Social-emotional CompetenceNCT05729815
Body-oriented Interventions on Preschoolers' Social-emotional Competence
A study testing Relaxation, Loose parts play and Combined in people with Social-emotional Competence, run by University of Évora at 1 site in Portugal.
Trial summary
Experimental study with 4 groups (3 experimental and 1 control). Examine the effects of 3 body-oriented intervention programs on preschoolers' social-emotional competence. Intervention programs focused on relaxation, loose parts play and combined loose parts play and relaxation, for 12 weeks with 2 30-min sessions per… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Social-emotional Competence
- What is being tested?
- Relaxation, Loose parts play and Combined
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2022to 9 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
- participants' age between 3 and 6 years
- do not have participated in a similar intervention program within the last 6 months
- do not have a physical condition that can affect the participation in the program.
Who cannot join
- participants' age less than 3 and under 6 years
- have participated in a similar intervention program within the last 6 months
- have a physical condition that can affect the participation in the program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Three Body-oriented Intervention Programs on Preschoolers' Social-emotional Competence
Experimental study with 4 groups (3 experimental and 1 control). Examine the effects of 3 body-oriented intervention programs on preschoolers' social-emotional competence.
Intervention programs focused on relaxation, loose parts play and combined loose parts play and relaxation, for 12 weeks with 2 30-min sessions per week.
Read the detailed description
To examine the chronic effects of the intervention programs, instruments were collected at baseline (pretest) and at the end of the 12-week period (post-test). To measure the acute effects, salivary cortisol was measured at the beginning and end of the 1st and the 24th sessions.
- Conditions
- Social-emotional Competence
- Being tested
- Relaxation, Loose parts play, Combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxationOther
Sessions focused on relaxations activities (Jacques Choque Method).
Loose parts playOther
Loose parts play-based sessions, with open-ended materials.
CombinedOther
Sessions focused on loose parts play and relaxation activities.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation group | Experimental | Relaxation program sessions had 3 phases: initial dialogue (2 min); a main section (25 min); final ritual (3 min). During the main section, participants listened and observed the therapist, who described and demonstrated all the exercises of the session, which were focused on Jacques Choque Method (Choque, 1994). Receives: Other: Relaxation |
| Loose parts play group | Experimental | Loose Parts Play program sessions had 3 phases: initial dialogue (2 min); main section (25 min); final ritual (3 min). During the main section, participants were allowed to play freely with any materials (loose parts) available in the playground. Receives: Other: Loose parts play |
| Combined group | Experimental | In the combined program, the sessions had 4 phases: initial dialogue (3 min); loose parts play moment (20 min); relaxation exercises moment (5 min); final ritual (2 min). Receives: Other: Combined |
| Control group | No intervention | No intervention. Maintained their usual routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotion discrimination
Emotion discrimination was measured through the Emotion-discrimination Task. This measurement consists in two performance tasks of increasing difficulty. In the task 1 (neutral condition) children were tested on their ability to discriminate between cars and flowers, and faces with hats versus faces with glasses. This neutral condition is not scored, since is used to check if children understood how to sort different cards. In task 2, children had a sheet in front of them with a sample drawing of one category in the top left corner (e.g. an angry face) and a drawing of the other category in the top right corner (e.g. a sad face). Then, children have six cards (with the same emotion) and one by one they have to place each card in the correct category after a demonstration. The cards that were placed correctly were counted with 1 point, with a maximum of 3 points.
Measured: 1 and 12 weeks
Change in Emotion identification
Emotion identification was measured through the Emotion-identification Task. The task consists of eight drawings of facial emotion expressions, two for each emotion (happiness, sadness, fear, and anger). Then the researcher show two sheets with four drawings of facial emotion expressions on each sheet and ask to the children: "Who looks happy?", and children have to point to the drawing with the correct facial expression. Next, the researcher ask if "Is there anybody else who looks happy?". This procedure is repeated for anger, sadness, and fear. The number of emotions correctly identified was recorded, with a maximum score of 2 per emotion.
Measured: 1 and 12 weeks
Change in Emotion recognition
Emotion recognition was measured thought the subscale Others' Emotion Recognition (6 items) of the Portuguese version of the Emotion Expression Questionnaire. This Subscale indicates the extent to which the child can recognise the parents' and others' emotions. Parents can rate to what degree each item is true on a 5-point scale (0=(almost) never, 1=rarely, 2=sometimes, 3=often, 4=(almost) always).
Measured: 1 and 12 weeks
Change in Positive and negative emotion expression
Positive emotion expression, and negative emotion expression was measured through the Negative Emotion Expression subscale (8 items) and Positive Emotion Expression subscale (6 items) from the EEQ. Parents scored on a 5-point scale (0=(almost) never, 1=rarely, 2=sometimes, 3=often, 4=(almost) always), the frequency, intensity, and duration of child's expressions of negative emotions (e.g., anger, sadness), and positive emotions (e.g., happiness, joy). The extent to which the child can calm down from the emotional episode was also measured (1=easy; 3= difficult).
Measured: 1 and 12 weeks
Change in Self-regulation
Self-regulation was measured through the Portuguese version of Head-Toes-Knees-Shoulders Task (HTKS). Using no materials, the HTKS has three sections with up to four paired behavioral rules: "touch your head" and "touch your toes"; "touch your shoulders" and "touch your knees". Child first respond naturally, but then had to perform the opposite of a dominant response (e.g., touch your head when the interviewer says "touch your toes"). This task includes three phases (each with 10 trials), and for each trial, the child received a score of 0 (incorrect), 1 (self-correct), or 2 (correct).
Measured: 1 and 12 weeks
Change in Stress regulation
Stress regulation was measured through cortisol levels (mcg/dL) was quantified in saliva samples collected at the same time and in the same place where the interventions occurred, before and after the 1st and 24th sessions. Samples were collected directly from each child's mouth, without stimulation, by passive droll during 5 minutes to a polyethylene tube.
Measured: 2 days
Change in Social competence
Social competence was obtained through the prosocial behaviors scale (5 items), and positive items from the peer problems scale (2 items) of the Portuguese version of Strengths and Difficulties Questionnaire (SDQ). Rated on a 3-point scale (0 = not true, 1 = somewhat true, and 2 = certainly true) the degree to which each item represented child's behavior in the last 3 months.
Measured: 1 and 12 weeks
Change in Externalizing problems
Externalizing problems was obtained also through the behavior problems scale (5 items), and hyperactivity scale (5 items) of the Strengths and Difficulties Questionnaire (SDQ). Rated on a 3-point scale (0 = not true, 1 = somewhat true, and 2 = certainly true) the degree to which each item represented child's behavior in the last 3 months.
Measured: 1 and 12 weeks
Change in Conflicts resolution
Conflicts resolution was measured through the conflict resolution strategies subscale (6 items) of the Portuguese version of Social Strategies Rating Scale (SSRS). Administered to teachers, which rated on a 5-point scale (1=never, 3=half of the time, 5=almost always) how often the child uses the social strategies during interactions with peers on preschool context.
Measured: 1 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start2 Jan 2022
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social-emotional CompetenceStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Dias Rodrigues, University of Évora
- Investigators
- Andreia D Rodrigues, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729815
- Sponsor's protocol ID
- BOICHI28122022
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2022
- Last updated
- 17 Feb 2023
- Results posted
- 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 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Body-oriented Intervention Programs on Preschoolers' Social-emotional Competence
- ClinicalTrials.gov ID
- NCT05729815
- Acronym / sponsor ID
- BOICHI28122022
- Conditions
- Social-emotional Competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 15 Feb 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.
Experimental study with 4 groups (3 experimental and 1 control). Examine the effects of 3 body-oriented intervention programs on preschoolers' social-emotional competence.
Intervention programs focused on relaxation, loose parts play and combined loose parts play and relaxation, for 12 weeks with 2 30-min sessions per week.
Detailed description
To examine the chronic effects of the intervention programs, instruments were collected at baseline (pretest) and at the end of the 12-week period (post-test). To measure the acute effects, salivary cortisol was measured at the beginning and end of the 1st and the 24th sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Relaxation group | Experimental | Other: RelaxationRelaxation program sessions had 3 phases: initial dialogue (2 min); a main section (25 min); final ritual (3 min). During the main section, participants listened and observed the therapist, who described and demonstrated all the exercises of the session, which were focused on Jacques Choque Method (Choque, 1994). |
| Loose parts play group | Experimental | Other: Loose parts playLoose Parts Play program sessions had 3 phases: initial dialogue (2 min); main section (25 min); final ritual (3 min). During the main section, participants were allowed to play freely with any materials (loose parts) available in the playground. |
| Combined group | Experimental | Other: CombinedIn the combined program, the sessions had 4 phases: initial dialogue (3 min); loose parts play moment (20 min); relaxation exercises moment (5 min); final ritual (2 min). |
| Control group | No intervention | –No intervention. Maintained their usual routines. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- participants' age between 3 and 6 years
- do not have participated in a similar intervention program within the last 6 months
- do not have a physical condition that can affect the participation in the program.
Key exclusion criteria (3 listed)
- participants' age less than 3 and under 6 years
- have participated in a similar intervention program within the last 6 months
- have a physical condition that can affect the participation in the program.
