Back to resultsSuicide Prevention by Empowering Adolescents in Pakistan (SEPAK) (SEPAK)
Primary Purpose
Self-harm
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
LEADS Plus educational posters
Question, Persuade, and Refer (Teachers) Plus educational posters
Screening by Professionals programme plus educational posters
educational posters
Question, Persuade, and Refer (Parents) Plus educational posters
Sponsored by
About this trial
This is an interventional prevention trial for Self-harm focused on measuring self-harm, suicide prevention, school-based intervention, Pakistan
Eligibility Criteria
Inclusion Criteria for students:
- age 12 - 17 years
- the school authority agrees for the student to participate;
- both parents and students willing to participate.
Exclusion Criteria students:
- 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.
If parents/guardians meet the following exclusion criteria, they are ineligible to participate:
- 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.
Inclusion criteria (schools)
- the school authority agrees to participate;
- the schools shall be non-specialist public schools;
- school contains at least 80 students;
- school has more than 3 teachers;
- no more than 60% of students are of either sex;
- informed consent from parents and students is obtained.
Exclusion criteria (schools)
- the school authority refuses to participate;
- 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:
- Health professionals practicing within selected union councils
- 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:
- working with pupils aged 12-17 years;
- their school authority agrees for the school to participate;
- willing to participate in the study;
If teachers and staff at school meet the following exclusion criteria; they are ineligible to participate:
- their school authority refuses for the school to participate;
- not willing to participate in the study
Sites / Locations
- Public schools
- Public schools
- Public Schools
- Public schools
- Public schools
- Public schools
- Public Schools
- Public schools
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Experimental
Arm Label
LEADS Plus educational posters
Question, Persuade, and Refer (Teachers) Plus educational posters
Screening by Professionals programme Plus educational posters
Educational poster
Question, Persuade, and Refer (Parents) Plus educational posters
Arm Description
A total of six group sessions with students using presentations and videos.
It is a manualised programme for gatekeepers (teachers). This includes both presentations and videos.
This is an indicated or selective intervention by health professionals who will review assessments (done using structured questionnaires) and refer students where necessary.
The control group will be exposed to the six educational posters.
It is a manualised programme for gatekeepers (parents). This includes both presentations and videos.
Outcomes
Primary Outcome Measures
Feasibility of undertaking a trial of the intervention
recruitment rate of the trial
Therapy log
acceptability of the interventions that will be evident from the attendance of participants in each session on a therapy log
Secondary Outcome Measures
The Global school-based student health survey (GSHS)
The is a self-administered questionnaire and covered ten key topics: alcohol use, dietary behaviors, drug use, hygiene, mental health, physical activity, protective factors, sexual behaviors, tobacco use, and violence and unintentional injury
Deliberate Self-Harm Inventory
DSHI will be used to collect information about episode of self-harm. Minimum score is 0 and maximum score is 34. Higher total score indicate the higher intensity of the problem.
Kessler Psychological Distress Scale
This will use to measure psychological distress. It's a 10 item scale measuring emotional states with a 5 level response scale. Minimum score is 10 and a maximum score is 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
Beck Scale for Suicidal Ideation (BSSI)
This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week. Minimum total score is 0 and maximum total score can be 38. Higher scores indicate worse outcome.
Euro-Qol (EQ-5D-5L)
A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression)
Client Service Receipt Inventory
We will collect information on the use of health services (including the informal sector such as faith healers/Imams)
Client Satisfaction Questionnaire
Participant satisfaction with services will be assessed using the Client Satisfaction. The total score ranges from 8 to 32. Higher scores indicate higher level of satisfaction. Questionnaire (CSQ)
Full Information
NCT ID
NCT04969718
First Posted
July 5, 2021
Last Updated
March 31, 2023
Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT04969718
Brief Title
Suicide Prevention by Empowering Adolescents in Pakistan (SEPAK)
Acronym
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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,
Four preventative interventions will be selected and translated after reviewing the international literature on youth suicide prevention programmes (e.g. SEYLE trial in Europe);
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;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-harm
Keywords
self-harm, suicide prevention, school-based intervention, Pakistan
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEADS Plus educational posters
Arm Type
Experimental
Arm Description
A total of six group sessions with students using presentations and videos.
Arm Title
Question, Persuade, and Refer (Teachers) Plus educational posters
Arm Type
Experimental
Arm Description
It is a manualised programme for gatekeepers (teachers). This includes both presentations and videos.
Arm Title
Screening by Professionals programme Plus educational posters
Arm Type
Experimental
Arm Description
This is an indicated or selective intervention by health professionals who will review assessments (done using structured questionnaires) and refer students where necessary.
