Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001704482
Ethics application status
Approved
Date submitted
4/11/2016
Date registered
12/12/2016
Date last updated
3/06/2021
Date data sharing statement initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Positive Behaviour Study - Evaluating Positive Behavioural Supports Intervention for Individuals with Acquired Brain Injury
Scientific title
Reducing Behaviours of Concern following Acquired Brain injury – Positive Behavioural Supports Intervention and Evaluation
Secondary ID [1] 290384 0
Nil
Universal Trial Number (UTN)
U1111-1189-0463
Trial acronym
PBS
Linked study record
Not applicable.

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 300699 0
Condition category
Condition code
Injuries and Accidents 300544 300544 0 0
Other injuries and accidents
Stroke 301012 301012 0 0
Haemorrhagic
Stroke 301054 301054 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will offer a 12 month behavior intervention using a Positive Behaviour Support (PBS) framework.
The intervention will be delivered by one or more of the following health professionals: neuropsychologist, occupational therapist, speech therapist and/or psychiatrist. As the intervention is individualised, therapists relevant to each individual's goals will be included. Therapists will be a mix of clinicians with varied degrees of experience, All therapists will receive supervision from an international expert in PBS provision through group and individual supervision.

Positive Behaviour Support aims to decrease problem behaviour by increasing quality of life. The aim of this approach is to make meaningful changes in the environment working with natural supports and help individuals to learn new skills and competencies so that problem behaviours become unnecessary. Essential to these strategies are i) the identification of valued outcomes by the individual and other stakeholders, ii) identification of the people in the individual's life who can assist them in attaining those outcomes, iii) identify the barriers to attaining those outcomes and iv) put in place strategies or environmental changes designed to improve the quality of life for the individual receiving support.
Structured flexibility: This intervention is invidualised and context-sensitive. It utilises a hypothesis-testing approach, and requires ongoing input. This framework is used flexibly rather than prescriptively. Clinicians are welcome and encouraged to draw from other evidence-based paradigms to enrich their intervention approach. For example, motivational interviewing, CBT, acceptance and commitment therapy, and others.

Successful achievement of goals will be measured using Goal Attainment Scaling. Review of goal attainment will occur on completion of intervention.

The number and frequency of sessions will be individualised. It is anticipated that participants will receive a session frequency of between 1 and 8 sessions per month, and an intervention duration of between 3 and 12 months, depending on the level of support required and number of therapists involved. Sessions will be provided to participants in their own homes or at our consulting suits in Hawthorn (Melbourne, Victoria). For participants who reside more than one hour from Melbourne, telehealth options will also be made available (e.g. Skype, phone calls).

Any materials provided to participants as part of the intervention will be individualised and developed as part of the intervention process. Therefore, there are no pre-specified materials to be reported. As part of the trial we are developing training materials based on the supervision sessions and drawing together existing PBS materials.
In regards to treatment fidelity, adherence to the framework will be monitored via a range of methods including: audio and video taping of 10-20% of sessions for review by a PBS expert. Regular supervision meetings with a PBS expert including feedback from the session reviews. After every clinical session, therapists will complete a treatment integrity checklist to identify which PBS approaches were used within each session, Therapists will self-rate the quality of their sessions. These checklists and ratings will be used to identify areas clinician's require additional supervision in.
Intervention code [1] 296213 0
Behaviour
Intervention code [2] 296586 0
Treatment: Other
Comparator / control treatment
Wait-list control group.

Participants in the wait-list group will commence the intervention 12 months after the date they were randomized.

During this 12 months, participants will receive whatever treatment they choose to seek – this may include no treatment or treatment from a GP (including medication), psychologist, psychiatrist, occupational therapist or speech pathologist.
Control group
Active

Outcomes
Primary outcome [1] 299962 0
Overt Behaviour Scale
Timepoint [1] 299962 0
Baseline (i.e. entry into study), 4 monthly intervals for the duration of the study. This will continue for 12 months following the completion of the intervention.
Completed by a close other (family member/ carer) of the person with acquired brain injury.
Secondary outcome [1] 328956 0
Goal Attainment Scaling - individualised method for setting and reviewing goals.
Timepoint [1] 328956 0
Reviewed at the end of the 12 month intervention.

