A Study Protocol of Primary Prevention Interventions for Substance Use and Suicide Prevention Among Youth in Kashmir: Development,Administration,and Evaluation

Abstract

Background:

Given the unique geopolitical positioning of Kashmir and its susceptibility to addiction and suicide, we present a protocol study that aims to design culturally tailored primary prevention for youth in Kashmir.

Novelty:

This study is the first attempt in the region to design and test a culturally tailored primary prevention intervention for youth mental health in Kashmir.

Objectives:

It aims to design culturally tailored primary prevention for youth in Kashmir and test it on the high-risk population.

Methods:

The study has three stages. (a) estimating risk factors for substance-use disorders (SUDs) and suicide in Kashmir among youth (16–24 years of age), (b) adapting an existing primary prevention intervention and psycho-social interventions to the culture-specific risk factors operating in Kashmir, (c) screening the at-risk youth in schools and colleges, (d) selecting suitable sample for pre/post-evaluation design, (e) administering a culturally-tailored primary-prevention intervention to the selected sample, and (f) evaluating the outcome variables which include parameters of symptom reduction and improved well-being. Data shall be analyzed utilizing both qualitative and quantitative methods. Risk factors will be estimated using thematic analysis. A culturally tailored primary prevention intervention will be designed by adapting an existing dialectical behavioral therapy skill training module to the Kashmir context. The effectiveness of the designed intervention will be evaluated through pre-and post-tests.

Expected Outcomes:

The study will provide a solid foundation for the mental health curriculum in schools and colleges. It is expected to reduce the number of mental disorders and contribute to a sustainable, mentally healthy Kashmir.

Key Messages:

This study aims to design and evaluate the effectiveness of a primary prevention intervention program for SUDs and suicide among youth in Kashmir.

Protocol Registration

This study has been prospectively registered with the Clinical Trials Registry India (CTRI); REF/2024/07/088718 (dated 15/07/2024).

The Global Burden of Diseases Report (2019) highlights a significant increase in disability-adjusted life years (DALYs) due to mental disorders, from 80 million to 125 million globally. Mental health expenditures in developed countries account for 3%–4% of gross domestic product (GDP), while they remain low in middle- and low-income nations. ¹ In this context, primary prevention, or preventive psychiatry, is critical.

Literature Review

Primary prevention aims to prevent the onset, disability, or relapse of mental disorders. ² Empirical evidence for the effectiveness of such interventions is essential to shift funding from treatment to prevention. ² There are many study designs. However, randomized controlled trials (RCT) and quasi-experiments are commonly used to assess the effectiveness of such interventions. However, establishing empirical effectiveness for primary prevention interventions can be methodologically challenging and needs a very high sample size. Therefore, prior identification of the models and the nature of prevention help solve these challenges.^3,4 Moreover, although primary prevention helps address risk factors, promoting protective factors is often stressed more than eliminating risk factors, owing to the nonmodifiable nature of specific risk factors like biology.^5,6 Primary prevention is crucial for adolescents and early adults at high risk due to rapid physical, social, and psychological changes during these life stages. ⁷ In Kashmir, over 20% of the population suffer from mental disorders, including depression, anxiety, post-traumatic stress disorder (PTSD), and schizophrenia, with substance use and suicide rates on the rise. ⁸ The Institute of Mental Health and Neurological Sciences (IMHANS) reports a dramatic increase in substance-use treatment visits, from 489 patients in 2016 to 7,420 in 2019. Additionally, 1.95% of Kashmir’s population suffers from substance dependence, signaling a crisis. ⁹ Suicide rates are also concerning, with 287 reported suicides in 2020 and 29% of youth (ages 15–29) experiencing suicidal ideation, with 9% attempting suicide.^10,11 Substance use is a significant risk factor for suicide. Both issues share common psycho-social drivers, ¹² making integrated prevention programs essential to address substance use, suicide, and mental distress effectively.

Novelty

This study represents the first protocol of its kind in Kashmir. This intervention has the potential to be used as a mental health curriculum for schools and colleges in Kashmir, which is expected to improve the region’s mental health landscape.

Objectives

The main objectives of this study are as follows:

To design culturally tailored primary prevention interventions for the mental health of young people in Kashmir.

To screen young persons for being at high risk of mental health issues in general and SUDs and suicide in particular.

To administer the designed intervention to young people who are at high risk of developing mental disorders and then to evaluate its effectiveness.

Methodology

Study Design/Study Participants/Setting

(Intervening Modalities) This is a single-group pre-post design.

The project will be implemented in the following phases.

