Universal Behavioral SupportsNCT06975267
Social and Emotional Learning in Norwegian Kindergarten
A study testing Norwegian version of Second Step Early Learning and Free play in people with Universal Behavioral Supports, run by Ostfold University College at 1 site in Norway.
Trial 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)… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Universal Behavioral Supports
- What is being tested?
- Norwegian version of Second Step Early Learning and Free play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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. The tertiary outcome is a cost-analysis.
Småsteg could impact the social communication 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.
- Conditions
- Universal Behavioral Supports
- Being tested
- Norwegian version of Second Step Early Learning, Free play
- Keywords
- Teacher training, second step
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norwegian version of Second Step Early LearningBehavioural
Also called Steg for Steg, Småsteg (Norwegian name)
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.
Free playBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Free play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, after end of intervention (week 29), and after a one year follow-up.
Secondary outcomes (1)
Empathy Questionnaire for Children (EmQue)
The secondary outcome is empathy, measured by parents using the Empathy Questionnaire for Children (EmQue), which comprises 15 items assessing emotion contagion, attention to others' feelings, and prosocial actions (Reiffe et al., 2010).
Measured: At baseline, after end of intervention (week 29), and after a one year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 May 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Universal Behavioral SupportsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controll trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Hugo Cogo-Moreira, Professor, Principal investigator, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975267
- Sponsor's protocol ID
- OstfoldUC300802
- Other IDs
- 353778
- Status last verified
- Aug 2026
- First submitted
- 8 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40859266
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06975267
- Acronym / sponsor ID
- OstfoldUC300802
- Conditions
- Universal Behavioral Supports
- Keywords
- Teacher training, second step
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- 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.
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. The tertiary outcome is a cost-analysis.
Småsteg could impact the social communication 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controll trial.
| Arm | Type | Receives |
|---|---|---|
| Norwegian version of second step early learning | Experimental | Behavioral: Norwegian version of Second Step Early LearningThe 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. |
| Free play | Active comparator | Behavioral: Free playAs 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Norwegian version of Second Step Early LearningAlso: Steg for Steg, Småsteg (Norwegian name)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. | Behavioural | Norwegian version of second step early learning |
| Free playControl 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. | Behavioural | Free play |
Primary outcome
Strength and Difficulties Questionnaire (SDQ)
Time frame: At baseline, after end of intervention (week 29), and after a one year follow-up.
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.
1 secondary outcome
Empathy Questionnaire for Children (EmQue)
Time frame: At baseline, after end of intervention (week 29), and after a one year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 40859266Dechsling 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.
- Individual participant dataSharing planned: Undecided
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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.
Hugo Cogo-Moreira, Professor principal investigator
Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norwegian version of Second Step Early Learning and Free play in people with Universal Behavioral Supports, run by Ostfold University College at 1 site in Norway.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Strength and Difficulties Questionnaire (SDQ) (time frame: At baseline, after end of intervention (week 29), and after a one year follow-up.). 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 NCT06975267, which also lists 1 linked publication.
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 15 Sep 2026.