Randomised Controlled Trial of Gaze-Based Attention Training Intervention for Infants with a Family History of Attention Deficit Hyperactivity Disorder: Follow-Up Outcomes at 2 and 3 Years
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| Title: | Randomised Controlled Trial of Gaze-Based Attention Training Intervention for Infants with a Family History of Attention Deficit Hyperactivity Disorder: Follow-Up Outcomes at 2 and 3 Years |
|---|---|
| Language: | English |
| Authors: | Amy Goodwin, Emily J. H. Jones, Tony Charman (ORCID |
| Source: | Journal of Attention Disorders. 2026 30(7):901-915. |
| Availability: | SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com |
| Peer Reviewed: | Y |
| Page Count: | 15 |
| Publication Date: | 2026 |
| Document Type: | Journal Articles Reports - Research |
| Descriptors: | Eye Movements, Infants, Training, Intervention, Attention Deficit Hyperactivity Disorder, Toddlers, Program Effectiveness, Outcomes of Treatment, Inhibition, Self Control, Attention Control, Foreign Countries, Child Behavior |
| Geographic Terms: | United Kingdom (London), United Kingdom (England) |
| Assessment and Survey Identifiers: | Child Behavior Checklist |
| DOI: | 10.1177/10870547261428660 |
| ISSN: | 1087-0547 1557-1246 |
| Abstract: | Objective: A previous randomised controlled trial of a computerised gaze-contingent attention training for 9-to-16-month infants with a family history of ADHD (intervention, n=20; control, n=23) found no endpoint differences on the primary outcome (an eye-tracking composite score of infant attention) nor on secondary outcomes (parent and observer ratings of infant attention in naturalistic contexts).Method: Here, we report follow-up at age 2 and 3 years to examine whether there are longer-term effects of the training. The pre-specified primary outcome was parent-reported early ADHD traits. Secondary outcomes included parent-report of inhibitory control and attention; researcher-rated observational measures of attentiveness, activity level and inhibition; and eye-tracking measures of cognitive control, attention disengagement and sustained attention. Results: At follow-up there was no intervention effect on the primary outcome parent-rated ADHD behaviours (effect size [ES] -0.28, 95% CIs -0.95 to 0.39). Secondary parent- and researcher-rated child behaviour and eye-tracking attention outcomes also did not significantly differ between the groups. The largest positive, albeit non-significant, effects were for the secondary outcomes parent-rated inhibitory control (ES=0.42 (95% CIs -0.09 to 0.94) and the composite eye-tracking measure (ES=0.40 (95% CIs -0.15 to 0.95). Conclusions: We demonstrate the feasibility of conducting experimental trials targeting early emerging ADHD characteristics in infancy. The intervention did not lead to significant differences in parent- or researcher-rated early ADHD behaviours or eye-tracking measures of attention control. However, the trend for long-term effects on CBQ inhibition, the attention composite and sustained attention justifies further interest. Further development and modification of the attention training may be necessary to test whether the approach holds promise as a potential pre-emptive intervention for infants with an elevated likelihood of ADHD. (J. of Att. Dis. 2026; 30(7) 901-915). |
| Abstractor: | As Provided |
| Entry Date: | 2026 |
| Accession Number: | EJ1507681 |
| Database: | ERIC |
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| FullText | Links: – Type: pdflink Url: https://content.ebscohost.com/cds/retrieve?content=AQICAHj0k_4E0hTGH8RJwT4gCJyBsGNe_WN95AvKlDbXJGqwxwHNzy5_0jB1yXYwLLxLwrkKAAAA4jCB3wYJKoZIhvcNAQcGoIHRMIHOAgEAMIHIBgkqhkiG9w0BBwEwHgYJYIZIAWUDBAEuMBEEDGyiQ6HZXJEKrKqG_wIBEICBmojJi-bu8a-pF4QudFBlG9Mwyy49sh7zliUJ5S64dsRJVY2QFZxA94pbhMk9ceCkNk6jfWXSAiSWtIZWNY8XWjfdNmlGyeEfeP7ZzkBNz2VP5Htnq6ohObr_tNcWgluwTOP_OB-02e7cMurYNkFORdUkMDcZPhJgfWPgTRI6UQOXovmptX2koIUlZtcqGAXwxs32niR-QLR4Omg= Text: Availability: 1 Value: <anid>AN0194258090;gs001jul.26;2026Jun05.02:55;v2.2.500</anid> <title id="AN0194258090-1">Randomised Controlled Trial of Gaze-Based Attention Training Intervention for Infants With a Family History of Attention Deficit Hyperactivity Disorder: Follow-up Outcomes at 2 and 3 Years </title> <p>Objective: A previous randomised controlled trial of a computerised gaze-contingent attention training for 9-to-16-month infants with a family history of ADHD (intervention, n = 20; control, n = 23) found no endpoint differences on the primary outcome (an eye-tracking composite score of infant attention) nor on secondary outcomes (parent and observer ratings of infant attention in naturalistic contexts). Method: Here, we report follow-up at age 2 and 3 years to examine whether there are longer-term effects of the training. The pre-specified primary outcome was parent-reported early ADHD traits. Secondary outcomes included parent-report of inhibitory control and attention; researcher-rated observational measures of attentiveness, activity level and inhibition; and eye-tracking measures of cognitive control, attention disengagement and sustained attention. Results: At follow-up there was no intervention effect on the primary outcome parent-rated ADHD behaviours (effect size [ES] −0.28, 95% CIs −0.95 to 0.39). Secondary parent- and researcher-rated child behaviour and eye-tracking attention outcomes also did not significantly differ between the groups. The largest positive, albeit non-significant, effects were for the secondary outcomes parent-rated inhibitory control (ES = 0.42 (95% CIs −0.09 to 0.94) and the composite eye-tracking measure (ES = 0.40 (95% CIs −0.15 to 0.95). Conclusions: We demonstrate the feasibility of conducting experimental trials targeting early emerging ADHD characteristics in infancy. The intervention did not lead to significant differences in parent- or researcher-rated early ADHD behaviours or eye-tracking measures of attention control. However, the trend for long-term effects on CBQ inhibition, the attention composite and sustained attention justifies further interest. Further development and modification of the attention training may be necessary to test whether the approach holds promise as a potential pre-emptive intervention for infants with an elevated likelihood of ADHD.</p> <p>Keywords: ADHD; attention training; randomised controlled trial; computer attention training; preschool</p> <hd id="AN0194258090-2">Introduction</hd> <p>ADHD is a heritable neurodevelopmental condition characterised by symptoms of inattention, hyperactivity and impulsivity ([<reflink idref="bib2" id="ref1">2</reflink>]; [<reflink idref="bib20" id="ref2">20</reflink>]), and has an estimated prevalence of 3% to 5% ([<reflink idref="bib51" id="ref3">51</reflink>]). In many European countries ADHD is not typically diagnosed until middle childhood ([<reflink idref="bib54" id="ref4">54</reflink>]). However, the genetic influences on ADHD show developmental stability across the preschool period and may be apparent from as early as one-and-a-half years ([<reflink idref="bib16" id="ref5">16</reflink>]). Infant and toddler temperamental characteristics including activity level, sustained attention, self-regulation and negative emotionality are related to later ADHD symptoms and diagnosis ([<reflink idref="bib33" id="ref6">33</reflink>]; [<reflink idref="bib38" id="ref7">38</reflink>]; [<reflink idref="bib58" id="ref8">58</reflink>]). Influential conceptual models of early temperamental predictors of later ADHD ([<reflink idref="bib46" id="ref9">46</reflink>], [<reflink idref="bib47" id="ref10">47</reflink>]) have also highlighted that, in infancy and toddlerhood, weakened effortful control in addition to dysregulation and irritability play a role ([<reflink idref="bib17" id="ref11">17</reflink>]; [<reflink idref="bib70" id="ref12">70</reflink>]). In preschoolers, ADHD-related behaviours can impact family functioning and well-being ([<reflink idref="bib8" id="ref13">8</reflink>]), and predict later mental health difficulties ([<reflink idref="bib11" id="ref14">11</reflink>]; [<reflink idref="bib59" id="ref15">59</reflink>]).</p> <p>There have been recent efforts to understand the developmental mechanisms of ADHD across the first years of life ([<reflink idref="bib32" id="ref16">32</reflink>]; [<reflink idref="bib42" id="ref17">42</reflink>]). Much of this work has focused on infants who have an elevated likelihood of developing ADHD because they have a family history of the condition. Recurrence estimates for individuals with a first degree relative with ADHD range between 10% and 15% ([<reflink idref="bib10" id="ref18">10</reflink>]; [<reflink idref="bib19" id="ref19">19</reflink>]; [<reflink idref="bib44" id="ref20">44</reflink>]). Prospective studies of infants with an older sibling or parent with ADHD have found behavioural differences, including higher parent-reported and observer-rated activity and inattention and higher negative vocalisations, by 12 months of age ([<reflink idref="bib3" id="ref21">3</reflink>]; [<reflink idref="bib43" id="ref22">43</reflink>]; [<reflink idref="bib61" id="ref23">61</reflink>]). In a larger cohort from which the current sample was drawn, [<reflink idref="bib23" id="ref24">23</reflink>] found no differences between infants with and without a family history of ADHD on a battery of parent and observer behavioural ratings or experimental (eye-tracking, EEG, physiological) measures. However, they did find that parent and observer ratings of infant activity, but not attention, at 10 months were associated with ADHD traits at 36 months. In the same cohort ([<reflink idref="bib5" id="ref25">5</reflink>]) found a lower oscillatory EEG theta-beta ratio at 10 months in infants with a family history of ADHD that related to temperament dimensions conceptually related to ADHD at 2 years.