Phase 1- Designing the primary prevention intervention for mental health in young people

Phase 2- Screening of a high-risk group among young people for mental health issues

Phase 3- Administering designed intervention to the identified high-risk young people

Phase 4- Evaluating intervention through pre-post tests (Table 2)

Study Design

Designing the Primary Prevention Intervention

The primary objective of this study is to design a primary prevention intervention for youth mental health in Kashmir. This objective will be accomplished through the following three stages.

Stage 1: Mapping the risk factors for mental health among the young people in Kashmir

To map the risk factors for youth mental health in Kashmir, in-depth interviews with various stakeholders across the power-interest grid will be conducted. Power can be operationalized as (a) knowledge, which refers to the level of information about the area under investigation, and (b) position, which refers to the extent of influence that can be exerted on the area under investigation. Interest refers to the level of interest shown in the area under investigation by the stakeholders because of personal, social, professional, or other stakes. Given these two parameters, the following stakeholders are identified to explore the risk factors of SUDs and suicide in Kashmir: psychiatrists, clinical psychologists, lawyers, clergy, teachers, students, parents, and police.

Based on the power and interest grid, these stakeholders can be classified into four categories.

1. High power and high interest (mental health professionals)

2. High power and low interest (government employees)

3. Low power and high interest (individuals with lived experience, families and caregivers, community members, students)

4. Low power and low interest (This category needs not be included as they are not expected to contribute much due to their low power and low interest).

Most of the participants will be identified before the study commences by locating the relevant stakeholders in Kashmir through the power-interest grid. Other participants will be recruited through purposive and “snowball” sampling. The sample size will depend on the saturation of the concepts. Data will be collected through in-depth interviews with these stakeholders. The interviews will start with an open-ended question inquiring about the general facets of youth mental health in Kashmir. Then, appropriate probes will be used. The interviews will be audio-taped and then transcribed.

The interview transcriptions will be analyzed. The analysis will include coding the transcriptions by highlighting the basic units and then clubbing the codes into categories. Then, they will be categorized into themes based on their underlying similarities. ¹³ This analysis will allow us to map the mental health landscape of young people in Kashmir. This will, in turn, allow us to inform the design of primary prevention interventions for mental health.

Stage 2: Selecting an existing primary prevention intervention

After examining a lot of literature and brainstorming by the research team, the skill training modules of dialectical behavioral therapy (DBT) ¹³ will be selected as a primary prevention intervention for mental health. It includes the modules mindfulness, emotional regulation, and interpersonal skills. DBT is an evidence-based treatment protocol, a skill-based modality to be used for primary prevention intervention for mental health problems. It has a transdiagnostic potential; that is, it addresses common underlying denominators (e.g., emotional dysregulation) across suicide and SUDs, among others. In addition, the skill training modules allow for group administration, which facilitates its administration in school and college classrooms. Since it has been borrowed from Eastern traditions, concepts like mindfulness are more suitable for adaptation.

Stage 3: Culturally adapting skill-training modules of DBT for youth mental health

It will be culturally adapted after selecting the skill-training module of DBT, ¹⁴ as the primary prevention intervention for Kashmir youth. Cultural adaptation will encompass two parameters: the risk factors for youth mental health operating in Kashmir and the experts’ inputs across various relevant domains (like mental health professionals, linguists, and people with lived experience of youth in Kashmir). Adaptations will be carried out at the following levels: linguistic, contextual (tracing historical roots of interventions in local culture), and situational (blending history with the present-day reality of the local culture).

Table 1 features some of the adaptations made thus far based on the preliminary mapping of the risk factors and the experts’ inputs.

Table 1.

Cultural Adaptation of Intervention in Light of Kashmir’s Common and Unique Risk Factors for Mental Health Problems and Expert Inputs.

Common Risk Factors	Interventions	Cultural Adaptation
Lack of psychological capital	Mindfulness	Tracing roots of mindfulness in the local cultureBreathing practices in the cultureGuided meditation (Kashmir-relevant imagery and symbols)
	Emotional regulation	Enriching Kashmiri emotional vocabulary
	Interpersonal effectiveness	Assertiveness training in the context of local collectivistic culture
Unique risk factor
Lack of spiritualityTransitioning into modernity	Psycho-spiritual interventions	Using spiritually-infused Kashmiri poetry and symbols from natureBalancing tradition and modernity

Intervention Structure

After adaptation, the intervention was compiled. It consists of seven modules: locus of control, self-knowledge, mindfulness, emotional regulation, interpersonal effectiveness, dealing with addictions, and psycho-spiritual modules. Each module consists of demonstrations, guided meditation practices, reflective exercises, art, story-telling, and folklore to ensure that its objectives are achieved. Furthermore, the intervention consists of a spiral-bound hard copy of the manual, its Canva/MS Office PowerPoint presentation, and a handout for participants in between sessions.

