Date

2023-08-28

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

The study will be carried out in selected primary class rooms of the Gampaha District in the Western Province. The schools will be selected by cluster randomization, target classrooms will be randomly selected and consenting participants allocated to the 2 arms using simple randomization. At baseline, all participants will be assessed on awareness about the letter recognition and letter to sound relationship using appropriate tools specifically designed for this study to confirm the retention of knowledge about the letters. At every subsequent assessment the previously introduced letter knowledge will be reassessed and documented. The intervention arm will receive the following: Instructions to the family on how to conduct home based training to reinforce the introduction of letters and to revise the knowledge acquired during the training. They will be requested to deliver home based training for a 30 minute period per day for five days a week for 12 weeks. At the end of 12 weeks, the child will be introduced to word formation using the knowledge of letters he has already gained. (i.e. if he has learnt 10 letters over the last 12 weeks those 12 letters will be used to make words). The same multi-sensory letter tool will be used to introduce the word formations. This training will also take place over 12 weeks. The number of words introduced will be 5 words/ weekly and the child will be meeting the trainer 2 weekly. Teaching methods used will include visual and phonological reinforcement. The active control arm will receive the following (current standard practice). The sequence of identifying the alphabetical knowledge and the introduction of letters will be identical to the test group: Home based package with activities based on paper and using picture cards where the child will be practicing at home for 30 minutes/day for 5 days a week with parent/ guardian. The control will not be given the multi-sensory tool kit designed for the test group but they will use mainly visual aids by using picture cards of the letters and by introducing the sounds of the letters to improve the phonological awareness. At 12 weeks point the child will be introduced to word formation using the knowledge of letters he has already gained. (i.e. if he has learnt 10 letters over the last 12 weeks those 12 letters will be used to make words). Paper based technique using pictures as visual aids will be the intervention tool. This training will also take place over 12 weeks. The number of words introduced will be 5 words/ weekly and the child will be meeting the trainer 2 weekly. Teaching methods used will include visual and phonological reinforcement. Both groups will undergo the identical assessment at the same assessment points. The assessment of outcomes will be carried out by a trained investigator who is blinded to the intervention.

Next Version

1.1.1. Phase2: Clinical trial phase: There will be two types of interventions. A. Multi-modal sensory sinhala alphabet tool (Group A) B. Conventional method (Group B) Two groups will be divided by randomization Method explain method of randomization page 17 1.13.1 till .3 Group A: Intervention with multi-modal sensory alphabet tool 23 letters including the modifiers will be used in this method together with the panel boards containing stories/ rhymes to provide phonological awareness i. Children will be assessed about the alphabetical awareness. The letters that children can identify will be documented. ii. They will be introduced the new letters in a standard sequence (graphically and phonologically simple to the most difficult). Initially one letter at a time and then depending on the response of the child more than one letter will be introduced. iii. All activities undertaken and the sequence of introduction of letters will be documented. iv. Children will be assessed two weekly to assess their ability to identify the letters. v. Their awareness about the letter recognition, letter to sound relationship will be assessed using appropriate set of tools specifically designed for this study to confirm the retention of knowledge about the letters. At every assessment the previously introduced letter knowledge will be reassessed and documented . vi. The family will be given instructions on how to conduct the home based training to reinforce the introduction of letters and to revise the knowledge acquired during the training. The home based training will be for a 30 minute period per day for five days a week. vii. At the end of the 12 weeks each child will be assessed by a trained research assistant who is blinded to the intervention. Both the test and the control groups will undergo the same assessments using a similar letter images to assess the number of letters the child has learnt to identify. The child’s visual and phonological awareness about the letters will be separately assessed. The responses will be documented and audio recorded. (assessment point 1: T2) viii. At 12 weeks point the child will be introduced to word formation using the knowledge of letters he has already gained. (i.e. if he has learnt 10 letters over the last 12 weeks those 12 letters will be used to make words). The same multi-sensory letter tool will be used to introduce the word formations. This training will also take place over 12 weeks. The number of words introduced will be 5 words/ weekly and the child will be meeting the trainer 2 weekly. Teaching methods used will include visual and phonological reinforcement. ix. At the end of the 24 weeks the child will be assessed on the following abilities by a blinded trained research assistant (assessment point 2: T2) a. reading of words b. reading of simple sentences c. comprehension of simple sentences All these will be documented and audio recorded x. At 36 months post intervention the students will undergo age level phonological skills and reading comprehension assessment by getting the all participant children to read a specific paragraph in their grade appropriate text book. Group B: Intervention with conventional method The current standard practice is to introduce letters by simply writing letters by the teacher with a related image to introduce the sound. This method will be used for the control group i. The sequence of identifying the alphabetical knowledge and the introduction of letters will be identical to the test group. (steps i- v in the test protocol) ii. The home based package will also include activities based on paper and using picture cards where the child will be practicing at home for 30 minutes/day for 5 days a week with parent/ guardian. The control will not be given the multi-sensory tool kit designed for the test group but they will use mainly visual aids by using picture cards of the letters made with sand paper and by introducing the sounds of the letters to improve the phonological awareness. Explanation * We used sand letters in the conventional method from the beginning. However, the phrase sand paper letter was not mentioned specifically in any of the proposals. We decided to inform the SLCTR to add that phrase in the convention arm because if we include that in a manuscript and it was not specifically mentioned there in the trial registry it may cause unwanted confusion among the reviewers when we submit a manuscript. Therefore, we inform this to the ERC as well, however it was not a deviation from the original proposal. iii. At the end of the 12 weeks each child will be assessed by a trained research assistant who is blinded to the intervention. Both the test and the control groups will undergo the same assessments using a similar letter images to assess the number of letters the child has learnt to identify. The child’s visual and phonological awareness about the letters will be separately assessed. The responses will be documented and audio recorded. (assessment point 1: T1) (primary outcome measurement point) iv. At 12 weeks point the child will be introduced to word formation using the knowledge of letters he has already gained. (i.e. if he has learnt 10 letters over the last 12 weeks those 12 letters will be used to make words). Paper based technique using pictures as visual aids will be the intervention tool. This training will also take place over 12 weeks. The number of words introduced will be 5 words/ weekly and the child will be meeting the trainer 2 weekly. Teaching methods used will include visual and phonological reinforcement. v. At the end of the 24 weeks the child will be assessed on the following abilities by a blinded trained research assistant (assessment point 2 :T2) reading of words reading of simple sentences comprehension of simple sentences All these will be documented and audio recorded. vi. On the completion of the 36 months of after the primary outcomes are assessed the students will undergo age level phonological skills assessment and reading comprehension assessment. Explanation * We wish to amend to proposed protocol as a secondary objective for Section 2, Page 7, Specific objectives to improve the quality of the research 2.4 To describe the phonological skills and reading comprehension between the intervention and control groups after an interval of 36 months of completing the intervention by getting the all participant children to read a specific paragraph in their grade appropriate text book.