</p> <p>Evidence-based interventions for children with ADHD include behavioural parent-training interventions and medication (Coghill et al., 2021; Faraone et al., 2021). However, there are limitations to the effectiveness and acceptability of both. Behavioural parent-training interventions can reduce associated behaviour problems such as oppositionality but do not affect core ADHD symptomatology (on blinded measures; [<reflink idref="bib15" id="ref26">15</reflink>]). Whilst medication has efficacy in reducing core ADHD symptoms, the long-term benefits remain uncertain ([<reflink idref="bib13" id="ref27">13</reflink>]) and there is resistance to the use of medication by some parents and professionals, particularly in young children ([<reflink idref="bib9" id="ref28">9</reflink>]). Dietary interventions have been shown to lead to some improvements in ADHD outcomes but the clinical significance of these effects is not clear ([<reflink idref="bib60" id="ref29">60</reflink>]). Cognitive training has been investigated as a potential intervention for children and adults diagnosed with ADHD but the impact on clinical symptoms is small, context-specific, and does not extend to long-term follow up ([<reflink idref="bib14" id="ref30">14</reflink>]; [<reflink idref="bib68" id="ref31">68</reflink>]).</p> <p>The applicability of the extant evidence-base for ADHD interventions to toddlers and preschoolers with emerging ADHD characteristics is also unclear (see [<reflink idref="bib58" id="ref32">58</reflink>]; for a recent review). An overarching goal of the recent attempts to identify mechanisms and pathways of cognitive and behavioural differences in infancy that may signal or underpin later-emerging ADHD characteristics is to inform the development of pre-emptive interventions to support infants at an elevated likelihood of later developing ADHD ([<reflink idref="bib32" id="ref33">32</reflink>]; [<reflink idref="bib41" id="ref34">41</reflink>]; [<reflink idref="bib42" id="ref35">42</reflink>]). In the past decade, research with typically developing infants has suggested that gaze-contingent eye tracking can enable cognitive training protocols and controlled trials to be conducted in the early developmental period ([<reflink idref="bib67" id="ref36">67</reflink>]). This has led to the suggestion that using cognitive training to target and strengthen attention skills in infancy, before the emergence of ADHD, and during a period of heightened neural and cognitive plasticity, may have potential to change developmental trajectories and impact later outcomes. Studies using gaze-contingent cognitive training with typically developing infants demonstrate distal training effects on eye-tracking measures used to assess executive attention skills ([<reflink idref="bib64" id="ref37">64</reflink>]), as well as improvements in behavioural measures of social attention ([<reflink idref="bib22" id="ref38">22</reflink>]) and physiological measures of stress ([<reflink idref="bib65" id="ref39">65</reflink>], [<reflink idref="bib66" id="ref40">66</reflink>]). Recent studies have begun to test such attention control training approaches in infants from low socioeconomic status backgrounds, preterm infants and toddlers showing signs of autism ([<reflink idref="bib4" id="ref41">4</reflink>]; [<reflink idref="bib50" id="ref42">50</reflink>]; [<reflink idref="bib57" id="ref43">57</reflink>]).</p> <p>INTERSTAARS ([<reflink idref="bib25" id="ref44">25</reflink>]) is the first randomised controlled trial (RCT) of a pre-emptive intervention for infants with a family history of ADHD. In INTERSTAARS, computer-based gaze-contingent cognitive training was used to target emerging attention skills in 9–16-month-old infants with a parent or an older sibling with ADHD. Conflict resolution, sustained attention, attentional disengagement, set shifting and maintaining and updating information are infant precursors of the still developing executive function system ([<reflink idref="bib28" id="ref45">28</reflink>]). By design the gaze-contingent training games targeted multiple components of the developing attention system including conflict resolution, sustained attention, working memory and cognitive control. We reasoned that although the attention 'deficits' in ADHD can vary in their nature between individuals, the cognitive training we delivered could either target specific components of attention that are weak or delayed, or alternatively just boost generic attention skills in a way that compensates for emerging areas of weakness. This is in line with the notion that executive attention and the broader constellation of executive function skills might act as a protective or modifying factor for later developmental outcomes against preceding or underlying vulnerability ([<reflink idref="bib30" id="ref46">30</reflink>]; [<reflink idref="bib31" id="ref47">31</reflink>]). In the initial INTERSTAARS trial ([<reflink idref="bib24" id="ref48">24</reflink>]), 43 infants were randomised to receive 9-weekly home-based sessions of either a) gaze-contingent attention training (<emph>n</emph> = 20), or b) infant-friendly passive viewing of videos (<emph>n</emph> = 23). At endpoint (immediately post-intervention) there was no impact on the primary blinded outcome measure (an eye-tracking composite score designed to assess infant attention skills) nor secondary behavioural outcomes of parent and observer ratings of infant attention in naturalistic contexts ([<reflink idref="bib24" id="ref49">24</reflink>]).</p> <p>The current study aims to examine whether there are longer-term effects of the infant gaze-contingent cognitive training on preschool ADHD traits. A previous pre-emptive trial of a parent-mediated intervention for infants with a family history of autism found significant follow-up effects at 3 years on autistic traits, despite no effects immediately post-intervention during infancy ([<reflink idref="bib27" id="ref50">27</reflink>]). Measuring dynamic changes in attention in infancy is challenging. It is possible that undetected changes in attention in infancy are consolidated into observable effects over the course of development ([<reflink idref="bib49" id="ref51">49</reflink>])—for example, through interaction with other cognitive processes ([<reflink idref="bib34" id="ref52">34</reflink>]; [<reflink idref="bib40" id="ref53">40</reflink>]). Alternatively, they may become more apparent as a child enters toddlerhood and preschool and begins to encounter situations which require greater attentional control ([<reflink idref="bib21" id="ref54">21</reflink>]). Cognitive training studies with adults and children with ADHD have often failed to incorporate longer-term follow-ups. However, of those that have, there is some indication of 'sleeper effects' (effects that are not observable immediately but are consolidated and emerge over time; [<reflink idref="bib68" id="ref55">68</reflink>]).</p> <p>In the present study, we report the pre-specified results from the follow-up of the INTERSTAARS trial at 2 and 3 years of age. Specifically, we tested the effects of the infancy gaze-contingent attention training intervention on early ADHD behaviours, temperamental traits related to later ADHD, and eye-tracking cognitive attentional control measures.</p> <hd id="AN0194258090-3">Methods</hd> <p></p> <hd id="AN0194258090-4">Participants and Design</hd> <p>INTERSTAARS was a Phase 2 randomised controlled trial conducted at two sites in the UK (London and Southampton). Forty-three 9- to 16-month-old infants with a first-degree relative (parent or older sibling) with a clinical or probable diagnosis of ADHD were randomised into the study. Participants were randomised to either the intervention (a home-based gaze-contingent attention training programme; <emph>n</emph> = 20) or active control (<emph>n</emph> = 23) group. Full methodological details for the trial, including details of the intervention and control programmes, can be found in the study protocol ([<reflink idref="bib25" id="ref56">25</reflink>]) and trial endpoint paper ([<reflink idref="bib24" id="ref57">24</reflink>]). The cognitive domains targeted by the games included conflict resolution (maintaining gaze towards a less salient target area while more salient non-targets were presented in the visual field), sustained attention (maintaining gaze on a stimulus to receive an audiovisual reward), working memory (remembering where to look to receive an audiovisual reward, e.g. an infant-friendly animation), and cognitive control (inhibiting a previous rule to learn a new one, and receive an audiovisual reward). Infants received up to nine weekly home-based sessions of the attention training (intervention arm) or an active control of infant-friendly non-gaze-contingent television clips (control arm). Exclusion criteria were (a) serious medical or developmental conditions such as epilepsy, heart conditions, cerebral palsy, intellectual disability, (b) significant uncorrected vision or hearing problems, (c) significant prematurity (&lt;36 weeks), (d) genetic conditions (e.g., Down's syndrome), (e) equipment unable to reliably track participant eyes during the baseline assessment after four attempts (<emph>n</emph> = 2).</p> <p>Immediate post-trial outcomes at the infant time point can be found in [<reflink idref="bib24" id="ref58">24</reflink>]. The present study focuses on the long-term follow-up of participants to the toddler and preschool period. Participant families were invited to King's College London for follow-up assessments when their child was 2 and 3 years of age. A slightly non-overlapping set of 30 families returned for follow-up at 2 years, and 30 families at 3 years (see Figure 1, Table 2). Ethical approval for the original randomised controlled trial and the present follow-up study was obtained from the London Central NHS Research Ethics Service (15/LO/0407). Parents of all participants provided written consent. The original randomised controlled was registered on ISRCTN (ISRCTN37683928, June 2015). Follow-up analyses and selected outcome measures were pre-specified on AsPredicted (MQ-INTERSTAARS Follow-up, #128765: https://aspredicted.org/gy9v-2ppb.pdf).