| 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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| University Grants Commission and National Institute of Mental Health and NeuroSciences, Hosur Road , Bangalore 560029, Karnataka, India |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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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 |
|
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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.
|
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| 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.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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. |
|
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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.
- What additional supporting information will be shared?
Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [infantamary28@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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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