title: Activities and participation of children and adolescents after mild traumatic brain injury and the effectiveness of an early intervention (Brains Ahead!): study protocol for a cohort study with a nested randomised controlled trial.
abstract: BACKGROUND
  Approximately 20 % of children and adolescents who have sustained mild traumatic brain injuries may experience long-term consequences, including cognitive problems, post-traumatic stress symptoms and reduced load-bearing capacity. The underestimation and belated recognition of these long-term consequences may lead to chronic and disruptive problems, such as participation problems in school and in social relationships. The aim of this study is to examine the level of activities and participation of children and adolescents up to 6 months after a mild traumatic brain injury and to identify possible outcome predictors. Another aim is to investigate the effectiveness of an early psychoeducational intervention and compare the results with those obtained with usual care.
  
  
  METHODS
  This paper presents the Brains Ahead! study design, a randomised controlled trial nested within a multicentre, longitudinal, prospective cohort study. The eligible participants include children and adolescents between 6 and 18 years of age who have experienced a mild traumatic brain injury within the last 2 weeks. The cohort study will include 500 children and adolescents with a mild traumatic brain injury and their caregivers. A subset of 140 participants and their caregivers will be included in the randomised controlled trial. Participants in the randomised controlled trial will be randomly assigned to either the psychoeducational intervention group or the usual care control group. The psychoeducational intervention involves one face-to-face contact and one phone contact with the interventionist, during which the consequences of mild traumatic brain injury and advice for coping with these consequences to prevent long-term problems will be discussed. Information will be provided both verbally and in a booklet. The primary outcome domain is activities and participation, which will be evaluated using the Child and Adolescent Scale of Participation. Participants are evaluated 2 weeks, 3 months and 6 months after the mild traumatic brain injury.
  
  
  CONCLUSIONS
  The results of this study will provide insight into which children with mild traumatic brain injury are at risk for long-term participation problems and may benefit from a psychoeducational intervention.
  
  
  BACKGROUND
  Netherlands Trial Register identifier NTR5153 . Registered on 17 Apr 2015.
authors.affiliation: Revant Rehabilitation Centre, Breda, The Netherlands.|Department of Neuropsychology and Psychopharmacology, Maastricht University, Maastricht, The Netherlands.
authors.forename: M Irene
authors.initials: MI
authors.lastname: Renaud
authors.affiliation: Revant Rehabilitation Centre, Breda, The Netherlands. S.Lambregts@revant.nl.|Department of Rehabilitation Medicine, Erasmus University Hospital/Sophia Children's Hospital, Rotterdam, The Netherlands. S.Lambregts@revant.nl.
authors.forename: Suzanne A M
authors.initials: SA
authors.lastname: Lambregts
authors.affiliation: The Hague University of Applied Sciences, Expertise Group Rehabilitation, The Hague, The Netherlands.|Sophia Rehabilitation, The Hague, The Netherlands.
authors.forename: Arend J
authors.initials: AJ
authors.lastname: de Kloet
authors.affiliation: Department of Paediatric Neurology, Erasmus University Hospital/Sophia Children's Hospital, Rotterdam, The Netherlands.
authors.forename: Coriene E
authors.initials: CE
authors.lastname: Catsman-Berrevoets
authors.affiliation: Revant Rehabilitation Centre, Breda, The Netherlands.
authors.forename: Ingrid G L
authors.initials: IG
authors.lastname: van de Port
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Maastricht University, Maastricht, The Netherlands.|School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: van Heugten
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D000367:Age Factors; D001924:Brain Concussion / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D057189:Checklist; D002648:Child; D002652:Child Behavior; D002985:Clinical Protocols; D004185:Disability Evaluation; D061345:Early Medical Intervention / Q000379:methods*; D004644:Emotions; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009426:Netherlands; D010174:Pamphlets; D010353:Patient Education as Topic; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D058992:Social Participation; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Activities; Adolescents; Children; Intervention; Mild traumatic brain injury; Participation; Randomised controlled trial; Study design