Children's Socio-emotional Skills and Psychiatric SymptomsNCT02178332
Yhteispeli - Effectiveness Study on Promoting Childrens' Socio-emotional Skills in School
A study testing Yhteispeli, whole school programme and Two theoretical lectures in people with Children's Socio-emotional Skills and Psychiatric Symptoms, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole school programme is effective in improving children's socio-emotional skills and mental health and socio-emotional skills. All Finnish elementary schools and their classes in 1-3 grades were invited to participate in the study. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Children's Socio-emotional Skills and Psychiatric Symptoms
- What is being tested?
- Yhteispeli, whole school programme and Two theoretical lectures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,400 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2013to 30 Sep 2015
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children from volunteering elementary schools and classes (grades 1 to 3) whose parents gave consent to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yhteispeli: Intervention Effectiveness on Elementary School Childrens' Socio-emotional Skills and Psychiatric Symptoms
The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole school programme is effective in improving children's socio-emotional skills and mental health and socio-emotional skills.
All Finnish elementary schools and their classes in 1-3 grades were invited to participate in the study. The schools were randomly allocated to receive either Yhteispeli programme or two lectures
- Being tested
- Yhteispeli, whole school programme, Two theoretical lectures
- Keywords
- Children, socio-emotional, socio-emotional skills, psychiatric symptoms, SDQ, Finland, School, School community, Teacher, Whole school approach, Intervention, Effectiveness study, Cluster randomised trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yhteispeli, whole school programmeOther
Two theoretical lecturesOther
| Study group | Role | What they receive |
|---|---|---|
| Yhteispeli, whole school programme | Experimental | Yhteispeli-programme aims to support children's socio-emotional skills and well being at schools. Schools receive the Yhteispeli manual and teachers receive 3 and head masters 2 lecture days about use of Yhteispeli methods including group discussions and exercises. In addition every school is visited 4 times to support the use of Yhteispeli methods. (Lectures for the head masters March 2013 - November 2013, teachers August 2013 - January 2014) Receives: Other: Yhteispeli, whole school programme |
| Two theoretical lectures | Active comparator | Teachers receive two theoretical lectures on development of children's socio-emotional skills (3 hours in November 2013 and 3 hours in March 2014 ). Receives: Other: Two theoretical lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in children's psychiatric symptoms
SDQ - The Strengths and Difficulties Questionnaires
Measured: 6 months after baseline and 18 months after baseline
Change in children's socio-emotional skills
A set of socio-emotional skills tests A set of questions regarding bullying
Measured: 6 months after baseline and 18 months after baseline
Secondary outcomes (3)
Change in children's emotion recognition (and processing)
A set of emotion recognition (and processing) tests
Measured: 6 months after baseline and 18 months after baseline
Change in children's executive functions
A set of cognitive functions tests
Measured: 6 months after baseline and 18 months after baseline
Change in teacher and work community (occupational) wellbeing
A set of teacher's occupational and work community wellbeing tests
Measured: 6 months after baseline and 18 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startMar 2013
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
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 Children's Socio-emotional Skills and Psychiatric SymptomsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Olli Kiviruusu, Finnish Institute for Health and Welfare
- Investigators
- Olli Kiviruusu, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178332
- Sponsor's protocol ID
- THL/455/6.00.00/2014
- Status last verified
- Nov 2021
- First submitted
- 3 Apr 2014
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjorklund K, Liski A, Samposalo H, Lindblom J, Hella J, Huhtinen H, Ojala T, Alasuvanto P, Koskinen HL, Kiviruusu O, Hemminki E, Punamaki RL, Sund R, Solantaus T, Santalahti P. "Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial. BMC Public Health. 2014 Oct 7;14:1042. doi: 10.1186/1471-2458-14-1042.
PubMed 25287298Kiviruusu O, Bjorklund K, Koskinen HL, Liski A, Lindblom J, Kuoppamaki H, Alasuvanto P, Ojala T, Samposalo H, Harmes N, Hemminki E, Punamaki RL, Sund R, Santalahti P. Short-term effects of the "Together at School" intervention program on children's socio-emotional skills: a cluster randomized controlled trial. BMC Psychol. 2016 May 26;4(1):27. doi: 10.1186/s40359-016-0133-4.
PubMed 27230903
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yhteispeli: Intervention Effectiveness on Elementary School Childrens' Socio-emotional Skills and Psychiatric Symptoms
- ClinicalTrials.gov ID
- NCT02178332
- Acronym / sponsor ID
- THL/455/6.00.00/2014
- Keywords
- Children, socio-emotional, socio-emotional skills, psychiatric symptoms, SDQ, Finland, School, School community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,400 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Tampere University
- Study start
- Mar 2013
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 30 Jun 2014 (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 cluster randomised trial is to investigate whether the Yhteispeli whole school programme is effective in improving children's socio-emotional skills and mental health and socio-emotional skills.
All Finnish elementary schools and their classes in 1-3 grades were invited to participate in the study. The schools were randomly allocated to receive either Yhteispeli programme or two lectures
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yhteispeli, whole school programme | Experimental | Other: Yhteispeli, whole school programmeYhteispeli-programme aims to support children's socio-emotional skills and well being at schools. Schools receive the Yhteispeli manual and teachers receive 3 and head masters 2 lecture days about use of Yhteispeli methods including group discussions and exercises. In addition every school is visited 4 times to support the use of Yhteispeli methods. (Lectures for the head masters March 2013 - November 2013, teachers August 2013 - January 2014) |
| Two theoretical lectures | Active comparator | Other: Two theoretical lecturesTeachers receive two theoretical lectures on development of children's socio-emotional skills (3 hours in November 2013 and 3 hours in March 2014 ). |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children from volunteering elementary schools and classes (grades 1 to 3) whose parents gave consent to participate
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 |
|---|---|---|
| Yhteispeli, whole school programme | Other | Yhteispeli, whole school programme |
| Two theoretical lectures | Other | Two theoretical lectures |
Primary outcome
Change in children's psychiatric symptoms
Time frame: 6 months after baseline and 18 months after baseline
SDQ - The Strengths and Difficulties Questionnaires
Change in children's socio-emotional skills
Time frame: 6 months after baseline and 18 months after baseline
A set of socio-emotional skills tests A set of questions regarding bullying
3 secondary outcomes
Change in children's emotion recognition (and processing)
Time frame: 6 months after baseline and 18 months after baseline
Change in children's executive functions
Time frame: 6 months after baseline and 18 months after baseline
Change in teacher and work community (occupational) wellbeing
Time frame: 6 months after baseline and 18 months after baseline
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 13 Dec 2021.
- Background: PubMed 25287298Bjorklund K, Liski A, Samposalo H, Lindblom J, Hella J, Huhtinen H, Ojala T, Alasuvanto P, Koskinen HL, Kiviruusu O, Hemminki E, Punamaki RL, Sund R, Solantaus T, Santalahti P. "Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial. BMC Public Health. 2014 Oct 7;14:1042. doi: 10.1186/1471-2458-14-1042.
- Results publication: PubMed 27230903Kiviruusu O, Bjorklund K, Koskinen HL, Liski A, Lindblom J, Kuoppamaki H, Alasuvanto P, Ojala T, Samposalo H, Harmes N, Hemminki E, Punamaki RL, Sund R, Santalahti P. Short-term effects of the "Together at School" intervention program on children's socio-emotional skills: a cluster randomized controlled trial. BMC Psychol. 2016 May 26;4(1):27. doi: 10.1186/s40359-016-0133-4.
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.
Olli Kiviruusu, PhD principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yhteispeli, whole school programme and Two theoretical lectures in people with Children's Socio-emotional Skills and Psychiatric Symptoms, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 13 Dec 2021. 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 Finland. 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?
Change in children's psychiatric symptoms (time frame: 6 months after baseline and 18 months after baseline). The study lists 2 primary outcomes in all. 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 NCT02178332, 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 13 Dec 2021.