The Study Design

Introduction

The Education Authority was delighted to collaborate on the study with the Dyslexia Research Trust - an Oxford-based charity that has done much research into the causes of learning conditions, and Dr Alex Richardson, senior fellow of Mansfield College at Oxford University, whose specialty is on how fatty acids can help with learning conditions. As it can take several weeks before fatty-acid supplementation show results, the collaborators opted for a simple design: a six-month-long trial throughout the 2002 school year, with a one-way cross-over at the mid-point.

• Nearly 200 children were initially identified. All of the children had some difficulties with coordination - many had additional problems with concentration and learning.
• A total of 12 schools participated, and crucially, the schools were to have a direct role in administering the treatment.
• The capsules were to be randomised, that is, assigned on the basis of a code that none of the researchers were able to access. As we were dealing with very inquisitive children, we had to ensure there was no detectable difference between placebo and active capsules.
• The capsules also had to be double-blinded, meaning that those taking the capsules and those giving out the capsules had to be 'blind' to which participants were on active and which on placebo.
• For the second three months of the trial, all would be on active. Under this design, when the data is analysed, it may be possible to see a response in those under active treatment in the first three months, that would be mirrored by the placebo group, when they switched to active for the second three months.

The Assessments

Recruiting and organising the trial was a major undertaking, but equally important was being very clear about what we were looking for.

We decided that we should greatly extend the various outcome measures so that we could advance the research into many different directions. Dr Portwood has a particular interest in Dyspraxia, while Dr Richardson's research has focused on Dyslexia and ADHD. A comprehensive assessment of each child was completed. Among the measures we assessed were:

• The Wechsler IQ assessment, which has 12 subtests looking at verbal, non-verbal and organisational skills, and distractibility levels
• A Motor assessment.
• Four subtests, including manual dexterity, ball skills, static balance and dynamic balance
• Reading
• Spelling
• Handwriting
• Drawing
• Visual memory
• Auditory memory
• Perceptual skills
• Breath Test
• Excitability/Hyperactivity: Teacher Assessment
• Excitability/Hyperactivity: Parental Assessment