About this trial
What is this study about? This study will test a program called "Newenkantun" (which refers to a hand-strength game in Mapuche culture) designed to help young children develop important social and emotional skills through play and physical activity. The program focuses on helping children learn how to understand and manage their emotions, get along with others, and make good decisions - skills that are important for success in school and life.
Why is this study being done? The early years of childhood are a critical time for developing social, emotional, and physical skills. Many children, especially those from low-income families, face challenges that make it harder to develop these skills. This study will test whether a program that combines active play, social-emotional learning, and family involvement can help young children in the Araucanía region of Chile develop these important abilities.
The program also aims to help children be more physically active, spend less time on screens, and get better sleep - all of which are important for healthy development.
Who can participate? Children ages 4-6 years old (attending transition levels 1 and 2 in early childhood education) in the cities of Temuco and Padre Las Casas in the Araucanía region of Chile. Both their teachers and parents/guardians will also participate in the program.
What will participants do? Children will participate in play-based activities at their schools over 16 weeks. These activities use storytelling and imaginative play (like pretending to be different characters) to help them practice social and emotional skills. The activities respect and incorporate the cultural background of the Araucanía region, including Mapuche cultural elements.
Teachers will receive training and support (both in-person and online) to learn how to teach social-emotional skills and promote healthy movement behaviors in their classrooms. They will receive materials and kits to help them run play activities.
Parents and guardians will receive support through an online platform, app, social media, and printed materials. They will learn about the importance of social-emotional development and healthy movement habits, and get practical tips for supporting these at home. The program includes 8 topics delivered over 4 months, with each topic taking about 30 minutes to complete.
What will be measured?
Researchers will measure:
Children's social and emotional skills (like managing emotions, getting along with others, and making responsible decisions) Physical activity levels, screen time, and sleep patterns Motor skills and thinking abilities Teachers' confidence and practices in teaching social-emotional skills Parents' support practices at home The school environment and how well it supports these skills
These measurements will happen at the beginning of the program, at the end, and at follow-up visits 3, 6, and 12 months after the program ends.
How is the study designed? The study uses a "stepped-wedge" design, which means that 10 schools will start the program at different times, chosen randomly. This design allows all schools to eventually receive the program while still allowing researchers to compare results. Each school will participate for 16 weeks, and researchers will follow what happens afterwards to see if the benefits last over time.
What are the potential benefits? If successful, this program could provide a practical, culturally appropriate way to help young children develop important social, emotional, and physical skills during a critical time in their development. The program is designed to be sustainable and could potentially be used in other schools and communities in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Schools
The school is located in the municipality of Temuco or Padre Las Casas (Araucanía Region, Chile).
The school offers pre-kindergarten (Transition Level 1) and/or kindergarten (Transition Level 2) classes within the national early childhood education curriculum.
The school is public or publicly subsidized.
Disqualifiers
Schools
The school took part in a structured socioemotional learning or physical activity program in the past 12 months.
The school has planned major structural changes during the study period (for example, closure, merger, or a change in the levels it offers).
Children
Trial design
Crossover
Treatments tested in this trial
Teacher Professional Development
BehavioralSixteen-week blended professional development program combining three in-person workshops with online asynchronous modules. Teachers learn to deliver SEL instruction and promote healthy movement behaviors through play-based activities. Training covers five SEL competencies, WHO 24-hour movement guidelines, and co-creation of culturally relevant sociodramatic play narratives. Includes materials kit, peer mentoring networks, and ongoing support via flexible platform. Aligned with Chilean early childhood curricular foundations.
Parent/guardian support
BehavioralAn eight-topic program delivered biweekly over 16 weeks through the Moodle platform, mobile app, social media, and printed materials. Each 30-minute module addresses SEL importance, healthy movement behaviors, family physical activity, goal-setting, and sustaining changes. Uses self-determination and social cognitive theory principles. Includes interactive videos, family activity logs, and moderated peer support groups. Adapted delivery for rural areas includes community workshops with intercultural facilitators.
