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Trials - SLCTR/2009/006

Protocol Change

Date

2009-09-14


Protocol

Protocol changed


Item Changed

Primary outcomes


Previous Version

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


Next Version

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