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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01598519
Other study ID # 2007BAI17B03
Secondary ID
Status Recruiting
Phase N/A
First received February 6, 2012
Last updated May 10, 2012
Start date February 2011
Est. completion date December 2012

Study information

Verified date May 2012
Source Shanghai Mental Health Center
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 19 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
suicide intervention
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.

Locations

Country Name City State
China Shanghai Mental Health Center Shanghai Shanghai

Sponsors (6)

Lead Sponsor Collaborator
Shanghai Mental Health Center Shanghai Pu Dong Institute of Education Development, Shanghai Sanling North Junior Middle School, Shanghai Sanling Senior Middle School, Shanghai Shangnan East Junior Middle School, Shanghai Yangsi Senior Middle School

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary students' score of mediating factors and suicide behaviors "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" No
Secondary students' score of suicide knowledge and attitude "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" No
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