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Trial registered on ANZCTR


Registration number
ACTRN12620000964910
Ethics application status
Approved
Date submitted
4/08/2020
Date registered
28/09/2020
Date last updated
28/09/2020
Date data sharing statement initially provided
28/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Training Attention in Children with Attention-Deficit/Hyperactivity Disorder
Scientific title
Training Selective, Sustained and Executive Attention in Children with Attention-Deficit/Hyperactivity Disorder: A Randomised Controlled Trial of the Training Attention Learning Initiative (TALI) Program.
Secondary ID [1] 300965 0
None
Universal Trial Number (UTN)
U1111-1250-2620
Trial acronym
ATICA
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Attention-Deficit/Hyperactivity Disorder (ADHD) 317085 0
Condition category
Condition code
Mental Health 315250 315250 0 0
Other mental health disorders

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 is comprised of four different activities, each lasting 4 minutes in duration. The first activity is set within a fish tank and targets aspects of selective attention. Children are required to locate target fish among a series of distractor fish which differ from the target in size and colour. The second activity is based on a pirate ship and focuses on sustained attention. Children are instructed to monitor a treasure chest on the screen and to select it only when it periodically stops moving. Activities 3 and 4 are both set within a circus and train aspects of attentional control (conflict resolution; response inhibition). In the third activity, a target elephant is presented in the centre of the screen and is flanked by nontarget elephants facing in either the same or opposite direction to the central elephant. Children are required to make a response (left or right) based on the direction that the central elephant is facing. In the fourth activity, children are instructed to press the screen when an elephant appears but to withhold responding when a lion appears. In total, training 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 4 core attention networks and related cognitive attention processes: selective attention (i.e., trains the child to attend to relevant stimuli whilst filtering out distractions), sustained attention (i.e., the child develops the ability to maintain his/her attention on an object over a prolonged period of time), interference control (i.e., the child develops the ability to choose what stimuli to attend to and which to ignore) and response inhibition (i.e., trains the child to respond to target stimuli and withhold responses from non-target stimuli). Children may complete the activities in any order, but they must complete all activities during each session.

TALI Train has been designed to be adaptive to the skill of the child. Therefore, as children progress through the levels within each activity, the tasks should become more difficult (e.g., more distracting stimuli are present). When children respond incorrectly, or fail to respond, prompts are given and levels become easier (e.g., less distracting stimuli are present) 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 regular contact with an unblinded member of the research team, and parents will complete a motivation log for each session.

Intervention code [1] 317340 0
Treatment: Devices
Intervention code [2] 318589 0
Behaviour
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 regular contact 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] 323490 0
Selective attention will be assessed using the Test of Everyday Attention for children second edition subtests: Balloon hunt, Balloons 5/Hector cancellation, Hector B cancellation (age dependent).
Timepoint [1] 323490 0
Baseline, Post-intervention (5 weeks after commencement of intervention, primary timepoint) and 6 months post commencement
Primary outcome [2] 323494 0
Sustained attention will be assessed using the target infrequent half of the Test of Variables of Attention.
Timepoint [2] 323494 0
Baseline, Post-intervention (5 weeks after commencement of intervention, primary timepoint) and 6 months post commencement
Primary outcome [3] 323495 0
Response inhibition will be assessed using the target frequent half of the Test of Variables of Attention.
Timepoint [3] 323495 0
Baseline, Post-intervention (5 weeks after commencement of intervention, primary timepoint) and 6 months post commencement
Secondary outcome [1] 382054 0
Primary outcome [4]: Interference control as measured by the Child Attention Network Task (ANT), a modified, child-friendly version of the flanker task.
Timepoint [1] 382054 0
Primary timepoint [4]: Baseline, Post-intervention (5 weeks after commencement of intervention, primary timepoint) and 6 months post commencement
Secondary outcome [2] 382055 0
Visuospatial working memory will be assessed using the Corsi Block Tapping Test.
Timepoint [2] 382055 0
Baseline, Post-intervention (5 weeks after commencement of intervention) and 6 months post commencement.
Secondary outcome [3] 382056 0
Auditory working memory will be assessed using the Digit Span test.
Timepoint [3] 382056 0
Baseline, Post-intervention (5 weeks after commencement of intervention) and 6 months post commencement.
Secondary outcome [4] 382057 0
Behavioural attention will be assessed using the Strengths and Weaknesses of ADHD-symptoms and Normal-behaviours questionnaire (SWAN).
Timepoint [4] 382057 0
Baseline, Post-intervention (5 weeks after commencement of intervention), 3 months and 6 months post commencement.
Secondary outcome [5] 382058 0
Executive functioning will be assessed using the Behaviour Rating Inventory of Executive Functions Second Edition.
Timepoint [5] 382058 0
Baseline, Post-intervention (5 weeks after commencement of intervention), 6 month and 12 months post commencement.
Secondary outcome [6] 382105 0
Impairment in everyday functioning will be assessed using the Impairment Rating Scale.
Timepoint [6] 382105 0
Baseline, Post-intervention (5 weeks after commencement of intervention), 3 months and 6 months post commencement.
Secondary outcome [7] 385267 0
Social impairment will be assessed using the Social Responsiveness Scale Second Edition.

Timepoint [7] 385267 0
Baseline, Post-intervention (5 weeks after commencement of intervention), 3 months and 6 months post commencement.

Eligibility
Key inclusion criteria
- Is between the ages of 5 years and 8 years 11 months at the time of randomisation.
- Has a primary DSM-IV or DSM-V diagnosis of ADHD as determined and confirmed by a trained clinician.
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
- Whose parents/guardians agree to not initiate any other nonpharmacological therapy or intervention for the purpose of treating their child’s inattention for the 5-week intervention phase of the study.
- Whose parents/guardians agree to keep a stable dose of ADHD medication for at least 4 weeks prior to trial entry, and for the 5-week intervention phase of the study.

