Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000634572
Ethics application status
Approved
Date submitted
23/04/2024
Date registered
16/05/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
16/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Contextualising and evaluating the preliminary effectiveness, feasibility, and acceptability of a Suicide Prevention Program for Secondary School Students in Nepal
Scientific title
Contextualising and evaluating the preliminary effectiveness, feasibility, and acceptability of a Suicide Prevention Program for Secondary School Students in Nepal
Secondary ID [1] 312014 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Suicidal thoughts 333666 0
Condition category
Condition code
Mental Health 330313 330313 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SafeTALK is a community-wide awareness program about suicide, its core concepts are Safety and Connectedness (Turley, 2018).
To implement the SafeTALK program in Nepal two training programs will need to be completed. The first program is the LivingWorks Applied Suicide Intervention Skills Training (ASIST) - two days (15 Hours) of in-person training. After completing ASIST, a two-day in-person workshop in the Suicide alertness SafeTALK Training for Trainers (T4T) course should also be completed. For this study, the candidate and supervisors will participate in two days of ASIST training (15 hours) in a group of 15 participants, and the PhD candidate will complete the 2 days T4T workshop before implementation of the program. Both ASIST and T4T trainings will be provided by registered trainers of LivingWorks Australia.
ASIST means applied suicide intervention skills training, which is two days' workshop containing recognising suicide invitaions, suicide risk assessment assessment and connecting to appropriate service and care to keep the person safe. It is pre-requisite for SafeTALK training for trainers T4T. Training for trainers' is a workshop, which enables the trainer to deliver the SafeTALK.
Phase I
Focus groups will be conducted to contextualise the SafeTALK program in Nepalese context. (qualitative study).
Students studying in grade nine and/or ten in Sunsari districts, parents, teachers, school nurses, mental health professionals, and representative health policymakers will be eligible to participate. The sample size will be 5 to 8 adolescents, 1 to 2 parents, 1 to 2 teachers, 1 school nurse, 1 psychiatric nurse, and 1 policymaker from the epidemiology and disease control division. They will be interviewed in two focus groups (one adolescent group and one stakeholder group). Each focus group will take 1-2 hours depending on the robustness of discussion. A package will be developed outlining the main elements of the existing program (SafeTALK) to facilitate the focus group discussion. This package will be sent to the participants as pre-reading and preparation (two weeks in advance). A guide for the topics to be discussed in the focus group discussion will be provided to participants.
Phase II (Intervention/exposure phase)
The contextualised SafeTALK program will be delivered by a LivingWorks (Australia) trained researcher (the Ph.D. candidate) who will implement the program across the classroom after having informed consent. The class will be divided into small class sizes (maximum of 30 in each group), up to four groups to deliver the program. One group will receive the intervention one time for approximately 3 hours SafeTALK training; the standard training designed by LivingWorks. containing classroom activities, short videos and discussion. While delivering the program to one group, other students who are not receiving the program at that moment, will be engaged by schoolteachers in other rooms. Maximum of two groups will be trained in one day, training will be completed in 2-3 days. Two support persons will be in the room throughout the intervention to provide mental health support to the participants if required. Session attendance will be marked by roll number of the students.
Phase III (qualitative study)
Feasibility and acceptability will be assessed by interview method using pre-developed interview schedule. The interviews will be taken by PhD candidate and audio recordings will be obtained with prior consent. Each interview will be conducted for 15-20 minutes. The sample size will be 5 adolescents,3 parents, 3 teachers, 3 nurses, and 3 policymakers from the epidemiology and disease control division (total 15-17). The study population will be selected purposively.
Intervention code [1] 328470 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338068 0
Contextualisation of SafeTALK suicide prevention program
Timepoint [1] 338068 0
Once after obtaining ethical clearance.
Primary outcome [2] 338069 0
Effectiveness of a Suicide prevention program on Suicidal behaviour will be assessed
Timepoint [2] 338069 0
After obtaining informed consent from the parents and adolescents, baseline data will be collected among 110 adolescents studying in grade 9 and/or 10 in a public school of Koshi Province of Nepal using Socio-demographic proforma, SIDAS and GHSQ. Then, the contextualised safeTALK program will be delivered by a trained researcher (PhD Candidate) and pos-test data will be collected six weeks after completion of the intervention to assess the effectiveness of the Program. It will take 15-20 minutes to fill out the survey form, and 2-3 hours for participating in intervention program.
Primary outcome [3] 338171 0
Effectiveness of a Suicide prevention program on help-seeking, will be assessed.
Timepoint [3] 338171 0
After obtaining informed consent from the parents and adolescents, baseline data will be collected among 110 adolescents studying in grade 9 and/or 10 in a public school of Koshi Province of Nepal using Socio-demographic proforma, SIDAS and GHSQ. Then, the contextualised safeTALK program will be delivered by a trained researcher (PhD Candidate) and pos-test data will be collected six weeks after completion of the intervention to assess the effectiveness of the Program. It will take 15-20 minutes to fill out the survey form, and 2-3 hours for participating in intervention program.
Secondary outcome [1] 434797 0
Feasibility and acceptability will be assessed as a composite outcome.
Timepoint [1] 434797 0
On completion of intervention.

Eligibility
Key inclusion criteria
Adolescents aged 15 and above studying in year nine and/or 10 of a government school of Nepal.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not providing informed consent from the parents and adolescents.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using G* Power following a t-test matched pair two-tailed priori analysis with 0.5 effect size and 99% power. The total calculated sample size was 100 and adding 10% attrition, the sample size will be 110 for the quantitative phase. Descriptive statistics, mean median, standard deviation, Interquartile range etc. will be calculated and inferential statistics paired t-test will be used to compare pre and post intervention scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
19/09/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 26279 0
Nepal
State/province [1] 26279 0
Koshi

Funding & Sponsors
Funding source category [1] 316365 0
University
Name [1] 316365 0
Western Sydney University- Research Training Program Stipend Scholarship.
Country [1] 316365 0
Australia
Primary sponsor type
University
Name
Western Sydney University- Research Training Program Stipend Scholarship.
Address
Country
Australia
Secondary sponsor category [1] 318549 0
None
Name [1] 318549 0
Address [1] 318549 0
Country [1] 318549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315169 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 315169 0
Ethics committee country [1] 315169 0
Australia
Date submitted for ethics approval [1] 315169 0
25/03/2024
Approval date [1] 315169 0
01/07/2024
Ethics approval number [1] 315169 0
H15955
Ethics committee name [2] 315181 0
Nepal Health Research Council
Ethics committee address [2] 315181 0
Ethics committee country [2] 315181 0
Nepal
Date submitted for ethics approval [2] 315181 0
24/05/2024
Approval date [2] 315181 0
Ethics approval number [2] 315181 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133890 0
Mrs Rita Pokharel Poudel
Address 133890 0
Western Sydney University, School of Nursing and Midwifery, Parramatta south campus, Locked Bag 1797 Penrith NSW 2751
Country 133890 0
Australia
Phone 133890 0
+61 492885195
Fax 133890 0
Email 133890 0
[email protected]
Contact person for public queries
Name 133891 0
Rita Pokharel Poudel
Address 133891 0
Western Sydney University, School of Nursing and Midwifery, Parramatta south campus, Locked Bag 1797 Penrith NSW 2751
Country 133891 0
Australia
Phone 133891 0
+61 492885195
Fax 133891 0
Email 133891 0
[email protected]
Contact person for scientific queries
Name 133892 0
Rita Pokharel Poudel
Address 133892 0
Western Sydney University, School of Nursing and Midwifery, Parramatta south campus, Locked Bag 1797 Penrith NSW 2751
Country 133892 0
Australia
Phone 133892 0
+61 492885195
Fax 133892 0
Email 133892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.