| CTRI Number |
CTRI/2018/01/011115 [Registered on: 02/01/2018] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study |
| Study Design |
Other |
|
Public Title of Study
|
Experience of mothers of children with Autism |
|
Scientific Title of Study
|
Experience of mothers of children with Autism Spectrum Disorders (ASD)-A qualitative Grounded theory approach |
| Trial Acronym |
ASD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NISHA LAILA |
| Designation |
Nursing Officer |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Cardio Thoracic Sciences Centre AIIMS NewDelhi 110029
M.Phil Nursing (part time)
Manipal College of Nursing
Manipal University Manipal
Karnataka 576104
South
DELHI
110029
India |
| Phone |
8860784830 |
| Fax |
|
| Email |
nirala786nishi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NISHA LAILA |
| Designation |
Nursing officer |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Cardio Thoracic Sciences Center AIIMS NewDelhi
M.Phil Nursing (part time)
Manipal College of Nursing
Manipal University Manipal
Karnataka 576104
South
DELHI
110029
India |
| Phone |
8860784830 |
| Fax |
|
| Email |
nirala786nishi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrLinu Sara George |
| Designation |
Professor and HOD |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Department of fundamentals of Nursing Manipal College of Nuirsing Manipal University Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
09845602400 |
| Fax |
|
| Email |
linu.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self Nisha Laila M.Phil Nursing Manipal College of Nursing Manipal Karnataka |
|
|
Primary Sponsor
|
| Name |
Notapplicable |
| Address |
Notapplicable |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NishaLaila |
Open Door School Division of Action ForAutism |
Action For Autism National Centre For Autism India Jasola Vihar Pocket7 NewDelhi 110025
South
DELHI |
8860784830
nirala786nishi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ActionForAutism |
Approved |
| KasturbaHospitalEthicalCommitteeManipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mothers of children with Autism Spectrum Disorders |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Mothers of children with autism between the age group of 24-50 years
Mothers who are able to speak ,read and write Hindi ,English
Have a child who is between the age group of 2-8 and had been diagnosed with Autism Spectrum Disorder.
Mothers whose children are receiving early intervention management and special education services in Open Door School , Action For Autism, NewDelhi.
Mothers who give consent to participate in the study
Mothers who had a child with moderate-severe symptoms of ASD
|
|
| ExclusionCriteria |
| Details |
Mothers of newly diagnosed children with autism-spectrum-disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exploring mothers experience of parenting a child with Autism Spectrum Disorder and deriving major themes and concepts based on qualitative grounded theory approach |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| developing a information booklet for mothers who are parenting children with Autism Spectrum Disorders |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2018 |
| Date of Study Completion (India) |
30/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/03/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is observational ,Qualitative research.The main purpose of the study is to Explore and describe the experiences of mothers on parenting children with Autism inorder to obtain a holistic view of the experience as they have lived over a period of time with a view to develop a holistic care booklet for mothers.The main study will be conducting in Open Door School Action For Autism India.There am selecting mothers of children with autism whose children are receiving early interventions,therapies and special education from Open Door School.
The main aim of this qualitative study is to derive major concepts and themes from the experiences of mothers based on grounded theory approach and qualitative data analysis .
The main study is not started yet.The recruitment of the samples will be starting in the month of february2018 and I obtained ethical approval from Action For Autism which is an independent ethical committee. But I also got clearance from the Institutional Ethical committee of Kasturba Hospital Manipal where I am persuing my M.Phil course.
The main site of the study is only Open Door School. I will start my study in the month of February./2018.The duration of data collection is 1-2 months.
Pilot study started in December 18th.Pilot study is not part of this protocol.The pilot study conducted in Centre For Child and Adolescent wellbeing (CCAW) which is a private child development centre where I got formal permission from the Director of the centre.
|