None listed
Conditions
Brief summary
Childhood inattention has been linked with poor academic outcomes, as well as increased risk of social, occupational and psychological problems later in life. Children with an Acquired Brain Injury (ABI) are particularly susceptible to attention deficits following their injury and may benefit from interventions aimed at enhancing attention. Training Attention and Learning Initiative (TALI Train), an adaptive cognitive training program, is a novel approach to improving attention capacity in young children. The impetus to develop this training program came from both the lack of suitable non-invasive, non-pharmacological treatments for young children with attention difficulties, and mounting evidence that targeted training can have a positive lasting impact on cognitive functions. TALI Train is yet to be trialled in children with an ABI and as such, its efficacy in this group is unknown. The primary objective of this study is therefore to evaluate whether the TALI Train program is able to reduce attention difficulties in children with an ABI. It is hypothesised that the training intervention will promote greater gains in cognitive attention (selective, sustained and attentional control) than the active control program. Secondary objectives include assessing comparative effects of the intervention and active control program on untrained areas including academic achievement, working memory and social functioning. In addition, this study will examine the potential predictors of training outcomes in children with an ABI including baseline attention abilities, the family environment, socioeconomic status, and parental mental health. Participants in this double blind, randomised controlled trial will be children with an ABI, aged between 4 years and 9 years 11 months. They will be randomly allocated to either (a) TALI Train (intervention group) or (b) an active control group using a program that is non-adaptive and has limited attention training potential. Both programs are delivered on a tablet, and children complete one 20 minute training session at home five times a week for a five week period. The efficacy of TALI Train compared to the placebo program will be assessed at pre-training and post-training, as well as at a 3-month and a 6-month follow-up.
Interventions
TALI Train is a gamed-based computerised training program, delivered on a tablet. The program comprises of four different activities, each lasting 4 minutes in duration. In total, 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 3 core attention networks and related cognitive attention processes: selective
TALI Train is a gamed-based computerised training program, delivered on a tablet. The program comprises of four different activities, each lasting 4 minutes in duration. In total, 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 3 core attention networks and related cognitive attention processes: selective attention, sustained attention and attentional control. Children may complete the activities in any order, but must complete all activities each session. Over time, as children progress through the levels within each activity, the tasks should become more difficult. TALI Train has been designed to be adaptive to the skill of the child. When children respond incorrectly, or fail to respond, prompts are given and levels become easier 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 weekly phone calls with an unblinded member of the research team, and parents will complete a motivation log for each session.
Sponsors
Professor Kim Cornish
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
4 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
- Is between the ages of 4 and 9 years 11 months at the time of randomisation - Has a primary diagnosis of an Acquired Brain Injury (ABI) - Has an attentional deficit as determined by the Conners EC or Conners 3 parent rating scale. Score above 60 (t-score: elevated range) on either of the subscales relating to inattentive behaviour (inattention: DSM Inattentive) of the Conners 3, or on the inattention/hyperactivity subscale of the Conners EC - At least 6 months has passed since the time of injury (in the case of TBI) or the conclusion of treatment e.g. chemotherapy (in the case of ABI due to cancers). - Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
Exclusion criteria
- Has a sensory or physical impairment that affects capacity to comprehend and follow study instructions - Has had a previous brain injury - Prior diagnosis of developmental delay - Diagnosed or borderline intellectual delay (IQ < 80 on the WASI or WPPSI) - More than 6 years has passed since the time of injury, or in the case of ABI due to cancers, since the conclusion of treatment (including chemotherapy)
Outcome results
None listed