SAGA for Toddlers. Supporting Children's Linguistic and Socio-Emotional Development in Early Childhood Education and Care

NCT07189104 | Recruiting

• 1 other identifier: 58/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the SAGA model support children's social-emotional development?
2. 2.Does the SAGA model support children's language development?

Conditions

Social Emotional Competence; Language Development

Keywords

social-emotional development; language development; intervention; toddlers; early childhood education and care; caregivers; mentalization theory; SAGA model; group intervention; shared reading intervention

Outcome Measures

Primary Outcomes (3)

• 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).

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year 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.

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year 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.

  Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year follow-up

Secondary Outcomes (7)

• Caregiver's emotional availability

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year follow-up

• Personnel mind-mindedness

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year follow-up

• Caregiver's mentalizing ability

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year follow-up

• Personnels' mentalizing ability

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 1-year follow-up

• Child's screen time

  1) Before the intervention, 2) Immediately after the 10-week intervention, 3) At 1-year follow up

Other Outcomes (5)

• Content of the reading sessions

  After each session, during the intervention (10 weeks)

• Number of sessions participated

  After each session during the intervention (10 weeks)

• Fidelity to the intervention

  During the intervention at week 1, week 5, and week 10.

Study Arms (2)

SAGA for Toddlers intervention

EXPERIMENTAL

The SAGA for Toddlers intervention.

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.

Interventions

SAGA for Toddlers BEHAVIORAL

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.

SAGA for Toddlers intervention

Eligibility Criteria

• Age: 11 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 36 -months old at the start of the study
• Living in Finland
• Attending Swedish speaking early childhood education and care

You may not qualify if:

• None

Sponsors & Collaborators

• University of Helsinki: lead
• Swedish Cultural Foundation in Finland: collaborator

Study Sites (1)

University of Helsinki

Helsinki, Uusimaa, 00014, Finland

RECRUITING

Related Publications (4)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Central Study Contacts

Mirjam Kalland, PhD

CONTACT

+358 504482222; mirjam.kalland@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a wait-list controlled cluster randomized trial

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 23, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)