Clinical trial NCT05756374: OUT to IN: an Outdoor Body-oriented Intervention Program
Official title: OUT to IN: an Outdoor Body-oriented Intervention Program to Improve Preschoolers' Social-emotional Competence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Typical Development
Keywords: social-emotional development
mental health
preschool
preventive care
body-oriented interventions
play
relaxation
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 271
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized trial is to examine the effects of a body-oriented intervention program on preschoolers' social-emotional competence.

The main question it aims to answer are: does OUT to IN effectively promotes preschoolers' self-awareness, self-regulation, relationship skills and motor competence? Participants are children between 3 and 6 years from portuguese preschools. The inclusion criteria are (a) participants' age between 3 and 6 years, (b) do not have participated in a similar intervention program within the last 6 months, and (c) do not have a physical condition that can affect the participation in the program. Children will be randomly allocated to the experimental group (who will participate in a 10-week intervention program with biweekly sessions of psychomotricity implemented outdoors) and to the control group (who will maintain their usual routines).

Detailed description: Main aim: Examine the effects of a body-mind intervention program developed in outer space on motor competence and socio-emotional competence (emotional awareness, self-regulation, relationship skills) of preschool aged children.

Participants: Children attending pre-school education. Inclusion criteria are: a) attending regular pre-school education; b) not having limitations (e.g. physical limitations; intellectual deficits) to take the assessment tests; c) not having limitations to participate in the intervention sessions; d) not using drugs that can influence the dependent variables; f) not participating in a similar intervention program for at least 2 months. 250-300 children are expected to be enrolled in this study.

Children will be randomly allocated to the experimental group (who will participate in a 10-week intervention program with biweekly sessions of psychomotricity implemented outdoors) and to the control group (who will maintain their usual routines). Children will be tested before and after the intervention period.

Outcome measures:

Motor competence will be assessed through the Test of Gross Motor Development II.

Social-emotional competence will be assessed through the Study on Social and Emotional Skills questionnaire reported by parents and teachers. Parents will also fill in the Emotional Expression Questionnaire. Children will be individually tested through the recognition, identification and emotional understanding tests, the Heads Toes Knees and Shoulders test, the Day and Night test and the interoceptive accuracy test.

Stress biomarkers will also be analysed through salivary analysis. Saliva collections will be made, in a non-stimulated way, asking each child to rinse their mouth with water for about 10 seconds, swallow it and wait 30 seconds. From that moment on, all the saliva produced will be accumulated in the mouth and placed in a tube kept on ice at regular intervals. Participants will remain in a comfortable position and not speak during the collection period.

Statistical analysis: Mann-Whitney test will be used to study differences at baseline between the OUT to IN group and the control group, and to study differences in the 10- week changes between both groups. Wilcoxon Test will be used for intragroup comparisons.

Eligibility criteria: Inclusion Criteria:

. attending regular pre-school education;

Exclusion Criteria:

* having limitations (e.g. physical limitations; intellectual deficits) to take the assessment tests;
* having limitations to participate in the intervention sessions;
* using drugs that can influence the dependent variables;
* participating in a similar intervention program for at least 2 months.

Primary outcomes:
measure: Emotion Understanding
timeFrame: 10 weeks
measure: Self Regulation
timeFrame: 10 weeks
measure: Relationship skills
timeFrame: 10 weeks
measure: Interoceptive Accuracy
timeFrame: 10 weeks
measure: Motor Competence.
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: University of Évora
Study officials:
References: