Attention-deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention
Conditions
Interventions
Current interventions as of 23/09/2008:
All children will be randomly assigned to either a diet group or a control group. Each group consists of 50 children. From each child at least two blood samples
Sponsors
Wageningen University (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ADHD diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV); diagnoses based on structured psychiatric interviews and standard questionnaires (Abbreviated Conners Scale, ADHD Rating Scale, Strengths and Difficulties Questionnaire) to be completed by parents and teachers 2. Children aged between 4 and 8 3. Children not taking medication such as methylphenidate 4. Parental permission for three blood tests 5. Sufficient command of the Dutch language
Exclusion criteria
Exclusion criteria: 1. Family circumstances hampering completion of the elimination diet 2. Children already on a diet or having been on a diet in the past two months 3. Children receiving behavioural therapy or medication at the time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Abbreviated Conners Scale (ACS) and the ADHD Rating Scale (ARS) are the two major rating scales for the outcomes of this study. They will be used during all measurement points, i.e. M1 (week 0), M2 (week 3), M3 (week 9), M4 (week 11) and M5 (week 13). 1. The ACS consists of 10 questions using a 4-point scale. A score of 15 represents two standard deviations above the mean cut-off. Scores can range from 0 to 30. The ACS will be completed by both the parents and the teacher 2. The ARS is based on the DSM-IV and consists of 9 inattention items and 9 hyperactivity/impulsivity items, and uses a 4-point scale. The answers to each question vary from Never or Rarely (0 points), Sometimes (1 point), Often (2 points) to Very Often (3 points). The ARS will be completed by the parents, teachers and the blinded paediatrician | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. A Structured Psychiatric Interview (SPI), based on DSM-IV criteria, will be used to assess comorbid disorders, like ODD and CD. This interview is taken at M1 (week 0), M3 (week 9) and M5 (week 13) and will be completed by the parents, the teacher and the blinded paediatrician 2. The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire, concerning emotional and conduct problems, hyperactivity/inattention, peer relationship and prosocial behaviour. The answers to each question are Not True, Somewhat True or Certainly True. Parents and the child?s teacher will fill in the SDQ at M2 (week 3), M3 (week 9) and M5 (week 13) 3. Physical complaints of the child will be identified with the Other Complaints Questionnaire. The questions concern the presence or absence of physical complaints such as gastrointestinal problems, headaches, eczema, unusual perspiration, sleep disturbances and asthma. The answers to each question are Yes (often complaints) or No (seldom or never complaints). Parents must fill in the questionnaire at M2 (week 3), M3 (week 9) and M5 (week 13) 4. All IgG-scores, IgE-scores and other blood values will be analysed | — |
Countries
Netherlands
Outcome results
None listed