Clinical trial NCT04969718: Suicide Prevention by Empowering Adolescents in Pakistan (SEPAK)
Official title: Suicide Prevention by Empowering Adolescents in Pakistan (SEPAK): A Feasibility Study for Research Capability and Trial Readiness in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-harm
Keywords: self-harm
suicide prevention
school-based intervention
Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2021-07-21
Enrollment: 1350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

Detailed description: There will be two research phases. In the first phase,

1. Four preventative interventions will be selected and translated after reviewing the international literature on youth suicide prevention programmes (e.g. SEYLE trial in Europe);
2. Focus groups will be undertaken with multiple stakeholders (students, teachers/staff at secondary schools, parents and health professionals) to decide on adaptations needed to the four selected interventions;
3. Adapted versions the four preventative SEPAK interventions will be produced after incorporating the modifications recommended by the focus groups with stakeholders.

In the second phase, the feasibility and acceptability of the four preventative SEPAK interventions will be examined in 4 secondary schools (each site) and one control group (each site) across 8 cities in Pakistan. The four preventative interventions will involve i. Delivering workshops for students at secondary schools to raise awareness on mental health and stresses that students face.

ii. Training school teachers/workers to act as facilitators and identify troubled students iii. Training parents to act as facilitators and identify and support troubled young people iv. Training of health professionals who work with young people to systematically use cut-off scores of established psychometric tools for referring young people to mental and social care services. Six posters on mental health awareness will display in the classrooms of the school allocated to the control group.

Eligibility criteria: Inclusion Criteria for students:

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

Exclusion Criteria students:

1. the school authority refuses for the student to participate;
2. the adolescents attend a specialist and/or independent or private school;
3. 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:

1. caring for pupils aged 12-17 years;
2. the school authority agrees for the school to participate;
3. willing to participate in the study;
4. willing for pupils they care for to participate in the baseline and post-intervention assessments.

If parents/guardians meet the following exclusion criteria, they are ineligible to participate:

1. the school authority refuses for the school to participate;
2. the pupils they care for attend a specialist and/or independent or private school;
3. 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.

Inclusion criteria (schools)

1. the school authority agrees to participate;
2. the schools shall be non-specialist public schools;
3. school contains at least 80 students;
4. school has more than 3 teachers;
5. no more than 60% of students are of either sex;
6. informed consent from parents and students is obtained.

Exclusion criteria (schools)

1. the school authority refuses to participate;
2. the adolescents attend a specialist and/or independent or private school;

Inclusion criteria (Health Professionals)

Health professionals are eligible to participate if they meet all the following criteria:

1. Health professionals practicing within selected union councils
2. Willing to participate in the study Exclusion criteria (health professionals)

(1) Health professionals not currently practicing within selected union councils (2) Not willing to participate in the study

Teachers/staff at schools

Teachers and other school staff are eligible to participate if they meet all the following criteria:

1. working with pupils aged 12-17 years;
2. their school authority agrees for the school to participate;
3. willing to participate in the study;

If teachers and staff at school meet the following exclusion criteria; they are ineligible to participate:

1. their school authority refuses for the school to participate;
2. not willing to participate in the study

Primary outcomes:
measure: Feasibility of undertaking a trial of the intervention
timeFrame: Change from baseline to 1-month post baseline
measure: Therapy log
timeFrame: Change from baseline to 1-month post baseline
Secondary outcomes:
measure: The Global school-based student health survey (GSHS)
timeFrame: Change in scores from baseline to outcome (1-month post baseline)
measure: Deliberate Self-Harm Inventory
timeFrame: Change in scores from baseline to outcome (1-month post baseline)
measure: Kessler Psychological Distress Scale
timeFrame: Change in scores from baseline to outcome (1-month post baseline)
measure: Beck Scale for Suicidal Ideation (BSSI)
timeFrame: Change in scores from baseline to outcome (1-month post baseline)
measure: Euro-Qol (EQ-5D-5L)
timeFrame: Change in scores from baseline to outcome (1-month post baseline)
measure: Client Service Receipt Inventory
timeFrame: Change in scores from baseline to outcome (1-month post baseline)
measure: Client Satisfaction Questionnaire
timeFrame: Scores reported by the participant on the scale after intervention at 1-month post baseline
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Public schools
state: Balochistan
city: Peshawar
country: Pakistan
facility: Public schools
state: KPK
city: Lahore
country: Pakistan
facility: Public Schools
state: Punjab
city: Multan
country: Pakistan
facility: Public schools
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Public schools
state: Punjab
city: Karachi
country: Pakistan
facility: Public schools
state: Sindh
city: Nawabshah
country: Pakistan
facility: Public Schools
state: Sindh
city: Hyderabad
country: Pakistan
facility: Public schools
state: Sind
Study officials:
References:
citation: 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.