| CTRI Number |
CTRI/2022/11/047280 [Registered on: 14/11/2022] Trial Registered Prospectively |
| Last Modified On: |
13/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Skill Training Program on Knowledge and Practice of Parents Regarding Care of Intellectually Disabled Children. |
|
Scientific Title of Study
|
Effectiveness of Skill Training Programme on Knowledge and Practice of Parents Regarding Care of Intellectually Disabled Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIDYALACSHMI |
| Designation |
Mscnursing dept of MHN |
| Affiliation |
VINAYAKA MISSIONS COLLEGE OF NURSING |
| Address |
VIDYALACSHMI M SC II YEAR CLASS ROOM SECOND FLOOR VINAYAKA MISSIONS COLLEGE OF NURSING HOSPITAL
AARUPADAI VEEDU MEDICAL COLLEGE AND CAMPUS KIRUMAMPAKKAM
CUDDALORE PUDUCHERRY MAIN ROAD
VIDYALACSHMI M SC II YEAR CLASS ROOM SECOND FLOOR VINAYAKA MISSIONS COLLEGE OF NURSING HOSPITAL
AARUPADAI VEEDU MEDICAL COLLEGE AND CAMPUS KIRUMAMPAKKAM
CUDDALORE PUDUCHERRY MAIN ROAD
Pondicherry
PONDICHERRY
607403
India |
| Phone |
09994400373 |
| Fax |
|
| Email |
vidyalacshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Ayee |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF MHN |
| Affiliation |
VINAYAKA MISSIONS COLLEGE OF NURSING |
| Address |
VIDYALACSHMI M SC II YEAR CLASS ROOM SECOND FLOOR VINAYAKA MISSIONS COLLEGE OF NURSING HOSPITAL
AARUPADAI VEEDU MEDICAL COLLEGE AND CAMPUS KIRUMAMPAKKAM
CUDDALORE PUDUCHERRY MAIN ROAD
VIDYALACSHMI M SC II YEAR CLASS ROOM SECOND FLOOR VINAYAKA MISSIONS COLLEGE OF NURSING HOSPITAL
AARUPADAI VEEDU MEDICAL COLLEGE AND CAMPUS KIRUMAMPAKKAM
CUDDALORE PUDUCHERRY MAIN ROAD
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9943077233 |
| Fax |
|
| Email |
malarayee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIDYALACSHMI |
| Designation |
Mscnursing dept of MHN |
| Affiliation |
VINAYAKA MISSIONS COLLEGE OF NURSING |
| Address |
VIDYALACSHMI M SC II YEAR CLASS ROOM SECOND FLOOR VINAYAKA MISSIONS COLLEGE OF NURSING HOSPITAL
AARUPADAI VEEDU MEDICAL COLLEGE AND CAMPUS KIRUMAMPAKKAM
CUDDALORE PUDUCHERRY MAIN ROAD
VIDYALACSHMI M SC II YEAR CLASS ROOM SECOND FLOOR VINAYAKA MISSIONS COLLEGE OF NURSING HOSPITAL
AARUPADAI VEEDU MEDICAL COLLEGE AND CAMPUS KIRUMAMPAKKAM
CUDDALORE PUDUCHERRY MAIN ROAD
Pondicherry
PONDICHERRY
607403
India |
| Phone |
09994400373 |
| Fax |
|
| Email |
vidyalacshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SATYA SPECIAL SCHOOL PUDUCHERRY |
|
|
Primary Sponsor
|
| Name |
SELF FUNDED |
| Address |
VINAYAKA MISSIONS COLLEGE OF NURSING AARUPADAI VEEDU MEDICAL COLLEGE CAMPUS KIRUMAMPAKKAM PONDICHERRY |
| 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 |
| vidyalacshmi |
SATYA SPECIAL SCHOOL PUDUCHERRY |
PLOT 6 7 8
ECR Road opposite siva vishnu mahal near shivaji statue ground floor room no 5 training skill room karuvadikuppam
puducherry
Pondicherry
PONDICHERRY |
09994400373
vidyalacshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (HUMAN STUDIES) VINAYAKA MISSIONS COLLEGE OF NURSING PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PARENTS WITH CARE OF INTELLECTUALLY DISABLED CHILDREN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
skill training programme |
Study will start after getting permission from the concerned authority of the selected special school at Puducherry The period of data collection is four weeks from the month of November 2022 Based on the inclusion criteria the subjects will be selected Pre test will be conducted by using the knowledge questionnaire and practice will be a checklist Then the selected life skill training program regarding care of intellectually disabled assessed by children be provided to the around everyday one hour After two weeks post test will be conducted among the subjects by using the same questionnaire |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Parents who are available during the period of data collection time.
Parents who can able to read and write Tamil and English. |
|
| ExclusionCriteria |
| Details |
Parents who were not willing to participate in the study.
Parents those who have any physical and psychological problems. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the level of knowledge and practice regarding care of intellectually disabled children among parents To evaluate the effectiveness of skill training program on care of intellectually disable children among parents
|
To assess the level of knowledge and practice regarding care of intellectually disabled children among parents To evaluate the effectiveness of skill training program on care of intellectually disable children among parents
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of skill training program on care of intellectually disable children among parents
To associate the pretest level of knowledge and practice regarding care of intellectually disable children among parents with their selected demographic variables |
To evaluate the effectiveness of skill training program on care of intellectually disable children among parents
To associate the pretest level of knowledge and practice regarding care of intellectually disable children among parents with their selected demographic variables |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/11/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a pre-experimental one group pretest post test study to evaluate the effectiveness of selected life skill training programme on knowledge and practice regarding care of intellectually disabled children among parents.Based on the inclusion criteria the samples are selected .Convenient sample technique is used ,sample size is 60 participants. A written informed consent will be obtained from the study participants. Pre-test knowledge will be assessed by using questionnaire and practice by checklist.Then selected skill training program regarding care of intellectually disabled children will be provided for 2 weeks .After two weeks post test will be conducted by using the same tool which was used in the Pre test. .The collected data will be complied for data analysis. |