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CTRI Number  CTRI/2025/07/091434 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral
Other (Specify) [Psychosocial Intervention]  
Study Design  Other 
Public Title of Study   Supporting Children and Adolescents in the Juvenile Justice System to stay away from Substance Use through group intervention 
Scientific Title of Study   Brief Group Intervention on Substance Use Prevention for Children in Conflict with Law 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mary Infanta P 
Designation  Ph.D. Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Room No 116, Department of Psychiatric Social Work, Dr.M.V. Govindaswamy Building, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur Road, Bengaluru, Karnataka

Bangalore
KARNATAKA
560029
India 
Phone  9591171250  
Fax    
Email  infantamary28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shreedevi AU 
Designation  Assistant Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences NIMHANS 
Address  Room No 122, Department of Psychiatric Social Work, Dr.M.V. Govindaswamy Building, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur Road, Bengaluru, Karnataka

Bangalore
KARNATAKA
560029
India 
Phone  9731510930  
Fax    
Email  shreedeviau@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreedevi AU 
Designation  Assistant Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences NIMHANS 
Address  Room No 122, Department of Psychiatric Social Work, Dr.M.V. Govindaswamy Building, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur Road, Bengaluru, Karnataka

Bangalore
KARNATAKA
560029
India 
Phone  9731510930  
Fax    
Email  shreedeviau@gmail.com  
 
Source of Monetary or Material Support  
University Grants Commission and National Institute of Mental Health and NeuroSciences, Hosur Road , Bangalore 560029, Karnataka, India 
 
Primary Sponsor  
Name  Mary Infanta.P 
Address  Ph.D.Scholar Department of Psychiatric Social Work, Dr. M.V. Govindaswamy Building, National Institute of Mental Health and Neuro Sciences, Bengaluru 560029, Karnataka 
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 
Mrs Kavitha MasaliThe Superintendent  Government Observation Home for Boys  Government Observation Home for Boys, Child Care Institutions (under the Juvenile Justice Care & Protection of Children act-2015) Markete Road, Koramangala 2nd Block, Madiwala, Bangalore 560068, Karnataka, INDIA
Bangalore
KARNATAKA 
9945623623

ohbangalore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
District Child Protection Unit – Directorate of Child Protection  Approved 
Institute Ethics Committee, NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Study samples will also include Children in Conflict with law who may not have prior exposure to any substance, as the intervention will focus universal, primary, and secondary prevention strategies. 
Patients  (1) ICD-10 Condition: F101||Alcohol abuse, (2) ICD-10 Condition: F121||Cannabis abuse, (3) ICD-10 Condition: F119||Opioid use, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief Group intervention  Brief Group Intervention: The study aims at substance use prevention among Children who are in conflict with the law by providing 9 group sessions for 3 consecutive days, 3 sessions per day for 45 minutes, focusing on the knowledge, attitude, and practice about substance use, the group intervention is delivered during their stay at the Juvenile Justice Homes. The total duration of the session will be 6 hours and 45 minutes. The sessions would enhance their knowledge and attitude towards the causes and consequences of substance use, essential drug resistance skills that help them to stay away from substance use post-incarceration.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Male 
Details  Children between the age group of 12 to 18 years who conflict with.
Children stay in the Government observation home for boys in Bengaluru for their legal proceedings under protective custody.
Children who speak Tamil, English, Kannada and who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  Children in Conflict with the Law who are not staying for 1 week or less, have any other psychological or mental health conditions that restrict them from participating in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increased and better Knowledge, attitude, and practice on substance use.
Reduced substance use behaviour.
The outcomes are measured through Knowledge, Attitude, and Practice on substance use questionnaire.  
Pre-assessment is on the day before the intervention, post-assessment (0-day) after the intervention,4 weeks, and 12 weeks after the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Increased positive coping than negative coping towards negative life events.
Better decision-making & problem-solving skills. 
Pre-assessment is on the day before the intervention, post-assessment (0-day) after the intervention,4 weeks, & 12 weeks after the intervention. 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   12/08/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response (Others) -  The necessary data of the respondents will be provided based on request and the assessments revealing a medical emergency or indicating will be referred to the competent authorities for further medical or psychosocial interventions.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  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 - Proposals should be directed to [infantamary28@gmail.com].