</p> <p>Graph: Figure 1. CONSORT participant flow diagram.</p> <hd id="AN0194258090-5">Outcome Measures</hd> <p></p> <hd id="AN0194258090-6">Primary Outcome</hd> <p>Follow-up outcomes at 2 and 3 years focused on preschool ADHD traits, and temperament traits related to the broader ADHD phenotype. The primary outcome was a standardised parent-report measure of early ADHD traits, the DSM ADHD subscale of the Child Behaviour Checklist (CBCL ([<reflink idref="bib1" id="ref59">1</reflink>])) at 2 and 3 years of age. Secondary outcomes were selected to assess broader temperament traits related to the ADHD phenotype and included:</p> <hd id="AN0194258090-7">Secondary Outcomes</hd> <p></p> <hd id="AN0194258090-8">Parent Report Measures</hd> <p>Parent questionnaires also allowed us to assess effects on more generic attention and regulatory skills. We selected the Inhibitory Control and Attention Focusing subscales of the Early Child Behaviour Questionnaire (ECBQ) at 2 years ([<reflink idref="bib52" id="ref60">52</reflink>]) and the Child Behaviour Questionnaire (CBQ) subscales at 3 years ([<reflink idref="bib56" id="ref61">56</reflink>]). For both measures, parents were asked to rate how often their child performed a range of behaviours during the last week on a 1 (never) to 7 (always) subscale.</p> <hd id="AN0194258090-9">Observational Measures</hd> <p>The 2- and 3-year follow-up visits to the laboratory lasted approximately 5 hours (including behavioural, clinical, eye-tracking and EEG assessments), spanning both the morning and afternoon and led by two researchers (who were blind to intervention group allocation). Multiple breaks were taken and the visits spanned two days for families who had to travel a distance to the lab. The eye-tracking tasks were prioritised and conducted in the morning when the toddlers were less fatigued. Following each laboratory visit, the two researchers discussed and agreed a single consensus global code for observed features of early ADHD behaviours (attentiveness, activity level, and inhibition to objects/the environment) across the visit and all tasks and activities undertaken. Using a modified scoring based on the Behaviour Rating Inventory for Children (BRIC) ([<reflink idref="bib26" id="ref62">26</reflink>]) scores for Attentiveness, Activity and Inhibition were agreed on a 1 to 7 Likert scale.[<reflink idref="bib9" id="ref63">9</reflink>]</p> <hd id="AN0194258090-10">Eye tracking measures</hd> <p>A composite of three eye-tracking tasks was selected to assess attentional differences at the neurocognitive level. Children sat on their caregiver's lap ~60 cm away from a computer screen (23-inch, 1920 × 1080 resolution, 16:9 aspect ratio). Eye-tracking data was acquired using a Tobii TX-300 eye tracker (Tobii AB, Stockholm, Sweden) sampling at 120 Hz. Stimuli were presented using a custom-written stimulus presentation framework (Task Engine, sites.google.com/site/taskenginedoc/) and run in Matlab R2020b (The MathWorks Inc., Natick, MA, USA) using Psychtoolbox 3 ([<reflink idref="bib7" id="ref64">7</reflink>]; [<reflink idref="bib37" id="ref65">37</reflink>]). At the beginning of the eye-tracking battery, a five-point calibration sequence was completed and repeated if fewer than four of the five points were accurately calibrated. From the broader battery of eye-tracking tasks (~30 min), three tasks were selected based on their malleability to attention training in previous studies with typically developing infants ([<reflink idref="bib4" id="ref66">4</reflink>]; [<reflink idref="bib64" id="ref67">64</reflink>]), and their inclusion in analyses of this cohort at the infant timepoint ([<reflink idref="bib24" id="ref68">24</reflink>]):</p> <p> <bold>Cognitive control</bold> (adapted from ([<reflink idref="bib39" id="ref69">39</reflink>]; [<reflink idref="bib64" id="ref70">64</reflink>])). A child's ability to learn a rule and later inhibit this information to shift attention to a new rule. The key outcome variable was the average percentage of correct responses in the learning and reversal phases of the task.</p> <p>At the beginning of each trial, the infant is presented with a fixation point in the centre of the screen. Once the infant looks to the fixation point, an audio reward is presented, followed by a visual reward (a short animated clip), which is presented on either the left or right of the screen. The visual reward is presented on 1 side for 9 consecutive trials (pre-switch) before switching to the other side for the subsequent 9 trials (post-switch). Anticipatory saccades are coded based on the child's looking behaviour during the anticipatory window (between the start of the auditory reward and the start of the visual reward). The dependent variable is the percentage of trials in which infants make a correct anticipatory saccade towards the location of the target stimuli in the pre- and post-switch phases.</p> <hd id="AN0194258090-11">Gap Disengagement Effect</hd> <p>A child's ability to disengage their attention from a stimulus ([<reflink idref="bib18" id="ref71">18</reflink>]). The key outcome variable was mean standard reaction time (SRT) in the overlap condition minus the SRT in the baseline condition of the gap-overlap task.</p> <p>The infant is presented with a stimulus in the centre of the screen (central stimulus, CS). Once the infant fixates on this central stimulus, a peripheral stimulus (PS) appears on the left or right of the screen. When the infant moves their gaze from the central to the peripheral stimulus they receive an audiovisual reward. There are three conditions in this task: baseline, overlap and gap. In the baseline condition, the central stimulus disappears at the same time that the peripheral stimulus appears. In the gap condition, there is a 200-ms gap between the removal of the central stimulus and the appearance of the peripheral stimulus. In the overlap condition, the central stimulus remains on the screen after the peripheral stimulus appears. The dependent variable is the saccadic reaction time (ms) to move the eyes from the central to the peripheral stimulus in the overlap minus baseline condition.</p> <p>Online validation: The task was presented in blocks of 12 trials. Each trial was coded as valid or invalid after presentation. Valid trials were those in which: (a) gaze remained on the CS until PS onset; (b) gaze arrived at the PS within 1200 ms of PS onset; (c) gaze did not arrive in less than 200 ms; (d) gaze did not go to the opposite side to the PS (indicative of anticipation). If after the fourth block (48 trials) fewer than 12 valid trials per condition (baseline, gap, overlap) had been acquired, a fifth block was run (total 60 trials).</p> <p>Offline validation: During analysis, each trial of the gap was re-inspected using inhouse software (TaskEngine 3), and re-coded for validity. This allowed a more fine-grained check of the data than during online validation, where time was constrained by the need to present the next trial. Valid trials were those in which: (a) gaze remained on the CS until PS onset, with no contiguous runs of missing data greater than 200 ms; (b) gaze remained on the PS after PS onset, with no runs of missing data greater than 100 ms; (c) gaze was on the CS within ±50 ms of PS onset, with no runs of missing data greater than 50 ms; (d) gaze did not go to the opposite side to the PS; (e) saccadic reaction time was not less than 200 ms or greater than 1200 ms. Final analysis is based on offline validation codes.</p> <p> <bold>Sustained attention</bold> (adapted from ([<reflink idref="bib64" id="ref72">64</reflink>])). A child's ability to maintain attention on a stimulus. The key outcome variable was peak look duration to a non-social wildlife video (where data duration &gt;30 s).</p> <p>The infant is presented with two 'interesting' (complex, detailed) and two 'boring' (noncomplex) static stimuli. For each stimulus, the experimenter records the length of the first 5 of the infant's looks towards the stimulus presentation area by depressing a button while the infant is looking. To qualify as a look the infant must visually engage with the stimulus for at least 1 s. To terminate the look, the infant must disengage from the stimulus for at least 1 s. The longest of the first 5 looks is termed the peak look duration. The dependent variable is the peak look duration averaged across the two blocks of the interesting stimulus presentation.