Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study Clinical Trial
Official title:
Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | May 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 6 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Child and Adolescent Psychiatry at the University Cologne | Cologne |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cologne |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | finger prick test to measure the PUFA blood concentration | It will taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. | Change from pre- assessment to post assessment four months after treatment begin | |
| Primary | Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers | 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. | Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin | |
| Secondary | 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 | ||
| Secondary | Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF) | 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 | Change from pre- assessment to post assessment four months after treatment begin. | |
| Secondary | Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV) | 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 from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin | |
| Secondary | Change in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC) | 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. | Change from pre- assessment to post assessment four months after treatment begin. |