Rehabilitation of Executive function in Paediatric Traumatic brain injury (REPeaT): protocol for a randomized controlled trial for treating working memory and decision-making

Abstract

BACKGROUND: Working memory allows us to hold information in an active state for short periods of time, and is essential in facilitating goal directed cognitive functioning. Difficulties in working memory and decision-making are common post childhood Traumatic Brain Injury (TBI). Despite this, there is a paucity of research pertaining to implementation and effectiveness of interventions to reduce these common difficulties which impact significantly on one's ability to function independently. One such intervention, Cogmed Working Memory Training Program, has shown success in improving working memory in other childhood clinical populations, but has received little evaluation in the TBI area. This study aims to evaluate whether Cogmed improves working memory and decision-making post childhood TBI and whether these benefits generalize to functional areas. METHODS: The study is a randomized controlled trial (RCT) of the Cogmed (RM version) intervention for children post-TBI. Children aged 7-15 years are initially screened for working memory impairments. Eligible participants are then randomized into either the treatment group (Cogmed) or the active-control group (Lexia Reading). Each group trains online for 50 min each day, 5 days per week, for 5 consecutive weeks. The online training is supported by online clinician meetings each week. Outcome neuropsychological and functional assessments are carried out immediately at the completion of the intervention and at 6 months follow-up. DISCUSSION: This study follows gold standard methodology in intervention research; uses a novel measure of decision-making; measures the effects of intervention on functional outcomes immediately and longer-term post intervention; uses online clinician support in order to allow more families easy access to the program; and promotes the use of technology to improve health services. If efficacious in improving working memory, decision-making, and functional outcomes, our team will then take a key role in implementing Cogmed into clinical care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000085370 . Trial Registration Date: 16/01/2017. Protocol Version/Date: HREC 35181G/18.08.2017. Study Status: Ongoing.