SuicideNCT00387855
An Evaluation of the SOS (Suicide Prevention) Program
A study testing SOS program in people with Suicide, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study was to investigate the impact of the SOS suicide prevention program on help-seeking, attitudes toward depression and suicide, and suicidal behavior among high school students. Current research protocol has extended this evaluation to the Middle School version of SOS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide
- What is being tested?
- SOS program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,471 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Attendance at school participating in study
- English speaking youth with parental consent.
Who cannot join
- 1.Youth who do not speak and read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Outcome Evaluation of the SOS Suicide Prevention Program
The purpose of this study was to investigate the impact of the SOS suicide prevention program on help-seeking, attitudes toward depression and suicide, and suicidal behavior among high school students. Current research protocol has extended this evaluation to the Middle School version of SOS.
Read the detailed description
Three cohorts have participated in outcome evaluations of the SOS suicide prevention program to assess its effects on help-seeking, attitudes toward depression and suicide, and suicidal behavior. The first two cohorts consisted of 25 public state high schools in Massachusetts, Georgia, and Connecticut. The third cohort consisted of 9 middle schools and 10 high schools from outside of Connecticut with high proportions of military dependants.
Hypotheses:
H1: Exposure to the SOS program will be significantly associated with lower rates of suicidal ideation and suicide attempts; greater levels of help-seeking; greater knowledge of and more adaptive attitudes toward depression and suicide; and increased communication with and perceived support from peers.
H2: The reduction in suicide attempts among youths exposed to the program can be explained by increases in knowledge about depression and suicide, more favorable attitudes regarding suicide, and improved communication with and support from peers.
Methods
- The intervention: The SOS program was presented to students in 2 consecutive classes over a 2 day period, typically in health or social studies classes. The SOS program's teaching materials include a video and a discussion guide. The video includes dramatizations depicting the signs of suicidality and depression, recommended ways to react to someone who is depressed and suicidal, as well as interviews with real people whose lives have been touched by suicide. Students are also asked to complete the Brief Screen for Adolescent Depression (BSAD), a brief screening instrument for depression that is derived from the Diagnostic Interview Schedule for Children IV (Lucas et al., 2001).
- The sample: The first cohort involved approximately 4000 students in 9 high schools in Columbus Georgia, Hartford Connecticut, and western Massachusetts over a two-year period. The second cohort consisted ove an additional 1100 students were recruited from 16 Technical High Schools in Connecticut. A third cohort consisted of over 600 students from 9 middle schools and 10 high schools from outside of Connecticut with high proportions of military dependants.
- The research design: The experimental design for the evaluation was a randomized control group design with posttest only data collection. At the beginning of each school year approximately half of the classes of teachers presenting the program were randomly assigned to the treatment group, which received the SOS Prevention Program in the fall/winter of that year; the other half were assigned to the control group, which did not receive the program until the evaluation is completed.
To ascertain the effect of the program on participants' knowledge of and attitudes toward suicide and help seeking behavior, students in both the treatment and control groups were asked to complete a short questionnaire 3 months following implementation of the program. Questionnaires were anonymous. After the outcome evaluation was completed, the group of students who did not receive the program earlier in the school year received the complete SOS Program.
- Conditions
- Suicide
- Being tested
- SOS program
- Keywords
- suicide, depression
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOS programBehavioural
Also called Signs of Suicide
screening and didactic programming to raise awareness of depression suicidality
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | receive SOS program Receives: Behavioral: SOS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
suicide attempts
Measured: 3 months
Secondary outcomes (2)
knowledge about depression/suicide
Measured: 3 months
attitudes about depression/suicide
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startSep 2001
- Primary completionDec 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), Patterson Trust, United States Department of Defense
- Responsible party
- Principal investigator, ROBERT H. ASELTINE, UConn Health
- Investigators
- Robert H Aseltine, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387855
- Sponsor's protocol ID
- CMHS1255
- Other IDs
- SM 05 014
- Status last verified
- Jul 2016
- First submitted
- 12 Oct 2006
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aseltine RH Jr, DeMartino R. An outcome evaluation of the SOS Suicide Prevention Program. Am J Public Health. 2004 Mar;94(3):446-51. doi: 10.2105/ajph.94.3.446.
PubMed 14998812Aseltine RH Jr, James A, Schilling EA, Glanovsky J. Evaluating the SOS suicide prevention program: a replication and extension. BMC Public Health. 2007 Jul 18;7:161. doi: 10.1186/1471-2458-7-161.
