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Recruiting NCT07189104

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

No phase Interventional Social Emotional Competence Language Development

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAGA for Toddlers.
Who it may be relevant to
Registry conditions: Social Emotional Competence, Language Development. Basic parameters: 11 months — 36 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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. Does the SAGA model support children's social-emotional development? 2. 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:

3\) 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.

Interventions

  • Behavioral SAGA for Toddlers
    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.

Primary outcome measures

  • Social Emotional development [Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up]
  • Language development [Time frame: 1) Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up]
  • Pro-social behavior [Time frame: Before the intervention, 2) Immediately after the 10-week intervention, 3) In 9-months follow-up]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Finland · 1 center
  • University of Helsinki — Helsinki

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

Identifiers

NCT: NCT07189104 · 58/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