| Date |
Item
Changed |
Previous
Version |
New
Version |
| 14/09/2009 |
Scientific title of trial |
Effectiveness of combined omega 3 & omega 6 in children with neuro-developmental disorders: an open trial |
Effectiveness of Omega-3 and Omega-6 in children with neuro-developmental disorders: a double-blind placebo-controlled study |
| 14/09/2009 |
Public Title of Trial(in lay language) |
Effectiveness of omega-3 & omega-6 in children with neuro-developmental disorders: an open trial |
Effectiveness of Omega-3 and Omega-6 in childhood behaviour disorders |
| 14/09/2009 |
Study design |
Open trial |
Double-blind placebo-controlled study |
| 14/09/2009 |
Inclusion criteria |
The sample will be selected from among children aged 6-10 years, diagnosed with neuro-developmental disorders (ADHD, autism, specific learning disorder and disruptive behaviour disorders). Children already on medication and / or other therapies will be included. Children with primary diagnosis of a neuro-developmental disorder but with other comorbid disorders will also be included in the study |
The sample will be selected from among children aged 6-12 years, diagnosed with ADHD. Children already on medication and those without medication will be included. Also, children with ADHD and other comorbid disorders (oppositional disorders, learning disability, tic disorder and autism) will be included |
| 14/09/2009 |
Target number/sample size
|
50 children randomly selected and representative of the selected disorders for study |
100 children randomly selected will be included in the study, equally divided into study and control groups |
| 14/09/2009 |
Primary outcome(s) |
Out come of improved behaviour will be assessed using following standerdized tools 1.Diagnosis of individual neuro-developmental disorders to be tested will be made using DSM IV TR criteria. Comorbid disorders will be similarly diagnosed. 2. SNAP IV completed by parent and teacher will be used to further validate the diagnosis of ADHD and assess the severity of the symptoms. SDQ will be used to assess the specific symptoms of ADHD and its impact. 3. Autism will be diagnosed using DSM IV TR criteria. 4. Structured psychometric assessments will be used to evaluate specific learning disability. 5. SNAP IV and SDQ will be used to objectively assess the outcome in ADHD in 1 month, 3 months, in addition to the clinical assessment. 6. A structured questionnaires will be used and completed by mothers to gather data on outcome at 1 month and 3 months from parents and teachers regarding learning disorders and disruptive behaviour disorders 7. A semi-structured questionnaire will be used to record demographic and socio-cultural information |
Outcome will be measured at one month, three months and six months after the onset of treatment. Tools of assessment: 1.Diagnosis of behaviour disorder will be made using DSM IV TR criteria. Comorbid disorders will be similarly diagnosed. 2. SNAP IV completed by parent and teacher will be used to further validate the diagnosis and assess the severity of the symptoms. SDQ will be used to assess the specific symptoms of ADHD and its impact. 3. SNAP IV and SDQ will be used to objectively assess the outcome in 1 month, 3 months and 6 months in addition to the clinical assessment. 4. Structured psychometric assessments will be used to evaluate any learning difficulties in the child. 5. A clinical assessment will be made to gather information from parents regarding their perception of child’s behaviour and level of satisfaction with treatment. 6. A semi-structured questionnaire will be used to record bio-data and other patient and family related information |
| 14/09/2009 |
Secondary
outcome(s)
|
Asses for side effects such as intolerance |
Asses for side effects such as tolerance |
| 14/09/2009 |
Anticipate start date |
03/Aug/2009 |
05/Oct/2009 |
| 14/09/2009 |
Anticipate end date |
03/Feb/2010 |
05/Apr/2010 |
