NCT06975267

Brief Summary

This project evaluates the effectiveness of the Norwegian version of Second Step Early Learning (Småsteg), 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. The hypothesis states that Småsteg is superior to play only in improving children's SEL. In the study, 990 children within 66 kindergartens will be recruited and allocated following 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. Småsteg could impact 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

May 8, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Teacher trainingsecond step

Outcome Measures

Primary Outcomes (1)

  • Strength and Difficulties Questionnaire (SDQ)

    The primary outcome is based on the Strength and Difficulties Questionnaire (SDQ; Goodman et al., 2003), which will be answered by parents and teachers. SDQ has 25 items and covers five dimensions: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.

    At baseline, after end of intervention (week 29), and after a one year follow-up.

Secondary Outcomes (1)

  • Empathy Questionnaire for Children (EmQue)

    At baseline, after end of intervention (week 29), and after a one year follow-up.

Other Outcomes (1)

  • Standardized 1st grade tests in Norwegian and mathematics

    At the time of one year follow-up.

Study Arms (2)

Norwegian version of second step early learning

EXPERIMENTAL

The Norwegian version of the Second Step Early Learning program, in Norwegian called Steg for steg, Småsteg. This is a 28 weeks program divided into five themes which aims to enhance and strengthen children's abilities to learn, show empathy, handle their emotions, friendships, and problem solving.

Behavioral: Norwegian version of Second Step Early Learning

Free play

ACTIVE COMPARATOR

As an active comparator, these children will get the additional time for free play in their kindergartens. The additional time is a reflection of the duration of the program in the intervention group.

Behavioral: Free play

Interventions

The interventions is a 28 weeks program divided into five themes. The themes are 1. Skills that promotes learning, 2. Empathy, 3. Managing emotions, 4. Friendship skills and problem solving, and 5. Transitioning to school. The intervention consists of daily activities. The guidebook is a central part of the program and provides the kindergarten teachers with practical tools and activities to implement the program in everyday settings. The guidebook includes: 28 weekly themes: Each week introduces a new theme with related activities and discussion topics. Brain-building games: Activities designed to strengthen children's cognitive skills and self-regulation. Songs and music: Songs that reinforce the learning of social skills. Parent connections: Information sheets and activities to involve parents in their children's social-emotional development. Puppet theatre: The use of hand puppets Dog and Snail to illustrate and discuss feelings and social situations.

Also known as: Steg for Steg, Småsteg (Norwegian name)
Norwegian version of second step early learning
Free playBEHAVIORAL

Control kindergartens will have additional designated playtime consisting of free play for 28 weeks. The checklist for play conditions is defined as when: Time is set aside in the daily kindergarten routine where (1) it is clearly announced or signaled to the children that it is now "free play", (2) it is an absence of requirements for sedentary sitting (unless it is part of the children's play), (3) it is not a situation where children are required to follow instructions (unless it is part of the children's play or general rules in the kindergarten (?)), (4) it is an absence of a pronounced learning outcome or goal with the activities available for the children (beyond what is defined by the children themselves), (5) the children can start and finish activities themselves, and choose what they want to participate in, and (6) adults can join in the game/initiate, but on the children's terms, and the children can choose to leave this game whenever they want.

Free play

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Kindergarten with approximately 15 children or more in the age group are eligble for enrollment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold University College

Halden, Østfold fylke, 1757, Norway

Location

Related Publications (1)

  • Dechsling A, Cipriano C, Bortveit L, Fjermestad KW, Karlsen ABA, Akerbaek TM, Tangen CB, Cogo-Moreira H. Examining the effectiveness of Second Step Early Learning versus free play on socio-emotional learning in kindergarten: a cluster randomized controlled trial protocol. Trials. 2025 Aug 26;26(1):308. doi: 10.1186/s13063-025-09047-7.

Related Links

Study Officials

  • Hugo Cogo-Moreira, Professor

    Østfold University College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Cogo-Moreira, Professor

CONTACT

Anders Dechsling, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Researchers are masked to the link between participant numbers and assigned arm.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomized controll trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations