Social Emotional CompetenceSAGA-TNCT07189104
SAGA for Toddlers. Supporting Children's Linguistic and Socio-Emotional Development in Early Childhood Education and Care
A study testing SAGA for Toddlers in people with Social Emotional Competence and Language Development, run by University of Helsinki at 1 site in Finland.
Trial summary
The goal of this study is to investigate whether a shared reading intervention including emotion and mind-related dialogues (SAGA for Toddlers) supports the development of 11 to 36 moth-old-children in early childhood education and care. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 11 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Social Emotional Competence, Language Development
- What is being tested?
- SAGA for Toddlers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 25 Sep 2025to Apr 2027
- 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 11 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 11 to 36 -months old at the start of the study
- Living in Finland
- Attending Swedish speaking early childhood education and care
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University of Helsinki
Helsinki, Uusimaa, 00014
Mirjam Kalland, PhD, +358 504482222, mirjam.kalland@helsinki.fi
About this study
The goal of this study is to investigate whether a shared reading intervention including emotion and mind-related dialogues (SAGA for Toddlers) supports the development of 11 to 36 moth-old-children in early childhood education and care.
The main questions it aims to answer are:
Read more
- Does the SAGA model support children's social-emotional development?
- Does the SAGA model support children's language development?
The participating children will attend the intervention at the early childhood education and care.
The participating personnel at the early childhood education and care will receive training, implement the intervention, and answer questionnaires.
The participating caregivers will attend caregiver-evenings and answers questionnaires.
Read the detailed description
Background:
The SAGA intervention model is based on mentalization theory, and it aims at supporting children's social-emotional development. The intervention includes regular shared reading sessions (at least three times a week) with children in small groups held by early childhood education and care (ECEC) professionals. The personnel receive training on the method and support on organizing the reading sessions. The SAGA model has been found to support children's prosocial behavior and reduce externalizing and internalizing problems. The research has also showed a connection between children's social-emotional and language development.
The first thousand days of a child's life are the most important for their development. In early childhood education and care, the integration of care and learning, places particularly high demands on educational quality and the pedagogues' competence to support children's emotional security, language, conceptual development, and exploratory learning as an organic whole. SAGA for Toddlers aims to use the SAGA model to strengthen the identification and naming of emotions in small groups of 11 to 36-month-old children. Stories in picture books meant for very young children that touch on emotions are selected for the sessions, and mentalization-based dialogue cards and emotion cards are used for the stories to support the discussions.
SAGA for Toddlers emphasizes the importance of relationship skills and to support caregivers' understanding of the importance of early years and shared reading of picture books with their children. This is achieved not by demanding parents to provide "more" for their children, which can increase parental stress, but by supporting parents in offering a daily routine with calmer presence, free-flowing time, shared moments and reading aloud. The SAGA for Toddlers intervention also includes caregivers´ evenings held at the ECEC premises with a simple meal plus a SAGA session to strengthen co-operation with caregivers in an easily accessible way.
Aims:
The main aim of this randomized controlled trial is to investigate whether the SAGA for Toddlers model is effective in supporting 11 to 36-month-old children's 1) social-emotional and 2) language development at Swedish speaking ECEC in Finland.
In addition, the study focuses on:
- Does the SAGA for Toddlers intervention support ECEC personnel's mentalizing abilities? 4) Does the SAGA for Toddlers intervention support caregiver's mentalizing abilities and emotional availability? 5) Does the SAGA for Toddlers intervention impact children's screen time? 5) What factors related to the child, caregivers and the ECEC personnel mediate or moderate the effectiveness of the SAGA for Toddlers intervention?
Participants and training:
ECEC centers are invited to participate in the study aiming to recruit 120 11 to 36-month-old children and their caregivers. From these centers half are randomized to receive the SAGA for Toddlers intervention and half are randomized to a waitlist control group.
The personnel of the intervention group will receive training to carry out the intervention at the ECEC, the waitlist control group will receive the intervention training after the data collection is finished. The intervention period will last for 10 weeks, including at least three SAGA for Toddlers intervention sessions per week.
The ECEC groups are offered support in the form of a resource teacher (master student/PhD student) who supports the centers in using the SAGA model and integrating it into their activities. Parents' evenings are held once before the intervention (an information session online or at the ECEC) and twice during the intervention (a workshop at the ECEC premises).
Data collection:
Data is collected 1) before the intervention, 2) during the 10-week intervention, 3) immediately after the intervention, and 3) in 9-month follow-up (9 months after the baseline measurement).
In addition to the outcome measures, the child's and caregivers' background is enquired with a background questionnaire before the intervention, including child age and gender, caregiver education, subjective economic situation, family structure, number of siblings, siblings' age, child's language skills and languages spoken at home, child's ECEC start age, age when child started to speak in sentences, screen time, hobbies and their frequency and start time, and amount of time spent reading aloud together.
Personnel's background is also enquired before the intervention, including gender, age, working experience, job title, current work tasks, education, and subjective economic situation.
- Conditions
- Social Emotional Competence, Language Development
- Being tested
- SAGA for Toddlers
- Keywords
- social-emotional development, language development, intervention, toddlers, early childhood education and care, caregivers, mentalization theory, SAGA model, group intervention, shared reading intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGA for ToddlersBehavioural
SAGA for Toddlers includes training sessions and workshops for the ECEC personnel on the mentalization-based shared reading intervention following the SAGA model. During the intervention shared reading sessions (5-10-minutes each) are held for groups of 2 to 3 children for 10 weeks (at least 3 sessions per week) at the ECEC by the personnel. Caregivers are involved in the intervention via caregiver meetings held at the ECEC by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| SAGA for Toddlers intervention | Experimental | The SAGA for Toddlers intervention. Receives: Behavioral: SAGA for Toddlers |
| Control group | No intervention | The personnel of the waitlist control-group will receive the intervention training after the data-collection is finished. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Emotional development
Social Emotional development is assessed by the personnel and caregivers with the 42-item Brief Infant-Toddler Social Emotional Assessment (BITSEA). The assessment includes two subscales Problem scores (31 items, range 0-62, higher scores indicate more problems) and Competence scores (11 items, range 0-22, higher scores indicate better social-emotional competence).
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Language development
Language development is reported by the caregivers using the MacArthur-Bates Communicative Development Inventory (MCDI), with separate questionnaires for 8- to 16-month-old, 16- to 30 month-old, and 2,5 to 4 year-old children, correct questionnaire is chosen based on the child's age. The questionnaires measure the size of the child's expressive vocabulary, and the child's use of gestures, sentences and grammar.
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Pro-social behavior
Pro-social behavior is assessed by the personnel and the caregivers with the 10-item child prosocial behavior questionnaire (CPBQ). The questionnaire including three subscales Comforting (range 1-15), Sharing (range 1-20), and Helping (range 0-15), higher scores indicate positive outcome.
Measured: Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Secondary outcomes (7)
Caregiver's emotional availability
Caregiver's emotional availability is measured with the 36-item Emotional Availability Self-Report (EA-SR). Following Salo and colleagues (2025) three subscales are calculated: Caregiver scale (12-items, range 8 to 60), Child scale (9-items, range 9 to 45), and Dyadic scale (15-items, range 15 to 75). Higher scores indicate better outcome.
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Personnel mind-mindedness
Personnel mind-mindedness is an index of mentalization ability. It is assessed with the mind-mindedness task. In this task, the pedagogue randomly selects four children from the children participating in the study, and freely describes them. The descriptions are audio-recorded and later transcribed. Each description will be analyzed using the coding system, which categorizes all the comments in the following categories: physical; behavioral; mental; self-referential; relational; general. A score will be obtained by calculating the number of attributes in each category. A total score (MM_TOT) will also be computed. It is assumed that more mental descriptions will indicate better mind-mindedness.
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Caregiver's mentalizing ability
Caregiver mentalizing is self-assessed with the 24-item Parental Mentalizing Questionnaire. The measure has four subscales: 1) Parental self-mentalizing ("SELF", 7 items, range: 7-49), 2) Parental child-mentalizing ("CHILD", 7 items, range: 7-49), 3) Lack of Effort ("LE", 5 items, range: 5-35), and 4) Curiosity ("C", 5 items, range: 5-35). Higher scores on the SELF, CHILD, and C subscales, and a lower score on the LE subscale indicate better outcome.
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Personnels' mentalizing ability
Personnels' mentalizing ability is self-assessed with the 28-item Mentalization Scale (MentS). MentS has three subscales: MentS-Self (MentS-S, 8 items, range 1-40) and MentS-Others (MentS-O, 10 items, range 10-50) assessing the ability to mentalize one self's or other people's minds, and MentS-Motivation (MentS-M, 10 items, range 10-50) assessing the respondent's motivation to mentalize about other people. Higher score means better outcome.
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Child's screen time
Child's screen time (hours per week) in 1) playing games, 2) watching content directed to children, 3) watching content directed to adults, and 4) other screen time, are enquired with a tailored questionnaire. Total screen time is calculated by summing the four types of screen time.
Measured: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 9-months follow up
Application names (screen time)
Application names used for video screen time and playing games with digital devices are enquired with a tailored questionnaire.
Measured: Time Frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 9-months follow up
Screen time language
Language primarily used for video screen time and playing games with digital devices are enquired with a tailored questionnaire.
Measured: Time Frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 9-months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start25 Sep 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Social Emotional CompetenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a wait-list controlled cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cultural Foundation in Finland
- Responsible party
- Principal investigator, Mirjam Kalland, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189104
- Sponsor's protocol ID
- 58/2025
- Acronym
- SAGA-T
- Status last verified
- May 2026
- First submitted
- 8 Sep 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Citation: Kalland, M., Linnavalli, T., & von Koskull, M. (2022). SAGA-supporting social-emotional development in early childhood education. The development of a mentalizing-based intervention. Education Sciences, 12(6), Article 409. https://doi.org/10.3390/educsci12060409
Citation: Kalland, M., & Linnavalli, T. (2023). Associations between social-emotional and language development in preschool children. Results from a study testing the rationale for an intervention. Scandinavian Journal of Educational Research, 67(5), 791-804. https://doi.org/10.1080/00313831.2022.207092
Martikainen, S., Kalland, M., Linnavalli, T., Kostilainen, K., Aittokoski, M., Reunamo, J., … Tervaniemi, M. (2024). Supporting social-emotional development in early childhood education and care - a randomized parallel group trial evaluating the impact of two different interventions. Scandinavian Journal of Educational Research, 68(5), 1069-1087. https://doi.org/10.1080/00313831.2023.2204119
Linnavalli, T., Martikainen, S., Belfrage, F., & Kalland, M. (2024). SAGA: results of a second trial testing a mentalizing-based reading intervention on children and staff in early childhood education. Frontiers in Education, 9. https://doi.org/10.3389/feduc.2024.1284474
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAGA for Toddlers. Supporting Children's Linguistic and Socio-Emotional Development in Early Childhood Education and Care
- ClinicalTrials.gov ID
- NCT07189104
- Acronym / sponsor ID
- SAGA-T / 58/2025
- Conditions
- Social Emotional Competence, Language Development
- Keywords
- social-emotional development, language development, intervention, toddlers, early childhood education and care, caregivers, mentalization theory, SAGA model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Swedish Cultural Foundation in Finland
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Sep 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.
The goal of this study is to investigate whether a shared reading intervention including emotion and mind-related dialogues (SAGA for Toddlers) supports the development of 11 to 36 moth-old-children in early childhood education and care.
The main questions it aims to answer are:
- Does the SAGA model support children's social-emotional development?
- Does the SAGA model support children's language development?
The participating children will attend the intervention at the early childhood education and care.
The participating personnel at the early childhood education and care will receive training, implement the intervention, and answer questionnaires.
The participating caregivers will attend caregiver-evenings and answers questionnaires.
Detailed description
Background:
The SAGA intervention model is based on mentalization theory, and it aims at supporting children's social-emotional development. The intervention includes regular shared reading sessions (at least three times a week) with children in small groups held by early childhood education and care (ECEC) professionals. The personnel receive training on the method and support on organizing the reading sessions. The SAGA model has been found to support children's prosocial behavior and reduce externalizing and internalizing problems. The research has also showed a connection between children's social-emotional and language development.
The first thousand days of a child's life are the most important for their development. In early childhood education and care, the integration of care and learning, places particularly high demands on educational quality and the pedagogues' competence to support children's emotional security, language, conceptual development, and exploratory learning as an organic whole. SAGA for Toddlers aims to use the SAGA model to strengthen the identification and naming of emotions in small groups of 11 to 36-month-old children. Stories in picture books meant for very young children that touch on emotions are selected for the sessions, and mentalization-based dialogue cards and emotion cards are used for the stories to support the discussions.
SAGA for Toddlers emphasizes the importance of relationship skills and to support caregivers' understanding of the importance of early years and shared reading of picture books with their children. This is achieved not by demanding parents to provide "more" for their children, which can increase parental stress, but by supporting parents in offering a daily routine with calmer presence, free-flowing time, shared moments and reading aloud. The SAGA for Toddlers intervention also includes caregivers´ evenings held at the ECEC premises with a simple meal plus a SAGA session to strengthen co-operation with caregivers in an easily accessible way.
Aims:
The main aim of this randomized controlled trial is to investigate whether the SAGA for Toddlers model is effective in supporting 11 to 36-month-old children's 1) social-emotional and 2) language development at Swedish speaking ECEC in Finland.
In addition, the study focuses on:
- Does the SAGA for Toddlers intervention support ECEC personnel's mentalizing abilities? 4) Does the SAGA for Toddlers intervention support caregiver's mentalizing abilities and emotional availability? 5) Does the SAGA for Toddlers intervention impact children's screen time? 5) What factors related to the child, caregivers and the ECEC personnel mediate or moderate the effectiveness of the SAGA for Toddlers intervention?
Participants and training:
ECEC centers are invited to participate in the study aiming to recruit 120 11 to 36-month-old children and their caregivers. From these centers half are randomized to receive the SAGA for Toddlers intervention and half are randomized to a waitlist control group.
The personnel of the intervention group will receive training to carry out the intervention at the ECEC, the waitlist control group will receive the intervention training after the data collection is finished. The intervention period will last for 10 weeks, including at least three SAGA for Toddlers intervention sessions per week.
The ECEC groups are offered support in the form of a resource teacher (master student/PhD student) who supports the centers in using the SAGA model and integrating it into their activities. Parents' evenings are held once before the intervention (an information session online or at the ECEC) and twice during the intervention (a workshop at the ECEC premises).
Data collection:
Data is collected 1) before the intervention, 2) during the 10-week intervention, 3) immediately after the intervention, and 3) in 9-month follow-up (9 months after the baseline measurement).
In addition to the outcome measures, the child's and caregivers' background is enquired with a background questionnaire before the intervention, including child age and gender, caregiver education, subjective economic situation, family structure, number of siblings, siblings' age, child's language skills and languages spoken at home, child's ECEC start age, age when child started to speak in sentences, screen time, hobbies and their frequency and start time, and amount of time spent reading aloud together.
