Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study
Conditions
Keywords
omega-3/omega-6 fatty acids, Pre-school children with ADHD symptoms, randomized controlled trial
Brief summary
The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
Detailed description
The study aims at the reduction of hyperactivity, inattention and impulsivity in pre-school children aged 3-6 years, visiting a preschool, and the prevention of clinical ADHD symptoms. The 3-6 years old children will be identified by a combined parent and teacher rating ADHD-symptoms questionnaire (FBB-ADHS-V). Children with ADHD symptoms \>90th percentile will participate in a following diagnostic process. The children (n = 150) will be randomised doubleblind to a control group (taking every day four capsules Equazen eye q, containing 400 mg fish oil and 100mg evening primrose oil - EPA (372mg), DHA (116mg), GLA (40mg) and vitamin E (7.2 mg) ) or placebo group. The study is divided into two phases with four months each. After unblinding after the first phase pre-school children taking placebo receive Omega-3/Omega-6 Fatty Acids. Children (n = 75) taking verum during first four months will be randomised doubleblind to verum or placebo. In this way the progress of the behaviour symptoms will be evaluated after a significant period of time (eigth months). Clinical examination (questionnaires, intelligence test, medical examination) and evaluation of ADHD symptoms through parents and teachers with several questionnaires will be used before beginning, after four months and after eight months. In addition the pre-school children will be taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. Additionally regular phone calls will be implemented. Medical examinations and meetings will taken place if required. If symptoms increase, children will be treated medical and/ or psychotherapeutically.
Interventions
DIETARY_SUPPLEMENTomega-3/omega-6 fatty acids (PUFAs)
Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Age: 3 - 6 years * Visit of a preschool (Kindergarten) * Parents have a command of the German language * Screening score \>90th percentile in a combined parent and teacher screening questionnaire
Exclusion criteria
* Hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine) * Consumption of omega fatty acids preparation * Consumption of fish oil-capsules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers | Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin | The FBB-ADHS-V Questionnaire is a developed parent and teacher rating scale which assesses several factors of hyperactivity, impulsivity and inattention problems in pre-school or at home. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ODD symptoms -parent/ teacher rated (FBB-ADHD-V) | Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin | — |
| Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF) | Change from pre- assessment to post assessment four months after treatment begin. | The CBCL and the TRF are well evaluated rating scales for the assessement of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively |
| Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV) | Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin | The DCL-ADHD and the DCL-ODD are external assessment questionnaires. Parents were asked 18 questions to hyperactivity, impulsivity and inattention by the rater or to symptom criteria for ODD. |
| Change in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC) | Change from pre- assessment to post assessment four months after treatment begin. | The Kaufman Assessment Battery for Children (K-ABC) is a standardized test that assesses intelligence and achievement in children aged 2;6 to 12;6 years. It is comprised of four global test scores that include: sequential processing scales, simultaneous processing scales, achievement scales and mental processing composite. There is an additional nonverbal scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| finger prick test to measure the PUFA blood concentration | Change from pre- assessment to post assessment four months after treatment begin | It will taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. |
Countries
Germany
Contacts
Primary ContactManfred Doepfner, Prof. Dr.
Outcome results
None listed