NCT04969718

Brief Summary

Self-harm is now seen as an epidemic affecting young people across the world and particularly in low and middle-income countries (LMIC) such as Pakistan. Young people in Pakistan often come across many troubles such as mental health and family problems, stress at school and social and economic inequalities. A youth suicide prevention programme is needed in Pakistan. Such programme will be based on secondary schools (where most young people are) and will support schools to work together with many public agencies to tackle the full range of troubles that young people face. Our main research aim is to work together with multiple stakeholders to culturally adapt and test the feasibility of three SEPAK interventions to prevent suicide among students in secondary schools in Pakistan (aged 12 to 17 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

8 active sites

Status
completed

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

July 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

July 5, 2021

Last Update Submit

March 31, 2023

Conditions

Keywords

self-harmsuicide preventionschool-based interventionPakistan

Outcome Measures

Primary Outcomes (2)

  • Feasibility of undertaking a trial of the intervention

    recruitment rate of the trial

    Change from baseline to 1-month post baseline

  • Therapy log

    acceptability of the interventions that will be evident from the attendance of participants in each session on a therapy log

    Change from baseline to 1-month post baseline

Secondary Outcomes (7)

  • The Global school-based student health survey (GSHS)

    Change in scores from baseline to outcome (1-month post baseline)

  • Deliberate Self-Harm Inventory

    Change in scores from baseline to outcome (1-month post baseline)

  • Kessler Psychological Distress Scale

    Change in scores from baseline to outcome (1-month post baseline)

  • Beck Scale for Suicidal Ideation (BSSI)

    Change in scores from baseline to outcome (1-month post baseline)

  • Euro-Qol (EQ-5D-5L)

    Change in scores from baseline to outcome (1-month post baseline)

  • +2 more secondary outcomes

Study Arms (5)

LEADS Plus educational posters

EXPERIMENTAL

A total of six group sessions with students using presentations and videos.

Other: LEADS Plus educational postersOther: educational posters

Question, Persuade, and Refer (Teachers) Plus educational posters

EXPERIMENTAL

It is a manualised programme for gatekeepers (teachers). This includes both presentations and videos.

Other: Question, Persuade, and Refer (Teachers) Plus educational postersOther: educational posters

Screening by Professionals programme Plus educational posters

EXPERIMENTAL

This is an indicated or selective intervention by health professionals who will review assessments (done using structured questionnaires) and refer students where necessary.

Other: Screening by Professionals programme plus educational postersOther: educational posters

Educational poster

ACTIVE COMPARATOR

The control group will be exposed to the six educational posters.

Other: educational posters

Question, Persuade, and Refer (Parents) Plus educational posters

EXPERIMENTAL

It is a manualised programme for gatekeepers (parents). This includes both presentations and videos.

Other: educational postersOther: Question, Persuade, and Refer (Parents) Plus educational posters

Interventions

This intervention covers depression and its symptoms, the link between depression and suicide, the risk and protective factors associated with suicide, the warning signs of suicide, seeking help and overcoming barriers to seeking help, and school and community suicide prevention resources. Six educational posters will also be displayed in class rooms

LEADS Plus educational posters

It is a manualised programme for gatekeepers, originally developed in the USA which to train teachers/school staff to identify the suicide risk in students and encourage students at risk of suicide to seek professional help. Six educational posters will also be displayed in classrooms.

Question, Persuade, and Refer (Teachers) Plus educational posters

This is an indicated or selective intervention which is based on students' responses to the baseline questionnaires. Participating health professionals review students' responses to the questionnaires used in the study and students whose scores meet pre-established cutoff points will be invited to participate in a professional mental health clinical assessment and if needed, referred to clinical services. Six educational posters will also be displayed in classrooms.

Screening by Professionals programme Plus educational posters

Six educational posters will be displayed in all schools in this cluster.

Educational posterLEADS Plus educational postersQuestion, Persuade, and Refer (Parents) Plus educational postersQuestion, Persuade, and Refer (Teachers) Plus educational postersScreening by Professionals programme Plus educational posters

It is a manualised programme for gatekeepers (parents), originally developed in the USA which to train parents to support the young people at risk of suicide. Six educational posters will also be displayed in classrooms.

Question, Persuade, and Refer (Parents) Plus educational posters

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age 12 - 17 years
  • the school authority agrees for the student to participate;
  • both parents and students willing to participate.

You may not qualify if:

  • the school authority refuses for the student to participate;
  • the adolescents attend a specialist and/or independent or private school;
  • the parents of students in a participating school, or the students themselves, have refused to sign the consent document.
  • Parents/guardians
  • Parents/guardians are eligible to participate if they meet all the following criteria:
  • caring for pupils aged 12-17 years;
  • the school authority agrees for the school to participate;
  • willing to participate in the study;
  • willing for pupils they care for to participate in the baseline and post-intervention assessments.
  • the school authority refuses for the school to participate;
  • the pupils they care for attend a specialist and/or independent or private school;
  • not willing to participate in the study or not willing for the pupils they care for to participate in the baseline and post-intervention assessments.
  • the school authority agrees to participate;
  • the schools shall be non-specialist public schools;
  • school contains at least 80 students;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Public schools

Quetta, Balochistan, 87300, Pakistan

Location

Public schools

Peshawar, KPK, 25000, Pakistan

Location

Public Schools

Lahore, Punjab Province, 42000, Pakistan

Location

Public schools

Multan, Punjab Province, 59300, Pakistan

Location

Public schools

Rawalpindi, Punjab Province, 43600, Pakistan

Location

Public schools

Hyderābād, Sindh, 17000, Pakistan

Location

Public schools

Karachi, Sindh, 74200, Pakistan

Location

Public Schools

Nawabshah, Sindh, 67450, Pakistan

Location

Related Publications (1)

  • Wasserman C, Hoven CW, Wasserman D, Carli V, Sarchiapone M, Al-Halabi S, Apter A, Balazs J, Bobes J, Cosman D, Farkas L, Feldman D, Fischer G, Graber N, Haring C, Herta DC, Iosue M, Kahn JP, Keeley H, Klug K, McCarthy J, Tubiana-Potiez A, Varnik A, Varnik P, Ziberna J, Postuvan V. Suicide prevention for youth--a mental health awareness program: lessons learned from the Saving and Empowering Young Lives in Europe (SEYLE) intervention study. BMC Public Health. 2012 Sep 12;12:776. doi: 10.1186/1471-2458-12-776.

MeSH Terms

Conditions

Self-Injurious BehaviorSuicide Prevention

Interventions

LeadReferral and Consultation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicide

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetalsProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 21, 2021

Study Start

July 1, 2021

Primary Completion

April 28, 2022

Study Completion

August 30, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Only anonymized data will be shared where necessary such as for the purpose of meta-analysis

Locations