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Trial registered on ANZCTR


Registration number
ACTRN12619000511134
Ethics application status
Approved
Date submitted
26/03/2019
Date registered
29/03/2019
Date last updated
3/07/2019
Date data sharing statement initially provided
29/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Training Attention in Children with Acquired Brain Injury
Scientific title
Training Attention in Children with Acquired Brain Injury: A Randomised Control Trial of the TALI Attention Training Program
Secondary ID [1] 295659 0
None
Universal Trial Number (UTN)
U1111-1218-0881
Trial acronym
TABI
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 309003 0
Inattention 309004 0
Condition category
Condition code
Neurological 307898 307898 0 0
Other neurological disorders
Mental Health 307899 307899 0 0
Studies of normal psychology, cognitive function and behaviour
Injuries and Accidents 310598 310598 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TALI Train is a gamed-based computerised training program, delivered on a tablet. The program comprises of four different activities, each lasting 4 minutes in duration. In total, sessions take 20 minutes to complete. Children will be required to complete five sessions per week for five weeks. TALI Train will be used in the child's home, and under the supervision of a parent or guardian.

The intervention targets the 3 core attention networks and related cognitive attention processes: selective attention, sustained attention and attentional control. Children may complete the activities in any order, but must complete all activities each session.

Over time, as children progress through the levels within each activity, the tasks should become more difficult. TALI Train has been designed to be adaptive to the skill of the child. When children respond incorrectly, or fail to respond, prompts are given and levels become easier until the child begins to make correct responses again. Each session the child recommences the activities at the level they finished on during their last session.

Children are rewarded for successful completion of an activity with a virtual toy. TALI Train is designed so that children are locked out following completion of a session until midnight, to ensure that only one session is completed each day.

Adherence to the intervention program will be assessed via the Tali web portal, during weekly phone calls with an unblinded member of the research team, and parents will complete a motivation log for each session.
Intervention code [1] 301978 0
Treatment: Devices
Comparator / control treatment
The active control program has been developed by Monash University, based on the TALI Train program. It is computerised, game-based and delivered on a tablet in the child's home under supervision of a parent or guardian.

The active control task utilises the same characters and rewards as TALI Train and sessions run for the same duration as the TALI program (e.g. 4 exercises each 4 minutes in duration). As in the intervention group, children will be required to complete 5 sessions a week for a period of 5 weeks.

This program requires children to use basic motor skills to touch, drag, move and rotate shapes around a screen. Importantly this program was designed to involve minimal attentional skills, and unlike TALI Train is not adaptive. Therefore, children complete the same exercises each day with no increase in complexity.

Adherence to the active control program will be assessed during weekly phone calls with an unblinded member of the research team, and parents will complete a motivation log for each session.
Control group
Active

Outcomes
Primary outcome [1] 306874 0
Selective attention will be assessed using the Test of Everyday Attention for Children (TEA-Ch 2) subtests: Balloon hunt or Hector cancellation (age-dependent).
Timepoint [1] 306874 0
Post-intervention - 5 weeks after commencement of intervention
Primary outcome [2] 306875 0
Sustained attention will be assessed using the TEA-Ch 2 Sustained Attention to Response Task subtest.
Timepoint [2] 306875 0
Post-intervention - 5 weeks after commencement of intervention
Primary outcome [3] 319445 0
Interference control as measured by the Child Attention Network Task (ANT), a modified, child-friendly version of the flanker task.
Timepoint [3] 319445 0
Post-intervention - 5 weeks after commencement of intervention
Secondary outcome [1] 349991 0
PRIMARY OUTCOME [4]

Response inhibition as measured by the Anticipated Response task, a stop-signal task.
Timepoint [1] 349991 0
Post-intervention - 5 weeks after commencement of intervention
Secondary outcome [2] 349992 0
Social skills will be assessed using the Paediatric Evaluation of Emotions, Relationships and Sociability (PEERS): emotion perception, emotion recognition, non-verbal gestures, and social perception subtests.
Timepoint [2] 349992 0
Post-intervention at 5 weeks, 3 months and 6 months post commencement
Secondary outcome [3] 349993 0
Mathematics ability will be assessed using the Wechsler Individual Achievement Test (WIAT-II) numerical operations and mathematical reasoning subtests.
Timepoint [3] 349993 0
Post-intervention - 5 weeks, 3 months and 6 months post commencement
Secondary outcome [4] 368209 0
Behavioural attention (inattentive and impulsive/hyperactive behaviour) will be assessed using the Strengths and Weaknesses of ADHD symptoms and Normal behaviour (SWAN).
Timepoint [4] 368209 0
Post intervention at 5 weeks, 3 months and 6 months post commencement
Secondary outcome [5] 368818 0
Visuospatial working memory will be assessed using the Corsi Block Tapping Test.
Timepoint [5] 368818 0
Post intervention at 5 weeks, 3 months and 6 months post commencement
Secondary outcome [6] 368819 0
Auditory working memory will be assessed using the Digit Span Task.
Timepoint [6] 368819 0
Post intervention at 5 weeks, 3 months and 6 months post commencement

Eligibility
Key inclusion criteria
- Is between the ages of 4 and 9 years 11 months at the time of randomisation
- Has a primary diagnosis of an Acquired Brain Injury (ABI)
- Has an attentional deficit as determined by the Conners EC or Conners 3 parent rating scale. Score above 60 (t-score: elevated range) on either of the subscales relating to inattentive behaviour (inattention: DSM Inattentive) of the Conners 3, or on the inattention/hyperactivity subscale of the Conners EC
- At least 6 months has passed since the time of injury (in the case of TBI) or the conclusion of treatment e.g. chemotherapy (in the case of ABI due to cancers).
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
Minimum age
4 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has a sensory or physical impairment that affects capacity to comprehend and follow study instructions
- Has had a previous brain injury
- Prior diagnosis of developmental delay
- Diagnosed or borderline intellectual delay (IQ < 80 on the WASI or WPPSI)
- More than 6 years has passed since the time of injury, or in the case of ABI due to cancers, since the conclusion of treatment (including chemotherapy)

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)
A statistician not directly involved in the analysis of the study results will be responsible for the implementation of the allocation. The documentation pertaining to the randomisation will be securely stored and inaccessible to researchers undertaking recruitment and testing. Researchers conducting screening and assessments will be unaware of group allocation for the duration of the trial (including data analysis). Prior to the commencement of each assessment session participants will be explicitly instructed not to discuss the contents of their assigned program with the researcher. Group allocation details and randomisation codes will only be available once all data collected have been entered into the study database for every participant and the database has been finalised, except in the case of an emergency. For any participant for whom the study blind is broken, the date, time, participant ID and reason for unblinding must be documented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (ratio 1:1, with blocks of 4) will be used to maintain balance between intervention arms. Computer-generated random numbers will be used to allocate participants. The randomisation will be stratified by injury severity (mild, moderate-severe, unknown).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Parents/guardians of the children receiving the treatment/s are also blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Latent growth curve modelling (LGCM) will be used to examine changes in attention over time. A multi-group approach will be used so that the trajectories of the intervention group with the active control group can be compared. LGCM will also allow for examination of other factors which predict improvement.

A sensitivity analysis will be conducted to assess whether training outcomes differed for those who did (compliers) and did not (non-compliers) adhere to the required training schedule.

To determine the sample size required to detect significant changes in the primary outcome measures from baseline to post-training (between-subjects), we conducted a priori power analysis using G*Power version 3.1.

For a power of 80%, a sample size of 40 is required to detect a large effect (f = 0.40) and a sample size of 98 for a medium effect (f = 0.25). Previous cognitive training RCTs (Laine, Fellman, Waris, & Nyman, 2018) have reported medium to large effect sizes (eta squared range 0.15 - 0.27). Therefore, assuming an allocation ratio of 1:1, a sample between 40 and 98 participants should be sufficient to achieve adequate statistical power.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
25/06/2019
Date of last participant enrolment
Anticipated
15/04/2020
Actual
Date of last data collection
Anticipated
15/10/2020
Actual
Sample size
Target
80
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11503 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 23529 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 300240 0
Government body
Name [1] 300240 0
NHMRC
Country [1] 300240 0
Australia
Primary sponsor type
Individual
Name
Professor Kim Cornish
Address
Monash University
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 299661 0
None
Name [1] 299661 0
Address [1] 299661 0
Country [1] 299661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301062 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 301062 0
The Royal Children’s Hospital Melbourne
50 Flemington Road
Parkville VIC 3052
Ethics committee country [1] 301062 0
Australia
Date submitted for ethics approval [1] 301062 0
13/09/2018
Approval date [1] 301062 0
19/11/2018
Ethics approval number [1] 301062 0
38132
Ethics committee name [2] 302961 0
Monash University
Ethics committee address [2] 302961 0
Monash University Human Research Ethics Committee
Building 3E, Room 111, Monash University Clayton Campus, Wellington Road, Clayton, VIC 3800
Ethics committee country [2] 302961 0
Australia
Date submitted for ethics approval [2] 302961 0
Approval date [2] 302961 0
10/12/2018
Ethics approval number [2] 302961 0
17446

Summary
Brief summary
Childhood inattention has been linked with poor academic outcomes, as well as increased risk of social, occupational and psychological problems later in life. Children with an Acquired Brain Injury (ABI) are particularly susceptible to attention deficits following their injury and may benefit from interventions aimed at enhancing attention.

Training Attention and Learning Initiative (TALI Train), an adaptive cognitive training program, is a novel approach to improving attention capacity in young children. The impetus to develop this training program came from both the lack of suitable non-invasive, non-pharmacological treatments for young children with attention difficulties, and mounting evidence that targeted training can have a positive lasting impact on cognitive functions.

TALI Train is yet to be trialled in children with an ABI and as such, its efficacy in this group is unknown. The primary objective of this study is therefore to evaluate whether the TALI Train program is able to reduce attention difficulties in children with an ABI. It is hypothesised that the training intervention will promote greater gains in cognitive attention (selective, sustained and attentional control) than the active control program.

Secondary objectives include assessing comparative effects of the intervention and active control program on untrained areas including academic achievement, working memory and social functioning. In addition, this study will examine the potential predictors of training outcomes in children with an ABI including baseline attention abilities, the family environment, socioeconomic status, and parental mental health.

Participants in this double blind, randomised controlled trial will be children with an ABI, aged between 4 years and 9 years 11 months. They will be randomly allocated to either (a) TALI Train (intervention group) or (b) an active control group using a program that is non-adaptive and has limited attention training potential. Both programs are delivered on a tablet, and children complete one 20 minute training session at home five times a week for a five week period. The efficacy of TALI Train compared to the placebo program will be assessed at pre-training and post-training, as well as at a 3-month and a 6-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85750 0
Prof Kim Cornish
Address 85750 0
Monash University
Clayton VIC 3800
Country 85750 0
Australia
Phone 85750 0
+61 3 990 20488
Fax 85750 0
Email 85750 0
[email protected]
Contact person for public queries
Name 85751 0
Danielle Courtney
Address 85751 0
Monash University
Clayton VIC 3800
Country 85751 0
Australia
Phone 85751 0
+61 3 990 53255
Fax 85751 0
Email 85751 0
[email protected]
Contact person for scientific queries
Name 85752 0
Kim Cornish
Address 85752 0
Monash University
Clayton VIC 3800
Country 85752 0
Australia
Phone 85752 0
+61 3 990 20488
Fax 85752 0
Email 85752 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
Relevant anonymised participant level data available on reasonable request to the researchers.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1742Informed consent form    375673-(Uploaded-28-06-2019-11-15-20)-Study-related document.pdf
2787Study protocol    375673-(Uploaded-28-06-2019-11-15-20)-Study-related document.pdf
2788Ethical approval    375673-(Uploaded-28-06-2019-11-16-17)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1742Informed consent form    375673-(Uploaded-28-06-2019-11-15-20)-Study-related document.pdf
2787Study protocol    375673-(Uploaded-19-11-2019-10-51-45)-Study-related document.pdf
2788Ethical approval    375673-(Uploaded-19-11-2019-10-52-15)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTraining attention in children with acquired brain injury: A study protocol of a randomised controlled trial of the TALI attention training programme.2019https://dx.doi.org/10.1136/bmjopen-2019-032619
N.B. These documents automatically identified may not have been verified by the study sponsor.