| CTRI Number |
CTRI/2024/02/062462 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Creating effective videos to teach appropriate social communication in children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Development of animated videos of social stories and comic strip conversations to enhance communication behaviours in children with Autism Spectrum Disorder |
| Trial Acronym |
SSCSCASD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aminath Samahath Shareef |
| Designation |
PG student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8197708001 |
| Fax |
|
| Email |
aminath.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena K D |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9448824346 |
| Fax |
|
| Email |
r.veena@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aminath Samahath Shareef |
| Designation |
Primary investigator |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8197708001 |
| Fax |
|
| Email |
aminath.mchpmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Aminath Samahath Shareef |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal Academy of Higher Education, 576104, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal Academy of Higher Education |
Manipal Academy of Higher Education, 576104, Madhav Nagar, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Devadas |
Kasturba Medical College |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal Academy of Higher Education, 576104
Udupi
KARNATAKA |
8202922577
usha.d@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Professionals who work with children with Autism (Speech Therapists, Occupational Therapists, Clinical Psychologists, Special Educators, Parents with a child diagnosed with Autism |
| Patients |
(1) ICD-10 Condition: F80-F89||Pervasive and specific developmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
For professionals: Minimum academic qualification: Postgraduate Degree in the related field and minimum work experience of 5 years in the field.
For parents: At least one child diagnosed with Autism and a minimum educational qualification level of a Bachelor’s Degree in any field. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development and validation of social stories, comic strip conversation and its’ validation. Optimizing and assessing the feasibility of the animated videos on children with ASD. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Administration of the validated videos in a group of children to test its efficacy |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need for the study: Structured animated videos as an intervention strategy is a novel approach for dealing with sociopragmatic skills. Children with ASD learn better via visual modality. Visual technology is amusing to children overall and particularly suitable for the communication necessities of children with autism. Children with ASD have core social and behavioral deficits. Therefore, to tackle these challenges, evidence-based intervention strategies are necessary. Only a few studies have been done in India with respect to social stories (SS) and comic strip conversations (CSCs) and as well as teaching through videos. Furthermore, validated content for SS and CSCs are unavailable in India, to use clinically. There has been little or no evidence on the effect of animated video materials in India, to use in ASD intervention programs Aims & objectives For primary objective: Development and validation of social stories, comic strip conversation and its’ validation. Optimizing and assessing the feasibility of the animated videos on children with ASD. For secondary objective: Administration of the validated videos in a group of children to test its efficacy
Method
Primary investigator will prepare social stories and comic strip conversation dialogues, based on information gathered from published resources, online platforms, clinicians and parents of children diagnosed with ASD, who are coming to the Department of Speech and Hearing. Once prepared, the Social Stories will be given to two English teachers from any schools in Udupi district, to check for if the Social stories adhere to the rules given by author. After that, All Social Stories and Comic strip conversations will be translated to Kannada language and given to 15 stakeholders for validation. The 15 stakeholders are 2 parents with a child diagnosed with ASD, 3 Occupational therapists, 3 special education teachers, 3 Clinical psychologists, 4 Speech and Language Pathologists. The parents with be recruited among those who come to the department o |