Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT07189104
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SAGA for Toddlers. Supporting Children's Linguistic and Socio-Emotional Development in Early Childhood Education and Care
Sponsor:
University of Helsinki
Organization:
Study Overview
Official Title:
SAGA for Toddlers. Supporting Children's Linguistic and Socio-Emotional Development in Early Childhood Education and Care
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAGA-T
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. 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.
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 1-year follow-up (1 year 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.
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 1-year follow-up (1 year 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: