| CTRI Number |
CTRI/2022/05/042458 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
09/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Emotion Education Programme for Parents, Teachers and Teens |
|
Scientific Title of Study
|
Development and effectiveness testing of an online emotion education program for parents, teachers and teens in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tony Sam George |
| Designation |
Professor and Dean |
| Affiliation |
CHRIST (Deemed to be University) |
| Address |
Professor of Psychology and dean of Social Sciences
Room Number 778, Central Block
Bangalore Central Campus
CHRIST (Deemed to be University), Hosur Road, Bangalore
KARNATAKA
560029
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9845079289 |
| Fax |
918040129000 |
| Email |
tony.sam.george@christuniversity.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Tony Sam George |
| Designation |
Professor and Dean |
| Affiliation |
CHRIST (Deemed to be University) |
| Address |
Department of Psychology
Room number 778, Central Block, 7th floor
Bangalore Central Campus
CHRIST (Deemed to be University), Hosur Road, Bangalore
KARNATAKA
560029
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9845079289 |
| Fax |
918040129000 |
| Email |
tony.sam.george@christuniversity.in |
|
Details of Contact Person
Public Query
|
| Name |
Tony Sam George |
| Designation |
Professor and Dean |
| Affiliation |
CHRIST (Deemed to be University) |
| Address |
Department of Psychology
Room Number 778, 7th floor, Central block
Bangalore Central Campus
CHRIST (Deemed to be University), Hosur Road, Bangalore
KARNATAKA
560029
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9845079289 |
| Fax |
918040129000 |
| Email |
tony.sam.george@christuniversity.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
US Department of State |
| Address |
US Department of State (Administered in cooperation with university of Nebraska, Omaha)2019-22 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Tony Sam George |
CHRIST (Deemed to be University) |
Department of Psychology,Room 788, Seventh floor, Central block, Bangalore Central campus
Hosur Road
Dharmaram College Post
Bangalore 560029
Bangalore
KARNATAKA |
9845079289
918040129000
tony.sam.george@christuniversity.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christ University Research Conduct and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emotional Regulation Skills for Teachers, Parents and Teens |
Intervention
The proposed intervention is a 4-module program delivered over 4 weeks. The modules are as follows:
Module 1: Basics of emotions
Module 2: Basics of emotion regulation
Module 3: Emotion regulation strategies
Module 4: Providing emotion education to children (only for parents & teachers)
The program is conceptualized in a unique online, self-administered format – is resource friendly, and easy to scale up.
Frequency: Weekly Once
Total Duration from start to end of intervention is one month.
Duration for each Module per week is one hour |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Teenagers: 13- 17 years of age
Parents: 34 to 60 years of age
Teachers: 24 to 60 years of age
|
|
| ExclusionCriteria |
| Details |
Teenagers: who are not proficient in English, who do not have access to internet enabled device
Parents: who are not proficient in English, who do not have access to internet enabled device
Teachers: who are not proficient in English, who do not have access to internet enabled device
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Emotion Awareness
Difficulties with Emotion Regulation
Emotion Regulation
Wellbeing
Difficulties with Emotion Regulation
Emotion Regulation
|
four weeks from baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
15/05/2022 |
| 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)
|
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
|
Emotion regulation skills among teens is associated with their mental health, social and academic outcomes. Adults also play a crucial role in children’s emotional socialization. Adults who have effective emotion regulation strategies can support and foster the development of emotion-regulation in children. The proposed study will focus on developing and testing an emotion education program for parents, teachers, and teens aged 13-17 years. The proposed intervention is designed as a 4-module online program delivered over 4 weeks covering various dimensions of emotion regulation. The hypotheses of the study are that there will be a significant improvement in the emotion regulation skills and attitudes in the three intervention groups (of teens, parents and teachers), as compared to the respective control groups.
|