| CTRI Number |
CTRI/2020/07/026684 [Registered on: 20/07/2020] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative phenomenological study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Perspectives of Occupational Therapists Regarding
Rapport Development for Children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Exploring occupational therapists perspectives regarding
rapport development for children with autism spectrum disorder in the states of Kerala and Karnataka: a
phenomenological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa Elizabeth Jacob |
| Designation |
Postgraduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy
3rd floor
Manipal College of Health Professions
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9947201701 |
| Fax |
|
| Email |
shilpa22.11.94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Rege |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy
3rd floor
Manipal College of Health Professions
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9739131050 |
| Fax |
|
| Email |
sumita.rege@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Rege |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy
3rd floor
Manipal College of Health Professions
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9739131050 |
| Fax |
|
| Email |
sumita.rege@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Aspire Child Development Centre KERALA Ernakulam Aspire Child Development Centre Ground floor Mulaykanpilil house Poyyechira Lane Seaport-airport road Near hotel Aryaas Kakkanad Cochin Kerala
|
| Jewel Autism Centre
Karar buildings Behind Abhilash Theatre Market Link Road Kottayam |
| National Institute of Physical Medicine and Rehabilitation Kalletumkara p o Thrissur 680683 |
| Prayatna Cenre for Child Development 32/1393A Pipeline Road Palarivattom p.o Cochin 682025
|
|
|
Primary Sponsor
|
| Name |
Shilpa Elizabeth Jacob |
| Address |
Department of Occupational Therapy
3rd floor
Manipal College of Health Professions
Manipal Academy of Higher Education |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shilpa Elizabeth Jacob |
Aspire Child Development Centre |
Director,
Ground floor,
Mulaykanpilil house
Poyyechira Lane
Seaport-airport road
Near hotel Aryaas
Kakkanad
Cochin
Kerala
Ernakulam
KERALA |
9947201701
shilpa22.11.94@gmail.com |
| Shilpa Elizabeth Jacob |
Jewel Autism Centre |
Occupational Therapy
Room No 3
Karar buildings
Behind Abhilash Theatre
Market Link Road
Kottayam
686001
Kottayam
KERALA |
9947201701
shilpa22.11.94@gmail.com |
| Shilpa Elizabeth Jacob |
National Institute of Physical Medicine and Rehabilitation |
Department of Occupational Therapy
Third floor
Kalletumkara p o
Thrissur
680683
Thrissur
KERALA |
9947201701
shilpa22.11.94@gmail.com |
| Shilpa Elizabeth Jacob |
Prayatna centre for child development |
Room No.8
Occupational Therapy Hall
32/1393A Pipeline Road
Palarivattom p.o
Cochin
682025
Ernakulam
KERALA |
9947201701
shilpa22.11.94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Occupational Therapists working with children with Autism Spectrum Disorder |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Occupational therapists with minimum of 2 years of experience working with children with Autism Spectrum Disorder |
|
| ExclusionCriteria |
| Details |
No specific criteria dilineated |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perspectives of occupational therapists regarding rapport development with children with Autism Spectrum Disorder |
Perspectives will be analysed at the end of data collection process. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2020 |
| Date of Study Completion (India) |
06/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a qualitative phenomenological study to explore Occupational Therapists’ perspectives regarding rapport development for children with Autism Spectrum Disorder in the states of Kerala and Karnataka. Occupational therapists with minimum two years of experience working with children with Autism spectrum Disorder will be recruited with informed consent.Focus group discussions will be conducted with six to eight participants in each group, with the help of an interview guide. The sessions will be audio recorded and transcribed. The data obtained from the field notes and transcripts of the focus group discussions will be analysed through an iterative thematic analysis process. Results of the study might help in formulating appropriate measures to assess rapport and hence to improve the quality of rapport with children with ASD. |