Attention training for infants at familial risk of ADHD INTERSTAARS: study protocol for a randomised controlled trialReport as inadecuate

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, 17:608

First Online: 28 December 2016Received: 27 April 2016Accepted: 31 October 2016DOI: 10.1186-s13063-016-1727-0

Cite this article as: Goodwin, A., Salomone, S., Bolton, P. et al. Trials 2016 17: 608. doi:10.1186-s13063-016-1727-0


BackgroundAttention 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.

Methods-designFifty 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.

DiscussionThis 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.

Trial registrationInternational Standard Randomised Controlled Trial registry: ISRCTN37683928. Registered on 22 June 2015.

KeywordsADHD Attention Infancy Cognitive training Early intervention Familial risk AbbreviationsADHDAttention deficit hyperactivity disorder

ANCOVAAnalysis of covariance

BASISBritish Autism Study of Infant Siblings

CBCDCentre for Brain and Cognitive Development

ESCSEarly Social Communication Scales

FPSFrames per second


KCTUKing’s Clinical Trials Unit

Lab-TABLaboratory Temperament Assessment Battery

REDCapResearch Electronic Data Capture

STAARSStudying Autism and ADHD Risks project

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1727-0 contains supplementary material, which is available to authorized users.

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Author: Amy Goodwin - Simona Salomone - Patrick Bolton - Tony Charman - Emily J. H. Jones - Andrew Pickles - Emily Robinson - Tim


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