Duration of the Intervention

The time to introduce the intervention and complete the pre-assessment is 1 hour. The intervention has 15 sessions, each 17 and 20 minutes long; 8 sessions are 1 hour long, and the other seven sessions are 1 hour and 20 minutes long. The 15 sessions span over 4 weeks (i.e., 1 month), with four sessions per week.

Intervention Testing

Before administering the intervention, content validation and a feasibility test will be carried out. Both quantitative and qualitative methods of data collection and analysis will be used to assess its validity and feasibility.

Study Participants

Screening of High-Risk Young People for Mental Health Problems

After the intervention is designed, the youth from higher secondary schools and colleges in Kashmir will be screened at high risk of mental disorders. Youths (aged 16–24), both male and female, studying in different schools and colleges of the selected district will be screened for the risk of mental health problems by using the following scales: The Problem Oriented Screening Instrument for Teenagers (POSIT), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7) for screening substance use, depression/suicide risk, and anxiety, respectively.

Eligibility Criteria

Inclusion Criteria for Participants

• Students whose POSIT, PHQ-9, and GAD-7 scores indicate a high or middle level of risk for substance use and mental health problems.

• Both genders

• Age group 16–24 years

Exclusion Criteria for the Participants

• Students whose POSIT, PHQ-9, and GAD-7 scores indicate no risk.

• Students who do not give consent to participate

Implementation Plan

The phases of sampling for evaluation will be as follows:

Convenience

The schools and colleges will be selected from a particular district of Jammu and Kashmir. The reason for selecting this district is that being an urban district, it is an educational hub where diversity of students in terms of almost all the demographics can be tapped, like age, gender, socio-economic status, rural and urban, and private and government educational institutions. Considering the sample demographics, two higher secondary (boys and girls) and two colleges (boys and girls) will be selected from the selected district.

Universal Screening

After selecting these schools and colleges, a universal screening will be carried out in these institutions using POSIT for substance use, PHQ-9 for depression, and GAD-7 for anxiety. The individuals who score high for any of these disorders will be identified and approached to invite them to participate in the designed primary prevention intervention.

If they are identified during screening, we will include participants who are already on psychiatric treatment. Participation in this intervention is expected to benefit them, and it would be unethical to withhold something that can benefit such participants.

Randomization

A list of positive cases, those who fall in the high-risk range for these disorders, will be prepared. Then, every second or fifth case will be selected from this list for participation in the intervention after seeking their assent and consent. If the second or fifth case is missing, then the next positive case will be approached to participate in the intervention. This intervention will be group-administered to the screened high-risk youths in the selected schools and colleges.

Sampling and Recruitment

The sample size of the positive cases on whom intervention will be administered was estimated using software G power version 3.1.9.7. The sample size for the study was determined using a matched-pairs t-test, assuming a moderate effect size of 0.4, a significance level (α) of 0.05, and a statistical power (1-β) of 0.80. This calculation yielded a required sample size of 36 participants to assess changes within the same group before and after the intervention. However, to account for potential attrition, the final sample size has been increased to 60 participants, with 15 participants selected from each of the 4 educational institutions (Figure 1).

Table 2.

Timelines of the Study.

Phases of the Study	Year 1	Year 2	Year 3
Mapping risk factors	Completed
Intervention-making	Completed
Screening		Ongoing
Baseline		Ongoing
Intervention period			Yet to start
Follow-up			Yet to start

Figure 1.

Flowchart Showing the Number of Students Included at Various Stages of Study.

Ethics Review

The project has been approved by the Institutional Ethics Committee (MSW/KU/2022 25/04/2022). The principle of confidentiality, controlled emotions, and nonjudgmental attitudes will constitute the fundamental components of any intervention. Strict data insulation will be followed in letter and spirit. All participants will be informed of the study, and informed consent will be documented before enrollment. In concrete terms, some aspects of ethics will look like the following in this study: (a) the experts will validate the intervention, (b) the institutional approval will be sought for screening and administering the intervention, and (c) the identities of the students identified as high-risk will be kept confidential by assigning them codes.

Data Collection and Statistical Analysis Plan

Project Team and Training

Before officially starting the data collection (i.e., identification of clients with substance use and suicidal ideation, the research team (one senior and two junior research fellows) will practice the use of the tools and techniques under the guidance of the principal investigator. All the researchers/fellows shall be trained in psychological first aid as well to professionally and scientifically manage the youth involved in substance use and suicidal ideation if they come across any such case while screening the clients from the field.

Official Approvals

Before conducting screening and mental health sessions in the selected institutions, the directors of school education and colleges will be approached for official permission to collect data.

