Children With Typical DevelopmentNCT05756374
OUT to IN: an Outdoor Body-oriented Intervention Program
A study testing OUT to IN in people with Children With Typical Development, run by University of Évora at 1 site in Portugal.
Trial 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?… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Typical Development
- What is being tested?
- OUT to IN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- . attending regular pre-school education;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OUT to IN: an Outdoor Body-oriented Intervention Program to Improve Preschoolers' Social-emotional Competence
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).
Read the 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.
- Conditions
- Children With Typical Development
- Being tested
- OUT to IN
- Keywords
- social-emotional development, mental health, preschool, preventive care, body-oriented interventions, play, relaxation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OUT to INBehavioural
OUT to IN comprises 20 body-oriented biweekly 40-minute sessions facilitated by a psychomotor therapist in a pedagogical partnership with the preschool teacher. Sessions are implemented outdoors. All sessions are framed in a context of freedom and self and mutual bodily resonance, according to the following structure: First, children are invited to engage in exercise play activities. Second, children engage in ludic relaxation proposals. Finally, children are asked to reflect on their bodily experiences and express themselves through different expressive mediators. Preschool teachers also participate in a 25-hour training focused on the underlying principles of OUT to In and participate in 20 body-oriented biweekly 20-minute relaxation sessions, facilitated by a psychomotor therapist.
| Study group | Role | What they receive |
|---|---|---|
| OUT to IN Group | Experimental | This group will participate in biweekly sessions of psychomotricity for 10 weeks. Sessions will be implemented in the outdoors of the preschool, by a psychomotor therapist and children's teacher. Sessions will involve physical play, relaxation and expressive activities. Receives: Behavioral: OUT to IN |
| Control group | No intervention | This will will maintain their usual routine at preschool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Understanding
Will be assessed through three tasks developed by the Focus on Emotions Group (focusonemotions.nl): emotion discrimination (children are asked to place six cards, whereby they could choose between two categories happy versus unhappy faces, and angry versus sad faces cards), identification (children are asked to point to the facial expressions according to the emotion words instructed by the experimenter), and emotion attribution in a situational context (children are presented with eight illustrated emotion-evoking vignettes, designed to evoke happiness, anger, fear and sadness, and asked how the protagonist is feeling by pointing the facial expression and verbally identifying the emotion).
Measured: 10 weeks
Self Regulation
Self-regulation is obtained through the the Day and Night task (DN), the Head Toes Knees and Shoulders task (HTKD) and the composite scale Externalizing Behaviors from the Strengths and Difficulties Questionnaire.
In the DN task whenever the child sees a black card, must say "day", whenever the child sees a white card, must say "night".
In the HTKS task whenever the child is asked to touch the feet, must touch the head and vice versa, when the child is asked to touch the shoulders, must touch the knees and vice versa.
Externalizing behaviors is obtained through a composite scale which comprises two SDQ scales: behavior problems and hyperactivity. Caregivers are asked to rate their children's behavior in a 3-point likert scale, from 1 (not true) to 3 (certainly true).
Measured: 10 weeks
Relationship skills
Empathy, Cooperation are Sociability are measured through the Study on Social and Emotional Skills Questionnaire (SSES), a caregivers and teacher report questionnaire. Caregivers and teachers were asked to fill in the Empathy (e.g. He/she can feel how others are feeling; He/she understands what others want), Cooperation (e.g., He/she works well with others; he/she likes to help others), and Sociability subscales (e.g., He/she has many friends; He/she makes friends easily) in a 5-point likert scale from one (completely disagree) to five (completely agree).
Emotion communication is obtained through the Emotion Vocabulary Questionnaire, a caregiver-report which assesses whether children know and use emotion and/or mental state words, in a 2-point likert scale from 1 (no) to 2 (yes). The EVQ includes either basis emotions (e.g., happy, angry), complex emotions (e.g., jealous, disappointed), and mental state words (e.g. thinking, dreaming).
Measured: 10 weeks
Interoceptive Accuracy
Interoceptive accuracy is measured through the Jumping Jack Paradigm (JJP). In the JJP task the child is first asked to sit in a chair looking at a calm screen for 3 minutes. Then examiner assesses his/her pulse to count the heart rate. Then the child is asked to choose one of the four circles, with different sizes that he/she believes it is equivalent to the heart rate. Then the child is asked to perform jumping jacks for 20 seconds. After the jumping jacks, the examiner measures her/his hear rate and asks the child to again choose one of the four circles that corresponds to his/her heart rate.
Measured: 10 weeks
Motor Competence.
