title: Attention training for infants at familial risk of ADHD (INTERSTAARS): study protocol for a randomised controlled trial.
abstract: Attention deficit hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder that can negatively impact on an individual's quality of life. It is pathophysiologically complex and heterogeneous with different neuropsychological processes being impaired in different individuals. Executive function deficits, including those affecting attention, working memory and inhibitory control, are common. Cognitive training has been promoted as a treatment option, based on the notion that by strengthening the neurocognitive networks underlying these executive processes, ADHD symptoms will also be reduced. However, if implemented in childhood or later, when the full disorder has become well-established, cognitive training has only limited value. INTERSTAARS is a trial designed to test a novel approach to intervention, in which cognitive training is implemented early in development, before the emergence of the disorder. The aim of INTERSTAARS is to train early executive skills, thereby increasing resilience and reducing later ADHD symptoms and associated impairment.
  
  
  
  Fifty 10-14-month-old infants at familial risk of ADHD will participate in INTERSTAARS. Infants will be randomised to an intervention or a control group. The intervention aims to train early attention skills by using novel eye-tracking technology and gaze-contingent training paradigms. Infants view animated games on a screen and different events take place contingent on where on the screen the infant is looking. Infants allocated to the intervention will receive nine weekly home-based attention training sessions. Control group infants will also receive nine weekly home visits, but instead of viewing the training games during these visits they will view non-gaze-contingent age-appropriate videos. At baseline and post treatment, infant attention control will be assessed using a range of eye-tracking, observational, parent-report and neurophysiological measures. The primary outcome will be a composite of eye-tracking tasks used to assess infant attention skills. Follow-up data will be collected on emerging ADHD symptoms when the infants are 2 and 3 years old.
  
  
  
  This is the first randomised controlled trial to assess the potential efficacy of cognitive training as a prevention measure for infants at familial risk of ADHD. If successful, INTERSTAARS could offer a promising new approach for developing early interventions for ADHD.
  
  
  
  International Standard Randomised Controlled Trial registry: ISRCTN37683928 . Registered on 22 June 2015.
authors.affiliation: Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK. amy.goodwin@kcl.ac.uk.
authors.forename: Amy
authors.identifier: 0000-0003-2585-8452
authors.initials: A
authors.lastname: Goodwin
authors.affiliation: Centre for Brain and Cognitive Development, Birkbeck, University of London, London, UK.
authors.forename: Simona
authors.initials: S
authors.lastname: Salomone
authors.affiliation: Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.|MRC Social, Genetic and Developmental Psychiatry Centre, IoPPN, King's College London, London, UK.|NIHR Biomedical Research Centre at South London and Maudsley NHS Trust, London, UK.
authors.forename: Patrick
authors.initials: P
authors.lastname: Bolton
authors.affiliation: Department of Psychology, IoPPN, King's College London, London, UK.
authors.forename: Tony
authors.initials: T
authors.lastname: Charman
authors.affiliation: Centre for Brain and Cognitive Development, Birkbeck, University of London, London, UK.
authors.forename: Emily J H
authors.initials: EJH
authors.lastname: Jones
authors.forename: Luke
authors.lastname: Mason
authors.affiliation: Department of Biostatistics, IoPPN, King's College London, London, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Pickles
authors.affiliation: Department of Biostatistics, IoPPN, King's College London, London, UK.
authors.forename: Emily
authors.initials: E
authors.lastname: Robinson
authors.affiliation: Department of Psychological Sciences, Birkbeck, University of London, London, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Smith
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.|Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.
authors.forename: Edmund J S
authors.initials: EJS
authors.lastname: Sonuga-Barke
authors.affiliation: School of Psychology, University of East London, London, UK.|Department of Psychology, University of Cambridge, Cambridge, UK.
authors.forename: Sam
authors.initials: S
authors.lastname: Wass
authors.affiliation: Centre for Brain and Cognitive Development, Birkbeck, University of London, London, UK.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Johnson
mesh_terms: D000367:Age Factors; D001288:Attention; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000235:genetics / Q000517:prevention & control* / Q000523:psychology; D002657:Child Development; D002675:Child, Preschool; D002985:Clinical Protocols; D003071:Cognition; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004311:Double-Blind Method; D061345:Early Medical Intervention / Q000379:methods*; D056344:Executive Function; D005260:Female; D020022:Genetic Predisposition to Disease; D040941:Heredity; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D008131:London; D008297:Male; D002666:Psychology, Child; D012107:Research Design; D055500:Resilience, Psychological; D013997:Time Factors; D016896:Treatment Outcome; D018910:Video Games; D014796:Visual Perception
keywords: ADHD; Attention; Cognitive training; Early intervention; Familial risk; Infancy