Extrait

Background and study aims An acquired brain injury (ABI) in childhood can lead to problems with working memory (i.e., the ability to hold information in our mind when doing things like trying to solve a problem or learn something new). This can cause further difficulties with learning, academic achievement, behaviour, and social functioning. Such difficulties can result in problems in everyday life, including school, which can impact on the quality of young people’s lives and that of their families. This study is evaluating a computerised working memory training programme with young people who have survived an ABI, and their families. We are interested in finding out what young people and their families think about the computerised training programme (e.g., how easy is it to use?) and whether the training programme helps with memory, attention, numeracy and literacy. This study will also investigate how young people who have survived an ABI compare with age- sex-, and IQ-matched individuals who have not experienced an ABI, on measures of general cognitive function, memory and attention. Who can participate? Children between the ages of 8 and 16 who have survived a brain injury and have difficulties with working memory. What does the study involve? The participating children complete a brief assessment of their working memory. If the child does not have working memory difficulties then they do not continue with the study. If the child does have working memory difficulties then we arrange to meet with them again within a week to complete further assessments and questionnaires. We also invite the child’s parents and teacher to complete some questionnaires. A researcher then visits the participants to introduce them to the computerised working memory training programme. We invite participants to use it for up to five weeks, about 35 minutes per session. These sessions are completed by the child and we ask parents to support their children if they have any questions when using the programme. There are two different types of programme – one aims to train working memory, and the other does not. All children participating in the research are randomly assigned to either the training programme or the non-training programme. We do not know which version of the programme the child is given until the end of the study. At the end of the study, if the child has used the non-training programme then they are offered the opportunity to use the training programme in their own time separately from the study. At the end of the training we ask the child’s parents and teachers to complete some further questionnaires and we invite the child to complete some assessments. We visit the participants again 6 months after completing the training to repeat the questionnaires and measures. What are the possible benefits and risks of participating? Participants will be contributing to research investigating working memory and attention in children who have survived an ABI. We are asking participants to commit to the study for about 6 months in total. Although this is quite a lot of work, the time involved each day during the computerised training programme may typically be quite small, about 35 minutes. Each training session can be saved and completed in several attempts if needed (i.e., over a few days). Children might become tired during the assessments or training sessions. To minimise the risk of becoming tired, the assessments are conducted over two to three relatively short sessions of 60 minutes each, and regular breaks for a rest will be included. In the unlikely event that the child becomes stressed or upset in any way, the assessments will be stopped immediately and reasons for distress will be explored. Information collected during the study will be kept anonymous and safe. At the end of each training session the anonymised data will be uploaded to a server via the internet. The company who own the training programme (and the server) may use the data for research purposes. With your permission we will let the child’s GP know that s/he is participating in this study but no results will be shared with the GP without permission. The only time we would disclose any of the information that the child has given us would be if criminal or other potentially harmful behaviour was made known. We would, however, aim to discuss this with parents first. We can give parents a brief report summarising how their child performed on the tests and an overall summary of the study findings. Where is the study run from? University of East Anglia, the MRC Cognition and Brain Sciences Unit, and the Cambridge Centre for Paediatric Neuropsychological Rehabilitation (UK) When is the study starting and how long is it expected to run for? September 2012 to September 2012 Who is funding the study? The British Academy and Action Medical Research (UK) Who is the main contact? Dr Anna Adlam [email protected]

Critère d'inclusion

• Topic: Neurological, Generic Health Relevance and Cross Cutting Themes; Subtopic: Neurological (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Nervous system disorders, Paediatrics

Liens

• ictrp
• isrctn