Clinical trial NCT06131229: Two Tutorial Action Programs, Incidental and Structured, on the General Welfare of Elementary School Students.
Official title: Emotional Education Program for the Promotion and Prevention of Mental Health in 2nd, 3rd and 4th Grade Primary School Students (ULERTUZ)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Emotional education, tutorial action, primary school
Lead sponsor: Oihana Sagasti
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de Educación a Distancia
First posted: 2023-11-14
Enrollment: 157
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A randomized controlled trial of three experimental groups and three control groups is proposed, with pretest, posttest.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in emotional intelligence
timeFrame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
measure: Change in self-concept
timeFrame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Secondary outcomes:
measure: Change in in emotional problems: anxiety and depression.
timeFrame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
measure: Change in behavioral problems: anger management, conduct problems and hyperactivity-impulsivity.
timeFrame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
measure: Change in contextual problems: problems with peers.
timeFrame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
measure: Change in socialization
timeFrame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Other outcomes:
Locations:
city: Sondika
country: Spain
facility: Oihana Sagasti Arrien
state: Bizkaia
Study officials:
name: OIHANA SAGASTI ARRIEN, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
References: