- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01598519
School-based Comprehensive Suicide Intervention in Shanghai, China
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Shanghai
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Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Mental Health Center
-
Contact:
- Qian Bian, MD
- Phone Number: 3284 +86-021-34289888
- Email: bianqian0602@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- students of grade 6,7,9,10 from four schools (2 middle schools, 2 high schools)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: study group
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.
|
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. |
NO_INTERVENTION: control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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"
|
"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"
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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"
|
"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"
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007BAI17B03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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