Infants at risk for Attention Deficit Hyperactivity Disorder (ADHD) Mental and Behavioural Disorders
Conditions
Interventions
Training Programme:
Individual training sessions will be conducted by research assistants in the participants’ homes under the supervision of an experienced postdoctoral researcher. Th
Sponsors
Birkbeck College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 12/01/2017 1. Infants will be under 14 months of age at enrolment; 2. Infants will have a first degree relative (an older sibling or a parent) with a clinical and/or research diagnosis of ADHD or a probable diagnosis of ADHD (assessed using DSM IV or V criteria). To note, depending on recruitment's rates, we may also recruit infants with an older sibling or parent with ASD; 3. Infants have agreed to take part in our affiliated STAARS project. Screening procedure for ADHD probable diagnosis: In order to maximise participation in the final months of recruitment the study team aim to introduce a targeted screening approach of specific populations. If an interested family will contact us about INTER-STAARS with a suspected diagnosis of ADHD for either a parent or child, we will assess eligibility using the following criteria: Children 1. For children aged = 6 years old: A shortened version of the Conners 3 (Conners, 2008) will be administered over the phone with a parent by a trained researcher. Cut-offs for inclusion will be: 2.1. Presence of 5 DSM-5 ADHD symptoms on either the inattention scale or the hyperactivity/impulsivity scale. 2.2. Positive score on the impairment scale. Adults 1. A shortened version of the Conners Adult ADHD Rating Scale (CAARS, Conners, Erhart & Sparrow, 2003) will be administered over the phone by a trained researcher. The cut-off for inclusion will be: 1.1. Presence of 5 DSM-5 ADHD symptoms for either the hyperactivity/impulsivity or inattention scale. Original inclusion criteria: 1. Infants will be under 12 months of age at enrolment; 2. Infants will have a first degree relative (an older sibling or a parent) with a clinical and/or research diagnosis of ADHD or a probable diagnosis of ADHD (assessed using DSM IV or V criteria). To note, depending on recruitment's rates, we may also recruit infants with an older sibling or parent with ASD
Exclusion criteria
Exclusion criteria: 1. Serious medical or developmental conditions, such as epilepsy, heart conditions, cerebral palsy, intellectual disability 2. Significant uncorrected vision or hearing problems; 3. Eye-tracker not able to track infants’ eyes after four consecutive attempts as measured during the pre-training home assessment Added 12/01/2017: 4. Down Syndrome in the older sibling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary outcome measure will be a composite measure of: 1. Cognitive control, expressed as the percentage of trials on which infants correctly anticipate the location of the target stimulus during both the learning and reversal phase 2. Disengaging visual attention as measured in the gap-overlap task by the difference in saccadic reaction times between the baseline and the overlap condition 3. Sustained attention, expressed as peak look duration during the interesting condition minus peak look duration during the boring condition (or alternatively we can use the ratio), across both home and lab-based measures. To note, in the lab-based sustained attention task only one type of stimulus is used to calculate the peak look duration Treatment blind analysis will be carried out to assess quality of data collected during testing sessions. Therefore we will use a home-lab composite primary outcome measure score UNLESS the following conditions are not met for at least 75% of the sample: 1. Cognitive control task: each infant must have a minimum 4 trials with anticipations (either correct or incorrect) for both learning and reversal phases 2. Gap-overlap task: each infant must have a minimum of 5 valid trials per condition (baseline, gap, overlap) 3. Sustained attention: a minimum of 4 'looks' per infant during both boring and interesting phases. 4. Time between last home session and post-training lab-visit less than 4 weeks If these conditions are not met for 75% of the sample, then we will EITHER use the home measures only (if 1, 2 and 3 are met for 75% of infants for the home battery, but 4 is not met) or the lab measures only, (if 1, 2 and 3 are not met for the home battery but 4 is met) to calculate the final composite score. If this is not possible (e.g. 1, 2, 3 and 4 are not met for the home battery) the | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will include: 1. Measures of generalisation to behaviour We will employ several behavioural measures of sustained attention and activity level at 14 months. These include: 1.1. Infant Behaviour Questionnaire (IBQ; assessment of temperament including domains such as attentional focusing, effortful control) 1.2. Toy play (duration of attention to objects) 1.3. Early Social Communication Scales (ESCS, Initiating Joint Attention and Responding to Joint Attention tasks) These measures tap behaviours that are relevant in everyday contexts for infants. For example, the IBQ asks about a child’s ability to pay attention for extended periods during book reading or interaction with a parent. Further, performance on these measures has been linked to levels of later ADHD symptoms. Thus, these measures will allow us to assess the generalisability of training effects to naturalistic contexts. | — |
Countries
England, United Kingdom
Contacts
Public ContactAmy Goodwin
Outcome results
None listed