| CTRI Number |
CTRI/2025/04/084126 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Assertiveness-Based Intervention Program (ABIP) on Assertiveness, Interpersonal Communication Skill and Resilience among adolescents |
|
Scientific Title of Study
|
Effectiveness of Assertiveness-Based Intervention Program (ABIP) on Assertiveness, Interpersonal Communication Skill and Resilience among adolescents of higher secondary schools, Sikkim |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujen Cintury |
| Designation |
Part-time PhD Scholar |
| Affiliation |
Sikkim Manipal College of Nursing, Sikkim Manipal University |
| Address |
Sikkim Manipal College of Nursing, 5th Mile Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
9609040397 |
| Fax |
|
| Email |
sujencintury12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Linu Sara George |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Fundamental of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845602400 |
| Fax |
|
| Email |
linu.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Linu Sara George |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Fundamental of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845602400 |
| Fax |
|
| Email |
linu.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing Manipal
Manipal Academy of Higher Education
Manipal
Department of Fundamental of Nursing
Madhav Nagar Eshwar Nagar Manipal
Karnataka 576104
India |
|
|
Primary Sponsor
|
| Name |
Sujen Cintury |
| Address |
Sikkim Manipal College of Nursing
Sikkim Manipal University
5th Mile Tadong
Gangtok Sikkim
India
Pin Code 737102 |
| Type of Sponsor |
Other [Self Sponsored ] |
|
|
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 Samrat Singh Bhandari |
Sikkim Manipal Institution of Medical Sciences, SMU |
Sikkim Manipal Institute of Medical Sciences
Sikkim Manipal University
Department of Psychiatry
Room Number 3
5th Mile Tadong
Gangtok
Sikkim
India
737102
East
SIKKIM |
8348767641
samrat.b@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents Studying in 7, 8, and 9 grade. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Assertiveness-Based Intervention Program (ABIP) |
Developed and validated Assertiveness-Based Intervention Program (ABIP) will be implemented in total of 8 sessions, one session/week, each lasting for 45 minutes.
Strategies such as lectures, group discussions, roleplay, worksheets and videos will be used to deliver the program.
The program will be implemented without interfering with participants’ academic schedules. |
| Comparator Agent |
Control group |
All Govt. Schools will be included in the study. Students fulfilling the inclusion criteria will be given the intervention and students from other school from a different cluster will be taken as control group. One school from different cluster is to avoid contamination. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1
Participants who fits into adolescents age group and studying in grade 7, 8 and 9 of selected government higher secondary schools of Sikkim
Participants who will give written assent, along with parental consent
Participants who will be available during time of data collection
Phase 2
Students belonging to unassertive and aggressive or passive-aggressive categories (0-22) will be included
|
|
| ExclusionCriteria |
| Details |
Participants who has previously participated in assertiveness training classes/program |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assertiveness, interpersonal communication skill and resilience
|
Pretest (baseline)
Post Test 1 on the last day of session and Post test 2/Follow up after 3 month of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participants are expected to have improvements in assertiveness in multiple contexts, like expressing needs and opinions confidently, standing up for themselves, developing better communication skills, and improving emotional regulation. |
Pretest (baseline)
Post Test 1 on the last day of session and Post test 2/Follow up after 3 month of intervention. |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="4"
Months="6"
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 - NO
|
|
Brief Summary
|
Purpose: Existing training program lacks customization, overemphasis on verbal skills, and lacks contextual scenarios, makes researcher to develop an assertiveness based intervention program for adolescents. Existing interventions program tend to focus on verbal communication skills or provide a generic framework without consideration for the local cultural context or the unique challenges faced by the adolescents of a particular geography like Sikkim. This creates a gap that the current study aims to address by designing and evaluating an assertiveness-based intervention program that is culturally relevant, context-specific, and comprehensive in its approach. This program not only focuses on verbal assertiveness but also includes training on non-verbal communication, emotional regulation, and coping mechanisms, ensuring that it addresses the multifaceted nature of adolescent development. Furthermore, this study will assess the long-term sustainability of these interventions, which has been largely unexplored in existing literature.
Hypotheses All hypotheses will be tested at the 0.05 level of significance. H1- There will be a significant difference in mean post-test assertiveness scores between the intervention and control groups among adolescents. H2- There will be a significant difference in mean post-test interpersonal communication skill scores between the intervention and control groups among adolescents. H3- There will be a significant difference in mean post-test resilience scores between the intervention and control groups among adolescents.
|