</p> <hd id="AN0194258090-12">Statistical Analysis</hd> <p>A prespecified analysis plan was published at https://aspredicted.org/gy9v-2ppb.pdf, after data collection. All data inspection prior to its publication had occurred blind to the true treatment group assignment variable. All reported outcome measures were based on assessment that followed the trial endpoint, results for which have been previously published. To increase power, models were constructed with time-specific effects at 2 and 3 years that were averaged to be combined into a single criterion. Models were estimated by maximum likelihood in Stata 18.0 using the gsem command using all available data, with outcome distribution and link function chosen to be appropriate for each outcome (Poisson count for CBCL scores, all others normal with robust standard errors for BRIC scores that had limited range), shared random effect to account for the correlation between 2 and 3 year outcomes, and randomisation factors included as covariates. As per the pre-registration, up to two further baseline covariates with 2 df Wald <emph>p</emph> &lt;.05 were also included in the model. Those included were BRIC Level-of-activity for CBQ Attention Focus and Inhibition; mother's age and IBQ Negative Affect for the eye-tracking composite; BRIC Level-of-activity for cognitive control; mother's age and child's age for Gap-overlap; mother's age for sustained attention, and mother's age and Mullen communication score for BRIC Activity level. For normal distribution models we report the average of the 2- and 3-year Cohen's <emph>d</emph> effect estimates (using the time specific within treatment group standard deviation). For the Poisson log-link model for the CBCL, the effect standardisation was based on the difference in the estimated marginal mean CBCL scores divided by the estimated variance of those over-dispersed Poisson scores at that marginal mean at 2 and 3 years respectively. Participants with either 2- or 3-year outcomes (or both) were included in treatment difference analyses. Under an assumption of data missing at random, missing data were ignorable. Appendix 2 of the Supplemental Material includes additional analyses that were not prespecified.</p> <p>The Forest-Plot showing confidence intervals is the currently preferred method for reporting the results of clinical trials, highlighting where the null hypothesis falls in relation to the alternative. Reviewer and Editorial comment encouraged us to consider Bayesian estimation approaches to help quantify evidential certainty. Maximum likelihood estimation for random effects models with small samples is often more straightforward than Bayesian estimation (which was found to be true in our case too), and for non-normal outcomes, where we have used robust standard errors for the confidence intervals, there is no such simple alternative in standard implementations of Bayesian estimation. Nonetheless, we undertook additional non-pre-registered analysis making use of the maximum likelihood derived Bayes factor approximation for evidence classification proposed by [<reflink idref="bib35" id="ref73">35</reflink>].</p> <p>Using chi-squared tests for binary and ordinal variables and t-tests for continuous variables we conducted an attrition analysis to examine differences on key sociodemographic baseline characteristics (group, site, sex, maternal education), the primary endpoint scores (eye tracking measures of disengagement, sustained attention, cognitive control) and the most closely related behavioural secondary endpoint scores (IBQ measures of duration of orienting, activity level and effortful control (regulation)) between those retained versus non-retained. We attempted to run a more parsimonious multivariate logistic regression to test for unique predictors of retention but the model did not resolve due to over-fitting.</p> <hd id="AN0194258090-13">Results</hd> <p>Figure 1 displays the CONSORT diagram extended to follow-up for the primary outcome.</p> <hd id="AN0194258090-14">Retention</hd> <p>From the total sample of 43 infants randomised, 33 (77%) had a primary outcome for this follow-up study (CBCL ADHD score at either or both 2- and 3-year assessments). At a univariate level only IBQ duration of orienting differed between those retained vs. non-retained, with duration of orienting being higher in those non-retained (see Table S1). However, we note that there is a lot of missing data on this measure at the endpoint assessment so this only compares <emph>n</emph> = 3 versus <emph>n</emph> = 30 participants.</p> <p>Table 1 displays the baseline characteristics of the original children by treatment group. Little imbalance is evident. Table 2 displays the summary statistics for the outcome measures studied here. Thirty-three (77%) of children were included in the follow-up analysis of the primary CBCL outcome. Figure 2 displays the effect estimates with signs adjusted such that effects to the right of the null line are considered beneficial, and the associated p-values. Confidence intervals shown are for nominal 95% without correction for multiple testing. There was no intervention effect on the primary outcome parent-rated ADHD behaviours with a negative (favouring the control group) non-significant effect size (ES) −0.28 (95% CIs −0.95 to 0.39). Secondary parent- and researcher-rated child behaviour and eye-tracking attention outcomes also did not differ between the groups with ES ranging from −0.07 (95% CIs −0.60 to 0.46) to 0.42 (95% CIs −0.09 to 0.94).</p> <p>Table 1. Baseline Descriptive Statistics by Treatment Assignment.</p> <p>Graph</p> <p> <ephtml> &lt;table&gt;&lt;colgroup&gt;&lt;col align="left" /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;/colgroup&gt;&lt;thead&gt;&lt;tr&gt;&lt;th align="left" rowspan="3"&gt;Variable&lt;/th&gt;&lt;th align="center" colspan="6"&gt;Treatment assignment&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th align="center" colspan="3"&gt;Control (&lt;italic&gt;N&lt;/italic&gt; = 23)&lt;/th&gt;&lt;th align="center" colspan="3"&gt;Active (&lt;italic&gt;N&lt;/italic&gt; = 20)&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th align="center"&gt;&lt;italic&gt;N&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;Mean&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;SD&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;N&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;Mean&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;SD&lt;/italic&gt;&lt;/th&gt;&lt;/tr&gt;&lt;/thead&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;Maternal age (years)&lt;/td&gt;&lt;td&gt;22&lt;/td&gt;&lt;td&gt;33.71&lt;/td&gt;&lt;td&gt;6.23&lt;/td&gt;&lt;td&gt;19&lt;/td&gt;&lt;td&gt;34.73&lt;/td&gt;&lt;td&gt;3.71&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Maternal education&lt;/td&gt;&lt;td&gt;22&lt;/td&gt;&lt;td /&gt;&lt;td /&gt;&lt;td&gt;19&lt;/td&gt;&lt;td /&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Secondary&lt;/td&gt;&lt;td&gt;9&lt;/td&gt;&lt;td&gt;(41%)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;5&lt;/td&gt;&lt;td&gt;(26%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Graduate&lt;/td&gt;&lt;td&gt;7&lt;/td&gt;&lt;td&gt;(32%)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;10&lt;/td&gt;&lt;td&gt;(53%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Postgraduate&lt;/td&gt;&lt;td&gt;6&lt;/td&gt;&lt;td&gt;(27%)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;4&lt;/td&gt;&lt;td&gt;(21%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Child female&lt;/td&gt;&lt;td&gt;11&lt;/td&gt;&lt;td&gt;(48%)&lt;/td&gt;&lt;td /&gt;&lt;td&gt;9&lt;/td&gt;&lt;td&gt;(45%)&lt;/td&gt;&lt;td /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Child age (months)&lt;/td&gt;&lt;td&gt;23&lt;/td&gt;&lt;td&gt;11.61&lt;/td&gt;&lt;td&gt;1.59&lt;/td&gt;&lt;td&gt;20&lt;/td&gt;&lt;td&gt;11.80&lt;/td&gt;&lt;td&gt;1.61&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;IBQ Activity&lt;/td&gt;&lt;td&gt;23&lt;/td&gt;&lt;td&gt;4.39&lt;/td&gt;&lt;td&gt;1.03&lt;/td&gt;&lt;td&gt;18&lt;/td&gt;&lt;td&gt;4.83&lt;/td&gt;&lt;td&gt;1.10&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;IBQ Orienting&lt;/td&gt;&lt;td&gt;23&lt;/td&gt;&lt;td&gt;3.43&lt;/td&gt;&lt;td&gt;1.12&lt;/td&gt;&lt;td&gt;18&lt;/td&gt;&lt;td&gt;2.67&lt;/td&gt;&lt;td&gt;0.91&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;IBQ Effortful Control&lt;/td&gt;&lt;td&gt;23&lt;/td&gt;&lt;td&gt;4.57&lt;/td&gt;&lt;td&gt;0.66&lt;/td&gt;&lt;td&gt;18&lt;/td&gt;&lt;td&gt;4.56&lt;/td&gt;&lt;td&gt;0.62&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;BRIC Attentiveness&lt;/td&gt;&lt;td&gt;22&lt;/td&gt;&lt;td&gt;3.77&lt;/td&gt;&lt;td&gt;1.51&lt;/td&gt;&lt;td&gt;19&lt;/td&gt;&lt;td&gt;3.16&lt;/td&gt;&lt;td&gt;1.34&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;BRIC Activity&lt;/td&gt;&lt;td&gt;22&lt;/td&gt;&lt;td&gt;5.23&lt;/td&gt;&lt;td&gt;1.27&lt;/td&gt;&lt;td&gt;19&lt;/td&gt;&lt;td&gt;5.42&lt;/td&gt;&lt;td&gt;0.96&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;BRIC Inhibition&lt;/td&gt;&lt;td&gt;22&lt;/td&gt;&lt;td&gt;4.50&lt;/td&gt;&lt;td&gt;1.26&lt;/td&gt;&lt;td&gt;19&lt;/td&gt;&lt;td&gt;4.29&lt;/td&gt;&lt;td&gt;0.87&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Mullen ELC&lt;/td&gt;&lt;td&gt;22&lt;/td&gt;&lt;td&gt;80.59&lt;/td&gt;&lt;td&gt;11.99&lt;/td&gt;&lt;td&gt;19&lt;/td&gt;&lt;td&gt;83.05&lt;/td&gt;&lt;td&gt;9.76&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt; </ephtml> </p> <p>1 <emph>Note</emph>. IBQ = Infant Behaviour Questionnaire; BRIC = behaviour rating inventory for children; Mullen ELC = Mullen early learning composite.</p> <p>Table 2. Follow-up Outcome Measures by Time and Treatment Assignment.