| CTRI Number |
CTRI/2018/02/012127 [Registered on: 23/02/2018] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Innovative Education Technology for Sexual and Reproductive Health for Teens |
|
Scientific Title of Study
|
Flipping to empower adolescents for sexual and reproductive health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratibha Singh |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Basni Phase 2
Jodhpur RAJASTHAN 342005 India |
| Phone |
8003996941 |
| Fax |
|
| Email |
drpratibha69@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pratibha Singh |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Basni Phase 2
RAJASTHAN 342005 India |
| Phone |
8003996941 |
| Fax |
|
| Email |
drpratibha69@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kuldeep Singh |
| Designation |
Dean Academics and Professor Pediatrics |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
All India Institute of Medical Sciences, Basni Phase 2
Jodhpur RAJASTHAN 342005 India |
| Phone |
8003996940 |
| Fax |
|
| Email |
kulpra@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Stars in Global Health from Grand Challenges Canada |
|
|
Primary Sponsor
|
| Name |
Grand Challenges Canada |
| Address |
MaRS Centre, West Tower
661 University Avenue, Suite 1720
Toronto, ON M5G 1M1
grandchallenges.ca
|
| 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 |
| Dr Pratibha Singh |
All India Institute of Medical Sciences Jodhpur |
Room Number 240,OPD Block, Department of Obstetrics and Gynecology Jodhpur RAJASTHAN |
8003996941
drpratibha69@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee at AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Educational Impact |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Students of the school will be provided reproductive health education through conventional method of didactic lectures |
| Intervention |
Flipped Classroom with mobile based app |
The students of selected school will be provided education with innovative method based on pedagogic principle of Flipped Classroom Technology |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
After permission from school authorities, parental consent will be obtained. Only those students whose parents give consent to participate in the study will be included. |
|
| ExclusionCriteria |
| Details |
Those not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gain in knowledge, complex understanding and behavioral skills for sexual and reproductive health among adolescent school children from baseline of 10 % to 40 % after intervention. |
1 day, 30 days and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Satisfaction Index more than 70 % |
At 18 months |
|
|
Target Sample Size
|
Total Sample Size="4000" Sample Size from India="4000"
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)
|
09/07/2018 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
What is the problem addressed by your innovation? (Maximum response allowed is 500 characters).  Discussing sexuality is still considered a taboo in Indian Society. Sex education to school children and adolescents is a challenge for teachers and is seldom taught in a way to create medically appropriate, affirmative outlook towards sexuality. The problem is much more compounded by myths associated with sex information resulting in poor sexual behavior, teenage pregnancy, sexually transmitted infections & sexual crimes. The problem is much higher in Rajasthan leading to sex discrimination. What is your proposed innovation? (Maximum response allowed is 500 characters).  Active learning by Flipped Classrooms where basic information about sexuality and reproductive health is provided through a mobile application to be viewed at home by the students at his/her own pace and class time in school is utilized for deeper learning, analysis, clarification with help of Clickers in presence of a facilitator who may be a class teacher or a competent and skilled health professionals. Pre class material includes small clips, presentations, short readings, quiz or stories. How will this innovation address this problem more effectively than current approaches? (Maximum response allowed is 500 characters).  The sexual and reproductive health needs of adolescents in India are currently overlooked or are not understood by the Indian healthcare system. These are also not integrated well into Life skills module. The approaches mostly consist of didactic lectures or talks but seldom encourage active participation. The present innovative idea will enable adolescent girls and boys with sufficient time to ponder over the material, their holistic participation in class will be ensured with help of Clickers. Describe how your innovation is relevant to poor, marginalized populations in low-or-middle-income countries (LMICs). (Maximum response allowed is 500 characters).  In the Rajasthan state of India, sex discrimination against the girl child, late schooling, early marriage predispose girls to heavy disadvantages resulting into the poor health of the community. Adolescent children are highly receptive to innovations. The Bold idea revolves around an innovative pedagogy of inverted classroom utilizing mobile app to distribute family acceptable material in local language and active learning during the class time. It is cheap, affordable, and culturally adaptable |