Personnel's background is also enquired before the intervention, including gender, age, working experience, job title, current work tasks, education, and subjective economic situation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a wait-list controlled cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| SAGA for Toddlers intervention | Experimental | Behavioral: SAGA for ToddlersThe SAGA for Toddlers intervention. |
| Control group | No intervention | –The personnel of the waitlist control-group will receive the intervention training after the data-collection is finished. |
Who may qualify
- Ages
- 11 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 11 to 36 -months old at the start of the study
- Living in Finland
- Attending Swedish speaking early childhood education and care
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SAGA for ToddlersSAGA for Toddlers includes training sessions and workshops for the ECEC personnel on the mentalization-based shared reading intervention following the SAGA model. During the intervention shared reading sessions (5-10-minutes each) are held for groups of 2 to 3 children for 10 weeks (at least 3 sessions per week) at the ECEC by the personnel. Caregivers are involved in the intervention via caregiver meetings held at the ECEC by the investigators. | Behavioural | SAGA for Toddlers intervention |
Primary outcome
Social Emotional development
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Social Emotional development is assessed by the personnel and caregivers with the 42-item Brief Infant-Toddler Social Emotional Assessment (BITSEA). The assessment includes two subscales Problem scores (31 items, range 0-62, higher scores indicate more problems) and Competence scores (11 items, range 0-22, higher scores indicate better social-emotional competence).
Language development
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Language development is reported by the caregivers using the MacArthur-Bates Communicative Development Inventory (MCDI), with separate questionnaires for 8- to 16-month-old, 16- to 30 month-old, and 2,5 to 4 year-old children, correct questionnaire is chosen based on the child's age. The questionnaires measure the size of the child's expressive vocabulary, and the child's use of gestures, sentences and grammar.
Pro-social behavior
Time frame: Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Pro-social behavior is assessed by the personnel and the caregivers with the 10-item child prosocial behavior questionnaire (CPBQ). The questionnaire including three subscales Comforting (range 1-15), Sharing (range 1-20), and Helping (range 0-15), higher scores indicate positive outcome.
7 secondary outcomes
Caregiver's emotional availability
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Personnel mind-mindedness
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Caregiver's mentalizing ability
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Personnels' mentalizing ability
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up
Child's screen time
Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 9-months follow up
Application names (screen time)
Time frame: Time Frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 9-months follow up
Screen time language
Time frame: Time Frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 9-months 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 8 May 2026.
- BackgroundCitation: Kalland, M., Linnavalli, T., & von Koskull, M. (2022). SAGA-supporting social-emotional development in early childhood education. The development of a mentalizing-based intervention. Education Sciences, 12(6), Article 409. https://doi.org/10.3390/educsci12060409
- BackgroundCitation: Kalland, M., & Linnavalli, T. (2023). Associations between social-emotional and language development in preschool children. Results from a study testing the rationale for an intervention. Scandinavian Journal of Educational Research, 67(5), 791-804. https://doi.org/10.1080/00313831.2022.207092
- BackgroundMartikainen, S., Kalland, M., Linnavalli, T., Kostilainen, K., Aittokoski, M., Reunamo, J., … Tervaniemi, M. (2024). Supporting social-emotional development in early childhood education and care - a randomized parallel group trial evaluating the impact of two different interventions. Scandinavian Journal of Educational Research, 68(5), 1069-1087. https://doi.org/10.1080/00313831.2023.2204119
- BackgroundLinnavalli, T., Martikainen, S., Belfrage, F., & Kalland, M. (2024). SAGA: results of a second trial testing a mentalizing-based reading intervention on children and staff in early childhood education. Frontiers in Education, 9. https://doi.org/10.3389/feduc.2024.1284474
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAGA for Toddlers in people with Social Emotional Competence and Language Development, run by University of Helsinki at 1 site in Finland.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 May 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 Finland. 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?
Contact Mirjam Kalland, PhD (+358 504482222, mirjam.kalland@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Emotional development (time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up). The study lists 3 primary outcomes in all. 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 NCT07189104, which also lists 4 linked publications.
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 8 May 2026.