</p> <p>Graph</p> <p> <ephtml> &lt;table&gt;&lt;colgroup&gt;&lt;col align="left" /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;col align="char" char="." /&gt;&lt;/colgroup&gt;&lt;thead&gt;&lt;tr&gt;&lt;th align="left" rowspan="4"&gt;Measure&lt;/th&gt;&lt;th align="center" colspan="12"&gt;Treatment assignment&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th align="center" colspan="6"&gt;Control (original &lt;italic&gt;N&lt;/italic&gt; = 23)&lt;/th&gt;&lt;th align="center" colspan="6"&gt;Active (original &lt;italic&gt;N&lt;/italic&gt; = 20)&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th align="center" colspan="3"&gt;24 m&lt;/th&gt;&lt;th align="center" colspan="3"&gt;36 m&lt;/th&gt;&lt;th align="center" colspan="3"&gt;24 m&lt;/th&gt;&lt;th align="center" colspan="3"&gt;36 m&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;th align="center"&gt;&lt;italic&gt;N&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;Mean&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;SD&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;N&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;Mean&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;SD&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;N&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;Mean&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;SD&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;N&lt;/italic&gt;&lt;/th&gt;&lt;th align="center"&gt;Mean&lt;/th&gt;&lt;th align="center"&gt;&lt;italic&gt;SD&lt;/italic&gt;&lt;/th&gt;&lt;/tr&gt;&lt;/thead&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;CBCL-ADHD&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;6.62&lt;/td&gt;&lt;td&gt;2.75&lt;/td&gt;&lt;td&gt;14&lt;/td&gt;&lt;td&gt;5.64&lt;/td&gt;&lt;td&gt;3.05&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;6.75&lt;/td&gt;&lt;td&gt;3.26&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;6.93&lt;/td&gt;&lt;td&gt;3.35&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;CBQ attention&lt;/td&gt;&lt;td&gt;12&lt;/td&gt;&lt;td&gt;4.08&lt;/td&gt;&lt;td&gt;0.74&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;4.37&lt;/td&gt;&lt;td&gt;1.10&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;4.36&lt;/td&gt;&lt;td&gt;1.25&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;3.90&lt;/td&gt;&lt;td&gt;1.33&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;CBQ inhibition&lt;/td&gt;&lt;td&gt;12&lt;/td&gt;&lt;td&gt;3.68&lt;/td&gt;&lt;td&gt;1.18&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;4.33&lt;/td&gt;&lt;td&gt;1.20&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;3.32&lt;/td&gt;&lt;td&gt;0.95&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;3.98&lt;/td&gt;&lt;td&gt;1.14&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;BRIC attentiveness&lt;/td&gt;&lt;td&gt;14&lt;/td&gt;&lt;td&gt;4.43&lt;/td&gt;&lt;td&gt;1.50&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;4.85&lt;/td&gt;&lt;td&gt;1.34&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;4.88&lt;/td&gt;&lt;td&gt;1.20&lt;/td&gt;&lt;td&gt;18&lt;/td&gt;&lt;td&gt;5.17&lt;/td&gt;&lt;td&gt;1.34&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;BRIC activity&lt;/td&gt;&lt;td&gt;14&lt;/td&gt;&lt;td&gt;4.79&lt;/td&gt;&lt;td&gt;1.42&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;4.77&lt;/td&gt;&lt;td&gt;0.93&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;4.94&lt;/td&gt;&lt;td&gt;1.00&lt;/td&gt;&lt;td&gt;18&lt;/td&gt;&lt;td&gt;4.67&lt;/td&gt;&lt;td&gt;0.84&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;BRIC inhibition&lt;/td&gt;&lt;td&gt;14&lt;/td&gt;&lt;td&gt;4.36&lt;/td&gt;&lt;td&gt;0.84&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;4.15&lt;/td&gt;&lt;td&gt;0.55&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;4.06&lt;/td&gt;&lt;td&gt;0.44&lt;/td&gt;&lt;td&gt;18&lt;/td&gt;&lt;td&gt;4.33&lt;/td&gt;&lt;td&gt;0.77&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Cognitive control&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;&amp;#8722;0.04&lt;/td&gt;&lt;td&gt;0.87&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;&amp;#8722;0.28&lt;/td&gt;&lt;td&gt;1.04&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;0.04&lt;/td&gt;&lt;td&gt;1.13&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;0.23&lt;/td&gt;&lt;td&gt;0.94&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Gap disengagement&lt;/td&gt;&lt;td&gt;14&lt;/td&gt;&lt;td&gt;0.03&lt;/td&gt;&lt;td&gt;1.02&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;&amp;#8722;0.04&lt;/td&gt;&lt;td&gt;0.83&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;&amp;#8722;0.01&lt;/td&gt;&lt;td&gt;0.88&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;0.04&lt;/td&gt;&lt;td&gt;1.16&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td&gt;Sustained attention&lt;/td&gt;&lt;td&gt;15&lt;/td&gt;&lt;td&gt;0.13&lt;/td&gt;&lt;td&gt;1.00&lt;/td&gt;&lt;td&gt;13&lt;/td&gt;&lt;td&gt;&amp;#8722;0.36&lt;/td&gt;&lt;td&gt;0.98&lt;/td&gt;&lt;td&gt;16&lt;/td&gt;&lt;td&gt;&amp;#8722;0.13&lt;/td&gt;&lt;td&gt;1.02&lt;/td&gt;&lt;td&gt;17&lt;/td&gt;&lt;td&gt;0.28&lt;/td&gt;&lt;td&gt;0.95&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt; </ephtml> </p> <p>2 <emph>Note</emph>. CBCL = child behaviour checklist; CBQ = Child Behaviour Questionnaire; BRIC = behaviour rating inventory for children.</p> <p>Graph: Figure 2. Standardised effect estimates for primary and secondary outcomes. Note. R prefix indicates reverse scale. CBCL = child behaviour checklist; CBQ = child behaviour Questionnaire; BRIC = behaviour rating inventory for children.</p> <p>Given positive trends for some measures we used the Bayes factor approximation for evidence classification proposed by [<reflink idref="bib35" id="ref74">35</reflink>]. Likelihood ratio estimates for CBQ inhibition (2.54), the composite (2.52) and sustained attention (5.67) provide positive evidence (values between 2 and 6) of an intervention effect. For all other outcomes shown in the forest plot, there was no evidence worthy of mention for or against the intervention (values less than 2).</p> <p>Additional analyses not included in the pre-specification were run on measures derived from the CBCL-ADHD subscale for attention, activity and impulsivity (2-items each); time paths of the eye-tracking attention measures; and time paths of the researcher-rated BRIC attention and activity measures (see Supplemental Materials). None of these were significant.</p> <hd id="AN0194258090-15">Discussion</hd> <p>Retention from the infancy endpoint to the 2- and 3-year follow-up was adequate with 77% of the sample retained with a primary outcome assessment at either or both 2 and 3 years. Attrition analysis did not reveal differential retention by key sociodemographic baseline characteristic or primary or secondary endpoint scores, except that non-retained participants had higher endpoint IBQ Duration of Orienting scores than those retained. Nevertheless, there was no significant intervention effect on the primary outcome of parent-rated early ADHD behaviours. Nor did we observe any intervention effect on the secondary outcomes of parent- and researcher-rated attention and inhibition or on the eye-tracking measures of attentional control. In addition to the pre-registered primary and secondary outcomes, we examined non-prespecified outcomes for the individual components comprising parent-reported early ADHD behaviours (attention, activity and impulsivity) and also additional time path analysis from baseline to follow-up on the eye-tracking measures and the researcher ratings of child attentiveness, activity and inhibition. None of these were significant. The null findings we report follow on from the previously reported endpoint finding of no intervention effect on either parent- or observer-rated infant attention or the endpoint primary outcome of an eye-tracking composite of infant attention ([<reflink idref="bib24" id="ref75">24</reflink>]). Thus, the results of the current trial analysis do not provide support for the notion that undetected changes in attentional control in infancy led to later attentional behavioural changes ([<reflink idref="bib49" id="ref76">49</reflink>]).</p> <p>The largest positive and moderate size, albeit non-significant, effects were for the secondary outcomes parent-rated inhibitory control (ES = 0.42 (95% CIs −0.09 to 0.94) and the composite eye-tracking measure (ES = 0.40 (95% CIs −0.15 to 0.95). Using the non-pre-registered Bayesian motivated strength of evidence classification of [<reflink idref="bib35" id="ref77">35</reflink>] likelihood ratio estimates for CBQ inhibition, the eye tracking composite and sustained attention provided some but not definitive positive evidence of an intervention effect. In combination these findings justify further interest and exploration in future similar trials. However, none of these outcomes were our pre-registered primary outcome measure in this follow-up study.</p> <p>CBQ inhibition measures toddler ability to inhibit or moderate their behaviour (e.g. wait when asked, stop an ongoing activity)—one of the key executive attention abilities targeted by the training, alongside sustained attention. The composite eye-tracking measure comprises tasks measuring cognitive control (attention shifting), attention disengagement and sustained attention—all components of the developing infant executive attention system targeted by the training. These signals—blind measures of both behaviour and cognitive development in line with the putative mechanism of effect of the attention training intervention—provide some encouragement. However, the overall non-significant primary and secondary outcomes at both trial endpoint ([<reflink idref="bib24" id="ref78">24</reflink>]) and this follow-up indicate that the training did not successfully shift cognitive development or behaviour, at least as measured with this modest sample size. We consider the methodological, measurement and implementation issues that may contribute to this pattern to guide and inform future studies.</p> <p>Prior work with typically developing infants has shown positive effects of the cognitive training on eye-tracking measures of attention, behavioural joint attention measures and physiological measures of stress ([<reflink idref="bib22" id="ref79">22</reflink>]; [<reflink idref="bib64" id="ref80">64</reflink>]; [<reflink idref="bib65" id="ref81">65</reflink>]). However, none of these studies reported on longer term neurocognitive or behavioural outcomes. The intervention has also shown preliminary positive findings in preterm infants, infants from low socioeconomic status backgrounds and toddlers with autism traits ([<reflink idref="bib4" id="ref82">4</reflink>]; [<reflink idref="bib50" id="ref83">50</reflink>]; [<reflink idref="bib57" id="ref84">57</reflink>]). By design the gaze-contingent training games targeted multiple components of the developing attention system including conflict resolution, sustained attention, working memory and cognitive control. However, in a partially overlapping cohort of ADHD family history infants, we found that parent and researcher ratings of attention were not associated with later ADHD traits but that ratings of activity were ([<reflink idref="bib24" id="ref85">24</reflink>]). Further longitudinal studies spanning the infancy to school age period are needed to help us to better understand how each of these components and other developmental characteristics such as dysregulation, irritability and negative affect relate to later ADHD symptom domains ([<reflink idref="bib47" id="ref86">47</reflink>]) that might then allow testing of more targeted or refined pre-emptive interventions. The current study focused on infants with a family history of ADHD who themselves are at elevated likelihood of developing ADHD and / or having elevated ADHD traits ([<reflink idref="bib32" id="ref87">32</reflink>]; [<reflink idref="bib42" id="ref88">42</reflink>]; [<reflink idref="bib55" id="ref89">55</reflink>]; [<reflink idref="bib62" id="ref90">62</reflink>]). Infant cognitive control training approaches that have shown promise in other populations may not have the same effect for these infants. A wide number of pre-, peri- and post-natal factors are known to be associated with ADHD, including family history of psychiatric disorders, maternal obesity, smoking during pregnancy, preeclampsia, childhood atopic diseases, breastfeeding and parenting style ([<reflink idref="bib6" id="ref91">6</reflink>]; [<reflink idref="bib29" id="ref92">29</reflink>]; [<reflink idref="bib36" id="ref93">36</reflink>]). These factors may impact on the effectiveness of cognitive training in ADHD family history infants and should be considered in future clinical trials. However, such studies would require large sizes if these factors were to be incorporated into trial inclusion criteria to ensure balance following randomisation or in order to be tested as moderators of intervention effects; and also may limit the generalisability of the findings to the wider ADHD population. Another issue that future studies will need to address is the longer-term outcomes of such infant initiated interventions given that preschool ADHD symptoms show moderate but not high stability into the school age years ([<reflink idref="bib45" id="ref94">45</reflink>]; [<reflink idref="bib48" id="ref95">48</reflink>]; [<reflink idref="bib63" id="ref96">63</reflink>]).</p> <p>Although adherence to the intervention protocol in terms of sessions attended was good (reported in ([<reflink idref="bib24" id="ref97">24</reflink>])) the nine sessions were weekly and on average spread over 93 days. Previous trials have had shorter and more intense training periods e.g. 14 to 16 days ([<reflink idref="bib22" id="ref98">22</reflink>]; [<reflink idref="bib64" id="ref99">64</reflink>]) and this change to the intensity of the protocol may have impacted the findings. Both of these studies reported increases in sustained attention following the training ([<reflink idref="bib22" id="ref100">22</reflink>]; [<reflink idref="bib64" id="ref101">64</reflink>]). In the current trial we did not find improvements at endpoint (ES = −0.05 (95% CIs −1.23 to 0.39)) ([<reflink idref="bib24" id="ref102">24</reflink>]) but at follow-up sustained attention had improved in the attention training group (ES = 0.34 (95% CIs −0.11 to 0.80)) albeit non-significantly. The weekly training sessions were home-based and eye-tracking fidelity (the proportion of time the eye-tracker detected the infant's gaze) was only moderate (68%); meaning the games sometimes reacted as though the infant was not looking when they were ([<reflink idref="bib24" id="ref103">24</reflink>]). It may be that ADHD family history infants require more intense or extended training to shift cognitive development than the current intervention was able to achieve. Future studies could test the relative efficacy of 'dose' in terms of total duration and sequencing of sessions with ADHD family history infants, as well as combining cognitive attention training with parent-mediated behavioural interventions ([<reflink idref="bib53" id="ref104">53</reflink>]).</p> <p>A cautionary note is that whilst meta-analysis of cognitive training approaches for children with a diagnosis of ADHD show positive effects on working memory performance, they do not show clear impacts on blinded measures of ADHD symptoms ([<reflink idref="bib14" id="ref105">14</reflink>]). However, the principle behind pre-emptive interventions for infants with an elevated likelihood of ADHD during the period of increased plasticity that motivated this study still stands ([<reflink idref="bib41" id="ref106">41</reflink>]; [<reflink idref="bib42" id="ref107">42</reflink>]). We note that in another neurodevelopmental condition pre-emptive parent-mediated social communication interventions show some evidence of benefit, including at follow up, in infants with an elevated likelihood of autism ([<reflink idref="bib27" id="ref108">27</reflink>]; [<reflink idref="bib69" id="ref109">69</reflink>]).</p> <hd id="AN0194258090-16">Conclusion</hd> <p>This study builds on our earlier report ([<reflink idref="bib24" id="ref110">24</reflink>]) to demonstrate the feasibility of conducting experimental trials targeting early emerging ADHD characteristics in infancy. Notably our study combined both neurocognitive and behavioural measurement of outcome following the experimental computer-based gaze-contingent cognitive training programme. In addition, we followed infants beyond endpoint for up to 18 months to age 3 years which has been done in few infant experimental studies of this kind. However, the intervention did not lead to differences in parent- or researcher-rated early ADHD behaviours, parent-rated ADHD-related temperament characteristics, or eye-tracking measures of attention control. Further development and modification of the attention training may be necessary to test whether the approach holds promise as a potential pre-emptive intervention for infants with an elevated likelihood of ADHD.</p> <hd id="AN0194258090-17">Supplemental Material</hd> <p>Graph: Supplemental material, sj-docx-1-jad-10.1177_10870547261428660 for Randomised Controlled Trial of Gaze-Based Attention Training Intervention for Infants With a Family History of Attention Deficit Hyperactivity Disorder: Follow-up Outcomes at 2 and 3 Years by Amy Goodwin, Emily JH Jones, Tony Charman, Jannath Begum-Ali, Greg Pasco, Luke Mason, Rebecca Holman, Simona Salomone, Alexandra Hendry, Tessel Bazelmans, Tim J Smith, Edmund JS Sonuga-Barke, Patrick Bolton, Sam Wass, Andrew Pickles and Mark H Johnson in Journal of Attention Disorders</p> <p>We thank the study families for the time and effort involved in participation. The INTERSTAARS Team comprises: Mary Agyapong, Eleanor Braithwaite, Samuele Cortese, Laurel Fish, Hanna Halkola, Chelsea Hobbs, Catherine J Holden, Anna Hunt, Sarah Kalwarowsky, Anna Kolesnik, Irina Manneraak, Nisha Narvekar, Ceri Peck, Giulia Pecora, Emily Robinson, Martin Ruddock, Abigail Runicles, Elle Scott, Salomé Silva, Harsharon Kaur Sondh, Chloe Taylor, Megan Tongs, George Vamvakas. We thank Professors Christopher Hollis (University of Nottingham), Richard Ashcroft (Queen Mary University) and Daniel Almirall (University of Michigan) for serving on the Independent Data Monitoring and Ethics Committee. For the purposes of open access, the author has applied a Creative Commons Attribution (CC BY) license to any Accepted Author Manuscript version arising from this submission.</p> <ref id="AN0194258090-18"> <title> Footnotes </title> <blist> <bibl id="bib1" idref="ref59" type="bt">1</bibl> <bibtext> Tony Charman</bibtext> </blist> <blist> <bibtext>Graph https://orcid.org/0000-0003-1993-6549</bibtext> </blist> <blist> <bibl id="bib2" idref="ref1" type="bt">2</bibl> <bibtext> Ethical approval for the original randomised controlled trial and the present follow-up study was obtained from the London Central NHS Research Ethics Service (15/LO/0407). Parents / carers of all participants provided written consent.</bibtext> </blist> <blist> <bibl id="bib3" idref="ref21" type="bt">3</bibl> <bibtext> Authors: AG, EJHJ, TC, AP, MHJ wrote the manuscript. EJHJ, MHJ, SW, AP, TC, TJS, ESB, PB, AG, LM, SS contributed to trial design. MHJ, EJHJ, ESB, SW, TS, PB, TC contributed to grant funding. AP conducted statistical analysis. AG, SS, RH, AH, TB, JBA, GP, INTERSTAARS Team collected data. LM, AG, EJHJ developed analytic pipelines. AG, LM, EJHJ, SW, RH, AH, TB, JBA, GP, INTERSTAARS Team processed and coded data. AG, EJHJ, JBA, GP, TC supervised data quality. All authors read and approved the final manuscript as submitted.</bibtext> </blist> <blist> <bibl id="bib4" idref="ref41" type="bt">4</bibl> <bibtext> The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by awards from MQ (MQ14PP83; MHJ, EJHJ, TC, SW, PB, TS, ESB) and the Medical Research Council (MR/K021389/1, MR/T003057/1; MHJ, TC, EJHJ, AP). AP received additional support from the NIHR KCL/South London and Maudsley NHS Foundation Trust Biomedical Research Centre and Senior Investigator Award NF-SI-0617-10120. The funder had no role in study design, data collection, data analysis, data interpretation, or writing the report. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.</bibtext> </blist> <blist> <bibl id="bib5" idref="ref25" type="bt">5</bibl> <bibtext> The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: SW has worked as a consultant for Lego, Fisher Price, Aardman Animations, Sky, Nikelodeon, the Discovery Channel and others. AP reports questionnaire royalties from WPS. TC has received consultancy fees from F. Hoffmann-La Roche Ltd. and royalties from Sage Publications and Guilford Press. ESB has received speaker fees from Shire, QBTech; received consultancy fees from Neurotech Solutions; and research support from Shire, QBTech. MHJ receives royalties from Wiley-Blackwell, OUP and MIT Press. The remaining authors have declared that they have no competing or potential conflicts of interest.</bibtext> </blist> <blist> <bibl id="bib6" idref="ref91" type="bt">6</bibl> <bibtext> Data are available following a review of requests subject to BASIS data sharing policies and ethical permissions as indicated here: https://<ulink href="http://www.basisnetwork.org/collaboration-and-project-affiliation/">www.basisnetwork.org/collaboration-and-project-affiliation/</ulink></bibtext> </blist> <blist> <bibl id="bib7" idref="ref64" type="bt">7</bibl> <bibtext> The randomised controlled trial was registered on ISRCTN (ISRCTN37683928: https://<ulink href="http://www.isrctn.com/ISRCTN37683928">www.isrctn.com/ISRCTN37683928</ulink>)</bibtext> </blist> <blist> <bibl id="bib8" idref="ref13" type="bt">8</bibl> <bibtext> Supplemental material for this article is available online.</bibtext> </blist> <blist> <bibl id="bib9" idref="ref28" type="bt">9</bibl> <bibtext> High activity and Low inhibition (high impulsivity) were reversed scored in analysis.</bibtext> </blist> <blist> <bibtext> * Joint senior authors</bibtext> </blist> <blist> <bibtext> # INTERSTAARS Team listed in the Acknowledgements</bibtext> </blist> </ref> <ref id="AN0194258090-19"> <title> References </title> <blist> <bibtext> Achenbach T. 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Development and Psychopathology, 29(1), 107–120. https://doi.org/10.1017/S0954579415001236</bibtext> </blist> </ref> <aug> <p>By Amy Goodwin; Emily JH Jones; Tony Charman; Jannath Begum-Ali; Greg Pasco; Luke Mason; Rebecca Holman; Simona Salomone; Alexandra Hendry; Tessel Bazelmans; Tim J Smith; Edmund JS Sonuga-Barke; Patrick Bolton; Sam Wass; Andrew Pickles and Mark H Johnson</p> <p>Reported by Author; Author; Author; Author; Author; Author; Author; Author; Author; Author; Author; Author; Author; Author; Author; Author</p> <p></p> <p>Amy Goodwin is a Post-Doctoral Researcher at the Institute of Psychiatry, Psychology and Neuroscience, King's College London. She co-ordinated Preschool Brain Imaging and Behaviour Project, a Europe-wide longitudinal study of early brain and cognitive development in children with and without neurodevelopmental conditions (such as autism, ADHD, developmental delay and epilepsy).</p> <p>Emily JH Jones is Professor of Developmental Translational Neuroscience at the Institute of Psychiatry, Psychology and Neuroscience, King's College London and Birkbeck College, University of London. Her research interests centre on understanding the cognitive and neural mechanisms that drive variability in the developmental trajectories of young children (BOND lab).</p> <p>Tony Charman is Emeritus Professor of Clinical Child Psychology at the Institute of Psychiatry, Psychology and Neuroscience, King's College London. His research aims to better understand development and mental health in autism and the clinical application of this work via screening, diagnostic, intervention and family history studies.</p> <p>Jannath Begum-Ali is a Post-Doctoral Researcher at Birkbeck College, University of London. She manages the Studying Autism and ADHD in earRly yearS (STAARS) project researching the early development of baby brothers and sisters of children with autism, ADHD and typical development. She is interested in early brain development and how individual differences in infancy can affect later life.</p> <p>Greg Pasco is a Post-Doctoral Researcher at the Institute of Psychiatry, Psychology and Neuroscience, King's College London and Birkbeck College, University of London. He leads on the clinical assessments in the BASIS and STAARS family history studies.</p> <p>Luke Mason is Lecturer in Biomarker Analysis at the Institute of Psychiatry, Psychology and Neuroscience, King's College London. His primary interest is in developing biomarkers of typical and atypical development, and using these in the contexts of psychiatric and neurodevelopmental conditions, and in global health studies.</p> <p>Rebecca Holman is a Research Assistant at Birkbeck College, University of London. She is interested in early interventions and how atypical development of emotional regulation strategies in infancy could predict behavioural problems in children with autism and ADHD.</p> <p>Simona Salomone was a Post-Doctoral Researcher at Birkbeck College, University of London. She is an experienced Clinical Trial Manager with a demonstrated history of working in the higher education industry.</p> <p>Alexandra Hendry is a Post-Doctoral Researcher at the University of Oxford. Her research focuses on developing ways to identify and help children most likely to struggle with executive functions. She leads the START (Supporting Toddlers with a family history of autism/ADHD to develop strong Attention, Regulation and Thinking skills) study.</p> <p>Tessel Bazelmans is a Post-Doctoral Researcher at the Institute of Psychiatry, Psychology and Neuroscience, King's College London and Birkbeck College, University of London. She is interested in understanding early neurotypical and neurodiverse development, with a focus on attention, sensory processing, and temperament.</p> <p>Tim J Smith is Professor in Data Science at the University of the Arts, London. He leads the Cognition in Naturalistic Environments (CINE) Lab which studies the relationship between media and minds across the lifespan.</p> <p>Edmund JS Sonuga-Barke is the Professor of Developmental Psychology, Psychiatry and Neuroscience at the Institute of Psychiatry, Psychology and Neuroscience, Kings College London, UK. He has conducted interdisciplinary research into the causes and treatment of ADHD—which has spanned thirty years.</p> <p>Patrick Bolton is a former Professor in Child &amp; Adolescent Psychiatry at the Institute of Psychiatry, Psychology and Neuroscience, King's College London. He has a particular interest in autism and the behavioural phenotypes of genetic disorders.</p> <p>Sam Wass is Professor at the University of East London. He is a developmental cognitive neuroscientist and Director of the Institute for the Science of Early Years and Youth (ISEY) which develops innovative, world-leading methods to study how early environments shape early development.</p> <p>Andrew Pickles is Emeritus Professor of Biostatistics and Psychological Methods at the Institute of Psychiatry, Psychology and Neuroscience, King's College London. His methodological work has dealt with longitudinal models for developmental data and the many and varied impacts of measurement error and how these can be overcome.</p> <p>Mark H Johnson is Professor of Experimental Psychology (1931) at the University of Cambridge and Birkbeck College, University of London. His laboratory currently focuses on typical, at-risk and atypical functional brain development in human infants and toddlers using a variety of different brain imaging, cognitive, behavioural, genetic and computational modelling techniques.</p> </aug> <nolink nlid="nl1" bibid="bib20" firstref="ref2"></nolink> <nolink nlid="nl2" bibid="bib51" firstref="ref3"></nolink> <nolink nlid="nl3" bibid="bib54" firstref="ref4"></nolink> <nolink nlid="nl4" bibid="bib16" firstref="ref5"></nolink> <nolink nlid="nl5" bibid="bib33" firstref="ref6"></nolink> <nolink nlid="nl6" bibid="bib38" firstref="ref7"></nolink> <nolink nlid="nl7" bibid="bib58" firstref="ref8"></nolink> <nolink nlid="nl8" bibid="bib46" firstref="ref9"></nolink> <nolink nlid="nl9" bibid="bib47" firstref="ref10"></nolink> <nolink nlid="nl10" bibid="bib17" firstref="ref11"></nolink> <nolink nlid="nl11" bibid="bib70" firstref="ref12"></nolink> <nolink nlid="nl12" bibid="bib11" firstref="ref14"></nolink> <nolink nlid="nl13" bibid="bib59" firstref="ref15"></nolink> <nolink nlid="nl14" bibid="bib32" firstref="ref16"></nolink> <nolink nlid="nl15" bibid="bib42" firstref="ref17"></nolink> <nolink nlid="nl16" bibid="bib10" firstref="ref18"></nolink> <nolink nlid="nl17" bibid="bib19" firstref="ref19"></nolink> <nolink nlid="nl18" bibid="bib44" firstref="ref20"></nolink> <nolink nlid="nl19" bibid="bib43" firstref="ref22"></nolink> <nolink nlid="nl20" bibid="bib61" firstref="ref23"></nolink> <nolink nlid="nl21" bibid="bib23" firstref="ref24"></nolink> <nolink nlid="nl22" bibid="bib15" firstref="ref26"></nolink> <nolink nlid="nl23" bibid="bib13" firstref="ref27"></nolink> <nolink nlid="nl24" bibid="bib60" firstref="ref29"></nolink> <nolink nlid="nl25" bibid="bib14" firstref="ref30"></nolink> <nolink nlid="nl26" bibid="bib68" firstref="ref31"></nolink> <nolink nlid="nl27" bibid="bib41" firstref="ref34"></nolink> <nolink nlid="nl28" bibid="bib67" firstref="ref36"></nolink> <nolink nlid="nl29" bibid="bib64" firstref="ref37"></nolink> <nolink nlid="nl30" bibid="bib22" firstref="ref38"></nolink> <nolink nlid="nl31" bibid="bib65" firstref="ref39"></nolink> <nolink nlid="nl32" bibid="bib66" firstref="ref40"></nolink> <nolink nlid="nl33" bibid="bib50" firstref="ref42"></nolink> <nolink nlid="nl34" bibid="bib57" firstref="ref43"></nolink> <nolink nlid="nl35" bibid="bib25" firstref="ref44"></nolink> <nolink nlid="nl36" bibid="bib28" firstref="ref45"></nolink> <nolink nlid="nl37" bibid="bib30" firstref="ref46"></nolink> <nolink nlid="nl38" bibid="bib31" firstref="ref47"></nolink> <nolink nlid="nl39" bibid="bib24" firstref="ref48"></nolink> <nolink nlid="nl40" bibid="bib27" firstref="ref50"></nolink> <nolink nlid="nl41" bibid="bib49" firstref="ref51"></nolink> <nolink nlid="nl42" bibid="bib34" firstref="ref52"></nolink> <nolink nlid="nl43" bibid="bib40" firstref="ref53"></nolink> <nolink nlid="nl44" bibid="bib21" firstref="ref54"></nolink> <nolink nlid="nl45" bibid="bib52" firstref="ref60"></nolink> <nolink nlid="nl46" bibid="bib56" firstref="ref61"></nolink> <nolink nlid="nl47" bibid="bib26" firstref="ref62"></nolink> <nolink nlid="nl48" bibid="bib37" firstref="ref65"></nolink> <nolink nlid="nl49" bibid="bib39" firstref="ref69"></nolink> <nolink nlid="nl50" bibid="bib18" firstref="ref71"></nolink> <nolink nlid="nl51" bibid="bib35" firstref="ref73"></nolink> <nolink nlid="nl52" bibid="bib55" firstref="ref89"></nolink> <nolink nlid="nl53" bibid="bib62" firstref="ref90"></nolink> <nolink nlid="nl54" bibid="bib29" firstref="ref92"></nolink> <nolink nlid="nl55" bibid="bib36" firstref="ref93"></nolink> <nolink nlid="nl56" bibid="bib45" firstref="ref94"></nolink> <nolink nlid="nl57" bibid="bib48" firstref="ref95"></nolink> <nolink nlid="nl58" bibid="bib63" firstref="ref96"></nolink> <nolink nlid="nl59" bibid="bib53" firstref="ref104"></nolink> <nolink nlid="nl60" bibid="bib69" firstref="ref109"></nolink> |
