Mental DisordersEarly Phase 1NCT01860313
Mental Health Training for Elementary Teachers Through Tele-education and Its Impact on the School Atmosphere
A Early Phase 1 study testing Web-based interactive education and Text and Video-based education in people with Mental Disorders, run by University of Sao Paulo.
Trial summary
The purpose of this study is to create a web-based interactive educational environment to train elementary teachers, to identify children and adolescents in need of specialized mental health care and give them some advises in managing problematic children in class. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Web-based interactive education and Text and Video-based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary Public Schools of Campos do Jordão City
- Internet Access
Who cannot join
- none
About this study
The purpose of this study is to create a web-based interactive educational environment to train elementary teachers, to identify children and adolescents in need of specialized mental health care and give them some advises in managing problematic children in class. After the creation of such an educational environment the psychoeducational project was tested in order to verify it's effectiveness.
Read the detailed description
Objectives: To develop and test the efficacy of a computer-based training to elementary school teachers of the most common mental health problems.
Outcomes: (a)early identification of the most common mental health problems among children and adolescents, (b)teacher's acquirement of manage skills to better deal with behavior problems and (c)teacher's acquisition of important knowledge to refer students to treatment when necessary.
Method: This research includes two steps: a pilot project (already implemented, whose data will be presented here) and a randomized clinical trial intervention (that will be implemented in a few months).
- Pilot project, without control group - Comprehended six sessions of educational videos covering basic concepts of mental health stigma and the main disorders that affects children and adolescents followed by discussion forums, quizzes and a conclusion web conferencing with a specialist.
- A randomized controlled trial with a sample of 176 teachers from nine elementary schools were randomly divided in three groups: a web-based interactive educational group (WBIE), a text and video-based educational group (TWBE) and a waiting list group (WL).
Outcome measures: knowledge, beliefs and attitudes of teachers in mental health and satisfaction with the training received.
Results: The results show that there was an increase in knowledge, attitude changes in mental health and reducing stigma among teachers of web-based interactive educational group. Indeed, comparing the three groups of study participants (WBIE, TVBE and WL), was verified that TVBE group compared with WL group did not show a significant statistical difference (B = 0.957, p = 0.127). Comparing WBIE with WL group, the WBIE answers correctly 1:44 (B = 1.44, p = 0.015). Regarding beliefs and attitudes, WBIE group increased significantly in the ability to identify children with mental health problems, search for mental health information, the ability to recognize colleagues with mental health problems. The average confidence in helping a student with mental health problems also showed increased after psychoeducational intervention in WBIE group.
Discussion: After adjusting educational tools, the methodology and with a bigger sample it's expected to have greater positive results. It's very important to offer teachers a basic apparatus so that they will be able to deal with mental health issues in schools.
- Conditions
- Mental Disorders
- Being tested
- Web-based interactive education, Text and Video-based education
- Keywords
- effectiveness, distance learning, mental health
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based interactive educationBehavioural
An educational program for training teachers and educators to better recognize mental health problems in adolescents and children
Text and Video-based educationBehavioural
This group received the material that composed the web-based education environment without any kind of interactivity. This material was composed by some videos about children mental health and a support text.
| Study group | Role | What they receive |
|---|---|---|
| Web-based interactive educational group | Experimental | This group was submited to the web-based interactive education created for train teachers in child mental health, how to identify mental health problems in children and to know how to deal with problematic children in class. Receives: Behavioral: Web-based interactive education; Behavioral: Text and Video-based education |
| Text and Video-based education | Experimental | This group received the material that composed the web-based education environment without any kind of interactivity. This material was composed by some videos about children mental health and a support text. Receives: Behavioral: Web-based interactive education; Behavioral: Text and Video-based education |
| Waiting List group | No intervention | This group was used as control group and did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge in Child and Adolescents Mental Health, beliefs and attitudes in Child Mental Health
Questions about knowledge, beliefs and attitudes in Child and Adolescents Mental Health applied before and after the intervention.
