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development and this may represent an important period for intervention.14 The premise of cognitive training is that repeated practice of a cognitive skill will result in gains for that skill.All assessments will occur at the Monash University Turner Psychology Clinics, Clayton, Victoria, Australia.TALI Train has been shown to improve cognitive attention and numeracy outcomes in children with intellectual delay due to conditions such as, autism spectrum disorder and Down syndrome.24 25 Further, for children with intellectual delay, TALI train has been found to be more beneficial for those with lower adaptive functioning and higher pre-intervention attention abilities.27 When delivered in the classroom to primary school children, TALI Train has been shown to improve inattentive and/ or hyperactive behaviours in the classroom and at home26 Objectives For children with ADHD, this study aims to assess: (1) whether TALI Train improves core attention and inhibitory control abilities (selective attention, sustained attention, response inhibition and interference control); (2) whether TALI Train improves performance on the following untrained domains: working memory, behavioural attention, functional impairment, executive and social functioning; (3) the long-term effects of TALI Train; and (4) predictors of the training outcomes.Cognitive training is theoretically based on the concept of neuroplasticity, the brain's capacity to alter structure and function in response to environmental factors.15 Meta analyses have shown that there are robust performance deficits in psychological processes for people with ADHD.4 Specifically, for children and adolescents with ADHD, moderate impairments in the domains of attention and inhibitory control are common.4 16 Cognitive training aims to strengthen neurocognitive functioning by external stimulation.17 The focus of most cognitive training approaches has been to achieve improvements in both directly trained domains but also in other untrained domains.These RCTs demonstrate targeting attention and inhibitory control can improve performance on objective measures for children with ADHD, including the Test of Variable Attention (TOVA) a validated, continuous performance test that measures attention and inhibitory control.9 10 For both RCTs however, there was no difference between the intervention and control conditions, on a range of secondary outcomes including parent and clinician ratings of ADHD symptoms, academic outcomes and functional impairment.9 10 These studies indicate that cognitive training may be useful in improving aspects of cognitive functioning for children with ADHD, but that further research is required to understand the lack of improvement for parent or clinician reported outcomes.The efficacy of TALI Train (here referred to as the intervention) compared with the placebo control programme will be evaluated at baseline, immediately postintervention, and at 3-month follow-up.Protected by copyright.

development and this may represent an important period
for intervention.14
The premise of cognitive training is that repeated practice
of a cognitive skill will result in gains for that skill.
Cognitive training is theoretically based on the concept
of neuroplasticity, the brain’s capacity to alter structure
and function in response to environmental factors.15
Meta analyses have shown that there are robust performance
deficits in psychological processes for people with
ADHD.4 Specifically, for children and adolescents with
ADHD, moderate impairments in the domains of attention
and inhibitory control are common.4 16 Cognitive
training aims to strengthen neurocognitive functioning
by external stimulation.17
The focus of most cognitive training approaches has
been to achieve improvements in both directly trained
domains but also in other untrained domains. When
gains are observed for tasks that share many elements
with the trained task they are said to illustrate near
transfer, whereas tasks that share fewer elements are said
to illustrate far transfer.18 An optimal result will be that
training benefits generalise, and improvements will be
observed both across similar tasks (near transfer) and in
domains associated with the trained skill (far transfer).
Several meta-analyses
and reviews have examined the
outcomes of cognitive training interventions for children
and adolescents with ADHD.19–23 Evidence of small
to moderate near transfer effects to the domain being
trained have been found, including the domains of attention,
inhibitory control and working memory for school-aged
children19 21 and working memory and inhibitory
control for preschoolers.20 22 The evidence for far transfer
to untrained domains is limited with less support for the
effect of cognitive training on outcomes such as, educational,
interpersonal and behavioural.19 21 22
Drawing conclusions from the outcomes of cognitive
training studies has been difficult as many of the
studies contain methodological limitations, including
non-random
assignment of participants and inadequate
control conditions. Two recent randomised
controlled trials (RCTs) of cognitive training for children
with ADHD (N=238, 8–12 years; 9, N=80, 7–14
years; 10) have addressed many of these limitations
by, for example, incorporating active control conditions
that are matched to the intervention condition by
time-on-
task
and reinforcers. These RCTs demonstrate
targeting attention and inhibitory control can improve
performance on objective measures for children with
ADHD, including the Test of Variable Attention (TOVA)
a validated, continuous performance test that measures
attention and inhibitory control.9 10 For both RCTs
however, there was no difference between the intervention
and control conditions, on a range of secondary
outcomes including parent and clinician ratings of
ADHD symptoms, academic outcomes and functional
impairment.9 10 These studies indicate that cognitive
training may be useful in improving aspects of cognitive
functioning for children with ADHD, but that further
research is required to understand the lack of improvement
for parent or clinician reported outcomes.
One programme that has demonstrated training
related improvements in attentional processes is an
adaptive cognitive training programme, TALI Train.24–26
TALI Train was developed to address the lack of effective,
non-pharmacological
treatments for children with
significant cognitive and attention deficits such as those
with intellectual and developmental disorders. The TALI
Train programme comprises four game-based
exercises
presented to children via a touchscreen tablet. A key
advantage of the TALI Train programme is that it can be
used at home, in schools, or in clinical settings, without
need for coaching or attendance at regular clinical
appointments.
TALI Train has been shown to improve cognitive attention
and numeracy outcomes in children with intellectual
delay due to conditions such as, autism spectrum
disorder and Down syndrome.24 25 Further, for children
with intellectual delay, TALI train has been found to be
more beneficial for those with lower adaptive functioning
and higher pre-intervention
attention abilities.27 When
delivered in the classroom to primary school children,
TALI Train has been shown to improve inattentive and/
or hyperactive behaviours in the classroom and at home26
Objectives
For children with ADHD, this study aims to assess: (1)
whether TALI Train improves core attention and inhibitory
control abilities (selective attention, sustained
attention, response inhibition and interference control);
(2) whether TALI Train improves performance on
the following untrained domains: working memory,
behavioural attention, functional impairment, executive
and social functioning; (3) the long-term
effects of TALI
Train; and (4) predictors of the training outcomes.
Trial design
This study is designed as a double blind, randomised,
controlled, superiority trial with two parallel groups
(equal allocation ratio). The efficacy of TALI Train
(here referred to as the intervention) compared with the
placebo control programme will be evaluated at baseline,
immediately postintervention, and at 3-month
follow-up.
The trial was designed in accordance with the Consolidated
Standards of Reporting Trials statement and will
be conducted and reported on the same basis. Roles
and responsibilities for the trial are defined in the Site
Signature and Delegation of Duties Log (refer to online
supplemental file 1).
METHOD AND ANALYSIS
Study setting
The study will be conducted in a predominantly urban
setting. All assessments will occur at the Monash University
Turner Psychology Clinics, Clayton, Victoria, Australia.
The intervention and the control programme will both be
BMJ Open: first published as 10.1136/bmjopen-2021-055385 on 16 June 2022. Downloaded from http://bmjopen.bmj.com/ on March 31, 2024 by guest. Protected by copyright.