Completed by the individual with acquired brain injury or close others (family member/ carer) as appropriate.
Secondary outcome [2] 328957 0
Frontal Systems Behavior scale (FrSBe)
Timepoint [2] 328957 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury and a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [3] 328958 0
Challenging Behaviour Self Efficacy Scale
Timepoint [3] 328958 0
Baseline, and at 4 monthly intervals.

Completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [4] 328959 0
Behaviour Recording sheet

Close other participants (family member/ carer) will be asked to record each time a behaviour occurs each day for 14 days. The types of behaviour included are verbal and physical aggression, socially and sexually inappropriate behaviour, repetitive behaviour, wandering/ absconding and lack of initiation.
Timepoint [4] 328959 0
For two weeks after to the baseline, and for two weeks after each 4 monthly interval.
Completed by a close other (family member/ carer) of the person with acquired brain injury.


These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [5] 328960 0
Carer Information Questionnaire (hours and cost of paid care, hours of unpaid care).
Timepoint [5] 328960 0
Baseline, and at 4 monthly intervals.
Completed by the individual with acquired brain injury and a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year (as appropriate), during the 12 month intervention and for a year of follow-up.
Secondary outcome [6] 328961 0
Community Integration Questionnaire Revised (CIQ-R)
Timepoint [6] 328961 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury and a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [7] 328962 0
Quality of Life on the Comprehensive Quality of Life Scale - Adult (ComQol-a5)
Timepoint [7] 328962 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [8] 328963 0
A one item QoL scale developed by the researchers (rate your QoL from 0 (worst) to 10 (best)).
Timepoint [8] 328963 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [9] 328964 0
Hospital anxiety and Depression Scale (HADS)
Timepoint [9] 328964 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [10] 328965 0
Mini International Neuropsychiatric Interview (MINI)
Timepoint [10] 328965 0
Baseline and at 12 monthly intervals.

Completed by the individual with acquired brain injury. If the individual is not able to complete this measure, it is completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [11] 328966 0
Healthcare Utilisation Diary
Timepoint [11] 328966 0
This measure is completed by the participants for the duration of the study. An entry is made by the participant each time they visit any healthcare professional or have a hospital admission.

Completed by the individual with acquired brain injury. If the individual is not able to complete this measure, it is completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [12] 328967 0
Medication questionnaire - name of medication, dose and frequency
Timepoint [12] 328967 0
Baseline and at 12 monthly intervals.

Completed by the individual with acquired brain injury and a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [13] 328968 0
Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [13] 328968 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury. If the individual is not able to complete this measure, it is completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [14] 328969 0
Drug Abuse Screening Test (DAST)
Timepoint [14] 328969 0
Baseline, and at 4 monthly intervals.

Completed by the individual with acquired brain injury. If the individual is not able to complete this measure, it is completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [15] 328970 0
Family Assessment Device (FAD) General Functioning (GF) Scale
Timepoint [15] 328970 0
Baseline, and at 4 monthly intervals.

Completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [16] 328971 0
Care And Needs Scale (CANS)
Timepoint [16] 328971 0
Baseline and at 12 monthly intervals.

Completed by a close other (family member/ carer) of the person with acquired brain injury.

These assessments will be completed during the wait-list year, during the 12 month intervention and for a year of follow-up.
Secondary outcome [17] 328972 0
Satisfaction with Intervention

A customised interview schedule has been developed with a range of questions to understand participants perceptions of the program, provide specific feedback on the overall program, the strategies, programs and people engaged with during the program and the impact it has had on the participants. Ratings include ‘not at all’, ‘a little’ and ‘a lot’. There are also 10-point Likert scales used for each individual therapy session (as rated separately by the therapist and the participants).
Timepoint [17] 328972 0
Completed by the individual with acquired brain injury and/or significant others as appropriate This is completed at the end of the 12 months of intervention.
Secondary outcome [18] 328973 0
Working Alliance Measure

Several meta analyses of a broad variety of helping contexts, kinds of clients, and problems have reported a consistent positive relation between the quality of the alliance and the results of the helping process. Broadly, The Working Alliance Measure measures (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond.
Timepoint [18] 328973 0
Completed by the individual with acquired brain injury or their close other as appropriate in the first 4 months of the intervention and repeated at the end of the 12months of intervention.