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| Header | DbId: eric DbLabel: ERIC An: EJ1507681 AccessLevel: 3 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Randomised Controlled Trial of Gaze-Based Attention Training Intervention for Infants with a Family History of Attention Deficit Hyperactivity Disorder: Follow-Up Outcomes at 2 and 3 Years – Name: Language Label: Language Group: Lang Data: English – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Amy+Goodwin%22">Amy Goodwin</searchLink><br /><searchLink fieldCode="AR" term="%22Emily+J%2E+H%2E+Jones%22">Emily J. H. Jones</searchLink><br /><searchLink fieldCode="AR" term="%22Tony+Charman%22">Tony Charman</searchLink> (ORCID <externalLink term="https://orcid.org/0000-0003-1993-6549">0000-0003-1993-6549</externalLink>)<br /><searchLink fieldCode="AR" term="%22Jannath+Begum-Ali%22">Jannath Begum-Ali</searchLink><br /><searchLink fieldCode="AR" term="%22Greg+Pasco%22">Greg Pasco</searchLink><br /><searchLink fieldCode="AR" term="%22Luke+Mason%22">Luke Mason</searchLink><br /><searchLink fieldCode="AR" term="%22Rebecca+Holman%22">Rebecca Holman</searchLink><br /><searchLink fieldCode="AR" term="%22Simona+Salomone%22">Simona Salomone</searchLink><br /><searchLink fieldCode="AR" term="%22Alexandra+Hendry%22">Alexandra Hendry</searchLink><br /><searchLink fieldCode="AR" term="%22Tessel+Bazelmans%22">Tessel Bazelmans</searchLink><br /><searchLink fieldCode="AR" term="%22Tim+J%2E+Smith%22">Tim J. Smith</searchLink><br /><searchLink fieldCode="AR" term="%22Edmund+J%2E+S%2E+Sonuga-Barke%22">Edmund J. S. Sonuga-Barke</searchLink><br /><searchLink fieldCode="AR" term="%22Patrick+Bolton%22">Patrick Bolton</searchLink><br /><searchLink fieldCode="AR" term="%22Sam+Wass%22">Sam Wass</searchLink><br /><searchLink fieldCode="AR" term="%22Andrew+Pickles%22">Andrew Pickles</searchLink><br /><searchLink fieldCode="AR" term="%22Mark+H%2E+Johnson%22">Mark H. Johnson</searchLink><br /><searchLink fieldCode="AR" term="%22INTERSTAARS+Team%22">INTERSTAARS Team</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="SO" term="%22Journal+of+Attention+Disorders%22"><i>Journal of Attention Disorders</i></searchLink>. 2026 30(7):901-915. – Name: Avail Label: Availability Group: Avail Data: SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com – Name: PeerReviewed Label: Peer Reviewed Group: SrcInfo Data: Y – Name: Pages Label: Page Count Group: Src Data: 15 – Name: DatePubCY Label: Publication Date Group: Date Data: 2026 – Name: TypeDocument Label: Document Type Group: TypDoc Data: Journal Articles<br />Reports - Research – Name: Subject Label: Descriptors Group: Su Data: <searchLink fieldCode="DE" term="%22Eye+Movements%22">Eye Movements</searchLink><br /><searchLink fieldCode="DE" term="%22Infants%22">Infants</searchLink><br /><searchLink fieldCode="DE" term="%22Training%22">Training</searchLink><br /><searchLink fieldCode="DE" term="%22Intervention%22">Intervention</searchLink><br /><searchLink fieldCode="DE" term="%22Attention+Deficit+Hyperactivity+Disorder%22">Attention Deficit Hyperactivity Disorder</searchLink><br /><searchLink fieldCode="DE" term="%22Toddlers%22">Toddlers</searchLink><br /><searchLink fieldCode="DE" term="%22Program+Effectiveness%22">Program Effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Outcomes+of+Treatment%22">Outcomes of Treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Inhibition%22">Inhibition</searchLink><br /><searchLink fieldCode="DE" term="%22Self+Control%22">Self Control</searchLink><br /><searchLink fieldCode="DE" term="%22Attention+Control%22">Attention Control</searchLink><br /><searchLink fieldCode="DE" term="%22Foreign+Countries%22">Foreign Countries</searchLink><br /><searchLink fieldCode="DE" term="%22Child+Behavior%22">Child Behavior</searchLink> – Name: Subject Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22United+Kingdom+%28London%29%22">United Kingdom (London)</searchLink><br /><searchLink fieldCode="DE" term="%22United+Kingdom+%28England%29%22">United Kingdom (England)</searchLink> – Name: SubjectThesaurus Label: Assessment and Survey Identifiers Group: Su Data: <searchLink fieldCode="SU" term="%22Child+Behavior+Checklist%22">Child Behavior Checklist</searchLink> – Name: DOI Label: DOI Group: ID Data: 10.1177/10870547261428660 – Name: ISSN Label: ISSN Group: ISSN Data: 1087-0547<br />1557-1246 – Name: Abstract Label: Abstract Group: Ab Data: Objective: A previous randomised controlled trial of a computerised gaze-contingent attention training for 9-to-16-month infants with a family history of ADHD (intervention, n=20; control, n=23) found no endpoint differences on the primary outcome (an eye-tracking composite score of infant attention) nor on secondary outcomes (parent and observer ratings of infant attention in naturalistic contexts).Method: Here, we report follow-up at age 2 and 3 years to examine whether there are longer-term effects of the training. The pre-specified primary outcome was parent-reported early ADHD traits. Secondary outcomes included parent-report of inhibitory control and attention; researcher-rated observational measures of attentiveness, activity level and inhibition; and eye-tracking measures of cognitive control, attention disengagement and sustained attention. Results: At follow-up there was no intervention effect on the primary outcome parent-rated ADHD behaviours (effect size [ES] -0.28, 95% CIs -0.95 to 0.39). Secondary parent- and researcher-rated child behaviour and eye-tracking attention outcomes also did not significantly differ between the groups. The largest positive, albeit non-significant, effects were for the secondary outcomes parent-rated inhibitory control (ES=0.42 (95% CIs -0.09 to 0.94) and the composite eye-tracking measure (ES=0.40 (95% CIs -0.15 to 0.95). Conclusions: We demonstrate the feasibility of conducting experimental trials targeting early emerging ADHD characteristics in infancy. The intervention did not lead to significant differences in parent- or researcher-rated early ADHD behaviours or eye-tracking measures of attention control. However, the trend for long-term effects on CBQ inhibition, the attention composite and sustained attention justifies further interest. Further development and modification of the attention training may be necessary to test whether the approach holds promise as a potential pre-emptive intervention for infants with an elevated likelihood of ADHD. (J. of Att. Dis. 2026; 30(7) 901-915). – Name: AbstractInfo Label: Abstractor Group: Ab Data: As Provided – Name: DateEntry Label: Entry Date Group: Date Data: 2026 – Name: AN Label: Accession Number Group: ID Data: EJ1507681 |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1177/10870547261428660 Languages: – Text: English PhysicalDescription: Pagination: PageCount: 15 StartPage: 901 Subjects: – SubjectFull: Eye Movements Type: general – SubjectFull: Infants Type: general – SubjectFull: Training Type: general – SubjectFull: Intervention Type: general – SubjectFull: Attention Deficit Hyperactivity Disorder Type: general – SubjectFull: Toddlers Type: general – SubjectFull: Program Effectiveness Type: general – SubjectFull: Outcomes of Treatment Type: general – SubjectFull: Inhibition Type: general – SubjectFull: Self Control Type: general – SubjectFull: Attention Control Type: general – SubjectFull: Foreign Countries Type: general – SubjectFull: Child Behavior Type: general – SubjectFull: United Kingdom (London) Type: general – SubjectFull: United Kingdom (England) Type: general – SubjectFull: Child Behavior Checklist Type: general Titles: – TitleFull: Randomised Controlled Trial of Gaze-Based Attention Training Intervention for Infants with a Family History of Attention Deficit Hyperactivity Disorder: Follow-Up Outcomes at 2 and 3 Years Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Amy Goodwin – PersonEntity: Name: NameFull: Emily J. H. Jones – PersonEntity: Name: NameFull: Tony Charman – PersonEntity: Name: NameFull: Jannath Begum-Ali – PersonEntity: Name: NameFull: Greg Pasco – PersonEntity: Name: NameFull: Luke Mason – PersonEntity: Name: NameFull: Rebecca Holman – PersonEntity: Name: NameFull: Simona Salomone – PersonEntity: Name: NameFull: Alexandra Hendry – PersonEntity: Name: NameFull: Tessel Bazelmans – PersonEntity: Name: NameFull: Tim J. Smith – PersonEntity: Name: NameFull: Edmund J. S. Sonuga-Barke – PersonEntity: Name: NameFull: Patrick Bolton – PersonEntity: Name: NameFull: Sam Wass – PersonEntity: Name: NameFull: Andrew Pickles – PersonEntity: Name: NameFull: Mark H. Johnson – PersonEntity: Name: NameFull: INTERSTAARS Team IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 01 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 1087-0547 – Type: issn-electronic Value: 1557-1246 Numbering: – Type: volume Value: 30 – Type: issue Value: 7 Titles: – TitleFull: Journal of Attention Disorders Type: main |
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