A randomised, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)Mental and Behavioural Disorders
- Registration Number
- ISRCTN47247160
- Lead Sponsor
- Child Psychiatry Department of Radboud University Nijmegen (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1. ADHD combined subtypes or hyperactive/impulsive subtypes diagnosed according to Diagnostic and Statistical Manual of mental disorders fourth edition (DSM IV); diagnoses based on structured psychiatric interviews and standard questionnaires (ten-item Conners list and ADHD rating scale) to be completed by parents and teachers
2. Children aged between three and eight
3. Children not taking or not responding adequately to medication
4. Behavioural problems originating prior to children reaching the age of four
1. Adopted children and foster children
2. Children taking and responding to medication
3. Co-existing neurological diseases, such as epilepsy, neurofibromatosis, etc..,
4. Intelligence Quotient (IQ) below 70
5. Alcohol/drugs use or smoking by mother during pregnancy
6. Prematurity/dysmaturity (children born before 36th week of pregnancy or with a weight below 1500 grams) or problems during delivery requiring admission to the neonatal intensive care unit
7. Children diagnosed Pervasive Developmental Disorder (PDD), Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and/or Multiple-Complex Developmental Disorder (MCDD)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parent and teacher ratings on the 10-item Conners list and the ADHD rating scale. There are three measurement points:<br>1. The start of the trial<br>2. The end of the baseline period, and <br>3. The end of the diet or control period
- Secondary Outcome Measures
Name Time Method 1. Parent ratings on oppositional defiant behaviour, aggressive behaviour, compulsive behaviour, nervous tremors or obsessive behaviour<br>2. Parents ratings on other complaints the child may experience. Questions are asked about physical complaints, such as gastrointestinal problems, headaches, stomach aches, eczema, asthma, ear, nose or throat complaints, nosebleeds, excessive sweating, and sleeping problems