NCT06721364

Brief Summary

Background Globally, around 800,000 people die annually by committing suicide with a disproportionate burden of 77% of these deaths occurring in low- and middle income countries. Suicidal ideation is frequently observed among adolescents and is directly associated with suicidal attempts. Pakistan has witnessed a marked escalation in suicide rates in recent years, with Gilgit-Baltistan reporting the highest incidence. Extensive scholarly inquiry suggests the potential role of suicide prevention strategies in mitigating suicidal ideation, attempts, and related fatalities. This study aims to validate and evaluate the efficacy of a locally contextualized suicide prevention programs called RAAHI (the Guide) and safeTALK in improving the mental wellbeing of school-going adolescents in the Gilgit Baltistan, Pakistan. Method and Analysis The investigation will evaluate the effectiveness of a locally contextualized suicide prevention intervention program called RAAHI based on internationally tested out program named safeTALK among 267 adolescents attending 4 private schools in Gilgit Baltistan, Pakistan, followed by its contextual validation. 'RAAHI', a suicide literacy module is designed to equip individuals with the knowledge and skills to recognize signs of suicidal ideation, engage them empathetically, and connect those in crisis with support. It promotes open discussions, combats stigma, and encourages preventive measures for widespread suicide literacy. The, safeTalk a 4-hour psychoeducational workshop, aimed to prevent adolescent suicide through presentations, videos, discussions, and interactive sessions. Participants learned to identify warning signs, engage in TALK steps (Tell, Ask, Listen, KeepSafe), and connect individuals with crisis support. Employing an \& interrupted time-series design through a pre-post-test framework, the study will assess the impact of the intervention at various time points, post intervention (T2) and follow up after 8 weeks (T3). Descriptive and inferential analyses (paired t test, ANOVA) will be carried out to gauge alterations in each measured outcome (including knowledge, confidence, willingness, and help-seeking behaviors) during the course of the study. Ethics and Dissemination The study protocol has been approved by the Ethical Review Committee of the Aga Khan University (registration number 2023-8509-24844). The study finding will be shared with the parents and school authorities through workshops conducted in Urdu. The study will be published in an open-access, peer-reviewed journal and presented at relevant conferences. Strengths and Limitations

  • Since there is no standard intervention available for suicide prevention for adolescents in Pakistani context, the current research will assist in up scaling contextualized suicide prevention intervention among school-going adolescents in Pakistan. However, due to time, budget and logistical constraints, this feasibility study will only be conducted In private schools of Gilgit Baltistan, Pakistan, limiting potentially diverse implementation experiences and outcomes in rural or public school settings. This may restrict the generalizability of the study findings. Moreover, employing a quasi-experimental design without an appropriate control group can potentially undermine the internal validity of the study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

October 20, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

suicide prevention programStrategiesinterventionmeasuremental WellbeingPsychological healthAdolescent Health

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation

    The degree of suicidal ideation among the participants will be measured through the Modified Scale of Suicidal Ideation by Miller et al. (1991), comprising 21 items. It was translated and used in the Urdu language by Bakht, Saeed, Noushad2, 3, and Shamoon (2017). The MSSI has shown strong internal consistency, with coefficient α ranging from 0.87 to 0.94

    Pre test, post test I and post test II after 8 weeks

Secondary Outcomes (3)

  • Attitude Toward Seeking Professional Psychological Help Scale (ATSPPHS)

    Pre test, post test I and post test II after 8 weeks

  • Depression, Anxiety and Stress level.

    Pre test, post test I and post test II after 8 weeks

  • Adaptive Coping strategies

    Pre test, post test I and post test II after 8 weeks

Other Outcomes (1)

  • Self Efficacy

    Pre test, post test I and post test II after 8 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

This is single arm pretest post-test, behavioural Suicide prevention intervention, so all the participants will be given the intervention

Behavioral: Suicide prevention treatment

Interventions

Intervention I:"RAAHI" RAAHI is a suicide literacy module that is specially designed to provide individuals with essential knowledge and skills by equipping them with tools to navigate the complexities of mental health and suicide prevention. This module aims to empower people to recognize signs of suicidal ideation, engage in empathetic communication through open discussion, combat stigma, and connect individuals in crisis with appropriate support and resources. The duration of the module will be of three hours. Intervention II: "safeTALK" The \"safeTalk\" program is a psychoeducational initiative designed for suicide prevention among adolescents, consisting of a 4-hour workshop that incorporates presentations, videos, discussions, and questions.The workshop is designed according to the standard practices of safeTALK, to assist participants in (a) identifying warning signs of suicide; (b) Avoiding frequent impulses to overlook, dismiss, or avoid discussions about suicide.

Single arm

Eligibility Criteria

Age12 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both male and female adolescents enrolled in grades IX and X who can comprehend English and Urdu languages will be included. In addition, they and their parents consent to participate in the study.

You may not qualify if:

  • Adolescents who will be absent or sick on the day of data collection and intervention will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga khan university

Karachi, Sindh, 74000, Pakistan

Location

MeSH Terms

Conditions

Suicide PreventionPsychological Well-Being

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Yasmin Parpio, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR
  • Rozina Nuruddin, PhD

    Aga Khan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not any
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Intervention I:"RAAHI" RAAHI is a suicide literacy module that is specially designed to provide individuals with essential knowledge and skills by equipping them with tools to navigate the complexities of mental health and suicide prevention. This module aims to empower people to recognize signs of suicidal ideation, engage in empathetic communication through open discussion, combat stigma, and connect individuals in crisis with appropriate support and resources. Intervention II: "safeTALK" The \"safeTalk\" program is a psychoeducational initiative designed for suicide prevention among adolescents, consisting of a 4-hour workshop that incorporates presentations, videos, discussions, and questions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal

Study Record Dates

First Submitted

October 20, 2024

First Posted

December 6, 2024

Study Start

January 30, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) collected in this study will not be made publicly available due to privacy concerns and institutional policies. However, the individual participant data (IPD) collected in this study will not be made publicly available due to privacy concerns and institutional policies. The data will be available to researchers upon reasonable request

Locations