An interventional study of Teacher Professional Development and Parent/guardian support in Socioemotional Development, Physical Activity and Sleep, sponsored by Universidad de La Frontera. Not yet recruiting at 2 sites in Chile. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Universidad de La Frontera · Not applicable, Interventional, and Prevention
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.
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 240 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Universidad de La Frontera is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Schools 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.
Behavioral: Teacher Professional Development · Behavioral: Parent/guardian support · Behavioral: Play-Based Activities and Environmental Modifications
Schools 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.
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.
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.
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.
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.
Time frame: Baseline and weeks 16, 32, 48, and 64
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline (T0), immediately after the class's 16-week intervention period, and 12 months after completion of the class's intervention period.
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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.
Time frame: Baseline, week 16 (end of intervention), and week 68 (12 months after the end of intervention)
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).
Time frame: At enrollment (before T0) and during the implementation.
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.
Time frame: Up to 16 weeks after the start of intervention
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.
Time frame: During each class's 16-week intervention period and up to 16 weeks after the start of the intervention
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.
Time frame: Each week, during the 16 weeks of the program implementation.
Maintenance: Percentage of classes maintaining core Newenkantun practices
RE-AIM Maintenance dimension (setting level). A class is considered to maintain the program when at least 3 of 5 core practices continue after the research team withdraws (sociodramatic play with intercultural narratives, regular use of the play materials kit, active play during class time, communication with families on program topics, and an active school-based program leader), assessed through educator reports and observation. Values range from 0% to 100%; higher values indicate greater maintenance.
Time frame: Weeks 42 and 68 after the start of intervention (6 and 12 months after the end of intervention)
Barriers and facilitators to implementation (Qualitative)
Semi-structured interviews and focus groups with educators, caregivers, school leaders, and community stakeholders, transcribed verbatim and analyzed using thematic content analysis, describing barriers, facilitators, acceptability, and contextual factors affecting implementation, as well as educators' SEL knowledge and classroom practices.
Time frame: During and after each class's 16-week intervention period, up to 12 months after completion.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The study protocol will be available from trial registration. The statistical analysis plan will be available before the database is locked. Informed consent forms and analytic code will be available at publication of the primary results. De-identified IPD will be available no later than 12 months after submission of the final report to ANID (expected [2030]) or at publication of the primary results, whichever comes first, and will remain available for a minimum of 10 years.
Access criteria: De-identified IPD will be deposited in a FAIR-compliant open repository [https://repositorio.anid.cl/] with a persistent identifier (DOI). Variables with low re-identification risk will be openly downloadable under a CC BY 4.0 license. Variables with higher risk (e.g., ethnicity, rural school stratum, cluster-level identifiers) will be available under controlled access to researchers who submit a brief proposal and sign a data use agreement that prohibits re-identification and onward sharing. Requests will be reviewed by the principal investigator and a data access committee that includes a representative of the participating communities. Publications using the data must acknowledge the Newenkantun study authors and its funding source (ANID/FONDECYT 1262579). Contact: nicolas.aguilar@ufrontera.cl
Data sharing details ↗ · repositorio.anid.cl
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