Play-Based Activities and Environmental Modifications
BehavioralDaily classroom-based sociodramatic play activities over 16 weeks using community co-created narratives reflecting the Araucanía region's intercultural context. Children engage in imaginative play with characters embodying social-emotional competencies and physical abilities. Activities promote executive function, emotion regulation, cooperation, and active movement. Classroom environments modified with equipment, signage, and designated active play zones to support physical activity and SEL skill development.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in children's socioemotional competencies as measured by the Children's Emotional Adjustment Scale - Preschool Version (CEAS-P) total score
Caregiver-reported questionnaire assessing preschool children's emotional adjustment, including emotion regulation, temper, and social-emotional functioning. The Chilean version was translated and culturally adapted for preschool populations (Cronbach's alpha 0.87-0.93). Higher scores indicate better emotional adjustment. Completed on paper or electronically at home. All classes are assessed at five time points: baseline and every 16 weeks thereafter. Classes cross over from control to intervention in four sequences, one at each 16-week step, so each class contributes both control and intervention measurements. The intervention effect will be estimated as the difference in scores between intervention and control periods using linear mixed-effects models accounting for clustering by class, repeated measures within children, and secular time trends.
Secondary outcomes
Change from baseline in device-measured physical activity (minutes per day of total physical activity and moderate-to-vigorous physical activity)
Measured with the SENS Motion accelerometer system worn continuously for at least 7 consecutive days, including nighttime, in a subsample of 120 children. Outcomes are average minutes per day of total physical activity and of moderate-to-vigorous physical activity, derived using validated algorithms for children aged 3-14 years.
Change from baseline in device-measured sleep duration (hours per night)
Measured with the SENS Motion accelerometer system worn continuously for at least 7 consecutive days, including nighttime, in a subsample of 120 children. Outcome is average nightly sleep duration in hours.
Change from baseline in device-measured sedentary time (minutes per day)
Measured with the SENS Motion accelerometer system worn continuously for at least 7 consecutive days, including nighttime, in a subsample of 120 children. Outcome is average minutes per day spent sitting or lying while awake.
Change from baseline in executive function as measured by the early years toolbox (EYT) task scores
Direct, individually administered tablet-based tasks from the Early Years Toolbox, translated and adapted into Spanish: Mr Ant (working memory; points) and Go/No-Go (inhibitory control; impulse control score). Higher scores indicate better executive function. Assessed at school by trained evaluators blinded to allocation, following child assent.
Other outcomes
Reach: Percentage of eligible children enrolled in the study
RE-AIM Reach dimension. Number of children whose caregivers give written informed consent, divided by the number of children enrolled in participating classes, multiplied by 100. Values range from 0% to 100%; higher values indicate greater reach. Representativeness will be described by comparing participants with non-participants on available characteristics (sex, age, municipality, and urban or rural school).
Adoption: Percentage of caregivers who complete the Newenkantun family program
RE-AIM Adoption dimension. Completion is defined as accessing at least 6 of the 8 family program topics through the digital platform, printed materials, or community sessions, recorded through platform logs and attendance records. Calculated as the number of caregivers who complete the program divided by the number of enrolled caregivers, multiplied by 100. Values range from 0% to 100%; higher values indicate greater adoption.
Implementation: Implementation fidelity score on the Newenkantun fidelity checklist
RE-AIM Implementation dimension. Structured checklist developed for this study and completed by trained observers and facilitators, recording whether core program components were delivered as planned (for example, educator workshops held, play materials kit in use, sociodramatic play sessions conducted, family topics released, and school-based leaders trained). The score is the percentage of core components delivered as planned per class, ranging from 0% to 100%; higher scores indicate greater fidelity.
Implementation: Percentage of planned classroom play sessions delivered
RE-AIM Implementation dimension (dose delivered). Number of Newenkantun sociodramatic and active play sessions delivered in each class, recorded in educator logs and verified during site visits, divided by the number of sessions planned for the 16-week program (\[16\] sessions), multiplied by 100. Values range from 0% to 100%; higher values indicate a greater dose delivered.
Sponsors and contacts
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Universidad de La Frontera
Lead sponsor
Pontificia Universidad Catolica de Valparaiso
Collaborator
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