Minimum age
5 Years
Maximum age
9 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Is unable to comprehend or follow study instructions (English), including where uncorrected sensory or physical/motor impairments are present (as reported by the parent or observed by the investigator).
- Has a history of major trauma
- Has a diagnosed or borderline intellectual delay as defined as IQ<80 on the WISC-V/WPPSI-IV.
- Has a known genetic or biological cause for their condition (e.g. Fragile X, fetal alcohol syndrome).
- Has comorbid diagnoses other than Autism Spectrum Disorder, with significant symptoms that, in the opinion of the investigator, may confound study data/assessments, i.e. oppositional defiant disorder, conduct disorder or severe mental health conditions (e.g. severe selective mutism). Participants with a learning disorder may participate provided the disorder does not impact their ability to take part in the trial.
- Has a sibling also enrolled/currently participating in the trial.
- Has previously participated in a study of TALI Train


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 researcher not directly involved in the analysis of the study results will be responsible for the implementation of the allocation. Allocation will be concealed using central randomisation by a computer. 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 has 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. On completion of the follow-up assessments researchers will open a sealed opaque envelope which contains details of the condition that the participant was assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (ratio 1:1, with blocks of 10) 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 medication status (i.e., takes medication for ADHD or does not take medication for ADHD).
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary endpoint, to demonstrate efficacy, is the Post-intervention assessment (5 weeks after commencement of intervention). The 3 month and 6 months post commencement assessments are defined as secondary endpoints (may demonstrate additional effects after the primary endpoint). To address the multiple (four) primary outcomes, we will apply a statistical correction for multiplicity.

Latent growth curve modelling (LGCM) will be used to examine changes in attention over time for each endpoint. 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 may predict improvement.

A priori power analysis using G*Power 3.1 determined that a sample size of 50 participants per intervention group would be sufficient to detect an effect size of 0.57 with 80% or more power on a two-tailed, between groups t-test and alpha criterion of .05. This analysis assumed a pilot randomised controlled trial and was based on the following parameters:
- t-test; means: difference between two independent means (two groups)
- tails: two-tailed
- alpha: .05
- power: .8
- Number of groups: 2
- Sample size: 50 per group
- Effect size d: 0.565


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.


Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment postcode(s) [1] 30027 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 305411 0
Government body
Name [1] 305411 0
Medical Research Future Fund (MRFF) - Australian Government Department of Health
Address [1] 305411 0
414 La Trobe St
Melbourne VIC 3000
Country [1] 305411 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Bellgrove
Address
Monash University, Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 305801 0
Individual
Name [1] 305801 0
Professor Kim Cornish
Address [1] 305801 0
Monash University, Wellington Rd, Clayton VIC 3800
Country [1] 305801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305733 0
Monash University Human Ethics Research Committee
Ethics committee address [1] 305733 0
Building 3E, Room 111, Monash University Clayton Campus, Wellington Road, Clayton, VIC 3800
Ethics committee country [1] 305733 0
Australia
Date submitted for ethics approval [1] 305733 0
30/04/2020
Approval date [1] 305733 0
23/06/2020
Ethics approval number [1] 305733 0
24095

Summary
Brief summary
Training Attention and Learning Initiative (TALI Train), an adaptive cognitive training program, is a novel approach to improving attention capacity in young children. TALI Train consists of four game-based training exercises presented on a touchscreen tablet that target selective attention, sustained attention, interference control and response inhibition. Although TALI Train targets multiple cognitive domains that are commonly impaired in children with ADHD, no study to date has assessed the benefits of this intervention in this clinical population.

The primary objective of this study is to evaluate whether the TALI Train program is able to reduce attention difficulties in children with ADHD. It is expected that children with ADHD who complete the TALI Train Program will show greater improvements in selective attention, sustained attention, interference control and response inhibition compared to children with ADHD who complete a control program. We also expect that children with ADHD who complete the TALI Train program will demonstrate greater improvements in behavioural inattention, everyday functioning, working memory, executive functioning and social impairment compared to children with ADHD who complete a control program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101394 0
Dr Hannah Kirk
Address 101394 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 101394 0
Australia
Phone 101394 0
+61 3 990 50230
Fax 101394 0
Email 101394 0
Hannah.Kirk@monash.edu
Contact person for public queries
Name 101395 0
Dr Sally Richmond
Address 101395 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 101395 0
Australia
Phone 101395 0
+61 3 99053935
Fax 101395 0
Email 101395 0
sally.richmond@monash.edu
Contact person for scientific queries
Name 101396 0
Prof Kim Cornish
Address 101396 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 101396 0
Australia
Phone 101396 0
+61 3 99020488
Fax 101396 0
Email 101396 0
Kim.Cornish@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised participant level data underlying published results will be made available upon request.
When will data be available (start and end dates)?
From time of trial outcome submission for up to 20 years.
Available to whom?
Researchers who provide a methodologically sound proposal to verify results.
Available for what types of analyses?
To verify trial outcomes.
How or where can data be obtained?
Through contacting the Principal Investigator (Mark.Bellgrove@monash.edu)
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7660 0
Study protocol
Citation [1] 7660 0
Link [1] 7660 0
Email [1] 7660 0
Other [1] 7660 0
Type [2] 7661 0
Informed consent form
Citation [2] 7661 0
Link [2] 7661 0
Email [2] 7661 0
Other [2] 7661 0
Type [3] 9055 0
Ethical approval
Citation [3] 9055 0
Link [3] 9055 0
Email [3] 9055 0
Other [3] 9055 0
Summary results
No Results