DepressionEarly Phase 1SEYLE-ISRAELNCT00906620
Saving and Empowering Young Lives in Europe (Israel)
A Early Phase 1 study testing QPR: question, persuade and refer (SEYLE) in people with Depression and Suicidality, run by Rabin Medical Center at 1 site in Israel.
Trial summary
SEYLE is a health promoting program for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk-taking and suicidal behaviors, to evaluate outcomes of different preventive programs and to recommend effective culturally adjusted models for promoting health of… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Suicidality
- What is being tested?
- QPR: question, persuade and refer (SEYLE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,247 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Jan 2012
- Phase
- Early Phase 1
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents between 13-17
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Saving and Empowering Young Lives in Europe in Israel, Evaluation, Intervention and Prevention
SEYLE is a health promoting program for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk-taking and suicidal behaviors, to evaluate outcomes of different preventive programs and to recommend effective culturally adjusted models for promoting health of adolescents in different European countries. Because of the significance of the SEYLE program and the importance of suicide research, Israel is honored to take part in this program and be a collaborator in it's implementation and research.
Read the detailed description
In this health promotion program, a pilot intervention study will be implemented to assess the effects of three different health promoting / suicide prevention programs in 11,000 students across 11 European countries (Sweden, Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain): 1. A general health promotion program targeting students' awareness on healthy/unhealthy behaviours and students' self-efficacy in diminishing unhealthy behaviours; 2. ProfScreen - screening by professionals of at-risk students through a questionnaire. For adolescents identified as high risk (screen positives) the program includes referral to mental health treatment and ensuring compliance. 3. QPR (Question, Persuade \& Refer) - a gatekeepers' program, training all adult staff at schools (teachers, counselors, nurses etc.) and parents on how to recognize \& refer a student with risk-taking behaviours or suffering from mental illness to mental-health help resources.
Each of these prevention programs uses a different active component in order to be successful. The first prevention program empowers the students by increasing their self-efficacy. The second prevention program (ProfScreen) empowers mental health professional in identifying subjects at risk. The third program (QPR) empowers teachers and parents in at-risk case finding and referring to mental health facilities. The registration of the complete RCT is available on the German Clinical Trials Registry (DRKS00000214).
- Conditions
- Depression, Suicidality
- Being tested
- QPR: question, persuade and refer (SEYLE)
- Keywords
- Data on student's healthy and at-risk lifestyles and their relation with health measured by well-being, depression and suicidality
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPR: question, persuade and refer (SEYLE)Other
The QPR prevention program will be used in two modules, one for school staff and one for parents. According to the US Surgeon General's National Strategy for Suicide Prevention (2001), "key gatekeepers" are "people who regularly come into contact with individuals or families in distress" and gatekeeper training has been identified as one of a number of promising prevention strategies.
| Study group | Role | What they receive |
|---|---|---|
| QPR intervention | Experimental | QPR intervention (Question, Persuade \& Refer): The QPR prevention program will be used in two modules, one for school staff and one for parents. According to the US Surgeon General's National Strategy for Suicide Prevention (2001), "key gatekeepers" are "people who regularly come into contact with individuals or families in distress" and gatekeeper training has been identified as one of a number of promising prevention strategies. Receives: Other: QPR: question, persuade and refer (SEYLE) |
| Awareness program | Experimental | The awareness programme is comprised of a leaflet, six posters and four seminars. The seminars are made up of one introductory lesson, and two interactive follow-up lessons with role play and one final meeting as a closing/debriefing lesson. Receives: Other: QPR: question, persuade and refer (SEYLE) |
| ProfScreen | Experimental | The program's primary objective is to help young people and their parents through the early identification of mental health problems, such as anxiety, depression, substance abuse, and suicide. Screening strategies are based on the valid premise that suicidal adolescents are under-identified, suffer from an active, often treatable mental illness such as depression and exhibit identifiable risk factors (Gould et al. 2003). A potential shortcoming of screening programs is that asking about suicide could increase suicidal ideation and behaviour. About this issue a recent study (Gould et al . 2005) on over 2300 students reported no evidence of iatrogenic effects of suicide screening and that screening in high schools is a safe component of youth suicide prevention efforts. Receives: Other: QPR: question, persuade and refer (SEYLE) |
| Control group | Experimental | The control group will comprise 250 subjects. After the baseline assessment, subjects will be randomized in one of the three intervention arms or in the control group. Individuals in the control group will undergo the same baseline and follow-up evaluations as subjects in the intervention arms and will receive the same leaflet about healthy lifestyles with information about the possibility to seek help for unhealthy, suicidal behaviour and mental health problems. In this arm, no additional intervention will be performed although the possibility of seeking help from mental health resources will be available. Receives: Other: QPR: question, persuade and refer (SEYLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy of different preventive programs.
Measured: 2012
Secondary outcomes (1)
rate of risk taking behavior among adolescents
Measured: 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alan apter, Rabin Medical Center
- Investigators
- Alan Stanley Apter, MD, Principal investigator, Schnider Children MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906620
- Sponsor's protocol ID
- 5277
- Acronym
- SEYLE-ISRAEL
- Status last verified
- Mar 2014
- First submitted
- 19 May 2009
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lustig S, Kaess M, Schnyder N, Michel C, Brunner R, Tubiana A, Kahn JP, Sarchiapone M, Hoven CW, Barzilay S, Apter A, Balazs J, Bobes J, Saiz PA, Cozman D, Cotter P, Kereszteny A, Podlogar T, Postuvan V, Varnik A, Resch F, Carli V, Wasserman D. The impact of school-based screening on service use in adolescents at risk for mental health problems and risk-behaviour. Eur Child Adolesc Psychiatry. 2023 Sep;32(9):1745-1754. doi: 10.1007/s00787-022-01990-z. Epub 2022 Apr 30.
PubMed 35488938Carli V, Wasserman C, Wasserman D, Sarchiapone M, Apter A, Balazs J, Bobes J, Brunner R, Corcoran P, Cosman D, Guillemin F, Haring C, Kaess M, Kahn JP, Keeley H, Kereszteny A, Iosue M, Mars U, Musa G, Nemes B, Postuvan V, Reiter-Theil S, Saiz P, Varnik P, Varnik A, Hoven CW. The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics. BMC Public Health. 2013 May 16;13:479. doi: 10.1186/1471-2458-13-479.
PubMed 23679917Kelleher I, Keeley H, Corcoran P, Ramsay H, Wasserman C, Carli V, Sarchiapone M, Hoven C, Wasserman D, Cannon M. Childhood trauma and psychosis in a prospective cohort study: cause, effect, and directionality. Am J Psychiatry. 2013 Jul;170(7):734-41. doi: 10.1176/appi.ajp.2012.12091169.
PubMed 23599019
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saving and Empowering Young Lives in Europe in Israel, Evaluation, Intervention and Prevention
- ClinicalTrials.gov ID
- NCT00906620
- Acronym / sponsor ID
- SEYLE-ISRAEL / 5277
- Conditions
- Depression, Suicidality
- Keywords
- Data on student's healthy and at-risk lifestyles and their relation with health measured by well-being, depression and suicidality
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,247 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 May 2009 (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.
SEYLE is a health promoting program for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk-taking and suicidal behaviors, to evaluate outcomes of different preventive programs and to recommend effective culturally adjusted models for promoting health of adolescents in different European countries. Because of the significance of the SEYLE program and the importance of suicide research, Israel is honored to take part in this program and be a collaborator in it's implementation and research.
Detailed description
In this health promotion program, a pilot intervention study will be implemented to assess the effects of three different health promoting / suicide prevention programs in 11,000 students across 11 European countries (Sweden, Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain): 1. A general health promotion program targeting students' awareness on healthy/unhealthy behaviours and students' self-efficacy in diminishing unhealthy behaviours; 2. ProfScreen - screening by professionals of at-risk students through a questionnaire. For adolescents identified as high risk (screen positives) the program includes referral to mental health treatment and ensuring compliance. 3. QPR (Question, Persuade \& Refer) - a gatekeepers' program, training all adult staff at schools (teachers, counselors, nurses etc.) and parents on how to recognize \& refer a student with risk-taking behaviours or suffering from mental illness to mental-health help resources.
Each of these prevention programs uses a different active component in order to be successful. The first prevention program empowers the students by increasing their self-efficacy. The second prevention program (ProfScreen) empowers mental health professional in identifying subjects at risk. The third program (QPR) empowers teachers and parents in at-risk case finding and referring to mental health facilities. The registration of the complete RCT is available on the German Clinical Trials Registry (DRKS00000214).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QPR intervention | Experimental | Other: QPR: question, persuade and refer (SEYLE)QPR intervention (Question, Persuade \& Refer): The QPR prevention program will be used in two modules, one for school staff and one for parents. According to the US Surgeon General's National Strategy for Suicide Prevention (2001), "key gatekeepers" are "people who regularly come into contact with individuals or families in distress" and gatekeeper training has been identified as one of a number of promising prevention strategies. |
| Awareness program | Experimental | Other: QPR: question, persuade and refer (SEYLE)The awareness programme is comprised of a leaflet, six posters and four seminars. The seminars are made up of one introductory lesson, and two interactive follow-up lessons with role play and one final meeting as a closing/debriefing lesson. |
| ProfScreen | Experimental | Other: QPR: question, persuade and refer (SEYLE)The program's primary objective is to help young people and their parents through the early identification of mental health problems, such as anxiety, depression, substance abuse, and suicide. Screening strategies are based on the valid premise that suicidal adolescents are under-identified, suffer from an active, often treatable mental illness such as depression and exhibit identifiable risk factors (Gould et al. 2003). A potential shortcoming of screening programs is that asking about suicide could increase suicidal ideation and behaviour. About this issue a recent study (Gould et al . 2005) on over 2300 students reported no evidence of iatrogenic effects of suicide screening and that screening in high schools is a safe component of youth suicide prevention efforts. |
| Control group | Experimental | Other: QPR: question, persuade and refer (SEYLE)The control group will comprise 250 subjects. After the baseline assessment, subjects will be randomized in one of the three intervention arms or in the control group. Individuals in the control group will undergo the same baseline and follow-up evaluations as subjects in the intervention arms and will receive the same leaflet about healthy lifestyles with information about the possibility to seek help for unhealthy, suicidal behaviour and mental health problems. In this arm, no additional intervention will be performed although the possibility of seeking help from mental health resources will be available. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents between 13-17
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| QPR: question, persuade and refer (SEYLE)The QPR prevention program will be used in two modules, one for school staff and one for parents. According to the US Surgeon General's National Strategy for Suicide Prevention (2001), "key gatekeepers" are "people who regularly come into contact with individuals or families in distress" and gatekeeper training has been identified as one of a number of promising prevention strategies. | Other | Awareness program, Control group, ProfScreen, QPR intervention |
Primary outcome
evaluate the efficacy of different preventive programs.
Time frame: 2012
1 secondary outcome
rate of risk taking behavior among adolescents
Time frame: 2012
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 7 Mar 2014.
- Derived from this study: PubMed 35488938Lustig S, Kaess M, Schnyder N, Michel C, Brunner R, Tubiana A, Kahn JP, Sarchiapone M, Hoven CW, Barzilay S, Apter A, Balazs J, Bobes J, Saiz PA, Cozman D, Cotter P, Kereszteny A, Podlogar T, Postuvan V, Varnik A, Resch F, Carli V, Wasserman D. The impact of school-based screening on service use in adolescents at risk for mental health problems and risk-behaviour. Eur Child Adolesc Psychiatry. 2023 Sep;32(9):1745-1754. doi: 10.1007/s00787-022-01990-z. Epub 2022 Apr 30.
- Derived from this study: PubMed 23679917Carli V, Wasserman C, Wasserman D, Sarchiapone M, Apter A, Balazs J, Bobes J, Brunner R, Corcoran P, Cosman D, Guillemin F, Haring C, Kaess M, Kahn JP, Keeley H, Kereszteny A, Iosue M, Mars U, Musa G, Nemes B, Postuvan V, Reiter-Theil S, Saiz P, Varnik P, Varnik A, Hoven CW. The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics. BMC Public Health. 2013 May 16;13:479. doi: 10.1186/1471-2458-13-479.
- Derived from this study: PubMed 23599019Kelleher I, Keeley H, Corcoran P, Ramsay H, Wasserman C, Carli V, Sarchiapone M, Hoven C, Wasserman D, Cannon M. Childhood trauma and psychosis in a prospective cohort study: cause, effect, and directionality. Am J Psychiatry. 2013 Jul;170(7):734-41. doi: 10.1176/appi.ajp.2012.12091169.
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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.
Alan Stanley Apter, MD principal investigator
Schnider Children MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing QPR: question, persuade and refer (SEYLE) in people with Depression and Suicidality, run by Rabin Medical Center at 1 site in Israel.
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 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 7 Mar 2014. 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 Israel. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
evaluate the efficacy of different preventive programs. (time frame: 2012). 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 NCT00906620, which also lists 3 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 7 Mar 2014.