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Effectiveness of a multisensory interactive Sinhala alphabet typeface tool compared to conventional techniques to improve recognition of letters and reading fluency in school children with dyslexia from the Gampaha District in Sri Lanka; a randomized clinical trial -

SLCTR Registration Number

SLCTR/2016/016


Date of Registration

16 Jun 2016

The date of last modification

Jun 16, 2016



Application Summary


Scientific Title of Trial

Effectiveness of a multisensory interactive Sinhala alphabet typeface tool compared to conventional techniques to improve recognition of letters and reading fluency in school children with dyslexia from the Gampaha District in Sri Lanka; a randomized clinical trial


Public Title of Trial

Effectiveness of a multisensory interactive Sinhala alphabet typeface tool to improve reading skills in school children with dyslexia in the Gampaha District, Sri Lanka.


Disease of Health Condition(s) Studied

Dyslexia


Scientific Acronym

None


Public Acronym

None


Brief title

New interactive tool for children dyslexia


Universal Trial Number

U1111-1181-6820


Any other number(s) assigned to the trial and issuing authority

ERC (Kelaniya):P/181/11/2015


Trial Details


What is the research question being addressed?

What is the effectiveness of a multisensory interactive Sinhala alphabet tool in improving language training in children with dyslexia from selected primary class rooms of the Gampaha District?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Active


Assignment

Parallel


Purpose

Other


Purpose

Phase 2


Intervention(s) planned

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:

  1. 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.

  2. 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:

  1. 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.

  2. 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.


Inclusion criteria

  1. Children aged 5years 0 months-7 years 11 months.

  2. Attending mainstream government schools situated in the Gampaha District.

  3. Features of dyslexia identified using a new screening test, followed by diagnosis of dyslexia based on DSM-V criteria: (any one of these) deficits in the i. Word reading accuracy ii. Reading rate or fluency iii. Reading comprehension Essential criteria Duration more than 6 months Onset during formal school age Significant impact on academic and occupational performance Difficulties not explained by intellectual disabilities.

  4. Children living with an adult caregiver who is literate and could comply with the home based training programme

  5. Families agreeing to take part for the full study period of 6 months (with the provision to withdraw as per the informed consent sheet)


Exclusion criteria

  1. Children who have other co-morbidities will be excluded from the study
  2. Autism Spectrum Disorder (DSM V criteria)
  3. Dysmorphic syndromes (Clinical exam)
  4. Attention Deficit Hyperactive Disorder (DSM V criteria)


Primary outcome(s)

The ability to recognize the letters. Measurement would be using a standard formula. The ability of the pth child in reading letters after ith week will be calculated using the following equation

Ri= (Ai – A0)* 100
          Ait

P – Pth participant Aip – Number of letters from the alphabet the pth participant can read at time i,

A0 -Number of letters from the alphabet the child can read at base line

Aitp – Total number of letters introduced to the pthchild during the period i

Rip- The change in ability of the pth child in reading letters from the alphabet after ith week.

The individual scores of the change in the ability to read letters will be aggregated into mean or median scores depending on the normality of distribution of the aggregate scores.


Primary outcome(s) - Time of assessment(s)

At baseline and every 2 weeks for a total of 24 weeks


Secondary outcome

  1. Ability to retain understanding about letters (measured using flash cards and standardized questions)

  2. Reading fluency (measured using flash cards and standardized questions)

The expected reading fluency is calculated as 95% and Reading comprehension is calculated as 80%.


Secondary outcome(s) - Time of assessment(s)

At baseline and every 2 weeks for a total of 24 weeks



Target number/sample size

140 (70 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-07-01


Anticipated end date

2018-07-01


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 18.11.2015 (Ref: P/181/11/2015)


Funding source

Sri Lanka College of Paediatricians



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Samanmali P. Sumanasena
Senior Lecturer in Disabilities and Consultant Paediatrician
Department of Disability Studies Faculty of Medicine University of Kelaniya Ragama
Tel: +94112958251
Mob: +94777256768
Fax: +94112958251
samanmalis@yahoo.com

Contact Person for Public Queries

Samanmali P. Sumanasena
Senior Lecturer in Disabilities and Consultant Paediatrician
Department of Disability Studies Faculty of Medicine University of Kelaniya Ragama
Tel: +94112958251
Mob: +94777256768
Fax: +94112958251
samanmalis@yahoo.com


Primary study sponsor/organization

Sri Lanka College of Paediatricians

No. 44/1 Gnanartha Pradeepa Mawatha, Colombo 00800, Sri Lanka.
Tel: +94-11-2683178
Fax: +94-11-2684625
paedsslcp@gmail.com
http://slcp.lk/

Secondary study sponsor (If any)

None