| CTRI Number |
CTRI/2023/11/060234 [Registered on: 24/11/2023] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of nurse led intervention on prosocial behaviour and empathy: Mixed method study with randomized control trial |
|
Scientific Title of Study
|
A mixed method study: Evaluate Nurse led intervention on level of prosocial behavior and empathy among children with ADHD, and parent’s perception on intervention at central part of Gujarat |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Franny Joel Emmanuel |
| Designation |
PhD Scholar |
| Affiliation |
Charotar University of Science and Technology |
| Address |
Room No. 310
Manikaka Topawala Institute of Nursing
Charusat University
Changa
Anand
Anand
GUJARAT
388421
India |
| Phone |
94090266609 |
| Fax |
|
| Email |
frannyemmanuel.nur@charusat.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Sharma |
| Designation |
Princiapal cum professor |
| Affiliation |
Charotar University of Science and Technology |
| Address |
Room 101,
Manikaka Topawala Institute of Nursing
Charusat University
Changa
Anand
Anand
GUJARAT
388421
India |
| Phone |
8140364743 |
| Fax |
|
| Email |
principal.mtin@charusat.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Franny Joel Emmanuel |
| Designation |
PhD Scholar |
| Affiliation |
Charotar University of Science and Technology |
| Address |
Manikaka Topawala Institute of Nursing
Charusat University
Changa
Anand
Anand
GUJARAT
388421
India |
| Phone |
94090266609 |
| Fax |
|
| Email |
frannyemmanuel.nur@charusat.ac.in |
|
|
Source of Monetary or Material Support
|
| Evolve Academy, Vadodara |
| Gurukrupa Residential apecial school, Anand |
| Mitral Rehabilitation centre, Mogri |
| Sarda Social Welfare trust, Maitry Sanstha, Nadiyad |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Kruti Kadakia |
Evolve |
Evolve Academy
Gotri
Vadodara
Vadodara
GUJARAT |
9820470133
krutikadakiya@gmail.com |
| Jignesh Thakkar |
Gurukrupa Residential school |
Gurukrupa Residential school
Man Mandir 5, Near town hall, Anand
Anand
GUJARAT |
9825707060
homjigs@yahoo.com |
| Mehulkumar Parmar |
Maitry Sanstha |
Maitry Sanstha
Sharda Social welfare Trust
Nadiyad
Kheda
GUJARAT |
9022342440
-
mehul.maitry@gmail.com |
| Pratibha Puranik |
Mitra Rehabilitation centre |
Mitra Rehabilitation centre
Mogri, Anand
Anand
GUJARAT |
9924959756
-
mitrarehab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee CHARUSAT(IEC-CHARUSAT) |
Approved |
| Institutional ethics committee CHARUSAT(IEC-CHARUSAT) |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F908||Attention-deficit hyperactivity disorder, other type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Nurse Led Intervention |
it has two components
Play therapy tool kit includes:
Games of emotions (Understanding the emotions through Story telling)
Act out loud (play way method how to show empathy, prosocial behavior)
Doodle therapy includes:
Sheets of doodle patterns for doodling.
2 sheets/patterns for 10 days.
In Last all patterns repetition.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
6-12 years old child diagnosed with mild to moderate level of ADHD
Those who are able to follow the instructions during Nurse led intervention
Child who can accompanied by their parents during all sessions of intervention
Those who is not going to receive any new alternative therapy during the intervention period.
|
|
| ExclusionCriteria |
| Details |
Child who has other medical/ surgical/ psychological problems or critically ill.
Children who cant understand English/gujarati/ hindi language.
Children who needs hospitalisation during the period of intervention.
Those who has experienced sudden loss in last 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| significant change in level of prosocial behaviour and empathy |
4 weeks/ 30 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
A mixed method study to Evaluate the effectiveness of Nurse led intervention on level of prosocial behavior and empathy
among children with ADHD, and parent’s perception on intervention at
central part of Gujarat. •Empathic and prosocial behaviors are key to successful social functioning because they motivate child with ADHD and allow individuals to understand others emotionally, these components are crucial for a society to show the belonginess. •Children form a large percentage of the population of our country •In western countries, extensive studies have been done to study these behaviours of ADHD children. Where as in India only few studies have been carried out, out of which non of them is covering Empathy and Prosocial behavior among ADHD with this kind of interventions. That is the reason why researcher wants to conduct present study. Hypothesis: 1Ho : There will be no significant difference between the level of prosocial behavior among child with behavior disorder before and after administration of nurse led intervention at 0.05 level of significance. 2Ho : There will be no significant difference between the level of empathy among child with behavior disorder before and after administration of nurse led intervention at 0.05 level of significance. 3Ho : There will be no significant correlation between level of prosocial behavior and empathy among child with behavior disorder at 0.05 level of significance.
|