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


Trial ID
ACTRN12613000585729
Ethics application status
Approved
Date submitted
18/05/2013
Date registered
24/05/2013
Date last updated
19/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Do people with severe traumatic brain injury benefit from making errors? A randomized control trial of the efficacy of error-based and errorless learning training
Scientific title
A randomized controlled trial comparing Error-based learning with Errorless Learning to improve awareness of deficits, skills generalisation and long term social outcomes in an adult Traumatic Brain Injury sample
Secondary ID [1] 282491 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 289128 0
Condition category
Condition code
Injuries and Accidents 289469 289469 0 0
Other injuries and accidents
Neurological 289545 289545 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Error-based learning (EBL) involves the use of systematic feedback and other metacognitive techniques to teach people self-regulation skills (i.e., self-reflection, anticipation, self-monitoring and self-correction of errors) during task performance.

Manualized treatment protocols have been developed for both interventions (errorless and error-based learning) from pilot research. Uniform elements of both error-based learning and errorless learning include: a) 8 weekly treatment sessions of approximately 90-120 minutes conducted in the participant’s own home; b) use of verbal reinforcement for correct performance; c) learning to prepare a main meal (a stir-fry) for the first 4 training sessions (1-4); and d) development of a set of errands for participants to learn in the home or community as the second multi-tasking training activity for the last 4 sessions (5-8).

Occupational therapists experienced with working with individuals with brain injuries will administer the face-to-face, in home rehabilitation program.
Intervention code [1] 287144 0
Rehabilitation
Comparator / control treatment
This RCT is using error-less learning (ELL) as an active control intervention. Errorless learning involves teaching individuals new skills by preventing them from making mistakes, to promote error free performance.

Occupational therapists experienced with working with individuals with brain injuries will administer this face-to-face, in home rehabilitation program.
Control group
Active

Outcomes
Primary outcome [1] 289572 0
Awareness of deficits and behavioural competency: The Patient Competency Rating Scale and Awareness Questionnaire
Timepoint [1] 289572 0
Within 1 week pre- and one week post-intervention, as well as at 6 month followup
Primary outcome [2] 289573 0
Generalisation of error self-regulation skills: The Cooking Task, as an ecological assessment of executive function
Timepoint [2] 289573 0
Within 1 week pre- and one week post-intervention
Primary outcome [3] 289574 0
Planning/organisation/rule following: The Zoo Map Test from the Behavioural Assessment of Dysexecutive Syndrome
Timepoint [3] 289574 0
Within 1 week pre- and one week post-intervention
Secondary outcome [1] 302754 0
Psychosocial functioning: Sydney Psychosocial Reintegration Scale
Timepoint [1] 302754 0
Within 1 week pre- and one week post-intervention, as well as at 6 month follow-up

Secondary outcome [2] 302755 0
The Care and Needs Scale (CANS)
Timepoint [2] 302755 0
Within 1 week pre- and one week post-intervention, as well as at 6 month follow-up


Eligibility
Key inclusion criteria
Participants from each centre will be eligible for the study if they are: aged 18-65 years, have had a severe TBI (as determined by posttraumatic amnesia and Glasgow Coma Scale), are deemed medically stable and live within a 50km radius of each metropolitan centre.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are unable to provide informed consent; have a combination of severe behavioral/motor/perceptual/language and cognitive impairment which would preclude the ability to undertake research of this nature; and/or psychotic symptoms or severe mood symptoms not under effective management.

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)
Potential participants will be identified by treating therapists or case managers in three large metropolitan-based brain injury rehabilitation services in Brisbane and Sydney, Australia. Patients who meet the inclusion criteria will be approached by their therapist or case manager, who will provide a brief summary of the study. If the patient is interested in taking part, he or she will provide their verbal consent for the project coordinator to contact them about the study.

A standard screening process will be employed to help ensure that the intervention targets a homogenous profile of participants with awareness and dysexecutive impairments across the centers.

Specifically, treating therapists will refer people with severe TBI who exhibit marked difficulties with instrumental activities of daily living (IADLs) and awareness deficits. Suitability for the study will be confirmed through tests of executive function at pre-assessment, as conducted by a blind assessor. Participants will receive a brief neuropsychological battery consisting of tests of attention, memory, and executive function. A global neuropsychological function composite will be calculated by summing and averaging age-adjusted standardized scores, and classified as ‘mild to moderate deficit’ (< -2 SD), or ‘severe deficit’ (equal to or > -2 SD).

Participants' global neuropsychological function (mild-moderate deficit [< -2 SD] or severe deficit [> -2 SD]) will be used to determine their subgroup for random allocation based on matched assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random assignment will be conducted independent of the project staff involved in the interventions and the blind assessor. For each subgroup (i.e., mild to moderate or severe deficit), participants will be randomly allocated to EBL or ELL using sequentially numbered and sealed opaque envelopes. The envelopes will contain group allocation on a written insert, based on a predetermined random computer generated sequence.
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
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis
Data will be screened to ascertain any state/site or therapist effects or the effects of demographic and clinical factors on outcome, with any significant variables treated as covariates in respective analyses. Participant attrition will be managed on an intention-to-treat basis. To compare the efficacy of EBL and ELL, a series of mixed 2 x 2 ANOVAs (group by time [pre vs post]) will be run with the error self-regulation dependent variables of: Cooking Task errors and Zoo Map Part 1 score. Mixed 2 x 3 ANOVAs (group by time [pre, post and follow-up]) will examine the long-term impact of each intervention on awareness of deficits, behavioral competency, role functioning and support needs. In each set of analyses, interaction effects will be examined to determine whether EBL is associated with greater gains than ELL relative to pre-intervention functioning.


In terms of sample size, the number of participants required was based on a previous RCT comparing a metacognitive condition with another treatment condition. Based on the same design and approach to statistical analysis, a conservative power analysis was conducted using an estimated medium effect size, alpha level of .05, and power of 0.8. According to G*Power a sample size of n = 123 is required to detect significant two-way interaction effects. Due to possible attrition, a total sample size of n = 135 will be required.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 287275 0
Government body
Name [1] 287275 0
NHMRC
Address [1] 287275 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 287275 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 286028 0
None
Name [1] 286028 0
Address [1] 286028 0
Country [1] 286028 0
Other collaborator category [1] 277396 0
University
Name [1] 277396 0
Griffith University
Address [1] 277396 0
School of Applied Psychology
Psychology Building (M24)
Griffith University
Messines Ridge Road
Mt Gravatt Qld 4122
Country [1] 277396 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289258 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 289258 0
Centres for Health Research
Princess Alexandra Hospital
37 Kent St
Wooloongabba, QLD, 4102
Ethics committee country [1] 289258 0
Australia
Date submitted for ethics approval [1] 289258 0
Approval date [1] 289258 0
26/03/2013
Ethics approval number [1] 289258 0
HREC/13/QPAH/096
Ethics committee name [2] 289259 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 289259 0
Office for Research
Bray Centre, Nathan Campus
Griffith University
170 Kessels Rd
Nathan, Qld, 4111
Ethics committee country [2] 289259 0
Australia
Date submitted for ethics approval [2] 289259 0
Approval date [2] 289259 0
06/05/2013
Ethics approval number [2] 289259 0
PSY/55/13/HREC
Ethics committee name [3] 289280 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 289280 0
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia, QLD, 4067
Ethics committee country [3] 289280 0
Australia
Date submitted for ethics approval [3] 289280 0
Approval date [3] 289280 0
10/05/2013
Ethics approval number [3] 289280 0
2013000598

Summary
Brief summary
Poor skills generalization poses a major barrier to successful outcomes of rehabilitation after traumatic brain injury (TBI). Error-based learning (EBL) is a relatively new intervention approach that aims to promote skills generalization by teaching people internal self-regulation skills, or how to anticipate, monitor and correct their own errors. This study aims to compare the efficacy of EBL and errorless learning (ELL) for improving awareness of deficits, skills generalization and long-term social outcomes after TBI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39994 0
A/Prof Tamara Ownsworth
Address 39994 0
School of Applied Psychology
Psychology Building (M24)
Griffith University
Messines Ridge Road
Mt Gravatt Qld 4122
Country 39994 0
Australia
Phone 39994 0
+61 7 3735 3307
Fax 39994 0
Email 39994 0
t.ownsworth@griffith.edu.au
Contact person for public queries
Name 39995 0
A/Prof Tamara Ownsworth
Address 39995 0
School of Applied Psychology
Psychology Building (M24)
Griffith University
Messines Ridge Road
Mt Gravatt Qld 4122
Country 39995 0
Australia
Phone 39995 0
+61 7 3735 3307
Fax 39995 0
Email 39995 0
t.ownsworth@griffith.edu.au
Contact person for scientific queries
Name 39996 0
A/Prof Tamara Ownsworth
Address 39996 0
School of Applied Psychology
Psychology Building (M24)
Griffith University
Messines Ridge Road
Mt Gravatt Qld 4122
Country 39996 0
Australia
Phone 39996 0
+61 7 3735 3307
Fax 39996 0
Email 39996 0
t.ownsworth@griffith.edu.au