NCT05729815

Brief 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 week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

December 28, 2022

Last Update Submit

February 15, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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).

    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).

    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).

    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.

    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.

    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.

    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.

    1 and 12 weeks

Study Arms (4)

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).

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.

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).

Other: Combined

Control group

NO INTERVENTION

No intervention. Maintained their usual routines.

Interventions

Sessions focused on relaxations activities (Jacques Choque Method).

Relaxation group

Loose parts play-based sessions, with open-ended materials.

Loose parts play group

Sessions focused on loose parts play and relaxation activities.

Combined group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andreia Dias Rodrigues

Evora, 7000-847, Portugal

Location

Study Officials

  • Andreia D Rodrigues

    PhD student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2022

First Posted

February 15, 2023

Study Start

January 2, 2022

Primary Completion

June 9, 2022

Study Completion

June 9, 2022

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations