AzTrials
AzTrials

Socioemotional DevelopmentNewenkantunNCT07871929

Newenkantun: a Play-based Program to Promote Socioemotional Learning in Early Childhood Education in Chile.

A study testing Teacher Professional Development, Parent/guardian support and Play-Based Activities and Environmental Modifications in people with Socioemotional Development and Physical Activity, run by Universidad de La Frontera at 2 sites in Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 4 years and olderHealthy volunteers can take part
What is being tested?
Teacher Professional Development, Parent/guardian support and Play-Based Activities and Environmental Modifications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesChile
Study dates
16 Nov 2026to 30 Nov 2029
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 4 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • The school principal signs an institutional authorization letter to take part in the study.
  • Children
Show all 16Show fewer
  • The child is enrolled in a participating pre-kindergarten or kindergarten class.
  • The child is between 4 and 6 years old.
  • A parent or legal caregiver gives written informed consent for the child to take part.
  • The child agrees to take part (verbal assent) before each assessment or activity.
  • Parents and caregivers
  • The person is the parent or legal caregiver of a participating child.
  • The person gives written informed consent to take part.
  • Educators and school staff
  • The person works as an educator, teaching assistant, or school leader with a participating class.
  • The person gives written informed consent to take part.

Who cannot join

  • 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
  • The parent or legal caregiver does not give consent or withdraws consent.
  • The child does not want to take part, shown verbally or through behavior.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas Aguilar-Farias, PhD contact

+56452596525

nicolas.aguilar@ufrontera.cl

Camila Mella-Garcia, MSc contact

+56452596512

camila.mella@ufrontera.cl

Chile2 sites
  • Department of Physical Education, Sports and Recreation, Universidad de La Frontera

    Temuco, Cautin, 4780000

    Nicolas Aguilar-Farias, PhD, +56452596525, nicolas.aguilar@ufrontera.cl

    Nicolas Aguilar-Farias, PhD

  • Pontificia Universidad Catolica de Valparaiso

    Valparaíso, Valparaiso

    Fernando Rodriguez-Rodriguez, PhD, fernando.rodriguez@pucv.cl

    Fernando Rodriguez-Rodriguez, PhD

Other trials in Chile

About this study

Official title: Newenkantun: a Play-based Program to Promote Socioemotional Learning Competencies in Children in Intercultural Contexts in Early Childhood Education in the Araucania Region.

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.

Read more

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.

Read the detailed description

STUDY RATIONALE Socioemotional learning (SEL) competencies developed in early childhood underpin later social, behavioral, and academic adjustment, and children in low-income settings are at greater risk of delays in socioemotional and self-regulatory development. Active and sociodramatic play are central vehicles for SEL in the preschool years, and healthy 24-hour movement behaviors (physical activity, limited screen time, and adequate sleep) are associated with better self-regulation and prosocial behavior. In the Araucanía Region of Chile, Mapuche and non-Mapuche educational traditions coexist, and Mapuche concepts such as che (person), newen (force), yamuwün (respect), and aukantun (play) align closely with SEL principles. Rigorously evaluated SEL programs for early childhood education in Latin America rarely integrate play and movement, genuine intercultural co-creation, and multiple levels of influence. Newenkantun, named after a Mapuche hand-strength game, was developed to address this gap and is aligned with the Chilean Ministry of Education's Socioemotional Learning Plan and the national early childhood curriculum. SEL is conceptualized using the five CASEL competencies: self-awareness, social awareness, self-management, relationship skills, and responsible decision-making.

STUDY PHASES Phase 1 comprises program development, participatory cultural adaptation, and a pilot study in two schools, one per municipality, with approximately 40 children and their caregivers. The pilot is used to optimize the intervention, assess feasibility, and refine the program logic model with community participation, using the same instruments and procedures as the main trial. Phase 2 is the stepped-wedge cluster randomized trial in 16 pre-kindergarten and kindergarten classes from 10 schools in Temuco and Padre Las Casas. Phase 3 comprises process, outcome, and impact evaluation and dissemination.

DESIGN RATIONALE The unit of randomization is the class. A stepped-wedge design was chosen because all participating classes eventually receive the intervention, which addresses community and educational concerns about withholding a promising program; rollout can be staggered to match implementation capacity and allow progressive refinement of locally co-created content; repeated measurements within each class increase statistical efficiency compared with a parallel cluster design with the same number of clusters; and the design includes a maintenance period to assess sustained effects.

SAMPLING, RANDOMIZATION, AND BLINDING Randomization is conducted in two stages. In the first stage, 10 schools, five per municipality, are selected by stratified random sampling, with strata defined by municipality, urban or rural location, and socioeconomic level based on the school vulnerability index. Sixteen classes are then identified in the selected schools. In the second stage, classes are allocated to four sequences of four classes each, which determine when each class crosses from the control to the intervention condition. Allocation uses restricted randomization to balance urban and rural classes across sequences, and classes from the same school are allocated to the same sequence to minimize contamination. The allocation is computer-generated by an independent statistician and remains concealed until the baseline assessment has been completed in all classes. Because of the educational nature of the intervention, children, caregivers, and educators cannot be blinded; assessors of directly measured child outcomes are blinded to allocation.

RECRUITMENT AND CONSENT PROCEDURES School principals sign an institutional authorization before any study activity begins. Caregivers are invited through informational meetings scheduled to suit families and supported by accessible graphic materials, and give written informed consent on paper or electronically. Educators and school staff give written informed consent. Before each assessment or program activity, children give developmentally appropriate assent supported by graphic materials, and any verbal or behavioral sign of refusal stops the activity without consequences. Recruitment is conducted by the research team independently of school leadership, and participants are told that declining or withdrawing has no academic, employment, or service-access consequences. Expected participant burden is 20 to 30 minutes per wave for the child assessment and for caregiver questionnaires, 30 to 60 minutes per educator training session or caregiver workshop, 60 to 90 minutes per focus group, and 45 to 60 minutes per individual interview.

INTERVENTION DELIVERY The 16-week program has two components delivered simultaneously and is grounded in sociocultural theory, self-determination theory, and social cognitive theory. The educator component begins with a participatory needs assessment in each school, followed by blended professional development that combines synchronous and asynchronous online modules with three in-person workshops per school. Workshops support the co-creation of intercultural sociodramatic narratives with educators, children, and families, drawing on the Mapuche worldview and the cultural heritage of the region; narrative characters emphasize social and physical abilities linked to self-care and care for the environment. Each school receives a play materials kit for active play during class time, and school-based leaders are trained to sustain the program after the research team withdraws, following a capacity-building, self-sustaining infrastructure model. The family component delivers eight topics every two weeks, about 30 minutes each, through a Moodle-based platform, a mobile app, social media, and printed materials for families with limited connectivity. Topics cover SEL, movement behaviors, family play and physical activity, recognizing changes in socioemotional competencies, goal setting, and sustaining change. Synchronous sessions focus on realistic home strategies, and content is reinforced through moderated peer-support groups, relapse-prevention strategies for behaviors such as excessive screen use, and specific strategies to engage fathers. In rural schools within Mapuche communities, sessions are led by intercultural facilitators in community settings agreed with families. During the control period, classes continue usual educational practice.

DATA COLLECTION SCHEDULE Assessments are conducted in all classes at baseline, before the allocation is disclosed, and at each subsequent step of the stepped-wedge rollout through the end of follow-up. At any given wave, classes may be in the control, intervention, or maintenance condition, and the same procedures are applied to all of them. The primary outcome and process measures are collected at every wave; most secondary measures are collected at baseline, after each class's intervention period, and 12 months later, to limit participant burden. Child assessments take place at school, caregiver questionnaires are completed at home on paper or electronically, and educator and classroom assessments are conducted during scheduled site visits. Standardized evaluation teams are trained for each municipality, and procedures are adapted to connectivity limitations and cultural protocols in rural and Mapuche communities. Device-based measures are collected in a subsample of 120 children selected for logistical feasibility. Instruments used with children and families have been translated and culturally adapted for Chilean preschool populations.

SAMPLE SIZE The number of clusters was fixed by feasibility at 16 classes, with an expected 15 participating children per class. Power was calculated for a closed-cohort stepped-wedge design with five measurement periods, using a multilevel model with fixed period effects solved by generalized least squares and a t-distribution with 14 degrees of freedom. Assuming a within-period intraclass correlation of 0.05, a cluster autocorrelation of 0.8, and an individual autocorrelation of 0.5, the design has 96% power to detect a standardized effect of 0.32, equivalent to an approximately 10% difference in SEL scores, at a two-sided alpha of 0.05; the minimum detectable effect is 0.24. Power remains at least 80% with 10 evaluable children per class, with intraclass correlations up to 0.20, or with up to 20% within-school contamination.

STATISTICAL ANALYSIS Intervention effects will be estimated with linear mixed-effects models, or generalized linear mixed models for non-normally distributed outcomes, including fixed effects for period and intervention condition and random effects for class and child, to account for clustering, repeated measures, and secular trends inherent to the stepped-wedge design. Models will be adjusted for the stratification variables, and a small-sample correction for degrees of freedom will be applied. The primary analysis follows the intention-to-treat principle and includes all randomized participants regardless of adherence; per-protocol and adherence-based sensitivity analyses will also be conducted. Effects will be reported as standardized mean differences. Moderation and mediation analyses will be adjusted for child age and sex. Missing data will be handled by multiple imputation under a missing-at-random assumption. Qualitative data from interviews and focus groups will be analyzed thematically, and quantitative and qualitative findings will be integrated using a convergent parallel mixed-methods design.

PROCESS EVALUATION Process evaluation is embedded throughout the trial and structured by the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance), with specific attention to cultural fidelity and to differences between urban and rural delivery. Interviews and focus groups with educators, caregivers, and community stakeholders capture barriers, facilitators, and contextual factors and are also used to monitor within-school contamination.

DATA MANAGEMENT, SAFETY, AND DISSEMINATION Data are managed on secure, password-protected platforms and stored on institutional servers with restricted access; paper questionnaires are coded and stored securely. Data quality is monitored through range and logic checks and regular audits, under a data management plan that meets national requirements for publicly funded research. The study is classified as minimal risk, and procedures for identifying, managing, and reporting adverse events are specified in the approved protocol. Results will be shared with participating schools, families, and communities, with regional and national education authorities, and through peer-reviewed publications.

Being tested
Teacher Professional Development, Parent/guardian support, Play-Based Activities and Environmental Modifications
Keywords
socioemotional learning, movement behaviors, early childhood education
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teacher Professional DevelopmentBehavioural

    Sixteen-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 supportBehavioural

    An 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 ModificationsBehavioural

    Daily 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.

Study groups in NCT07871929
Study groupRoleWhat they receive
Newenkantun InterventionExperimentalSchools in this arm receive the 16-week Newenkantun program, a multilevel play-based intervention designed to promote social-emotional learning (SEL) competencies and healthy movement behaviors in young children. Components include: (1) blended teacher training (in-person workshops + online modules) on SEL and play-based activity promotion; (2) parent support via app/platform covering 8 topics on SEL and movement behaviors; (3) sociodramatic play activities co-created with communities incorporating Mapuche cultural values and classroom environmental modifications.
Receives: Behavioral: Teacher Professional Development; Behavioral: Parent/guardian support; Behavioral: Play-Based Activities and Environmental Modifications
Control - Usual practiceNo interventionSchools in this arm continue with their standard early childhood education curriculum and usual classroom practices while in the control phase. Teachers follow the regular Chilean early childhood education curricular foundations without additional training or support related to social-emotional learning or structured play-based activities. Children participate in typical classroom activities, and families receive standard communications from the school. No additional materials, training, or support for promoting social-emotional learning or healthy movement behaviors are provided during this phase. All schools begin in this control condition and remain here until their randomly assigned crossover time to receive the Newenkantun intervention. This design ensures that all participating schools eventually receive the intervention while allowing for comparison between control and intervention conditions across different time periods.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and weeks 16, 32, 48, and 64

Secondary outcomes (19)
  1. 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.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  2. 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.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  3. 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.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  4. 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.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  5. Change from baseline in parenting style dimension scores as measured by the Parenting Styles and Dimensions Questionnaire

    Caregiver self-report questionnaire yielding mean scores for authoritative, authoritarian, and permissive parenting dimensions. Higher scores indicate greater use of the corresponding parenting style. The Parenting Styles and Dimensions Questionnaire (PSDQ) comprises 29 items, each rated from 1 (never) to 5 (always). The score is the mean of the items, ranging from 1 to 5 per domain. In the authoritative parenting domain, higher scores indicate more frequent use of authoritative parenting practices, which is considered a better outcome. In the authoritarian parenting domain, higher scores indicate more frequent use of authoritarian parenting practices, which is considered a worse outcome. In the permissive parenting domain, higher scores indicate more frequent use of permissive parenting practices, which is considered a worse outcome.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  6. Change from baseline in Home Socioemotional Support Practices Questionnaire Total Score

    Caregiver self-report questionnaire developed by the research team for this study, assessing how often caregivers engage in home practices that support children's socioemotional development, such as talking about emotions, shared play, and consistent routines. It comprises 20 items rated from 1 (never) to 5 (always); the total score is the mean of the items and ranges from 1 to 5. Higher scores indicate more frequent supportive practices, which is considered a better outcome.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  7. Change from baseline in family functioning as measured by the self-report family inventory (SFI-II)

    Caregiver self-report questionnaire assessing perceived family functioning. The Health/Competence subscale of the Self-Report Family Inventory, Version II comprises 36 items on family closeness, communication, problem solving, and autonomy, each rated from 1 (fits our family very well) to 5 (does not fit our family). The score is the mean of the items, ranging from 1 to 5, after reverse-scoring negatively worded items as specified in the instrument manual. Lower scores indicate healthier family functioning, which is considered a better outcome. Completed on paper or electronically at home.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  8. Change from baseline in educators' SEL beliefs as measured by the SEL beliefs scale

    Educator self-report. The comfort subscale of the Social-Emotional Learning Beliefs Scale comprises 12 items on educators' confidence in teaching social and emotional skills, each rated from 1 (strongly disagree) to 5 (strongly agree). The score is the mean of the items, ranging from 1 to 5. Higher scores indicate greater comfort, which is considered a better outcome.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  9. Change from baseline in educators' self-efficacy for promoting healthy eating, movement behaviors, screen time, sleep, and socioemotional development

    Educator self-report questionnaire developed by the research team assessing confidence in promoting healthy eating, physical activity, limited screen time, sleep, and socioemotional development in children. Higher scores indicate greater self-efficacy.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  10. Change from baseline in organizational readiness for change score

    Educator and administrator self-report questionnaire assessing the school team's collective commitment and perceived capability to implement the program (School's Readiness for Change - Teacher version. Wanless SB, 2014). Higher scores indicate greater readiness.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  11. Change from baseline in classroom physical and social environment as measured by the Environment and Policy Assessment and Observation (EPAO) instrument

    Structured classroom observation and document review conducted by trained observers during scheduled site visits, assessing physical activity-related practices, play equipment, outdoor time, screen use, educator engagement, and SEL-related classroom practices. Subscale and total scores are computed; higher scores indicate more supportive environments.

    Measured: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.

  12. Change From Baseline in Caregiver-Reported Physical Activity (Minutes per Day)

    Average daily minutes of physical activity of any intensity, including active play, reported by caregivers using a questionnaire adapted from the SUNRISE Study Parent Questionnaire. Administered to the full sample, on paper or electronically at home. Higher values indicate more physical activity.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  13. Change From Baseline in Caregiver-Reported Recreational Screen Time (Minutes per Day)

    Average daily minutes of sedentary recreational screen use (television, video, computer, tablet, smartphone, and video games), excluding educational use at school, reported by caregivers using a questionnaire adapted from the SUNRISE Study Parent Questionnaire. Administered to the full sample. Lower values indicate less screen time.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  14. Change From Baseline in Caregiver-Reported Sleep Duration (Hours per Day)

    Average total sleep duration per 24 hours, including nighttime sleep and daytime naps, reported by caregivers using a questionnaire adapted from the SUNRISE Study Parent Questionnaire. Administered to the full sample.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  15. Percentage of Participants Meeting All Three WHO 24-Hour Movement Guidelines for Children Under 5 Years

    Percentage of children meeting all three recommendations simultaneously, based on caregiver-reported data: at least 180 minutes per day of physical activity, no more than 1 hour per day of sedentary screen time, and 10 to 13 hours per day of sleep from the SUNRISE Study Parent questionnaire. Each child is classified as meeting or not meeting all three guidelines at each time point.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  16. Change from baseline in Single-Leg Standing Balance Time (Seconds)

    Time in seconds a child can stand on one leg without support, assessed at school by trained evaluators blinded to allocation. Record the best of 2 trials up to a maximum of 30 seconds. Higher values indicate better static balance.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  17. Change from baseline in Supine-to-Stand Time (Seconds)

    Time, in seconds, for a child to rise from lying on the back (supine) to a fully standing position as quickly as possible, then run to a target 3 meters away and back, assessed at school by trained evaluators blinded to allocation. The fastest of 2 trials is recorded. Lower values indicate better motor competence.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  18. Change from baseline in Handgrip Strength (Kilograms)

    Maximal isometric grip strength in kilograms, measured with a hand dynamometer adjusted for child hand size, assessed at school by trained evaluators blinded to allocation. The best of 2 trials per hand is recorded. Higher values indicate greater muscular strength

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

  19. Change from baseline in Standing Long Jump Distance (Centimeters)

    Horizontal distance in centimeters jumped from a standing position with both feet together, measured from the take-off line to the back of the closest heel on landing, assessed at school by trained evaluators blinded to allocation. Record the best of 2 attempts. Higher values indicate greater lower-limb muscular power.

    Measured: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start16 Nov 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

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
Crossover
Model description
This study uses a stepped-wedge cluster-randomized trial design, with schools (clusters) as the unit of randomization. Schools and classes will be randomly assigned to receive the 16-week Newenkantun intervention at different time points across the study period. All schools start in a control phase (continuing usual practices). At predetermined intervals, schools cross over from the control phase to the intervention phase, following a randomized sequence. Eventually, all schools receive the intervention, but at staggered times. After completing the intervention, schools enter a maintenance phase with follow-up assessments at 3, 6, and 12 months.
Masking
Single blind
Who is masked
Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07871929
Sponsor's protocol ID
UFRO-2026-1262579
Other IDs
1262579
Acronym
Newenkantun
Status last verified
Oct 2026
First submitted
1 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) supporting all published results will be shared, including: child-level outcomes (CEAS-P, Early Years Toolbox, motor battery, ECDI, caregiver-reported movement behaviors) and derived daily accelerometry summaries; caregiver-level questionnaires; educator-level questionnaires; school environment scores; allocation sequence, period, and cluster identifiers; and a data dictionary. Data will be de-identified before deposit: names, exact dates of birth, school names, and small-area identifiers will be removed or coarsened. Raw accelerometer files, audio recordings, and qualitative transcripts will not be shared because of re-identification risk in small rural and Mapuche communities. Sharing complies with ANID's open-access policy and Chilean personal data protection law, and data stewardship will follow FAIR and CARE principles for Indigenous data governance.

Publications

  • Schindler HS, Kholoptseva J, Oh SS, Yoshikawa H, Duncan GJ, Magnuson KA, Shonkoff JP. Maximizing the potential of early childhood education to prevent externalizing behavior problems: A meta-analysis. J Sch Psychol. 2015 Jun;53(3):243-63. doi: 10.1016/j.jsp.2015.04.001.

    PubMed 26054817
  • Pullen T, Bottorff JL, Sabiston CM, Campbell KL, Eves ND, Ellard SL, Gotay C, Fitzpatrick K, Sharp P, Caperchione CM. Utilizing RE-AIM to examine the translational potential of Project MOVE, a novel intervention for increasing physical activity levels in breast cancer survivors. Transl Behav Med. 2019 Jul 16;9(4):646-655. doi: 10.1093/tbm/iby081.

    PubMed 30060250
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Questions about this trial

What is this clinical trial studying?

A study testing Teacher Professional Development, Parent/guardian support and Play-Based Activities and Environmental Modifications in people with Socioemotional Development and Physical Activity, run by Universidad de La Frontera at 2 sites in Chile.

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 16 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. 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 Nicolas Aguilar-Farias, PhD (+56452596525, nicolas.aguilar@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in children's socioemotional competencies as measured by the Children's Emotional Adjustment Scale - Preschool Version (CEAS-P) total score (time frame: Baseline and weeks 16, 32, 48, and 64). 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 NCT07871929, which also lists 7 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 13 Oct 2026.

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