Data Management

Data will be entered on a master sheet in Excel, and all data will be codified. The data will be kept in password-protected computers and files.

Screening Tools

The Problem Oriented Screening Instrument for Teenagers (POSIT) ¹⁵

The POSIT is a multiple-problem screening tool developed by the National Institute on Substance Use, specifically for adolescents aged 12 through 19. ¹⁵ The POSIT is meant for ages 16–19, and the age group for this study is 16–24. This scale will be adapted for Kashmir to resolve this and other cultural discrepancies in the POSIT. The adaptation will include the following facets: (a) extending the upper limit of the scale from 19 to 24 years (rationale for doing so is that, unlike teens in the West, many age-sensitive items in the scale, particularly about financial independence, are relevant for both teens as well as young adults in Kashmir); (b) translation of the scale in the local language and (c) reverse scoring of few items to fit the risk and protective factors to suit the regional context.

Patient Health Questionnaire 9 ¹⁶

The following two versions of the PHQ-9 will be used: Patient Health Questionnaire Modified for Teens (Depression) (12–18 years) and PHQ-9 (Depression) for participants who are 18 and older. PHQ-9 is a self-administered questionnaire that assesses the severity of depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria. These scales also help in measuring suicide risk. Depression was included because the situation analysis of risk factors for SUDs and suicide among youth in Kashmir revealed that though these disorders can be standalone diagnoses, they usually have underlying psychopathologies. Therefore, PHQ-9 was selected to assess the risk of underlying psychopathology, which may make an individual more susceptible to SUDs and suicide.

Generalized Anxiety Disorder-7 ¹⁷

The GAD-7 is a 7-item anxiety scale, which is a valid and efficient tool for screening and assessing the severity of anxiety in clinical practice and research. The scores 0–4, 5–9, 10–14, and 15–21 represent minimal, mild, moderate, and severe anxiety, respectively. The reason for using this scale is again to identify the underlying psychopathology for SUD and suicide.

For evaluating the outcomes of the intervention, a comprehensive assessment comprising the following scales, POSIT, PHQ-9, and GAD-7, shall be administered at the baseline (i.e., before conducting the intervention) and eight weeks after the baseline. Given the transdiagnostic nature of this intervention, it is expected to improve multifaceted aspects of mental health among youths, which include symptom reduction, mindfulness, emotional regulation, interpersonal skills, and dealing with addictions.

Statistical Analysis

Depending on the nature of the variables (continuous or dichotomous), relevant parametric and nonparametric statistical tests will be used by observing the following steps:

The screening of the participants using POSIT will provide risk levels along six functional areas, which are substance use, physical health, mental health, family relationships, educational status, and aggressive behavior/delinquency. Moreover, PHQ-9 and GAD-7 will be used to assess levels of depression and anxiety.

A suitable statistical test will determine the frequency distribution of participants with middle/high-risk levels.

Sample characteristics will be defined using descriptive statistics.

These scores will be compared with sociodemographic variables using an independent t-test (for continuous variables) or a chi-squared test (for categorical variables).

The POSIT, PHQ-9, and GAD-7 will be administered before and after the intervention. To assess the effectiveness of the designed intervention, pre-and post-test scores will be compared using a within-group or “paired t-test.”

Discussion

There is an increasing trend in the prevalence of mental health disorders,^7,9 including SUD and suicide among young people in Kashmir.^9–11 In this regard, the use of primary prevention will help bring down the numbers and move toward a more resilient society. As research has shown primary prevention to be highly effective in mental health promotion,^1,2,6 culturally-tailored primary prevention for local young people will be a significant development in this regard. From a theoretical and methodological perspective, this is a risk detection and well-being enhancement intervention in terms of building the psychological capital of young people (through mindfulness, emotional regulation, interpersonal skills, and dealing with addictions). From a methodological perspective, it is a targeted prevention for high-risk young people for mental disorders,^2,3 and to establish its empirical evidence, a pre- and post-design will be used.

Expected Limitations and Strengths

Since this study uses a pre-post design, it will inherently have limitations due to the absence of a control group. Regardless, sufficient empirical evidence will be gathered using this study design to prove its effectiveness.

Expected Outcomes

The outcomes of this study will provide a culturally tailored primary prevention intervention for the local youth population. Such an intervention can be introduced as a mental health curriculum for schools and colleges. This can be a promising step toward improving the state’s mental health landscape. Besides, the intervention will be tested to provide evidence for its effectiveness. However, concerning the study’s limitations, the intervention will be tested using a pre and post-test design with no control group, which may have limitations for the generalization of results. Nevertheless, sufficient evidence will be generated for shifting the attention of policymakers toward primary prevention of mental health issues.

Supplemental Material

Supplemental material for this article is available online.