Eligibility
Key inclusion criteria
TBI (any severity, any number) and/or ABI (stroke, hypoxic injury)
Aged 18-65 years
Any time post-injury
Displays behaviours of concern as defined by the Overt Behaviour Scale
Significant other available to participate (family member, house manager, attendant carer, treating staff)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurodegenerative disorder, Alcohol related brain injury, malignant tumour, congential disorder, intellectual disability.
Severe unresolved pre-injury or current psychiatric condition (e.g. schizophrenia, depression, personality disorder) or substance abuse disorder on HoNOS-ABI (Health of the nation outcome scale - acquired brain injury) or multiple inpatient psychiatric admissions
Currently receiving services/treatment for behaviour (e.g. psychological therapy, psychiatry, other allied health)
People highly dependent on medical care

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)
Allocation was concealed by use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization with random block lengths, using the Ralloc procedure of Stata 14 (Stata Corporation, College Station, Texas, 2015), stratified by categorized OBS scores. OBS scores at baseline were characterised as low (<5), medium (5 - 13), high (>13) for the stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No statistical technique was used to determine sample size.
Intention to treat analyses will be carried out, meaning that whether or not participants remain in the trial we would endeavour to follow them up. Random effects regression, incorporating generalized models for non-normal data as needed, will be used to model Overt Behaviour Scale (OBS) scores as functions of treatment (PBS intervention vs waitlist control) and time point. This approach will also be used to model the above-mentioned secondary outcome variables. Effect sizes will also be calculated. Finally, to examine predictors of successful response to intervention, random effects regressions will be employed to model relationships between outcome measures (OBS and secondary measures) and variables of interest including the nature and severity of BoC on OBS, time since injury, psychiatric history and baseline family function on FAD).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/09/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
5/05/2017
Date of last data collection
Anticipated
30/06/2020
Actual
30/06/2020
Sample size
Target
50
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 14529 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 294776 0
Government body
Name [1] 294776 0
Institute for Safety, Compensation and Recovery Research
Country [1] 294776 0
Australia
Primary sponsor type
Individual
Name
Professor Jennie Ponsford
Address
Monash-Epworth Rehabilitation Research Centre, 185-187 Hoddle St, Richmond, Victoria, 3121.
Country
Australia
Secondary sponsor category [1] 293623 0
None
Name [1] 293623 0
Address [1] 293623 0
Country [1] 293623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296184 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 296184 0
Ethics committee country [1] 296184 0
Australia
Date submitted for ethics approval [1] 296184 0
24/07/2015
Approval date [1] 296184 0
28/08/2015
Ethics approval number [1] 296184 0
CF15/2884 - 2015001191

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

Contacts
Principal investigator
Name 69902 0
Prof Jennie Ponsford
Address 69902 0
Monash-Epworth Rehabilitation Research Centre, 185-187 Hoddle St, Richmond, Victoria, 3121
Country 69902 0
Australia
Phone 69902 0
+61394268923
Fax 69902 0
+61394268924
Email 69902 0
[email protected]
Contact person for public queries
Name 69903 0
Amelia Hicks
Address 69903 0
Monash-Epworth Rehabilitation Research Centre, 185-187 Hoddle St, Richmond, Victoria, 3121
Country 69903 0
Australia
Phone 69903 0
+61394268923
Fax 69903 0
+61394268924
Email 69903 0
[email protected]
Contact person for scientific queries
Name 69904 0
Jennie Ponsford
Address 69904 0
Monash-Epworth Rehabilitation Research Centre, 185-187 Hoddle St, Richmond, Victoria, 3121
Country 69904 0
Australia
Phone 69904 0
+61394268923
Fax 69904 0
+61394268924
Email 69904 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
We did no seek ethics approval for this, and it is not a relevant outcome for our study.


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
SourceTitleYear of PublicationDOI
EmbasePositive behaviour support for adults with acquired brain injury and challenging behaviour: A randomised controlled trial.2022https://dx.doi.org/10.1016/j.rehab.2021.101604
N.B. These documents automatically identified may not have been verified by the study sponsor.