Clinical trial NCT06975267: Social and Emotional Learning in Norwegian Kindergarten: A Randomised Controlled Trial
Official title: The Effectiveness of the Norwegian Version of Second Step Early Learning vs. Free Play on Socio-Emotional Learning in Kindergarten: A Cluster Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social and Emotional Learning
Lead sponsor: Ostfold University College
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2025-05-16
Enrollment: 900
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controll trial.
Primary purpose: OTHER

Brief summary: This project evaluates the effectiveness of the Norwegian version of Second Step Early Learning, a program of 28 weeks that emphasizes learning, friendship skills, and managing several strong feelings (e.g., scared, worried, surprised, frustrated, excited), not only anger, on socio-emotional learning (SEL) in kindergartens versus play is a cluster randomized controlled trial. Our hypothesis states that Småsteg is superior to play only in improving children's SEL. We will allocate 990 children within 66 kindergartens, which will be the randomization at the school level. The primary outcome is based on the Strength and Difficulties Questionnaire (SDQ), which will be answered by parents and teachers at baseline, immediately after the 28 weeks of intervention and then six months after the change to the new school (K1). The secondary outcome is empathy, assessed by the Empathy Questionnaire for Children (EmQue), a parent report-based questionnaire comprising 15 items assessing three domains: emotion contagion, attention to other's feelings, and prosocial actions.

We believe that the Småsteg impacts the joint attention score, which, in turn, affects the SDQ score. A mobile application (app) will be developed to track children's behaviors via teachers, parents, and children's activities. This study contributes to the scientific understanding of how such interventions can impact SEL and future academic achievement in kindergarten-aged children but also brings insights into mechanisms throughout intervention like Småsteg in early childhood might help the development of SEL, shaping early education policies and practices.


Eligibility criteria: Inclusion Criteria:

* All children in the appropriate age group are eligble for inclusion in the study.
* Kindergarten with approximately 15 children or more in the age group are eligble for enrollment.

Exclusion Criteria:

* Kindergartens cannot have implemented the Norwegian version of Second Step Early Learning as an active intervention in their kindergarten for at least the past four years from the start of this study.
* Less than 15 participants in the kindergarten.

Primary outcomes:
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: At baseline, after end of intervention (week 29), and after a one year follow-up.
Secondary outcomes:
measure: Empathy Questionnaire for Children (EmQue)
timeFrame: At baseline, after end of intervention (week 29), and after a one year follow-up.
Other outcomes:
measure: Standardized 1st grade tests in Norwegian and mathematics
timeFrame: At the time of one year follow-up.
Locations:
city: Halden
country: Norway
facility: Østfold University College
state: Østfold
Study officials:
affiliation: Østfold University College
name: Hugo Cogo-Moreira, Professor
role: PRINCIPAL_INVESTIGATOR
References: