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Digital cognitive training in children with attention-deficit/hyperactivity disorder: a study protocol of a randomised controlled trial

Introduction Attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders and is a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with daily functioning. Children with ADHD are developmentally vulnerable, with the disorder linked to emotional regulation difficulties, behavioural disturbances, as well as academic challenges. Emerging evidence suggests that children with ADHD may benefit from cognitive training interventions, including those focused on attention. This study aims to assess the immediate and long-term efficacy of an attention training intervention in children with ADHD. Methods and analysis This study is a preregistered, parallel, double blind, randomised controlled trial. Participants will comprise 104 children with a diagnosis of ADHD aged 5–8 years 11 months. Participants will be randomly allocated to either an adaptive, digital game-based (1) attention training programme (intervention) or (2) a numeracy programme (control). Both programmes will be delivered on a touchscreen tablet, and children will complete five 20 min sessions per week for a 5-week period at home (25 sessions in total). Assessments of the primary outcome (ie, attention and inhibitory control) and secondary outcomes (ie, selective attention, interference control, sustained attention, inhibition, behavioural attention, impairment in everyday functioning, working memory and executive functioning) will occur at preintervention, immediately postintervention and at 3-month follow-up. Multivariate linear regression will be employed to examine primary and secondary outcomes. The data analyst will be blinded to group membership. Ethics and dissemination Ethics approval has been obtained from the Monash University HREC (20495). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities. Trial registration number ACTRN12620000964910, UTN U1111-1250-2620.

needs correcting. • In the statistical methods section, specifically on the second paragraph, authors repeat executive functioning twice: "The same approach will be used to evaluate the secondary outcomes, change in behavioural attention, impairment in everyday functioning, executive functioning, working memory, executive functioning and social impairment from pre-to post-intervention, between the intervention and control group." Also, this sentence seems "unfinished". I would suggest adding: … social impairment from pre-to post-intervention, between the intervention and control group, will be assessed (or analyzed, or considered).

REVIEWER
Lim, Choon Guan Institute of Mental Health, Developmental Psychiatry REVIEW RETURNED 30-Nov-2021

GENERAL COMMENTS
The protocol is well written and clear. A few comments which may make it clearer for readers: • In the intervention program section, the authors provide information regarding the administration of the intervention and its specific targets, however, a description of the four TALI Train tasks is not present. I believe it would be of interest to add a small description of each task for the reader to better understand how selective attention, sustained attention, response inhibition, and interference control are being trained.
We have added a brief description of the four TALI tasks to "Intervention Program" section (page 8): "(1) Selective attention -this task aims to improve the ability to attend to specific sensory information [28]. Children are required to locate targets among a series of distractors that differ from the target in size, color, pattern, and orientation.
(2) Sustained attentionthis task aims to improve the ability to maintain alertness via a vigilance task. Children are required to monitor a moving target and to indicate when the target stops moving as quickly as they can.
(3) Inhibitionthis task is based on the Go/No-Go paradigm and aims to improve the ability to inhibit a motor response [29]. Children are required to press the screen when a target appears but to withhold responding when a non-target appears. (4) Interference control -this task aims to improve the ability to ignore interference from distractors. This task presents a target that is flanked by non-targets facing in either the same (i.e., congruent) or opposite (i.e., incongruent) direction to the target. Children are required to make a response (left or right) depending on the direction the target is facing. " • In the adherence section, the last sentence (lines 10 to 13) is not very clear since it is quite extensive. I would suggest: Caregivers will be asked to rate their expectation regarding the effectiveness of the program on their child's attention abilities (from 1 -'no improvement'to 10 -'substantial improvement') after the first week of training, immediately post-intervention, and at 3month follow-up.
We thank the reviewer for this suggestion and have made the following change to improve clarity.
"Caregivers will also be asked to rate their expectation regarding the effectiveness of the program on their child's attention abilities (from 1 'no improvement' to 10 'substantial improvement') after the first week of training, immediately post-intervention and at 3-month follow-up." • In the primary outcomes section, the authors mention the abbreviation TEA-Ch2 for the first time without previously introducing the name of the task.
We thank the reviewer for bringing this to our attention and have made the following change: "Selective attention will be measured by the Test of Everyday Attention for Children Second Edition (TEA-Ch2) [27]." • In table 2, authors state the psychometric properties of the outcome measures, however, the information provided is not always consistent. For example, for most of the questionnaires (observational measures), the range of the Likert scale is specified, but this information is not provided for the Impairment Rating Scale, for instance. Table 2 was refined to introduce a higher level of consistency. For example, this involved adding Likert scale descriptors for the Conners 3, Conners EC, DAWBA, Dimensions of Mastery Questionnarie, SWAN, etc.

The information in
Additionally, in some cases, the domains assessed by the rating scales are provided (e.g., Impairment Rating Scale) and in others they are not (e.g., Behavior Rating Inventory of Executive Functions; BRIEF2). For consistency purposes, when available, I would suggest adding the same information (e.g., range of the Likert scale, domains of assessment, internal consistency) to all outcomes presented.
Where applicable the subscales for each rating scale were added to Table 2.
Moreover, in the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior (SWAN) psychometric properties description authors state that the Likert scale ranges from "'far below' to 'far below'". I believe this could be a small oversight that needs correcting.
This was an error that we have corrected as follows: "seven-point Likert scale ranging from 'far below average' to 'far above average'" • In the statistical methods section, specifically on the second paragraph, authors repeat executive functioning twice: "The same approach will be used to evaluate the secondary outcomes, change in behavioural attention, impairment in everyday functioning, executive functioning, working memory, executive functioning and social impairment from pre-to post-intervention, between the intervention and control group." The second reference to executive functioning was an oversight and has been removed.
Also, this sentence seems "unfinished". I would suggest adding: … social impairment from pre-to post-intervention, between the intervention and control group, will be assessed (or analyzed, or considered).
We have modified this sentence for clarity as follows: "change in behavioural attention, impairment in everyday functioning, executive functioning, working memory and social impairment from pre-to post-intervention, between the intervention and control group will be assessed." Reviewer: 2 Dr. Choon Guan Lim, Institute of Mental Health 1. Explaining the age range for subjects: why ages 5-8?
We have added te following to the introduction to clarify our age range: If cognitive training can improve the cognitive abilities of children with ADHD then there may be important implications for developmental trajectories. Investigating this impact for children who have just started school is particularly important because attention processes are undergoing rapid development and this may represent an important period for intervention [14] 2. For the inclusion criteria, further clarification about whether significant inattentive symptoms need to be present. The screening process appears to suggest so.
The requirement for inattentive symptoms is detailed on page 8: "Children who meet all the inclusion criteria and none of the exclusion criteria will be invited to progress to screening. Attention difficulties will be screened via a parent-reported online questionnaire (108 items, Conners 3 [6-10 years] or 110 items, Conners Early Childhood [EC, 5-6 years], Table 1). Participants scoring above the clinical cut off of 65 (T-score, "Elevated Score") on either of the two subscales relating to inattentive behaviour (inattention or DSM Inattentive) on the Conners 3, or on the inattention/hyperactivity subscale of the Conners EC will be deemed eligible for the current study." 3. The TALI Train program was previously developed for children with intellectual disability. Were modifications made for this study?
We have clarified the extra difficulty levels that were added to the TALI after the initial trial: "The intervention program was initially designed for children with an intellectual disability. Additional difficulty levels were added for each task when the intervention program was evaluated for primary school children and this was the version used in the current study [26]."

GENERAL COMMENTS
I would like to congratulate the authors on their efforts to improve the manuscript. Given that all revisions have been successfully carried, I believe your work is ready for publication. Congratulations!