Motor Competence is assessed through the Test of Gross Motor Development-Second Edition (TGMD-2). Simple and playful exercises (throwing a ball, jumping, etc.) are performed to assess locomotion (running; galloping; hopping; leaping; jumping and sliding) and object control skills (striking; dribbling; catching; kicking; throwing and rolling). Each children performs every activity for two trials.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start4 Jan 2021
- Primary completion26 Feb 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Typical DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guida Veiga, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756374
- Sponsor's protocol ID
- #20088
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OUT to IN: an Outdoor Body-oriented Intervention Program to Improve Preschoolers' Social-emotional Competence
- ClinicalTrials.gov ID
- NCT05756374
- Acronym / sponsor ID
- #20088
- Conditions
- Children With Typical Development
- Keywords
- social-emotional development, mental health, preschool, preventive care, body-oriented interventions, play, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OUT to IN Group | Experimental | Behavioral: OUT to INThis group will participate in biweekly sessions of psychomotricity for 10 weeks. Sessions will be implemented in the outdoors of the preschool, by a psychomotor therapist and children's teacher. Sessions will involve physical play, relaxation and expressive activities. |
| Control group | No intervention | –This will will maintain their usual routine at preschool. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- . attending regular pre-school education;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OUT to INOUT to IN comprises 20 body-oriented biweekly 40-minute sessions facilitated by a psychomotor therapist in a pedagogical partnership with the preschool teacher. Sessions are implemented outdoors. All sessions are framed in a context of freedom and self and mutual bodily resonance, according to the following structure: First, children are invited to engage in exercise play activities. Second, children engage in ludic relaxation proposals. Finally, children are asked to reflect on their bodily experiences and express themselves through different expressive mediators. Preschool teachers also participate in a 25-hour training focused on the underlying principles of OUT to In and participate in 20 body-oriented biweekly 20-minute relaxation sessions, facilitated by a psychomotor therapist. | Behavioural | OUT to IN Group |
Primary outcome
Emotion Understanding
Time frame: 10 weeks
Will be assessed through three tasks developed by the Focus on Emotions Group (focusonemotions.nl): emotion discrimination (children are asked to place six cards, whereby they could choose between two categories happy versus unhappy faces, and angry versus sad faces cards), identification (children are asked to point to the facial expressions according to the emotion words instructed by the experimenter), and emotion attribution in a situational context (children are presented with eight illustrated emotion-evoking vignettes, designed to evoke happiness, anger, fear and sadness, and asked how the protagonist is feeling by pointing the facial expression and verbally identifying the emotion).
Self Regulation
Time frame: 10 weeks
Self-regulation is obtained through the the Day and Night task (DN), the Head Toes Knees and Shoulders task (HTKD) and the composite scale Externalizing Behaviors from the Strengths and Difficulties Questionnaire. In the DN task whenever the child sees a black card, must say "day", whenever the child sees a white card, must say "night". In the HTKS task whenever the child is asked to touch the feet, must touch the head and vice versa, when the child is asked to touch the shoulders, must touch the knees and vice versa. Externalizing behaviors is obtained through a composite scale which comprises two SDQ scales: behavior problems and hyperactivity. Caregivers are asked to rate their children's behavior in a 3-point likert scale, from 1 (not true) to 3 (certainly true).
Relationship skills
Time frame: 10 weeks
Empathy, Cooperation are Sociability are measured through the Study on Social and Emotional Skills Questionnaire (SSES), a caregivers and teacher report questionnaire. Caregivers and teachers were asked to fill in the Empathy (e.g. He/she can feel how others are feeling; He/she understands what others want), Cooperation (e.g., He/she works well with others; he/she likes to help others), and Sociability subscales (e.g., He/she has many friends; He/she makes friends easily) in a 5-point likert scale from one (completely disagree) to five (completely agree). Emotion communication is obtained through the Emotion Vocabulary Questionnaire, a caregiver-report which assesses whether children know and use emotion and/or mental state words, in a 2-point likert scale from 1 (no) to 2 (yes). The EVQ includes either basis emotions (e.g., happy, angry), complex emotions (e.g., jealous, disappointed), and mental state words (e.g. thinking, dreaming).
Interoceptive Accuracy
Time frame: 10 weeks
Interoceptive accuracy is measured through the Jumping Jack Paradigm (JJP). In the JJP task the child is first asked to sit in a chair looking at a calm screen for 3 minutes. Then examiner assesses his/her pulse to count the heart rate. Then the child is asked to choose one of the four circles, with different sizes that he/she believes it is equivalent to the heart rate. Then the child is asked to perform jumping jacks for 20 seconds. After the jumping jacks, the examiner measures her/his hear rate and asks the child to again choose one of the four circles that corresponds to his/her heart rate.
Motor Competence.
Time frame: 10 weeks
Motor Competence is assessed through the Test of Gross Motor Development-Second Edition (TGMD-2). Simple and playful exercises (throwing a ball, jumping, etc.) are performed to assess locomotion (running; galloping; hopping; leaping; jumping and sliding) and object control skills (striking; dribbling; catching; kicking; throwing and rolling). Each children performs every activity for two trials.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OUT to IN in people with Children With Typical Development, run by University of Évora at 1 site in Portugal.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Understanding (time frame: 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2023.