No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Parent and teacher ratings on the 10-item Conners list and the ADHD rating scale. There are three measurement points: (i) the start of the trial; (ii) the end of the baseline period, and (iii) the end of the diet or control period.
Secondary outcome
Parent ratings on oppositional defiant behaviour, aggressive behaviour, compulsive behaviour, nervous tremors or obsessive behaviour.
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.
Background summary
80 children, 3-8 years old, are randomly assigned to either a diet group or a control group. After a two weeks-baseline period, 40 children will follow a four-week food elimination diet, whilst the children assigned to the control group will be placed on a waiting list; they will adhere to their normal food pattern. Children in the control group are not offered any other treatment. Identical questionnaires and measurement times are used for the two groups and will be completed by parents and teachers at the start of the trial, after the baseline period and after the diet- or controlperiod. Following the final measurement, families in the control group may also choose to start the food elimination diet.
Study objective
The effects of foods on children with ADHD will be determined in a randomized, controlled trial. Can the results of earlier open-diet trials in the Netherland, i.e. 60% of the participants showed an improvement in behaviour of 50% or more, be confirmed? The prediction tested is that a few foods diet wil lead to a significant improvement of behaviour in children with ADHD.
Intervention
The children are assigned at random to either a diet group or a control group. Each group consists of 40 children. Following the baseline period, the children placed in the diet group will follow a 4-week food elimination diet, whilst the children assigned to the control group will be placed on a waiting list; they will adhere to their normal food pattern. Children in the control group are not offered any other treatment. Identical questionnaires and measurement times are used for the two groups. Following the final measurement, families in the control group may also choose to start the food elimination diet.
Landluststraat 15
J. Karman
Landluststraat 15
Middelburg 4337 KA
The Netherlands
janckarman@planet.nl
Landluststraat 15
J. Karman
Landluststraat 15
Middelburg 4337 KA
The Netherlands
janckarman@planet.nl
Inclusion criteria
1. ADHD combined subtypes or hyperactive/impulsive subtypes diagnosed according to DSM IV; diagnoses based on structured psychiatric interviews and standard questionnaires (10-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.
Exclusion criteria
1. Adopted children and foster children;
2. Children taking and responding to medication;
3. Co-existing neurological diseases, such as epilepsy, neurofibromatosis, etc.;
4. 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 PDD, PDD-NOS and/or MCDD.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL205 |
| NTR-old | NTR242 |
| Other | : N/A |
| ISRCTN | ISRCTN47247160 |