Mental DisordersZASMDNCT02401984
Zurcher Adolescent Screening for Mental Disorder
An observational study of Mental Disorders, run by Filomena Sabatella at 1 site in Switzerland.
Trial summary
Mental disorders are common in youth and adults. Symptoms of mental are aggravated by unemployment. Compared to the working population, the unemployed have higher rates of poor health, a tendency toward negative emotionality and depression, show symptoms of exhaustion more frequently, and experience disturbed sleep or… Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Screening
- How many people
- 83 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Aug 2015
- Phase
- Observational
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be recruited in Institutions Coaching unemployed Young People.
Who may be able to join
- 40 unemployed Young adults, Age 16-25,
- 40 working Young adults, Age 16-25,
- informed consent to participate in the study.
Who cannot join
- insufficient understanding of the German language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zürcher Adoleszenz-Screening-Instrument Psychischer Störungen
Mental disorders are common in youth and adults. Symptoms of mental are aggravated by unemployment. Compared to the working population, the unemployed have higher rates of poor health, a tendency toward negative emotionality and depression, show symptoms of exhaustion more frequently, and experience disturbed sleep or have a sleep disorder. It can be reasonably expected that unemployment in adolescents and young adults causes the same symptoms and behaviors as in adults. In those youth with a mental disorder, particularly an untreated one, the transfer from school to the employment market can be hindered. At the same time, the investigators notice an increase in early disability pensions due to mental health issues among adolescents. Thus, the early recognition and treatment of mental disorders and psychological strain is crucial in promoting the employment of young people and supporting their connection to the employment market.With this project the investigators want to implement an early intervention and reach out to unemployed youth. The investigators identified the period between graduation and first employment as the ideal moment of intervention, because this time period is a critical period in which young people are exposed to increasing personal challenges. Conducting an intervention before a psychological stress transforms into a mental disorder, can prevent harm and suffering to the afflicted person. In addition, early intervention could help prevent the need to enroll in the early disability pension program.
Read the detailed description
Mental disorders are common. A WHO study shows (Gore, Bloem, Ferguson, Coffey and Mathers, 2011) that during adolescence; most of the years lost because of illness are due to neuropsychiatric disorders such as depression, substance abuse and schizophrenia. Steinhausen, Metzke and Kannenberg (1998) found that 22% of the children and adolescents living in the canton of Zurich, suffer from mental disorders. The figures are comparable with Wittchen, Nelson and Lachner (1998) who fund 27% of the adolescents fitting the DSM IV (Diagnostic and Statistical Manual) criteria for mental disorders.
Mental disorders are particularly stressful in combination with unemployment. Unemployed are often in a worse physical condition compared to employed people; they tend to negative emotional states and depression, fatigue and sleep disorders. It is to be expected that unemployment will have the same effect on adolescents. Fergusson, Horwood and Lynskey (1997) showed that in 16 to 25 years old, the increase of the unemployment was correlated with the increase of mental distress having consequences like depression, anxiety, substance abuse and attempts to suicide.
The aim of this project is to validate a screening tool for the early recognition of mental disorders among young unemployed. The screening tool will be composed by no more than 50 items.
The participants will be requested to fill out the screening tool and in a second phase, they will be asked to participate in a face to face, standardized clinical Interview, the Munich-Composite International Diagnostic Interview (M-CIDI) (Wittchen, Lachner, Wunderlich and Pfister, 1998).
To ensure that the screening tool differentiates between 'at risk' and 'non at risk' patients, the sample will be composed by 40 unemployed young adults, Age 16-25 and 40 working young adults, age 16-25.
Statistical Analysis: After the data collection the data from the screening and the clinical interview will be tested for sensitivity and specificity. To evaluate both the Receiver Operating Characteristic (ROC) and other methods will be used. The prognostic validity of the screening tool will be additionally calculated with a logistic regression. The data analysis will be executed with SPSS 21.
Missing data will be excluded from the sample.
- Conditions
- Mental Disorders
- Being tested
- Screening
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Participants will fill out a short screening questionnaire where different aspects of mental health and behavioral problems will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Screening | A Screening tool will be administered to the participants. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM IV diagnosis
Measured: 1-2 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filomena Sabatella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Filomena Sabatella, Zurich University of Applied Sciences
- Investigators
- Agnes von Wyl, Professor, Study director, University of applied sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401984
- Sponsor's protocol ID
- 2014-0575
- Acronym
- ZASMD
- Status last verified
- Feb 2017
- First submitted
- 3 Mar 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zürcher Adoleszenz-Screening-Instrument Psychischer Störungen
- ClinicalTrials.gov ID
- NCT02401984
- Acronym / sponsor ID
- ZASMD / 2014-0575
- Conditions
- Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Filomena SabatellaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Mar 2015 (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.
Mental disorders are common in youth and adults. Symptoms of mental are aggravated by unemployment. Compared to the working population, the unemployed have higher rates of poor health, a tendency toward negative emotionality and depression, show symptoms of exhaustion more frequently, and experience disturbed sleep or have a sleep disorder. It can be reasonably expected that unemployment in adolescents and young adults causes the same symptoms and behaviors as in adults. In those youth with a mental disorder, particularly an untreated one, the transfer from school to the employment market can be hindered. At the same time, the investigators notice an increase in early disability pensions due to mental health issues among adolescents. Thus, the early recognition and treatment of mental disorders and psychological strain is crucial in promoting the employment of young people and supporting their connection to the employment market.With this project the investigators want to implement an early intervention and reach out to unemployed youth. The investigators identified the period between graduation and first employment as the ideal moment of intervention, because this time period is a critical period in which young people are exposed to increasing personal challenges. Conducting an intervention before a psychological stress transforms into a mental disorder, can prevent harm and suffering to the afflicted person. In addition, early intervention could help prevent the need to enroll in the early disability pension program.
Detailed description
Mental disorders are common. A WHO study shows (Gore, Bloem, Ferguson, Coffey and Mathers, 2011) that during adolescence; most of the years lost because of illness are due to neuropsychiatric disorders such as depression, substance abuse and schizophrenia. Steinhausen, Metzke and Kannenberg (1998) found that 22% of the children and adolescents living in the canton of Zurich, suffer from mental disorders. The figures are comparable with Wittchen, Nelson and Lachner (1998) who fund 27% of the adolescents fitting the DSM IV (Diagnostic and Statistical Manual) criteria for mental disorders.
Mental disorders are particularly stressful in combination with unemployment. Unemployed are often in a worse physical condition compared to employed people; they tend to negative emotional states and depression, fatigue and sleep disorders. It is to be expected that unemployment will have the same effect on adolescents. Fergusson, Horwood and Lynskey (1997) showed that in 16 to 25 years old, the increase of the unemployment was correlated with the increase of mental distress having consequences like depression, anxiety, substance abuse and attempts to suicide.
The aim of this project is to validate a screening tool for the early recognition of mental disorders among young unemployed. The screening tool will be composed by no more than 50 items.
The participants will be requested to fill out the screening tool and in a second phase, they will be asked to participate in a face to face, standardized clinical Interview, the Munich-Composite International Diagnostic Interview (M-CIDI) (Wittchen, Lachner, Wunderlich and Pfister, 1998).
To ensure that the screening tool differentiates between 'at risk' and 'non at risk' patients, the sample will be composed by 40 unemployed young adults, Age 16-25 and 40 working young adults, age 16-25.
Statistical Analysis: After the data collection the data from the screening and the clinical interview will be tested for sensitivity and specificity. To evaluate both the Receiver Operating Characteristic (ROC) and other methods will be used. The prognostic validity of the screening tool will be additionally calculated with a logistic regression. The data analysis will be executed with SPSS 21.
Missing data will be excluded from the sample.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Other: ScreeningA Screening tool will be administered to the participants. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited in Institutions Coaching unemployed Young People.
Key inclusion criteria (3 listed)
- 40 unemployed Young adults, Age 16-25,
- 40 working Young adults, Age 16-25,
- informed consent to participate in the study.
Key exclusion criteria (1 listed)
- insufficient understanding of the German language.
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 |
|---|---|---|
| ScreeningParticipants will fill out a short screening questionnaire where different aspects of mental health and behavioral problems will be assessed. | Other | Screening |
Primary outcome
DSM IV diagnosis
Time frame: 1-2 Week
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 Feb 2017.
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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.
Agnes von Wyl, Professor study director
University of applied sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders, run by Filomena Sabatella at 1 site in Switzerland.
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 3 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 Feb 2017. 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 Switzerland. 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?
DSM IV diagnosis (time frame: 1-2 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2017.