Two Tutorial Action Programs, Incidental and Structured, on the General Welfare of Elementary School Students.

November 9, 2023 updated by: OIHANA SAGASTI ARRIEN

Emotional Education Program for the Promotion and Prevention of Mental Health in 2nd, 3rd and 4th Grade Primary School Students (ULERTUZ)

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.

Study Overview

Detailed Description

The implementation of emotional education in educational centers is increasingly necessary for the promotion of a complete state of physical, mental and social well-being in children throughout the entire educational stage, and especially in early stages of development.

The present work aims at a double verification. On the one hand, it is intended to test the effectiveness of a structured program of emotional education in second, third and fourth grade of primary education and, on the other hand, to test the differential effect of this program in relation to an incidental tutorial action based on the ordinary school curriculum. A randomized controlled trial is proposed in Lauro Ikastola with three experimental groups (second, third and fourth year 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.

The general objective of the proposal is the promotion of the emotional well-being of children in a particularly turbulent stage of the school cycle (2nd, 3rd and 4th grades of Primary Education) and the prevention of behavioral and/or emotional problems that may arise in later stages. The specific objectives to be achieved through the intervention in the priority population are the improvement in the following aspects: 1) Emotional intelligence; 2) Self-concept; 3) Socialization; 4) Emotional problems (depression and anxiety); 5) Behavioral problems (anger control, behavioral problems and impulsivity); and 6) Contextual problems (problems among peers). Additionally, the following two objectives are set as indirect results of the intervention in the agents involved: 5) to improve the emotional development of the parents whose children participate in the program; 6) to improve the emotional development of the tutors in charge of implementing the program.

The total sample is made up of 157 primary school students from Lauro Ikastola HLBHIP, a private school for infant, primary, secondary and high school education (municipality of Lujua, Vizcaya). From each of the three grades for which the program is intended (2nd, 3rd and 4th), two classes per grade will be selected by accessibility, which will be randomly assigned to the control group (CG) or the experimental group (GE). The emotional education program (ULERTUZ) will be applied to the experimental group and the control group will follow the academic curriculum provided by each school for each school year. The main measurement instruments will be the Adult Emotional Development Questionnaire (CDE-A), the Bar-On Emotional Intelligence Inventory EQ-I:YV, the Socialization Battery (BAS 1-2), the System for the Assessment of Children and Adolescents (SENA) and the Beck Inventory for Children and Adolescents-2 (BYI-2).

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bizkaia
      • Sondika, Bizkaia, Spain, 48150
        • Oihana Sagasti Arrien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any physical or psychological condition incompatible with the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured emotional education program (PEE)
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.
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.
Active Comparator: Incidental tutorial action based on the school's regular curriculum (PCO)
An incidental tutorial action focused on the ordinary school curriculum for the 23-24 school year.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in emotional intelligence
Time Frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
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
Time Frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in in emotional problems: anxiety and depression.
Time Frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
SENA. Child and Adolescent Assessment System (Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A. and del Barrio, V. 2015). The purpose of the SENA is the multi-source assessment of a broad spectrum of emotional and behavioral problems (depression, anxiety, hyperactivity and impulsivity, disruptive behavior, substance use, eating behavior problems, learning problems...), contextual problems (problems with family, school and peers), as well as areas of vulnerability (emotional regulation problems, isolation, rigidity...) and psychological resources (self-esteem, social integration and competence, emotional intelligence...). The age of application is from 3 to 18 years old and has 3 different levels depending on the age of the persons assessed .
Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in behavioral problems: anger management, conduct problems and hyperactivity-impulsivity.
Time Frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
SENA. Child and Adolescent Assessment System (Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A. and del Barrio, V. 2015). The purpose of the SENA is the multi-source assessment of a broad spectrum of emotional and behavioral problems (depression, anxiety, hyperactivity and impulsivity, disruptive behavior, substance use, eating behavior problems, learning problems...), contextual problems (problems with family, school and peers), as well as areas of vulnerability (emotional regulation problems, isolation, rigidity...) and psychological resources (self-esteem, social integration and competence, emotional intelligence...). The age of application is from 3 to 18 years old and has 3 different levels depending on the age of the persons assessed .
Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in contextual problems: problems with peers.
Time Frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
SENA. Child and Adolescent Assessment System (Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A. and del Barrio, V. 2015). The purpose of the SENA is the multi-source assessment of a broad spectrum of emotional and behavioral problems (depression, anxiety, hyperactivity and impulsivity, disruptive behavior, substance use, eating behavior problems, learning problems...), contextual problems (problems with family, school and peers), as well as areas of vulnerability (emotional regulation problems, isolation, rigidity...) and psychological resources (self-esteem, social integration and competence, emotional intelligence...). The age of application is from 3 to 18 years old and has 3 different levels depending on the age of the persons assessed .
Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in socialization
Time Frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
BAS. Socialization Battery (Silva and Martorell, 1983). Version for teachers (BAS-1) and version for parents (BAS-2). Age of application: 6 to 15 years old. These are rating scales in four facilitating dimensions of socialization (Leadership, Joviality, Social sensitivity and Respect-self-control), three disturbing ones (Aggressiveness-tertiality, Apathy-withdrawal and Anxiety-timidity) and a global scale of social adaptation or criterion-socialization. The BAS-1 (teacher compliance) has 118 items, and the BAS-2 (parent compliance) has 114 items.
Baseline 1 week before treatment, Post-treatment 8 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: OIHANA SAGASTI ARRIEN, PhDcandidate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

June 21, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • OSA-16054158C-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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