Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)NCT03387007
Psycho-social Support on Mental Health and Hope of Adolescents Affected by Earthquake in Nepal
A study testing Psychosocial support training for school teachers in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Tokyo University.
Trial summary
Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, hope can help adolescents cope with the challenges better. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
- What is being tested?
- Psychosocial support training for school teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,912 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents studying in grade 6, 7 and 8 of the selected schools at the time of data collection
- Adolescents with written consent from themselves and their guardian
Who cannot join
- Adolescent who refused to participate
About this study
Official title: Effect of Psycho-social Support Training by School Teachers on Improving Mental Health and Hope of School Going Adolescents in Earthquake Affected Districts in Nepal
Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, hope can help adolescents cope with the challenges better. For resource poor disaster prone settings, school teachers can provide timely psycho-social support that could improve mental health and hope among adolescents.
Nepal is a disaster prone country that faced a devastating earthquake in 2015 that claimed thousands of lives and left many homeless which could have affected the mental health of adolescents.This study was conducted in schools of Dhading, a severely earthquake affected district and schools of Myagdi, a least affected district by earthquake in Nepal. The intervention focused on training school teachers on psycho-social support for adolescents.
Read the detailed description
Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, some adolescents can have better hope that helps them to cope with the challenges following adverse events such as earthquake.
Nepal is a low income and disaster prone country that ranks 11th for earthquake risks globally. In April 2015, the country faced a devastating earthquake of 7.8 Magnitude that killed thousands of people. Fourteen out of seventy five districts in Nepal were declared as severely affected districts.
However, the adolescents may not have received enough psychosocial support after the earthquake. The damage caused by earthquake was further worsened by the political instability in the country leading to delay in reconstruction work in earthquake-affected areas. Difficult circumstances following the earthquake could have affected the mental of adolescents negatively. However, the evidence on mental health status of adolescents following massive disaster such as earthquake remains inadequate.
For resource poor and disaster prone settings such as Nepal, school teachers can provide timely psychosocial support that could improve mental health and hope among adolescents. School based teacher mediated interventions could be more sustainable and feasible in the complex scenario of post-disaster settings. However, evidence on teacher mediated interventions in low resource disaster settings remain inadequate.
The objectives of this study were to assess mental health and level of hope among the adolescents in selected districts and examine the effect of school teachers' training on psychosocial support on mental health and hope among the adolescents.
The intervention for this study was schoolteachers' training on psycho-social support. A clinical psychologist provided 2-day training on psycho-social support for 22 schoolteachers (2 teachers from each intervention school). The training guidelines were adapted from the United Nations Relief and Works Agency (UNRWA) on psycho-social support for education in emergencies. The training provided basic skills to the schoolteachers so that they will be able to provide psycho-social support for children affected. The lesson learned from the training was intended to be applied by the school teachers in their everyday regular school activities. A follow up study was conducted at 6 months follow up among the adolescents to assess the change in their mental health status and hope.
- Being tested
- Psychosocial support training for school teachers
- Keywords
- adolescent, mental health, hope, psycho-social support, school teachers, earthquake
- Medical subject headings
- Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial support training for school teachersBehavioural
The intervention for this study was schoolteachers' training on psychosocial support.A clinical psychologist provided 2-day training (a total of 16 hours) training on psychosocial support for the schoolteachers
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Two teachers from each of the schools included in this arm received training on providing psycho-social support to their students to be implemented in their regular routine school activities Receives: Behavioral: Psychosocial support training for school teachers |
| Control | No intervention | The teachers from the schools in this arm did not receive training on psycho-social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline post traumatic stress symptoms at 6 months
Post traumatic stress disorder symptoms among adolescents using Child post traumatic symptom scale symptom scale which is a 17 item scale. The minimum score is 0 and maximum score is 52. Higher score indicates higher symptoms for PTSD.
Measured: baseline and 6 month follow up
Change from baseline depression symptoms at 6 months
Depression symptoms among adolescents using depression self rating scale which is an 18 item scale. The minimum score is 0 and maximum score is 36. Higher scores indicate higher symptoms for depression.
Measured: baseline and 6 month follow up
Change from baseline hope at 6 months
Hope as an antecedent of resilience and positive aspect of mental health using Children's Hope scale which is a 6 item scale. The minimum score is 0 and maximum score is 1 and maximum score is 36. The higher score indicate higher hope.
Measured: baseline and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study startJun 2016
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolina Dhital, Tokyo University
- Investigators
- Rolina Dhital, MHSc, Principal investigator, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387007
- Sponsor's protocol ID
- TUniversity
- Status last verified
- Dec 2017
- First submitted
- 21 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhital R, Shibanuma A, Miyaguchi M, Kiriya J, Jimba M. Effect of psycho-social support by teachers on improving mental health and hope of adolescents in an earthquake-affected district in Nepal: A cluster randomized controlled trial. PLoS One. 2019 Oct 1;14(10):e0223046. doi: 10.1371/journal.pone.0223046. eCollection 2019.