PubMed 17640366
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outcome Evaluation of the SOS Suicide Prevention Program
- ClinicalTrials.gov ID
- NCT00387855
- Acronym / sponsor ID
- CMHS1255
- Conditions
- Suicide
- Keywords
- suicide, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,471 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), Patterson Trust, United States Department of Defense
- Study start
- Sep 2001
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Oct 2006 (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 purpose of this study was to investigate the impact of the SOS suicide prevention program on help-seeking, attitudes toward depression and suicide, and suicidal behavior among high school students. Current research protocol has extended this evaluation to the Middle School version of SOS.
Detailed description
Three cohorts have participated in outcome evaluations of the SOS suicide prevention program to assess its effects on help-seeking, attitudes toward depression and suicide, and suicidal behavior. The first two cohorts consisted of 25 public state high schools in Massachusetts, Georgia, and Connecticut. The third cohort consisted of 9 middle schools and 10 high schools from outside of Connecticut with high proportions of military dependants.
Hypotheses:
H1: Exposure to the SOS program will be significantly associated with lower rates of suicidal ideation and suicide attempts; greater levels of help-seeking; greater knowledge of and more adaptive attitudes toward depression and suicide; and increased communication with and perceived support from peers.
H2: The reduction in suicide attempts among youths exposed to the program can be explained by increases in knowledge about depression and suicide, more favorable attitudes regarding suicide, and improved communication with and support from peers.
Methods
- The intervention: The SOS program was presented to students in 2 consecutive classes over a 2 day period, typically in health or social studies classes. The SOS program's teaching materials include a video and a discussion guide. The video includes dramatizations depicting the signs of suicidality and depression, recommended ways to react to someone who is depressed and suicidal, as well as interviews with real people whose lives have been touched by suicide. Students are also asked to complete the Brief Screen for Adolescent Depression (BSAD), a brief screening instrument for depression that is derived from the Diagnostic Interview Schedule for Children IV (Lucas et al., 2001).
- The sample: The first cohort involved approximately 4000 students in 9 high schools in Columbus Georgia, Hartford Connecticut, and western Massachusetts over a two-year period. The second cohort consisted ove an additional 1100 students were recruited from 16 Technical High Schools in Connecticut. A third cohort consisted of over 600 students from 9 middle schools and 10 high schools from outside of Connecticut with high proportions of military dependants.
- The research design: The experimental design for the evaluation was a randomized control group design with posttest only data collection. At the beginning of each school year approximately half of the classes of teachers presenting the program were randomly assigned to the treatment group, which received the SOS Prevention Program in the fall/winter of that year; the other half were assigned to the control group, which did not receive the program until the evaluation is completed.
To ascertain the effect of the program on participants' knowledge of and attitudes toward suicide and help seeking behavior, students in both the treatment and control groups were asked to complete a short questionnaire 3 months following implementation of the program. Questionnaires were anonymous. After the outcome evaluation was completed, the group of students who did not receive the program earlier in the school year received the complete SOS Program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: SOS programreceive SOS program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Attendance at school participating in study
- English speaking youth with parental consent.
Key exclusion criteria (1 listed)
- 1.Youth who do not speak and read English
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 |
|---|---|---|
| SOS programAlso: Signs of Suicidescreening and didactic programming to raise awareness of depression suicidality | Behavioural | 1 |
Primary outcome
suicide attempts
Time frame: 3 months
2 secondary outcomes
knowledge about depression/suicide
Time frame: 3 months
attitudes about depression/suicide
Time frame: 3 months
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 Jul 2016.
- Background: PubMed 14998812Aseltine RH Jr, DeMartino R. An outcome evaluation of the SOS Suicide Prevention Program. Am J Public Health. 2004 Mar;94(3):446-51. doi: 10.2105/ajph.94.3.446.
- Background: PubMed 17640366Aseltine RH Jr, James A, Schilling EA, Glanovsky J. Evaluating the SOS suicide prevention program: a replication and extension. BMC Public Health. 2007 Jul 18;7:161. doi: 10.1186/1471-2458-7-161.
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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.
Robert H Aseltine, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOS program in people with Suicide, run by UConn Health at 1 site in United States.
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 Jul 2016. 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 United States. 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?
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?
suicide attempts (time frame: 3 months). 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 NCT00387855, which also lists 2 linked publications.
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 Jul 2016.