NCT07355179

Brief Summary

The goal of this cluster-randomized trial is to investigate how a co-created, affordance-based approach - developed in collaboration with children - and combined with educator training, can support preschool children's engagement in active play and their holistic development.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

December 29, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

December 29, 2025

Last Update Submit

April 27, 2026

Conditions

Children With Typical Neurodevelopment

Keywords

childhoodpsychomotor interventionmotor competencesocialemotional competencesexecutive functionsphysical activityPhysically active play

Outcome Measures

Primary Outcomes (1)

  • physical literacy (motor competence)

    Children's physical literacy will be assessed using Movement Assessment Battery for Children and interviews. Movement ABC consists of 3 subtests that measure three different areas: Manual dexterity; Aiming and grasping; and Balance. Assessed using the Movement Assessment Battery for Children (total standardized score derived from manual dexterity, aiming and grasping, and balance).

    2 months

Secondary Outcomes (6)

  • Social, Emotional, and Behavioral Competences (educator-reported)

    2 months

  • Social and Emotional Competences (parents-reported)

    2 months

  • Executive Functioning

    2 months

  • Physical Activity

    2 months

  • Positional Interactions

    2 months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Implementation quality of the PLAY UP intervention

    2 months

  • Acceptability of the PLAY UP intervention

    2 months

  • Feasibility of the pilot phase

    2 months

Study Arms (2)

participant group

EXPERIMENTAL

Children in the experimental group will receive a 15-session intervention. Intervention will be implemented in the outdoors of the kindergarten, by a psychomotor therapist and children's educator. Sessions will involve active play and will prioritize, strengthen and expand opportunities for children to engage with their surroundings.

Behavioral: PLAY UP

Comparison group

NO INTERVENTION

This group will maintain their regular school routine.

Interventions

PLAY UPBEHAVIORAL

The PLAY UP intervention comprises 15 outdoor sessions (60 minutes each), delivered twice weekly by a psychomotor therapy professional, with the classroom educator providing pedagogical support. Sessions adopt a co-creation approach, actively engaging children in shaping play experiences while leveraging environmental affordances that promote movement and social interaction. Each PLAY UP session follows a structure, beginning with a warm-up (experimentation time) that allows children to move freely and explore environmental affordances through active play. The main section combines guided reflection, child-led activity choices, and collective movement exploration, with adults facilitating engagement and expanding play possibilities. Sessions conclude with a symbolization and meaning-making phase, supporting reflection on experiences and promoting meaningful learning.

participant group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • regular attendance in preschool; have no limitations to participate in intervention.

You may not qualify if:

  • participating in a similar intervention program for at least 3 months; having limitations (e.g. physical limitations; intellectual neurodisorder) to take the assessment tasks;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriela Almeida

Evora, Évora District, 7000, Portugal

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 21, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

ongoing

Locations

PT(1)