| CTRI Number |
CTRI/2026/02/103191 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Development of self-help manuals for the management of violence in adolescents |
|
Scientific Title of Study
|
Development of self-help manuals for adolescents and caregivers for the management of violence in adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIRPSG-2024-01-06041 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Pain |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Human Behaviour and Allied Sciences (IHBAS) |
| Address |
Institute of Human Behaviour and Allied Sciences (IHBAS)
Post Box No 9520, Jhilmil, Dilshad Garden
Delhi-110095, INDIA
East
DELHI
110095
India |
| Phone |
8527008818 |
| Fax |
|
| Email |
a.pain.psyd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita Pain |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Human Behaviour and Allied Sciences (IHBAS) |
| Address |
Institute of Human Behaviour and Allied Sciences (IHBAS)
Post Box No 9520, Jhilmil, Dilshad Garden
Delhi-110095, INDIA
East
DELHI
110095
India |
| Phone |
8527008818 |
| Fax |
|
| Email |
a.pain.psyd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Pain |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Human Behaviour and Allied Sciences (IHBAS) |
| Address |
Institute of Human Behaviour and Allied Sciences (IHBAS)
Post Box No 9520, Jhilmil, Dilshad Garden
Delhi-110095, INDIA
East
DELHI
110095
India |
| Phone |
8527008818 |
| Fax |
|
| Email |
a.pain.psyd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan,
P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
Program Officer (e-PMS)
Indian Council of Medical Research
Ansari Nagar, New Delhi-110029
Email: po.epms@icmr.gov.in
Contact us:011-26589571 |
| Type of Sponsor |
Other [ICMR is a government organization that conducts and promotes biomedical research in India. ] |
|
|
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 |
| Amrita Pain |
Institute of Human Behaviour and Allied Sciences |
Institute of Human Behaviour and Allied Sciences (IHBAS)
Room 104, Academic Block, Human Behaviour Department,
Post Box No 9520, Jhilmil, Dilshad Garden
Delhi-110095, INDIA
East
DELHI |
8527008818
a.pain.psyd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee (IEC)-IHBAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents with a history of violent behaviour (s) and their parents/ primary care-givers; teachers who have a history of witnessing or intervening with students displaing violent behaviours. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self-help manuals for management of violence in adolescents for adolescents and caregivers |
Details of the behavioural intervention: The self-help manuals will primarily be based on principles of behaviour therapy, cognitive behaviour therapy and positive psychotherapy to help both groups recognize, identify and name emotions, thoughts and behaviours leading to violent behaviours. Intervention modules for adolescents will focus on biulding capacity for cognitive, emotional and self-regulation, coping with distress and tools for regulating negative emotions, problem solving and assertive skills, communication skills and help-seeking behaviours from reliable adults.
The self-help manual for care-givers will focus on identifying deviant behaviours and safely intervene to help the adolescent manage violent urges or thoughts before an act of violence is committed, or to improve functioning after the act to enable better adjustment after effective management of violent urges. The manual will also include management of distress, coping and relaxtion skills for adult caregivers of adolescents with violent behaviours. The control group will receive brief counseling based on the assessments conducted and possible management strategies. |
| Intervention |
Self-help manuals for management of violence in adolescents for adolescents and caregivers |
The self-help manuals will primarily be based on principles of behaviour therapy, cognitive behaviour therapy and positive psychotherapy to help both groups recognize, identify and name emotions, thoughts and behaviours leading to violent behaviours. Intervention modules for adolescents will focus on biulding capacity for cognitive, emotional and self-regulation, coping with distress and tools for regulating negative emotions, problem solving and assertive skills, communication skills and help-seeking behaviours from reliable adults. The self-help manual for care-givers will focus on identifying deviant behaviours and safely intervene to help the adolescent manage violent urges or thoughts before an act of violence is committed, or to improve functioning after the act to enable better adjustment after effective management of violent urges. The manual will also include management of distress, coping and relaxtion skills for adult caregivers of adolescents with violent behaviours. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for adolescents: Within the age range of 10 years and 18 years with self-reports or a single or more documented act of engaging in violent behaviour(s) in the last 6 months as reported by teachers and/or parents. Adolescents in conflict with the law under the Juvenile Justice Act will be included.
Inclusion criteria for Parents: Parents or primary care-givers of adolescents who have met the inclusion criteria for being participants in the study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for adolescents: Those with no history of known hostile or aggressive behaviours adolescents with current, active psychopathology displaying aggressive behaviours.
Exclusion criteria for Parents/ Primary care-givers: Parents with active psychopathology that interferes with in-depth interviews will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is currently in Phase 1 of literature review, procurement of equipment, seeking permission from schools (government-aided and private) and observation homes under the Government of India and beginning data collection through the selected participants after CTRI permission. This will help determining the baseline of nature and magnitude of violent behaviours in adolescents. |
2-3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The intervention design and validation of the intervention will be Phase 2 of the study. Self-help manuals for adolescents will aim to empower adolescents to recognize urges for violence and reach out for help before committing an act of violence. The self-help manual for caregivers will help to identify and safely, effectively manage the risk of violence among adolescents.
|
2 years. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
20/02/2026 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Currently, the project research associates have been recruited and a thorough literature review and narrative analysis of the research articles has helped establish the structure for a semi-structured interview for the adolescents, parents/ primary care-givers and teachers. The schools and observation homes for seeking permission and collecting data have been identified via stratified random sampling. The adolescents and parent/ teacher interview will help identify the nature, severity and socio-emotional correlates of violence in adolescents in Delhi, apart from the quantitative data from the tests to be used. This will conclude in the next 2- 3 months, concluding Phase 1 of the study. Recruitment of participants for the study will begin after receiving CTRI permission.
A systematic review paper on international and national research studies conducted in the field of violence in adolescents has been completed, the manuscript of the study has being drafted for submission for publication. |