  6. For how long will this data be available start date provided 12-07-2025 and end date provided 12-08-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
India, with a population of 253 million, has 21% of this massive population comprised of children, a statistic that emphasizes India’s status as home to one of the largest child and adolescent populations globally; that means every fifth person in India belongs to the age group of 10 to 19 years.  (Census-India 2011; UNICEF 2023). The Magnitude of Substance Use in India Report, 2019 shows a prevalence of 1.8% opioids, 1.3% alcohol, 1.17% volatile solvents, and 0.9% cannabis among adolescents (MoSJE). The Global Youth Tobacco Survey (GYTS-4) in 2019 revealed that one-fifth of students aged 13 to 15 had ever used any form of tobacco product, and 2.8% of students had ever used e-cigarettes. (MoHFW, 2021). Lifetime substance-use disorder prevalence rates ranged between 22% and 96% for juvenile justice-involved adolescents, higher than the 7%–11% prevalence rates for adolescents in the general population (Rohan et al.2020). In the Indian context, the term “Children In Conflict With Law” (CICL) refers to individuals below the age of 18 years who are alleged or found to have committed offenses.  (The Juvenile Justice (Care and Protection of Children) Act, 2015). This can encompass various unlawful behaviors, from petty crimes to more serious offenses. These children come into contact with the legal system due to their actions, causing consequences that can include judicial proceedings, detention, or rehabilitation measures. Children in conflict with the law are vulnerable to substance abuse due to a variety of bio-psycho-social factors. Adolescents struggling with psychosocial vulnerabilities, particularly those linked to substance use, can often find themselves in conflict with the law. (Whitesell,2013) The adolescent brain is still developing and drug use can have long-term negative effects. Early drug use initiation can lead to faster development of dependence in adulthood. Young people are more vulnerable to drug use than adults are (UNDOC,2023). Children in conflict with the law (CICL) and children in need of care and protection (CINCP) have a higher prevalence of mental health- and substance use related problems; similarly, juveniles with mental health problems have a higher chance of coming in contact with JJS (Snehi, Gupta., 2020) Meta-analysis findings suggest drug users were 7 to 8 times more likely to offend than nondrug users, and integrating psychosocial interventions into rehabilitation frameworks gives a higher chance of breaking this cycle (Bennett T., 2008). 
Often, within correctional settings, attention leans toward the legal dimensions of CICL, overshadowing the issue of substance use and intervention focusing on this aspect. Works of literature exist in the Indian context on curative perspectives of substance use in this population. Very few studies focus on the prevention and promotional aspects of substance use, and studies suggest that preventive strategies should be strengthened for at-risk populations: school dropouts, first-time offenders, and juveniles with externalizing disorders (Snehil & Gupta, 2020). Research on interventions for preventing substance use among Children in Conflict with the Law (CICL) is limited, especially in terms of examining the deep psychosocial factors that contribute to substance misuse and the development of preventive and promotive strategies, this gap is notably evident in the context of India (Das et al 2016). The current study aims to fill the existing research gap in the literature on preventive interventions for substance use in this population.
The current study uses the Quasi-experimental research design with pre-post research design without a control group, comprising three phases, namely the need assessment phase, the intervention phase, and the post-assessment phase. This research design allows the same group to be compared over time by considering the data trend before and after the intervention. During the first qualitative phase, the researcher conducts focus group discussions with Children in conflict with the Law, Key Informant interviews with key stakeholders, and field experts and In-depth interviews with the Parents of Children in conflict with the Law to identify the existing needs for psychosocial intervention needs in addressing substance use among Children in conflict with the law that time bounding, contextual and culturally sensitive. The samples are recruited voluntarily with prior informed written consent, and the sample size for this phase will be decided based on data saturation. The data will be audio-recorded and transcribed to identify the relevant themes. A group intervention module will be developed based on the emerging themes from the needs assessment. The content, duration, and methodology of the sessions will be validated by the experts. The study’s second phase aims at the delivery of the intervention based on the intervention module to 65 Participants who will be recruited based on the inclusion-exclusion criteria on a consecutive sampling method after prior informed assent from Children in Conflict with the law (CICL) and consent from parents of CICL. The research tools include ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) by WHO to assess the pattern and severity of Substance use, Brief COPE- Carver C.S., 1997, to identify the coping pattern, and the Strength and Difficulty Questionnaire (SDQ), a brief behavioural screening questionnaire to screen the internalising and externalising problems in the subjects along with the Knowledge, attitude practice questionnaire and Socio-demographic sheets to collect the basic profiles. During the post-intervention period, the Knowledge, Attitude and Practice questionnaire will be used at two times a month after the intervention and  3 months later as a follow-up. Data would be assessed using appropriate statistical tests based on the normality of data distribution. 

 
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