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 |
|---|---|---|
| RelaxationSessions focused on relaxations activities (Jacques Choque Method). | Other | Relaxation group |
| Loose parts playLoose parts play-based sessions, with open-ended materials. | Other | Loose parts play group |
| CombinedSessions focused on loose parts play and relaxation activities. | Other | Combined group |
Primary outcome
Change in Emotion discrimination
Time frame: 1 and 12 weeks
Emotion discrimination was measured through the Emotion-discrimination Task. This measurement consists in two performance tasks of increasing difficulty. In the task 1 (neutral condition) children were tested on their ability to discriminate between cars and flowers, and faces with hats versus faces with glasses. This neutral condition is not scored, since is used to check if children understood how to sort different cards. In task 2, children had a sheet in front of them with a sample drawing of one category in the top left corner (e.g. an angry face) and a drawing of the other category in the top right corner (e.g. a sad face). Then, children have six cards (with the same emotion) and one by one they have to place each card in the correct category after a demonstration. The cards that were placed correctly were counted with 1 point, with a maximum of 3 points.
Change in Emotion identification
Time frame: 1 and 12 weeks
Emotion identification was measured through the Emotion-identification Task. The task consists of eight drawings of facial emotion expressions, two for each emotion (happiness, sadness, fear, and anger). Then the researcher show two sheets with four drawings of facial emotion expressions on each sheet and ask to the children: "Who looks happy?", and children have to point to the drawing with the correct facial expression. Next, the researcher ask if "Is there anybody else who looks happy?". This procedure is repeated for anger, sadness, and fear. The number of emotions correctly identified was recorded, with a maximum score of 2 per emotion.
Change in Emotion recognition
Time frame: 1 and 12 weeks
Emotion recognition was measured thought the subscale Others' Emotion Recognition (6 items) of the Portuguese version of the Emotion Expression Questionnaire. This Subscale indicates the extent to which the child can recognise the parents' and others' emotions. Parents can rate to what degree each item is true on a 5-point scale (0=(almost) never, 1=rarely, 2=sometimes, 3=often, 4=(almost) always).
Change in Positive and negative emotion expression
Time frame: 1 and 12 weeks
Positive emotion expression, and negative emotion expression was measured through the Negative Emotion Expression subscale (8 items) and Positive Emotion Expression subscale (6 items) from the EEQ. Parents scored on a 5-point scale (0=(almost) never, 1=rarely, 2=sometimes, 3=often, 4=(almost) always), the frequency, intensity, and duration of child's expressions of negative emotions (e.g., anger, sadness), and positive emotions (e.g., happiness, joy). The extent to which the child can calm down from the emotional episode was also measured (1=easy; 3= difficult).
Change in Self-regulation
Time frame: 1 and 12 weeks
Self-regulation was measured through the Portuguese version of Head-Toes-Knees-Shoulders Task (HTKS). Using no materials, the HTKS has three sections with up to four paired behavioral rules: "touch your head" and "touch your toes"; "touch your shoulders" and "touch your knees". Child first respond naturally, but then had to perform the opposite of a dominant response (e.g., touch your head when the interviewer says "touch your toes"). This task includes three phases (each with 10 trials), and for each trial, the child received a score of 0 (incorrect), 1 (self-correct), or 2 (correct).
Change in Stress regulation
Time frame: 2 days
Stress regulation was measured through cortisol levels (mcg/dL) was quantified in saliva samples collected at the same time and in the same place where the interventions occurred, before and after the 1st and 24th sessions. Samples were collected directly from each child's mouth, without stimulation, by passive droll during 5 minutes to a polyethylene tube.
Change in Social competence
Time frame: 1 and 12 weeks
Social competence was obtained through the prosocial behaviors scale (5 items), and positive items from the peer problems scale (2 items) of the Portuguese version of Strengths and Difficulties Questionnaire (SDQ). Rated on a 3-point scale (0 = not true, 1 = somewhat true, and 2 = certainly true) the degree to which each item represented child's behavior in the last 3 months.
Change in Externalizing problems
Time frame: 1 and 12 weeks
Externalizing problems was obtained also through the behavior problems scale (5 items), and hyperactivity scale (5 items) of the Strengths and Difficulties Questionnaire (SDQ). Rated on a 3-point scale (0 = not true, 1 = somewhat true, and 2 = certainly true) the degree to which each item represented child's behavior in the last 3 months.
Change in Conflicts resolution
Time frame: 1 and 12 weeks
Conflicts resolution was measured through the conflict resolution strategies subscale (6 items) of the Portuguese version of Social Strategies Rating Scale (SSRS). Administered to teachers, which rated on a 5-point scale (1=never, 3=half of the time, 5=almost always) how often the child uses the social strategies during interactions with peers on preschool context.
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 17 Feb 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.
Andreia D Rodrigues principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation, Loose parts play and Combined in people with Social-emotional Competence, 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 3 inclusion and 3 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 17 Feb 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?
Change in Emotion discrimination (time frame: 1 and 12 weeks). The study lists 9 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 17 Feb 2023.