, we are more likely to conduct 20 studies including 5 participants in each rather than one study with 100 participants. This approach allows for a nuanced evaluation of the individual factors that contribute to the effectiveness of an intervention. When working with people with major neurocognitive disorder, a small-N approach is useful because experimental control is unaffected by individual differences in behaviour and other factors such as the progression of dementia (see Steingrimsdottir & Artnzen, 2015 for a detailed discussion).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment outside Australia
Country [1] 26187 0
New Zealand
State/province [1] 26187 0
Auckland

Funding & Sponsors
Funding source category [1] 315968 0
University
Name [1] 315968 0
The University of Auckland
Country [1] 315968 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318110 0
None
Name [1] 318110 0
Address [1] 318110 0
Country [1] 318110 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314792 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314792 0
Ethics committee country [1] 314792 0
New Zealand
Date submitted for ethics approval [1] 314792 0
11/03/2024
Approval date [1] 314792 0
Ethics approval number [1] 314792 0

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

Contacts
Principal investigator
Name 132746 0
Dr Rebecca Sharp
Address 132746 0
Science Centre, Symonds Street, Auckland, 1010, The University of Auckland
Country 132746 0
New Zealand
Phone 132746 0
+642102467280
Fax 132746 0
Email 132746 0
r.sharp@auckland.ac.nz
Contact person for public queries
Name 132747 0
Rebecca Sharp
Address 132747 0
Science Centre, Symonds Street, Auckland 1010, The University of Auckland
Country 132747 0
New Zealand
Phone 132747 0
+642102467280
Fax 132747 0
Email 132747 0
r.sharp@auckland.ac.nz
Contact person for scientific queries
Name 132748 0
Rebecca Sharp
Address 132748 0
Science Centre, Symonds Street, Auckland, 1010, The University of Auckland
Country 132748 0
New Zealand
Phone 132748 0
+642102467280
Fax 132748 0
Email 132748 0
r.sharp@auckland.ac.nz

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21793Study protocol  r.sharp@auckland.ac.nz 387422-(Uploaded-04-03-2024-13-49-22)-Study-related document.docx



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.