NCT06884020

Brief Summary

This project aims to investigate children's difficulties with emotional regulation in the school environment, to develop an early intervention programme for preschool children (5 years old) and their families, and to explore the relationship between emotional regulation and various risk and protective factors, including variables such as gender, age, socio-economic context, parenting styles, social skills and academic performance. Data analysis will facilitate the adaptation of the intervention to the needs of the school population. Methodologically, the project will adopt a quasi-experimental design with control and experimental groups, using a convenience sample drawn from two schools in Tarragona. This design will make it possible to compare the effectiveness of the programme in improving children's emotional skills.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 19, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 27, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

emotional regulationemotional education programpre-school ageSchool environmentchildhoodschool-age

Outcome Measures

Primary Outcomes (2)

  • Emotional Self-Control (BASC-3 Scores)

    Assessment of emotional self-control using the BASC-3, completed by parents/guardians and school staff. Higher scores indicate lower emotional self-control and greater difficulty in managing emotions effectively. BASC-3 scores range from 0 to 120, where higher scores reflect greater difficulties in emotional self-control.

    Baseline (Week 5), post-intervention (Week 15 and Week 45).

  • Emotional Regulation (BRIEF-P Scores)

    Assessment of emotional regulation using the BRIEF-P, completed by parents/guardians and school staff. Higher scores indicate greater emotional dysregulation, reflecting difficulties in managing and modulating emotional responses effectively. BRIEF-P scores range from 30 to 90, where higher scores reflect greater emotional dysregulation.

    Baseline (Week 5), post-intervention (Week 15 and Week 45).

Secondary Outcomes (1)

  • Behavioral and Emotional Problems (BASC-3 Scores)

    Baseline (Week 5 of the school year) Post-intervention (Week 15 and Week 45 of the school year) Follow-up (Up to 1 year after study completion)

Study Arms (2)

Intervention group

EXPERIMENTAL

Group 1: Pre-assessment: Assessment of emotional regulation, psychological problems and executive functioning through behavioural tests completed by parents and teachers. Intervention: Participants receive a weekly emotional education program (8 sessions of 45 minutes each, plus an additional 1-hour session with the family in the middle of the program). Intervention facilitator: A doctoral student (psychologist and teacher) conducts the sessions. Participants: The program is offered to the entire group of 5-year-old preschool children (I5), regardless of their pre-assessment results, with the informed consent of parents or guardians. Location: The intervention will be delivered in the early childhood education classroom. Post-intervention evaluation: Conducted both in the short term (immediately after the end of the program) and in the medium to long term (4-5 months after the end of the program).

Behavioral: EMOTIONAL REGULATION PROGRAMME

Control group

NO INTERVENTION

Group 2: Pre-assessment: Similar to group 1, assessment of emotional regulation, psychological problems and executive functioning through behavioural tests completed by parents and teachers. Intervention: This group will not receive the emotional education program during the initial phase of the study. Participants: The entire group of 5-year-old preschool children (I5), with the informed consent of parents or guardians. Post-assessment: Short-term evaluation: Conducted at the same time as Group 1, immediately after the end of the intervention program for the experimental group. Medium to long-term evaluation: Conducted at the same time as Group 1, 4-5 months after the end of the intervention programme for the experimental group. The control group will not receive the intervention until after this evaluation. Intervention facilitator: A doctoral student (psychologist and trained teacher). Location: The intervention will be delivered in the early childhood education classroom

Interventions

This programme works on early identification and implementation of strategies to improve self-awareness and facilitate children's emotions. This intervention is designed to be delivered in the educational setting by the tutor in the form of a learning situation with 8 sessions plus 1 family session. The topics covered are: * Embarking on an emotional journey * Recognising our emotions * Emotions have a voice * Identifying different emotions * How do I make decisions? * Emotion, action, and consequence * Learning to self-regulate * Celebrating our learning

Intervention group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Student of Early Childhood Education

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Universitat Rovira i Virgili

Tarragona, Tarragona, 43007, Spain

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Josefa Dra. Canals, Full Professor

    University Rovira i Virgili

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: There are two groups in this project. One group will receive the emotional education intervention first, and when this group and the control group (who did not receive the intervention) complete the post-intervention assessment, the control group will also receive the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Educational psychologist - Teacher

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 19, 2025

Study Start

January 12, 2024

Primary Completion

April 23, 2024

Study Completion

June 30, 2025

Last Updated

March 19, 2025

Record last verified: 2025-02

Locations