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CTRI Number  CTRI/2025/07/091076 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of a Comprehensive Health Empowerment Programme on Knowlede,Attitude and Practise Related to Sexual and Reproductive Health among tribal adolescent girls 
Scientific Title of Study   Effectiveness of a Comprehensive Health Empowerment Initiative on Sexual and Reproductive Health Learning Outcomes among tribal adolescent girls - A Mixed Method Approach 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smitha J S 
Designation  PhD Scholar 
Affiliation  Nitte Usha Institute of Nursing Sciences 
Address  Department of OBG Nursing Nitte Usha Institute of Nursing Sciences Nitte Deemed To be University Paneer Derlakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8907947123  
Fax    
Email  smitha.23pnns108@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr.Sabitha Nayak 
Designation  Vice Principal 
Affiliation  Nitte Usha Institute of Nursing Sciences 
Address  Department of OBG Nursing Nitte Usha Institute of Nursing Sciences Nitte Deemed To be University Paneer Derlakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448842698  
Fax    
Email  sabitha@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Smitha J S 
Designation  PhD Scholar 
Affiliation  Nitte Usha Institute of Nursing Sciences 
Address  Department of OBG Nursing Nitte Usha Institute of Nursing Sciences Nitte Deemed To be University Paneer Derlakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8907947123  
Fax    
Email  smitha.23pnns108@student.nitte.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Smitha JS 
Address  PhD Scholar,Nitte Usha Institute of Nursing Sciences,Derlakatte,Mangalore Karnataka,India Pincode 575018 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSabitha Nayak  Sree Gokulam Medical College and Research Foundation  Department of OBG Nursing Sree Gokulam Medical college campus Alamthara,Venjaramoodu Pincode:695607
Thiruvananthapuram
KERALA 		 9448842698

sabitha@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,SREE GOKULAM MEDICAL COLLEGE AND RESEARCH FOUNDATION,VENJARAMOODU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tribal adolescent girls aged 10-17 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive Health Empowerment Initiative   The Comprehensive Health Empowerment Initiative refers to a multi-media awareness package in the local language, covering key aspects of sexual and reproductive health such as pubertal changes, menstruation and menstrual hygiene, diet during adolescence, menstrual irregularities, adolescent pregnancy and its complications, sexually transmitted diseases (STDs) and their prevention, and contraceptive methods. A single one-hour session will be conducted for each participant, either in small groups or one-to-one settings, at Samoohya Padamuri in the tribal settlements. These sessions will be continued until adequate sampling is completed as per the inclusion criteria. The impact of the intervention on knowledge, attitude, and practice (KAP) will be assessed at one week, one month, and three months following the session. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  17.00 Year(s)
Gender  Female 
Details  Phase 1
Inclusion Criteria
Adolescent Girls aged 13 to 17 years, residing in the selected tribal settlements.
Parents of adolescent girls, residing in the selected tribal settlements.
Health volunteers with less than 1 year of working experience in the selected tribal settlements
Individuals those who have ability and willingness to provide informed consent
Phase2
Adolescent girls
who are in the age group of 13–17years.
who are willing to participate in the study with parental consent
who belongs to kani tribal community
Who are able to understand and communicate in malayalam
who are available at the time of data collection  
 
ExclusionCriteria 
Details 
Phase 1
Individuals unable to communicate effectively in the local language.
Individuals with severe mental or physical illnesses that may impede their participation
Individuals who have previously participated in a similar study or discussion
Phase2
Adolescent girls
Who are having any mental disabilities
who are the temporary residents or migrants not there on the day of data collection
Those who are currently receiving treatment or counseling for reproductive health issues 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
knowledge attitude and practice regarding sexual and reproductive health  knowledge attitude and practice regarding sexual and reproductive health will be assessed one week,one month and three month after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   01/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  smitha.23pnns108@student.nitte.edu.in

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study aims to explore the beliefs and perceptions surrounding sexual and reproductive health among tribal adolescent girls aged 13 to 17 years in Kuttichal and Vithura Panchayats, Thiruvananthapuram district, Kerala. It also seeks to evaluate the effectiveness of a Comprehensive Health Empowerment Initiative on improving their knowledge, attitudes, and practices through a mixed-method approach.In Phase 1, Focus Group Discussions  will be conducted with adolescent girls, their parents, and local health volunteers to understand their beliefs, practices, and challenges. Insights gained from this phase will help to design a culturally appropriate health education program in the local language.In Phase 2, the Comprehensive Health Empowerment Initiative will be implemented. The program includes a one hour video assisted session and a booklet covering key topics such as puberty, menstruation, menstrual hygiene, adolescent pregnancy, sexually transmitted infections , and contraception. This will be followed by regular short video reinforcements over three months and supported by telephonic follow ups to encourage learning retention. Sessions will be conducted in small groups at Samoohya Padanamuri in the tribal settlements.The effectiveness of the intervention will be assessed by comparing pre  and post test scores in knowledge, attitudes, and practices using structured tools. This study aims to empower tribal adolescent girls with essential health knowledge and life skills, helping them make informed choices and contributing to better health outcomes in their communities.

 
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