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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
6/05/2022
Date data sharing statement initially provided
28/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Training in Children with Attention-Deficit/Hyperactivity Disorder
Scientific title
Cognitive Training in Children with Attention-Deficit/Hyperactivity Disorder: A Randomised Controlled Trial
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
The intervention training program is a gamed-based computerised training program, delivered on a tablet. In total, training sessions take 20 minutes to complete. Children will be required to complete five sessions per week for five weeks. The training program will be used in the child's home, and under the supervision of a parent or guardian.

The intervention targets four core attention and inhibitory control abilities: 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.

The intervention program has been designed to be adaptive to the skill of the child. Therefore, as children progress through the levels within each activity, the tasks become more difficult.

To enhance motivation, the game utilities child-friendly characters, and children are rewarded for successful completion of an activity.

Adherence to the intervention program will be assessed via a 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
In order to control for generic training effects and to maintain blindness to group allocation, a commercially available active control program will be utilised. The active control program is also computerised, game-based and delivered on a tablet in the child's home under supervision of a parent or guardian. As with the intervention program, the active control program is a motivational, reward-based and adaptive program which will be played for 20 minutes per session. As in the intervention group, children will be required to complete 5 session a week for a period of 5 week.

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
The primary outcome is change in attention and response inhibition performance as measured by the T.O.V.A.® Attention Comparison Score (ACS).
The T.O.V.A.® ACS is a composite score consisting of the sum of three component scores: 1) reaction time (RT) mean Half-1 (highly infrequent targets), 2) RT variability total (both halves), and 3) d-prime Half-2 (highly frequent targets).
Timepoint [1] 323490 0
Baseline, Post-intervention (5 weeks after commencement of intervention, primary timepoint) and 3 months post commencement of intervention.
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
Baseline, Post-intervention (5 weeks after commencement of intervention, primary timepoint) and 3 months post commencement of intervention.
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 3 months post commencement of intervention.
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 3 months post commencement of intervention.
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) and 3 months post commencement of intervention.
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),3 months post commencement of intervention,
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 post commencement of intervention.
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 post commencement of intervention.
Secondary outcome [8] 409427 0
Sustained attention performance as measured by the T.O.V.A.® (response time variability and omission errors)
Timepoint [8] 409427 0
i) between baseline (pre-intervention) and the immediate post-intervention time point;
ii) between baseline and the 3-month post-intervention time point.
Secondary outcome [9] 409428 0
Inhibition as measured by the T.O.V.A (commission errors and anticipatory responses)
Timepoint [9] 409428 0
i) between baseline (pre-intervention) and the immediate post-intervention time point;
ii) between baseline and the 3-month post-intervention time point.
Secondary outcome [10] 409429 0
Selective attention as measured by the TEACh (Balloon Hunt and Hector Cancellation; mean targets located)
Timepoint [10] 409429 0
i) between baseline (pre-intervention) and the immediate post-intervention time point;
ii) between baseline and the 3-month post-intervention time point.

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 (if the child is medicated) 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
Sex
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 monogenic cause for their ADHD diagnosis.
- 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.
- Have not previously participated in a study of a cognitive training program
- Do not have a sibling also enrolled in this study

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 post commencement assessments are defined as secondary endpoint (may demonstrate additional effects after the primary endpoint). To address the multiple (four) primary outcomes, we will apply a statistical correction for multiplicity.

For all outcomes (primary and secondary), estimates and 95% CI’s for the mean scores for the intervention and control groups for each time point will be presented. Multivariate linear regression will be used to estimate the difference between arms (intervention vs control) in the change in outcome scores i) from baseline until post-intervention assessment at 5 weeks (immediate effect), and ii) from baseline until post-intervention assessment at 3 months (sustained effects). Point estimates, 95% CI’s and p-values for the hypothesis test with null hypothesis of no difference between arms will be provided. For both the immediate and sustained effects models, baseline outcome and age will be controlled for as covariates in the analysis.

An a priori power analysis was based on the probability of finding at least one true intervention effect across the four primary outcomes (disjunctive or minimal power). The effect size for the sample size calculation was based on two RCTs of cognitive training for children with ADHD which have reported small (Cohen’s d 0.28) to medium (eta squared 0.13) effect sizes. For a disjunctive power of 90%, assuming equal group sizes, a correlation of 0.2 between outcomes, and after applying a Bonferroni correction (alpha level of .0125), a total sample size of 104 is required to detect a medium effect for at least one of the four outcomes (ds = 0.5). This study will aim to recruit 52 participants per group to achieve adequate statistical power.

Exploratory analyses will be conducted to assess the potential effect of the following factors on training outcomes: sleep, intrinsic motivation, ADHD medication, adherence to assigned program and family functioning.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2021
Actual
11/03/2021
Date of last participant enrolment
Anticipated
Actual
20/09/2021
Date of last data collection
Anticipated
23/12/2021
Actual
7/01/2022
Sample size
Target
100
Accrual to date
Final
55
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
Country [1] 305411 0
Australia
Funding source category [2] 310384 0
Government body
Name [2] 310384 0
Australian National Health and Medical Research Council Developmental grant (APP1135686)
Country [2] 310384 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
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
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
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
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7661Informed consent form    379584-(Uploaded-06-04-2022-10-42-04)-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
EmbaseDigital cognitive training in children with attention-deficit/hyperactivity disorder: a study protocol of a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-055385
N.B. These documents automatically identified may not have been verified by the study sponsor.