NCT01598519

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

February 6, 2012

Last Update Submit

May 10, 2012

Conditions

Keywords

school-basedadolescent suicideinterventionscreening

Outcome Measures

Primary Outcomes (1)

  • 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"

Secondary Outcomes (1)

  • 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"

Study Arms (2)

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.

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.

Interventions

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

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • students of grade 6,7,9,10 from four schools (2 middle schools, 2 high schools)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

May 15, 2012

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations