None listed
Conditions
Brief summary
The primary objective of this study is to evaluate whether an adaptive cognitive control program is able to reduce attention difficulties in children with ADHD. It is expected that children with ADHD who complete the intervention training 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 intervention 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.
Interventions
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
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.
Sponsors
Professor Mark Bellgrove
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 9 Years
Healthy volunteers
No
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.
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
Outcome results
None listed