PubMed 31574127
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psycho-social Support Training by School Teachers on Improving Mental Health and Hope of School Going Adolescents in Earthquake Affected Districts in Nepal
- ClinicalTrials.gov ID
- NCT03387007
- Acronym / sponsor ID
- TUniversity
- Keywords
- adolescent, mental health, hope, psycho-social support, school teachers, earthquake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,912 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, hope can help adolescents cope with the challenges better. For resource poor disaster prone settings, school teachers can provide timely psycho-social support that could improve mental health and hope among adolescents.
Nepal is a disaster prone country that faced a devastating earthquake in 2015 that claimed thousands of lives and left many homeless which could have affected the mental health of adolescents.This study was conducted in schools of Dhading, a severely earthquake affected district and schools of Myagdi, a least affected district by earthquake in Nepal. The intervention focused on training school teachers on psycho-social support for adolescents.
Detailed description
Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, some adolescents can have better hope that helps them to cope with the challenges following adverse events such as earthquake.
Nepal is a low income and disaster prone country that ranks 11th for earthquake risks globally. In April 2015, the country faced a devastating earthquake of 7.8 Magnitude that killed thousands of people. Fourteen out of seventy five districts in Nepal were declared as severely affected districts.
However, the adolescents may not have received enough psychosocial support after the earthquake. The damage caused by earthquake was further worsened by the political instability in the country leading to delay in reconstruction work in earthquake-affected areas. Difficult circumstances following the earthquake could have affected the mental of adolescents negatively. However, the evidence on mental health status of adolescents following massive disaster such as earthquake remains inadequate.
For resource poor and disaster prone settings such as Nepal, school teachers can provide timely psychosocial support that could improve mental health and hope among adolescents. School based teacher mediated interventions could be more sustainable and feasible in the complex scenario of post-disaster settings. However, evidence on teacher mediated interventions in low resource disaster settings remain inadequate.
The objectives of this study were to assess mental health and level of hope among the adolescents in selected districts and examine the effect of school teachers' training on psychosocial support on mental health and hope among the adolescents.
The intervention for this study was schoolteachers' training on psycho-social support. A clinical psychologist provided 2-day training on psycho-social support for 22 schoolteachers (2 teachers from each intervention school). The training guidelines were adapted from the United Nations Relief and Works Agency (UNRWA) on psycho-social support for education in emergencies. The training provided basic skills to the schoolteachers so that they will be able to provide psycho-social support for children affected. The lesson learned from the training was intended to be applied by the school teachers in their everyday regular school activities. A follow up study was conducted at 6 months follow up among the adolescents to assess the change in their mental health status and hope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psychosocial support training for school teachersTwo teachers from each of the schools included in this arm received training on providing psycho-social support to their students to be implemented in their regular routine school activities |
| Control | No intervention | –The teachers from the schools in this arm did not receive training on psycho-social support |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents studying in grade 6, 7 and 8 of the selected schools at the time of data collection
- Adolescents with written consent from themselves and their guardian
Key exclusion criteria (1 listed)
- Adolescent who refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial support training for school teachersThe intervention for this study was schoolteachers' training on psychosocial support.A clinical psychologist provided 2-day training (a total of 16 hours) training on psychosocial support for the schoolteachers | Behavioural | Intervention |
Primary outcome
Change from baseline post traumatic stress symptoms at 6 months
Time frame: baseline and 6 month follow up
Post traumatic stress disorder symptoms among adolescents using Child post traumatic symptom scale symptom scale which is a 17 item scale. The minimum score is 0 and maximum score is 52. Higher score indicates higher symptoms for PTSD.
Change from baseline depression symptoms at 6 months
Time frame: baseline and 6 month follow up
Depression symptoms among adolescents using depression self rating scale which is an 18 item scale. The minimum score is 0 and maximum score is 36. Higher scores indicate higher symptoms for depression.
Change from baseline hope at 6 months
Time frame: baseline and 6 month follow up
Hope as an antecedent of resilience and positive aspect of mental health using Children's Hope scale which is a 6 item scale. The minimum score is 0 and maximum score is 1 and maximum score is 36. The higher score indicate higher hope.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Derived from this study: PubMed 31574127Dhital R, Shibanuma A, Miyaguchi M, Kiriya J, Jimba M. Effect of psycho-social support by teachers on improving mental health and hope of adolescents in an earthquake-affected district in Nepal: A cluster randomized controlled trial. PLoS One. 2019 Oct 1;14(10):e0223046. doi: 10.1371/journal.pone.0223046. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolina Dhital, MHSc principal investigator
Tokyo University
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial support training for school teachers in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Tokyo University.
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 2 inclusion and 1 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline post traumatic stress symptoms at 6 months (time frame: baseline and 6 month follow up). The study lists 3 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 NCT03387007, 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 29 Dec 2017.