Measured: baseline and 1 month (just after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionJul 2012
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Euripedes C. Miguel, University of Sao Paulo
- Investigators
- Euripedes Miguel, Full Prof, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860313
- Sponsor's protocol ID
- 573974/2008-0
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Training for Elementary Teachers Through Tele-education and Its Impact on the School Atmosphere
- ClinicalTrials.gov ID
- NCT01860313
- Acronym / sponsor ID
- 573974/2008-0
- Conditions
- Mental Disorders
- Keywords
- effectiveness, distance learning, mental health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 May 2013 (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 is to create a web-based interactive educational environment to train elementary teachers, to identify children and adolescents in need of specialized mental health care and give them some advises in managing problematic children in class. After the creation of such an educational environment the psychoeducational project was tested in order to verify it's effectiveness.
Detailed description
Objectives: To develop and test the efficacy of a computer-based training to elementary school teachers of the most common mental health problems.
Outcomes: (a)early identification of the most common mental health problems among children and adolescents, (b)teacher's acquirement of manage skills to better deal with behavior problems and (c)teacher's acquisition of important knowledge to refer students to treatment when necessary.
Method: This research includes two steps: a pilot project (already implemented, whose data will be presented here) and a randomized clinical trial intervention (that will be implemented in a few months).
- Pilot project, without control group - Comprehended six sessions of educational videos covering basic concepts of mental health stigma and the main disorders that affects children and adolescents followed by discussion forums, quizzes and a conclusion web conferencing with a specialist.
- A randomized controlled trial with a sample of 176 teachers from nine elementary schools were randomly divided in three groups: a web-based interactive educational group (WBIE), a text and video-based educational group (TWBE) and a waiting list group (WL).
Outcome measures: knowledge, beliefs and attitudes of teachers in mental health and satisfaction with the training received.
Results: The results show that there was an increase in knowledge, attitude changes in mental health and reducing stigma among teachers of web-based interactive educational group. Indeed, comparing the three groups of study participants (WBIE, TVBE and WL), was verified that TVBE group compared with WL group did not show a significant statistical difference (B = 0.957, p = 0.127). Comparing WBIE with WL group, the WBIE answers correctly 1:44 (B = 1.44, p = 0.015). Regarding beliefs and attitudes, WBIE group increased significantly in the ability to identify children with mental health problems, search for mental health information, the ability to recognize colleagues with mental health problems. The average confidence in helping a student with mental health problems also showed increased after psychoeducational intervention in WBIE group.
Discussion: After adjusting educational tools, the methodology and with a bigger sample it's expected to have greater positive results. It's very important to offer teachers a basic apparatus so that they will be able to deal with mental health issues in schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Web-based interactive educational group | Experimental | Behavioral: Web-based interactive education, Behavioral: Text and Video-based educationThis group was submited to the web-based interactive education created for train teachers in child mental health, how to identify mental health problems in children and to know how to deal with problematic children in class. |
| Text and Video-based education | Experimental | Behavioral: Web-based interactive education, Behavioral: Text and Video-based educationThis group received the material that composed the web-based education environment without any kind of interactivity. This material was composed by some videos about children mental health and a support text. |
| Waiting List group | No intervention | –This group was used as control group and did not receive any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary Public Schools of Campos do Jordão City
- Internet Access
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 |
|---|---|---|
| Web-based interactive educationAn educational program for training teachers and educators to better recognize mental health problems in adolescents and children | Behavioural | Text and Video-based education, Web-based interactive educational group |
| Text and Video-based educationThis group received the material that composed the web-based education environment without any kind of interactivity. This material was composed by some videos about children mental health and a support text. | Behavioural | Text and Video-based education, Web-based interactive educational group |
Primary outcome
Knowledge in Child and Adolescents Mental Health, beliefs and attitudes in Child Mental Health
Time frame: baseline and 1 month (just after the intervention)
Questions about knowledge, beliefs and attitudes in Child and Adolescents Mental Health applied before and after the intervention.
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 22 May 2013.
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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.
Euripedes Miguel, Full Prof principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Web-based interactive education and Text and Video-based education in people with Mental Disorders, run by University of Sao Paulo.
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 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Knowledge in Child and Adolescents Mental Health, beliefs and attitudes in Child Mental Health (time frame: baseline and 1 month (just after the intervention)). 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 22 May 2013.