AzTrials
AzTrials

Self-harmSEPAKNCT04969718

Suicide Prevention by Empowering Adolescents in Pakistan (SEPAK)

A study testing LEADS Plus educational posters, Question, Persuade, and Refer (Teachers) Plus educational posters and Screening by Professionals programme plus educational posters in people with Self-harm, run by Pakistan Institute of Living and Learning at 8 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Self-harm
What is being tested?
LEADS Plus educational posters, Question, Persuade, and Refer (Teachers) Plus educational posters and Screening by Professionals programme plus educational posters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,350 participants
Where
8 sitesPakistan
Study dates
1 Jul 2021to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • age 12 - 17 years
  • the school authority agrees for the student to participate;
  • both parents and students willing to participate.
  • the school authority agrees to participate;
  • the schools shall be non-specialist public schools;
  • school contains at least 80 students;
Show all 21Show fewer
  • school has more than 3 teachers;
  • no more than 60% of students are of either sex;
  • informed consent from parents and students is obtained.
  • 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)
  • 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

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.
  • the school authority refuses to participate;
  • the adolescents attend a specialist and/or independent or private school;

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Pakistan8 sites

  • Public schools

    Hyderābād, Sindh, 17000

  • Public schools

    Karachi, Sindh, 74200

  • Public Schools

    Lahore, Punjab Province, 42000

  • Public schools

    Multan, Punjab Province, 59300

  • Public Schools

    Nawabshah, Sindh, 67450

  • Public schools

    Peshawar, KPK, 25000

  • Public schools

    Quetta, Balochistan, 87300

  • Public schools

    Rawalpindi, Punjab Province, 43600

Other trials in Pakistan

About this study

Official title: Suicide Prevention by Empowering Adolescents in Pakistan (SEPAK): A Feasibility Study for Research Capability and Trial Readiness in Pakistan

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).

Read the 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.

Conditions
Self-harm
Being tested
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
Keywords
self-harm, suicide prevention, school-based intervention, Pakistan
Medical subject headings
Self-Injurious Behavior, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEADS Plus educational postersOther

    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

  • Question, Persuade, and Refer (Teachers) Plus educational postersOther

    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.

  • Screening by Professionals programme plus educational postersOther

    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.

  • educational postersOther

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

  • Question, Persuade, and Refer (Parents) Plus educational postersOther

    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.

Study groups in NCT04969718
Study groupRoleWhat they receive
LEADS Plus educational postersExperimentalA total of six group sessions with students using presentations and videos.
Receives: Other: LEADS Plus educational posters; Other: educational posters
Question, Persuade, and Refer (Teachers) Plus educational postersExperimentalIt is a manualised programme for gatekeepers (teachers). This includes both presentations and videos.
Receives: Other: Question, Persuade, and Refer (Teachers) Plus educational posters; Other: educational posters
Screening by Professionals programme Plus educational postersExperimentalThis is an indicated or selective intervention by health professionals who will review assessments (done using structured questionnaires) and refer students where necessary.
Receives: Other: Screening by Professionals programme plus educational posters; Other: educational posters
Educational posterActive comparatorThe control group will be exposed to the six educational posters.
Receives: Other: educational posters
Question, Persuade, and Refer (Parents) Plus educational postersExperimentalIt is a manualised programme for gatekeepers (parents). This includes both presentations and videos.
Receives: Other: educational posters; Other: Question, Persuade, and Refer (Parents) Plus educational posters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of undertaking a trial of the intervention

    recruitment rate of the trial

    Measured: Change from baseline to 1-month post baseline

  2. Therapy log

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

    Measured: Change from baseline to 1-month post baseline

Secondary outcomes (7)

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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)

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

  6. Client Service Receipt Inventory

    We will collect information on the use of health services (including the informal sector such as faith healers/Imams)

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

  7. 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)

    Measured: Scores reported by the participant on the scale after intervention at 1-month post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start1 Jul 2021
  3. Primary completion28 Apr 2022
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04969718
Sponsor's protocol ID
SEPAK
Acronym
SEPAK
Status last verified
Mar 2023
First submitted
5 Jul 2021
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only anonymized data will be shared where necessary such as for the purpose of meta-analysis

Publications

  • 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.

    PubMed 22971152

Questions about this trial

What is this clinical trial studying?

A study testing LEADS Plus educational posters, Question, Persuade, and Refer (Teachers) Plus educational posters and Screening by Professionals programme plus educational posters in people with Self-harm, run by Pakistan Institute of Living and Learning at 8 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of undertaking a trial of the intervention (time frame: Change from baseline to 1-month post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04969718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in