SuicideNCT01598519
School-based Comprehensive Suicide Intervention in Shanghai, China
A study testing suicide intervention in people with Suicide, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The primary aim of this study is to examine whether a school-based suicide intervention is effective in reducing suicide related risk factors in a population of middle and high students. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- suicide intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2012
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- students of grade 6,7,9,10 from four schools (2 middle schools, 2 high schools)
Who cannot join
- students who are not attending school because of long term sickness or moving to other school,or going aboard, etc.
- students whose parents don't agree to participate the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Qian Bian, MD, +86-021-34289888 ext. 3284, bianqian0602@qq.com
About this study
The primary aim of this study is to examine whether a school-based suicide intervention is effective in reducing suicide related risk factors in a population of middle and high students. It hypothesized that receiving the intervention will reduce the severity of suicide related risk factors such as depression, hopelessness, suicidal behaviors and increasing protective factors such as social support, self esteem, suicide knowledge and attitude and so on, as compared to the control group.
Read the detailed description
A total of 3000 students from two junior schools (grade 7 and 8) and two senior schools (grade 10 and 11) in Shanghai Pu Dong district were recruited in our study. All students were randomly assigned into universal study group or universal control group by class level. In those two groups, high risk of suicidal students were identified by screening. A universal suicide intervention was conducted in the universal study group; an indicated suicide intervention was conducted in the indicated study group. All students in universal study group and universal control group completed the self-administered questionnaire before and 6 months after the end of universal intervention. High risk of suicidal students in the indicated study group and indicated control group completed another self-administered questionnaire before, 6 months and 18 months after the end of the indicated intervention.
- Conditions
- Suicide
- Being tested
- suicide intervention
- Keywords
- school-based, adolescent suicide, intervention, screening
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suicide interventionBehavioural
universal intervention:(1)students: 4 sections about cherishing life, coping strategies, suicide and depression disorder during 2 semesters, each session lasting 45 minutes.(2)gatekeeper: 4 sessions about teenagers psychological crisis intervention strategies during 2 semesters, 30minutes per session.
indicated intervention: (1)student: 2 semesters, 20 sessions' group life skill and cognitive-behavioral psychological training lesson, including Youth rational emotive group tutoring(eight classroom sessions), Coping skill group tutoring(six classroom sessions)and Behavior group tutoring(six classroom sessions), once a week, each session lasting 1.5hours.(2)gatekeeper: a social support net.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 1500 students are randomized to receive a universal suicide intervention apart from usual school psychology classes. Furthermore, high risk of suicidal students screened in study group will receive an indicated suicide intervention in addition to usual school psychology classes. Receives: Behavioral: suicide intervention |
| control group | No intervention | 1500 students are randomized to receive usual school psychology classes. High risk of suicidal students screened in control group will receive usual psychology classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
students' score of mediating factors and suicide behaviors
Measured: "Change from baseline in suicide behavior at 6 months after the end of the intervention" and "Change from baseline in suicide behavior at 18 months after the end of intervention"
Secondary outcomes (1)
students' score of suicide knowledge and attitude
Measured: "Change from baseline in suicide knowledge at 6 months after the end of the intervention" and "Change from baseline in suicide knowledge at 18 months after the end of intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pu Dong Institute of Education Development, Shanghai Sanling North Junior Middle School, Shanghai Shangnan East Junior Middle School, Shanghai Sanling Senior Middle School, Shanghai Yangsi Senior Middle School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598519
- Sponsor's protocol ID
- 2007BAI17B03
- Status last verified
- May 2012
- First submitted
- 6 Feb 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Comprehensive Suicide Intervention in Shanghai, China
- ClinicalTrials.gov ID
- NCT01598519
- Acronym / sponsor ID
- 2007BAI17B03
- Conditions
- Suicide
- Keywords
- school-based, adolescent suicide, intervention, screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Pu Dong Institute of Education Development, Shanghai Sanling North Junior Middle School, Shanghai Shangnan East Junior Middle School, Shanghai Sanling Senior Middle School, Shanghai Yangsi Senior Middle School
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 May 2012 (estimated)
- 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.
The primary aim of this study is to examine whether a school-based suicide intervention is effective in reducing suicide related risk factors in a population of middle and high students. It hypothesized that receiving the intervention will reduce the severity of suicide related risk factors such as depression, hopelessness, suicidal behaviors and increasing protective factors such as social support, self esteem, suicide knowledge and attitude and so on, as compared to the control group.
Detailed description
A total of 3000 students from two junior schools (grade 7 and 8) and two senior schools (grade 10 and 11) in Shanghai Pu Dong district were recruited in our study. All students were randomly assigned into universal study group or universal control group by class level. In those two groups, high risk of suicidal students were identified by screening. A universal suicide intervention was conducted in the universal study group; an indicated suicide intervention was conducted in the indicated study group. All students in universal study group and universal control group completed the self-administered questionnaire before and 6 months after the end of universal intervention. High risk of suicidal students in the indicated study group and indicated control group completed another self-administered questionnaire before, 6 months and 18 months after the end of the indicated intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: suicide intervention1500 students are randomized to receive a universal suicide intervention apart from usual school psychology classes. Furthermore, high risk of suicidal students screened in study group will receive an indicated suicide intervention in addition to usual school psychology classes. |
| control group | No intervention | –1500 students are randomized to receive usual school psychology classes. High risk of suicidal students screened in control group will receive usual psychology classes. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- students of grade 6,7,9,10 from four schools (2 middle schools, 2 high schools)
Key exclusion criteria (2 listed)
- students who are not attending school because of long term sickness or moving to other school,or going aboard, etc.
- students whose parents don't agree to participate the study
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 |
|---|---|---|
| suicide interventionuniversal intervention:(1)students: 4 sections about cherishing life, coping strategies, suicide and depression disorder during 2 semesters, each session lasting 45 minutes.(2)gatekeeper: 4 sessions about teenagers psychological crisis intervention strategies during 2 semesters, 30minutes per session. indicated intervention: (1)student: 2 semesters, 20 sessions' group life skill and cognitive-behavioral psychological training lesson, including Youth rational emotive group tutoring(eight classroom sessions), Coping skill group tutoring(six classroom sessions)and Behavior group tutoring(six classroom sessions), once a week, each session lasting 1.5hours.(2)gatekeeper: a social support net. | Behavioural | study group |
Primary outcome
students' score of mediating factors and suicide behaviors
Time frame: "Change from baseline in suicide behavior at 6 months after the end of the intervention" and "Change from baseline in suicide behavior at 18 months after the end of intervention"
1 secondary outcome
students' score of suicide knowledge and attitude
Time frame: "Change from baseline in suicide knowledge at 6 months after the end of the intervention" and "Change from baseline in suicide knowledge at 18 months after the end of intervention"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suicide intervention in people with Suicide, run by Shanghai Mental Health Center at 1 site in China.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
students' score of mediating factors and suicide behaviors (time frame: "Change from baseline in suicide behavior at 6 months after the end of the intervention" and "Change from baseline in suicide behavior at 18 months after the end of intervention"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2012.