Home » Trials » SLCTR/2022/029


“Vivesa”: Let’s read storybooks - Evaluating the effectiveness of an online, self-paced training intervention for Sinhala speaking parents of children with complex communication needs: A pilot study

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SLCTR Registration Number

SLCTR/2022/029


Date of Registration

02 Dec 2022

The date of last modification

Dec 23, 2022



Application Summary


Scientific Title of Trial

“Vivesa”: Let’s read storybooks - Evaluating the effectiveness of an online, self-paced training intervention for Sinhala speaking parents of children with complex communication needs: A pilot study


Public Title of Trial

A pilot study to evaluate the effectiveness of an online, self-paced training intervention on the accurate implementation of the Read, Ask, Answer, Prompt strategy during shared storybook reading compared to book reading without use of strategy in parents of children with complex communication needs


Disease or Health Condition(s) Studied

Complex communication needs in children


Scientific Acronym

None


Public Acronym

None


Brief title

Evaluating the effectiveness of an online, self-paced training for parents: A pilot study


Universal Trial Number

U1111-1279-4907


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

ERC- P/59/07/2022


Trial Details


What is the research question being addressed?

  1. What is the effectiveness of the, online self-paced communication partner training program and subsequent online coaching, on parents’ ability to implement the targeted communication partner intervention during shared storybook reading activity?

  2. What is the level of parental satisfaction regarding an online, self-paced training program?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment

Single


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

Study setting – Ayati National Center for Children with Disabilities

Study population – Parents of children who receive services from the Augmentative and Alternative Communication (AAC) clinic at the Ayati Center

Intervention Steps: A. Completion of the online, self-paced training program • The link to the website, “Vivesa: Let’s read storybooks” (Home | My Site (hirunijayathilake1.wixsite.com)) will be provided to the participants to access the training program. • The participants will be expected to watch seven short videos of the training program regarding the Read, Ask, Answer, Prompt (RAAP) strategy and to answer the short quizzes given at the end of five videos (all the videos except the introduction and conclusion videos). • A time period of two weeks will be provided to the participants to complete the online, self-paced training program.

B. Completion of two online coaching sessions • Within a week of completing the video-based training intervention, the participants will be expected to engage in two one-to-one coaching sessions. • The coaching sessions will be held synchronously through Zoom or WhatsApp as preferred by each participant. • The coaching sessions will be conducted by the primary investigator. • The duration of a coaching session will be 30 minutes. • During the coaching sessions, the participants will be given an opportunity to clarify their doubts regarding the content discussed in the video-based training program and feedback on their performance at the pre-test will be given to each participant. • The coaching sessions will be held at a time convenient to both the participants and the researcher.


Inclusion criteria

CCN – Complex Communication Needs AAC – Augmentative and Alternative Communication RAAP – Read, Ask, Answer, Prompt Strategy

Inclusion Criteria for Parents: 1. Being a parent or caregiver of a child aged three to seven years with complex communication needs using Avaz/or able to use Avaz Augmentative and Alternative Communication application to communicate 2. Sinhala being the primary language 3. Having a minimum education level of GCE (Ordinary Level) or an appropriate literacy level to understand the content of the communication partner training program 4. Having no known speech, language, or hearing impairment 5. Availability of technology including stable internet facilities and an electronic device to access the online training program. (The tablet borrowed by the AAC lending library will be only used to access Avaz communication app. The participants are expected to have another device to access the video-based training program and the online coaching sessions since they are expected to use the Avaz app with their children during the coaching sessions.) 6. Consenting to participate in an online, self-paced training program

Inclusion criteria for children - 1. Age between 3 to 7 years 2. Sinhala being the first language 3. Hearing and vision being within functional limits or corrected to be within functional limits 4. Demonstrating a significant communication impairment as determined as being on level V or less on the Communication Matrix (Rowland, 2012). 5. Ability to verbally express 50 words or less 6. Being able to use an aided AAC system with a minimum of 08 graphic symbols per page 7. Having access to a tablet and a high-tech communication app borrowed from the AAC lending library at Ayati Center 8. Having adequate motor skills to be able to point with a finger 9. Having signed consent from parents or guardians to get the participation of the child


Exclusion criteria

Exclusion criteria for children:- 1. Being a parent or a caregiver of a child aged three to seven years with CCN using any other AAC system except Avaz/not able to use Avaz AAC application



Primary outcome(s)

1.

The proposed study focuses on the effectiveness of the aforementioned training program on the parental use of the RAAP strategy. In order to measure the effectiveness of the communication partner training program (the intervention), • A pre-test will be conducted by recording a 10-minute video of parents and children engaging in a shared storybook reading activity to measure the number of times where all the steps of the Read, Ask, Answer, Prompt strategy was implemented accurately by parents. • A post-test will be conducted by obtaining a 10-minute video recording of parents and children engaging in a shared storybook reading activity to measure the number of times where all the steps of the Read, Ask, Answer, Prompt strategy were implemented accurately following parents participating in the online training. • The difference of the number of times where all the steps of the Read, Ask, Answer, Prompt strategy were implemented accurately will be obtained by subtracting the number during the post-test from that of the pre-test.

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Pre-test and post-test administered at the baseline and the conclusion of the intervention program

]

Secondary outcome(s)

1.

At the end of the online, self-paced training program, a self-administered satisfaction survey with a five point Likert Scale will be provided to the participants to determine the level of satisfaction regarding the content and the technological aspects of the training program.

[

At the conclusion of the intervention program

]

Target number/sample size

08 parent-child dyads


Countries of recruitment

Sri Lanka


Anticipated start date

2022-12-03


Anticipated end date

2022-12-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

None



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-09-14


Approval number

P/59/07/2022


Details of Ethics Review Committee

Name: ERC, Faculty of Medicine, University of Kelaniya
Institutional Address:Ethics review committee, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama.
Telephone:0112961267
Email: ercmed@kln.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

S.A.H.D Jayathilake
Undergraduate – BSc. (Hons) Speech and Hearing Sciences
Faculty of Medicine, University of Kelaniya

0767343947

hirunijayathilake14@gmail.com

Contact Person for Public Queries

Dr. N.A. Muttiah
Senior Lecturer, Department of Disability Studies. Faculty of Medicine, University of Kelaniya
Department of Disability Studies, Faculty of Medicine, University of Kelaniya, P.O box 6, Thalagolla Road, Ragama
+94112958337
+94722160400
+94112958337
nimisha@kln.ac.lk


Primary study sponsor/organization

Department of Disability Studies, Faculty of Medicine, University of Kelaniya,

P.O box 6, Thalagolla Road, Ragama
+94 11 2961000

diststaff@kln.ac.lk
https://medicine.kln.ac.lk/depts/dds/

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results