NCT06131229

Brief Summary

The aim of this paper is twofold: on the one hand, to test the effectiveness of a structured emotional education program in second, third and fourth grade primary school students and, on the other hand, to test the differential effect of such a program in relation to an incidental tutorial action focused on the ordinary school curriculum. A randomized controlled trial is proposed in Lauro Ikastola with three experimental groups (second, third and fourth of primary education) and three active control groups (one for each of the three courses) with pretest and posttest and with the duration of a school year.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

October 2, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

November 9, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

Emotional education, tutorial action, primary school

Outcome Measures

Primary Outcomes (2)

  • Change in emotional intelligence

    Bar-On EQ-I:YV. BarOn Emotional Intelligence Inventory: youth version. Spanish version Age of application: 7 to 18 years old. The inventory is composed of 60 items to assess emotional intelligence and its different socioemotional components by means of several scales (Intrapersonal, Interpersonal, Adaptability, Stress Management and General Mood), in addition to providing an index of total Emotional Intelligence. It has two response control scales (Inconsistencies and Positive Impression), can be applied in individual or group format and lasts approximately 20-25 minutes.

    Baseline 1 week before treatment, Post-treatment 8 months from baseline

  • Change in self-concept

    BYI-2, Beck Inventories for Children and Adolescents-2. Spanish adaptation. The Beck Child and Adolescent Inventories-2 (BYI-2) are five questionnaires published by Pearson and aimed at the assessment of depression, anxiety, anger, disruptive behavior, and self-concept in children and adolescents aged 7 to 18 years and 11 months. They are short, self-administered questionnaires that can be used separately or combined, and are simple and quick to administer. Each inventory consists of 20 statements, formulated in the first person, about thoughts, feelings or behaviors related to emotional and social disorders, to be answered with a frequency scale of four options (Never = 0; Sometimes = 1; Often = 2; Always = 3). The application time is between 5 and 10 minutes for each inventory. In the present case, we will only use the Beck Self-Concept Inventory for Children and Adolescents (BSCI-Y).

    Baseline 1 week before treatment, Post-treatment 8 months from baseline

Secondary Outcomes (4)

  • Change in in emotional problems: anxiety and depression.

    Baseline 1 week before treatment, Post-treatment 8 months from baseline

  • Change in behavioral problems: anger management, conduct problems and hyperactivity-impulsivity.

    Baseline 1 week before treatment, Post-treatment 8 months from baseline

  • Change in contextual problems: problems with peers.

    Baseline 1 week before treatment, Post-treatment 8 months from baseline

  • Change in socialization

    Baseline 1 week before treatment, Post-treatment 8 months from baseline

Study Arms (2)

Structured emotional education program (PEE)

EXPERIMENTAL

A tutorial action focused on a structured program of emotional education with 20 activities divided into 5 blocks with specific objectives. The program involves 34 hours of group work, one per week in the tutoring hour, throughout the 23-24 school year.

Behavioral: Structured emotional education program (PEE)

Incidental tutorial action based on the school's regular curriculum (PCO)

ACTIVE COMPARATOR

An incidental tutorial action focused on the ordinary school curriculum for the 23-24 school year.

Behavioral: Incidental tutorial action based on the school's regular curriculum (PCO)

Interventions

The principal investigator, together with the class-tutor of the experimental groups, conducts the 20 activities of which the program is composed during the hour dedicated to tutorial action. The sessions are held at Lauro School on Monday mornings in the respective classrooms, with the possibility of using the courtyard and other multipurpose rooms if the activities so require. Each session lasts one hour and is held throughout the school year 23-24.

Structured emotional education program (PEE)

One hour tutorial action per week according to the regular school curriculum. This curriculum contemplates the incidental approach to the problems that arise in daily life and the work with the KIVA program.

Incidental tutorial action based on the school's regular curriculum (PCO)

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age from 6 to 10 years.
  • To be enrolled in Lauro School.
  • To be in second, third or fourth grade of elementary school.

You may not qualify if:

  • Any physical or psychological condition incompatible with the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oihana Sagasti Arrien

Sondika, Bizkaia, 48150, Spain

Location

MeSH Terms

Interventions

Urination

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • OIHANA SAGASTI ARRIEN, PhDcandidate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: A randomized controlled trial of three experimental groups and three control groups is proposed, with pretest, posttest.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D candidate in health psychology

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

October 2, 2023

Primary Completion

June 21, 2024

Study Completion

September 20, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations