Overview

This trial is active, not recruiting.

Condition children's socio-emotional skills and psychiatric symptoms
Treatments yhteispeli, whole school programme, two theoretical lectures
Sponsor National Institute for Health and Welfare, Finland
Collaborator Ministry of Education and Culture
Start date March 2013
End date September 2015
Trial size 4400 participants
Trial identifier NCT02178332, THL/455/6.00.00/2014

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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)
yhteispeli, whole school programme
(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 ).
two theoretical lectures

Primary Outcomes

Measure
Change in children's psychiatric symptoms
time frame: 6 months after baseline and 18 months after baseline
Change in children's socio-emotional skills
time frame: 6 months after baseline and 18 months after baseline

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 7 years up to 10 years old.

Inclusion Criteria: - All children from volunteering elementary schools and classes (grades 1 to 3) whose parents gave consent to participate Exclusion Criteria:

Additional Information

Official title Yhteispeli: Intervention Effectiveness on Elementary School Childrens' Socio-emotional Skills and Psychiatric Symptoms
Principal investigator Päivi Santalahti, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.