Condition category
Mental and Behavioural Disorders
Date applied
19/06/2015
Date assigned
22/06/2015
Last edited
22/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Attention deficit/hyperactivity disorder (ADHD) is a developmental condition that has a significant impact on a person’s education, social development and communication. Medication is often used as a treatment but this has limited effects. Psychological approaches, although more acceptable to many, have not worked well, perhaps due to being administered too late in development. The best time to intervene is likely to be in infancy, before the disorder fully develops and when brains are more amenable to positive environmental effects. To test this idea we will undertake a study of a novel computer-based attention training treatment for infants identified as being at increased genetic risk for ADHD. The training approach uses state of the art technology to link attention allocation (as measured by infant gaze) to rewarding images and outcomes on the screen – thus reinforcing concentration and strengthening attention capacity (as previously shown in typically developing infants). We are interested to see whether such effects can also be seen in infants at risk for ADHD, whether there are knock-on effects on early manifestations of ADHD behaviours, and what the brain processes underpinning such effects might be. If the initial study is successful, we will plan a larger scale effectiveness RCT in the near future.

Who can participate?
Children under 12 months old identified as being at increased genetic risk of ADHD as they all have an immediate family member with the condition.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (training group) are given up to 12 weekly ‘in home’ sessions of the computer-based training over a 3 month period (one session a week). Those in group 2 (control) are given up to 12 weekly ‘in home’ sessions (over a 3 month period) of non-contingent videos. The aim is to run the sessions at the participants family home but they can be run in the clinic or in the lab based on the family’s needs and wishes. Pre-training (10 months) and post-training assessments (14 months) are administered both at home and in the lab, at the Centre for Brain and Cognitive Development (CBCD). An intermediate home-based assessment is also carried out after the first six training sessions. In additional, longer-term follow-ups occur at 24 and 36 months through a linked study (MRC-STAARS).

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Centre for Brain and Cognitive Development (London), University of Southampton, King’s College London, South London and Maudsley NHS Foundation Trust and the Solent NHS Trust (UK)

When is the study starting and how long is it expected to run for?
April 2015 to March 2018

Who is funding the study?
MQ Transforming Mental Health (UK)

Who is the main contact?
1. Dr Simona Salomone (public)
2. Dr Emily Jones (scientific)
3. Professor Mark Johnson (scientific)

Trial website

http://www.staars.org/#!interstaars/cm2a

Contact information

Type

Public

Primary contact

Dr Simona Salomone

ORCID ID

http://orcid.org/0000-0002-7658-5784

Contact details

Institute of Psychiatry
Psychology and Neuroscience (IoPPN)
De Crespigny Park
London
se58af
United Kingdom

Type

Scientific

Additional contact

Dr Emily Jones

ORCID ID

Contact details

Centre for Brain and Cognitive Development (CBCD)
Birkbeck College
Malet Street
London
wc1e7hx
United Kingdom

Type

Scientific

Additional contact

Professor Mark Johnson

ORCID ID

Contact details

Centre for Brain and Cognitive Development (CBCD)
Birkbeck College
Malet Street
London
wc1e7hx
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Attention control training for infants at risk of ADHD: a randomised controlled trial

Acronym

INTER-STAARS

Study hypothesis

The study hypotheses are the following:
1. The proposed training programme will improve attention control in infants at familial risk for ADHD
2. These effects will be mediated by changes in the executive attention system and will transfer to a range of testing contexts in the short and medium term
3. These changes in neurocognitive function will be associated with reductions in early emerging symptoms of ADHD

Ethics approval

NRES – London Central, ref: 15/LO/0407.

Study design

Phase 2 randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Infants at risk for Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

1. Training Programme:
Individual training sessions will be conducted by research assistants in the participants’ homes under the supervision of an experienced postdoctoral researcher. The infant training protocol consists of a battery of gaze-contingent adaptive tasks targeting attention control. These tasks are designed to train attention control across cognitive domains that include sustained attention, working memory, visual search and inhibitory control. Tasks are designed to be attractive and enjoyable for infants, to maximise participant retention and acceptability of the intervention to families. Games are adaptive, such that they become harder as infants perform better. This maintains motivation and ensures that training is targeted at an appropriate level for individual infants.
2. Control Training:
The Control group will receive up to 12 weekly ‘in home’ sessions over three months (approximately one session per week) of infant-directed commercial videos. Set-up, procedures, audiovisual complexity and duration of clips will matched to the training condition where possible.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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) then we will select either the lab or the home composite on the basis of which battery has the greater proportion of infants who meet criteria 1, 2 and 3.

Secondary outcome measures

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.

Overall trial start date

01/04/2015

Overall trial end date

30/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Other

Age group

Neonate

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/07/2015

Recruitment end date

30/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre For Brain and Cognitive Development (CBCD) (lead centre)
Birkbeck College, Malet Street
London
WC1E 7HX
United Kingdom

Trial participating centre

University of Southampton
Highfield Campus
Southampton
SO17 1BJ
United Kingdom

Trial participating centre

King's College London
Institute of Psychiatry, Psyschology and Neuroscience (IoPPN), De Crespigny Park
London
SE5 8AF
United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust (SLaM)
Mausdsley Hospital, Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

Solent NHS Trust
Adelaide Health Centre, Western Community Hospital, William Macleod Way
Southampton
SO16 4XE
United Kingdom

Sponsor information

Organisation

Birkbeck College

Sponsor details

Malet Street
Bloomsbury
London
wc1e7hx
United Kingdom

Sponsor type

University/education

Website

http://www.bbk.ac.uk

Funders

Funder type

Charity

Funder name

MQ Transforming Mental Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes