NCT02178332

Brief 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. The schools were randomly allocated to receive either Yhteispeli programme or two lectures

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
Last Updated

December 13, 2021

Status Verified

November 1, 2021

Enrollment Period

2.6 years

First QC Date

April 3, 2014

Last Update Submit

November 29, 2021

Conditions

Children's Socio-emotional Skills and Psychiatric Symptoms

Keywords

Childrensocio-emotionalsocio-emotional skillspsychiatric symptomsSDQFinlandSchoolSchool communityTeacherWhole school approachInterventionEffectiveness studyCluster randomised trial

Outcome Measures

Primary Outcomes (2)

  • Change in children's psychiatric symptoms

    SDQ - The Strengths and Difficulties Questionnaires

    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

    6 months after baseline and 18 months after baseline

Secondary Outcomes (3)

  • Change in children's emotion recognition (and processing)

    6 months after baseline and 18 months after baseline

  • Change in children's executive functions

    6 months after baseline and 18 months after baseline

  • Change in teacher and work community (occupational) wellbeing

    6 months after baseline and 18 months after baseline

Other Outcomes (4)

  • Change in teacher and parent interaction

    6 months after baseline and 18 months after baseline

  • Change in children's and teachers' perceptions of class environment

    6 months after baseline and 18 months after baseline

  • Change in teaching and parenting styles

    6 months after baseline and 18 months after baseline

  • +1 more other outcomes

Study Arms (2)

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)

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 ).

Other: Two theoretical lectures

Interventions

Yhteispeli, whole school programmeOTHER
Yhteispeli, whole school programme
Two theoretical lecturesOTHER
Two theoretical lectures

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children from volunteering elementary schools and classes (grades 1 to 3) whose parents gave consent to participate

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olli Kiviruusu

Helsinki, Finland

Location

Related Publications (2)

  • 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.

    PMID: 25287298BACKGROUND

  • Kiviruusu 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.

    PMID: 27230903RESULT

Study Officials

  • Olli Kiviruusu, PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

April 3, 2014

First Posted

June 30, 2014

Study Start

March 1, 2013

Primary Completion

September 30, 2015

Study Completion

September 30, 2015

Last Updated

December 13, 2021

Record last verified: 2021-11

Locations

FI(1)