Arm Title
Educational poster
Arm Type
Active Comparator
Arm Description
The control group will be exposed to the six educational posters.
Arm Title
Question, Persuade, and Refer (Parents) Plus educational posters
Arm Type
Experimental
Arm Description
It is a manualised programme for gatekeepers (parents). This includes both presentations and videos.
Intervention Type
Other
Intervention Name(s)
LEADS Plus educational posters
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Question, Persuade, and Refer (Teachers) Plus educational posters
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Screening by Professionals programme plus educational posters
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
educational posters
Intervention Description
Six educational posters will be displayed in all schools in this cluster.
Intervention Type
Other
Intervention Name(s)
Question, Persuade, and Refer (Parents) Plus educational posters
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of undertaking a trial of the intervention
Description
recruitment rate of the trial
Time Frame
Change from baseline to 1-month post baseline
Title
Therapy log
Description
acceptability of the interventions that will be evident from the attendance of participants in each session on a therapy log
Time Frame
Change from baseline to 1-month post baseline
Secondary Outcome Measure Information:
Title
The Global school-based student health survey (GSHS)
Description
The is a self-administered questionnaire and covered ten key topics: alcohol use, dietary behaviors, drug use, hygiene, mental health, physical activity, protective factors, sexual behaviors, tobacco use, and violence and unintentional injury
Time Frame
Change in scores from baseline to outcome (1-month post baseline)
Title
Deliberate Self-Harm Inventory
Description
DSHI will be used to collect information about episode of self-harm. Minimum score is 0 and maximum score is 34. Higher total score indicate the higher intensity of the problem.
Time Frame
Change in scores from baseline to outcome (1-month post baseline)
Title
Kessler Psychological Distress Scale
Description
This will use to measure psychological distress. It's a 10 item scale measuring emotional states with a 5 level response scale. Minimum score is 10 and a maximum score is 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
Time Frame
Change in scores from baseline to outcome (1-month post baseline)
Title
Beck Scale for Suicidal Ideation (BSSI)
Description
This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week. Minimum total score is 0 and maximum total score can be 38. Higher scores indicate worse outcome.
Time Frame
Change in scores from baseline to outcome (1-month post baseline)
Title
Euro-Qol (EQ-5D-5L)
Description
A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression)
Time Frame
Change in scores from baseline to outcome (1-month post baseline)
Title
Client Service Receipt Inventory
Description
We will collect information on the use of health services (including the informal sector such as faith healers/Imams)
Time Frame
Change in scores from baseline to outcome (1-month post baseline)
Title
Client Satisfaction Questionnaire
Description
Participant satisfaction with services will be assessed using the Client Satisfaction. The total score ranges from 8 to 32. Higher scores indicate higher level of satisfaction. Questionnaire (CSQ)
Time Frame
Scores reported by the participant on the scale after intervention at 1-month post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for students:
age 12 - 17 years
the school authority agrees for the student to participate;
both parents and students willing to participate.
Exclusion Criteria students:
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.
If parents/guardians meet the following exclusion criteria, they are ineligible to participate:
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.
Inclusion criteria (schools)
the school authority agrees to participate;
the schools shall be non-specialist public schools;
school contains at least 80 students;
school has more than 3 teachers;
no more than 60% of students are of either sex;
informed consent from parents and students is obtained.
Exclusion criteria (schools)
the school authority refuses to participate;
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:
Health professionals practicing within selected union councils
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:
working with pupils aged 12-17 years;
their school authority agrees for the school to participate;
willing to participate in the study;
If teachers and staff at school meet the following exclusion criteria; they are ineligible to participate:
their school authority refuses for the school to participate;
not willing to participate in the study
Facility Information:
Facility Name
Public schools
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Facility Name
Public schools
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
Facility Name
Public Schools
City
Lahore
State/Province
Punjab
ZIP/Postal Code
42000
Country
Pakistan
Facility Name
Public schools
City
Multan
State/Province
Punjab
ZIP/Postal Code
59300
Country
Pakistan
Facility Name
Public schools
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan
Facility Name
Public schools
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Facility Name
Public Schools
City
Nawabshah
State/Province
Sindh
ZIP/Postal Code
67450
Country
Pakistan
Facility Name
Public schools
City
Hyderabad
State/Province
Sind
ZIP/Postal Code
17000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only anonymized data will be shared where necessary such as for the purpose of meta-analysis
Citations:
PubMed Identifier
22971152
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.
Results Reference
result
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