Promoting Social-emotional Development and Self-esteem in Primary School Students

NCT ID: NCT06019429

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-01

Brief Summary

This is an effectiveness study into a program ("HiRO") for improving social-emotional development, self esteem and the perceived classroom peer context in primary school students (aged 4-13 years). To this end, schools are divided into three conditions based on the choice of the schools (non-randomized): 1) School As Usual, 2) HiRo without judo classes, and 3) HiRO with judo classes. In all participating schools, social-emotional skills, self-image, emotional problems, and classroom peer context are measured three times by means of questionnaires (both self-report and parent-report).

In The Netherlands primary schools are obliged to offer students training in social-emotional development. Schools can decide to develop their own program or make use of existing programs delivered by third parties, such as HiRO. In this study HiRO is compared to school as usual, that is, any other program offered to promote social -emotional development than HiRO.

The main questions to answer are:

• What is the effect of HiRO on the development of prosocial behavior?
• What is the effect of HiRO on the development of emotional problems (depression, anxiety)?
• What is the effect of HiRO on self-esteem?
• What is the effect of HiRO on perceived peer context?

Researchers will compare HiRO with and without judo to "school as usual" testing the following hypotheses:

HiRO will result in increased prosocial skills as compared to school as usual. HiRO will result in decreased emotional problems as compared to school as usual.

HiRO will result in increased self-esteem as compared to school as usual. HiRO will result in improved perceived peer context as compared to school as usual.

Detailed Description

This is a non-randomized trial, with a 3 (time) x 3 (condition) within-between subjects design.

All children (and their parents) within the participating primary schools are asked to join this study. Independent of participation in this study, all children in these schools will receive the intervention as it is part of the curriculum focussing on the development of prosocial skills.

Schools will be called to ask if participants would like to participate in the study: schools choose in what condition participation is desired. In march/april 2023: schools share information letter with parents by email/in school app with a link to the informed consent. In june 2023: during end-of-the-year meetings with parents, teachers will approach parents that have not responded yet whether participation is approved. In addition, children in group 8 (with possible children of 12 years and older) will get information from teachers about the study and an information letter. Subsequently, children will be asked whether participation is approved. Assessements will take place in classrooms of the participating schools during school hours for children 8 years and older. For children younger than 8 years parent report will be used.

This study will obtain a data set with a hierarchical structure. The three observations are nested within students, students are nested within classrooms and classrooms are nested within schools. Therefore, a three-level growth model will be used. Lee and Hong (2021) provided sample size guidelines based on simulation studies for three-level growth models using Monte Carlo methods while considering various realistic ICC values at the three levels. The conservative estimation is made that only 10 out of 23 (average number of students per class) students per class participate in this study. Therefore the simulation results of Lee and Hong (2021) provided for 10 students per group are considered. Across all fixed effects and an intraclass correlation coeffcient at level 3 (schools) of .15, 2 out of 6 power rates were found to be below the .80 level, when 50 groups are included. With 100 groups included, all power rates were found to exceed .87. Based on these numbers, the aim is to include 75 groups in total, bringing the total number of participating students (again assuming 10 participants per group) to 10x75 = 750.

Multilevel regression analyses will be performed to evaluate the effect of HiRO on social-emotional development, self-esteem, and the perceived classroom peer context. Multilevel analyses is an intent-to-treat procedure that does not impute missing data but deals with incomplete data by assuming that the available data for a given subject are representative of that subject's deviation from the average trends across time. The level1 model includes the time variable, which captures within-person variation over time, in the level 2 model between person characteristics such an intervention condition are used to predict the slope estimates. In the level 3 model between group characteristics can be modeled.

Conditions

Prosocial Behavior; Anxiety Disorders and Symptoms; Attention Deficit Hyperactivity Disorder; Healthy; Emotional Problem; Self Esteem; Peer Group

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HiRO plus judo

In this condition, students receive weekly classes aimed to promote social-emotional development. In addition, they will receive 6 judo classes.

Group Type: EXPERIMENTAL

HiRO +judo

Intervention Type: BEHAVIORAL

In the condition HiRO with judo, students receive the same treatment as offered in the HiRO condition. In addition, they receive physical judo classes that are designed to translate the above-mentioned values to the behavioral level.

HiRO

In this condition, students receive weekly classes aimed to promote social-emotional development.

Group Type: EXPERIMENTAL

HiRO

Intervention Type: BEHAVIORAL

HiRO consists of weekly lessons. The lessons are aimed to promote social-emotional development. More specifically, lessons are designed to develop and enhance 1) trust, 2) collaboration, 3) respect, 4) self control, 5) resilience, 6) discipline, 7) joy. The annual program consists of four phases:

Phase 1 & 3: Fundamental phase (6 weeks) Engaging with the values through movement. In these phases, group formation and establishing behavioral expectations are central. In the Fundamental phase, one value is addressed school-wide each week. The entire school starts with trust and ends with discipline.

Phase 2 & 4: Theme weeks (12 lessons) A customized series of Experiential lessons for each class. Experiential learning is the guiding principle of the program, with a strong foundation based on the values upheld in judo. The learning cycle forms the basis for each experiential lesson within HiRO, and focusses on concrete experience, reflective observation, conceptualization, and practice.

School as usual

In this condition, students receive any amount of classes organized by their school to promote social-emotional development.

Group Type: ACTIVE_COMPARATOR

School as usual

Intervention Type: BEHAVIORAL

Any amount of classes offered to promote social-emotional development

Interventions

HiRO

HiRO consists of weekly lessons. The lessons are aimed to promote social-emotional development. More specifically, lessons are designed to develop and enhance 1) trust, 2) collaboration, 3) respect, 4) self control, 5) resilience, 6) discipline, 7) joy. The annual program consists of four phases:

Phase 1 & 3: Fundamental phase (6 weeks) Engaging with the values through movement. In these phases, group formation and establishing behavioral expectations are central. In the Fundamental phase, one value is addressed school-wide each week. The entire school starts with trust and ends with discipline.

Phase 2 & 4: Theme weeks (12 lessons) A customized series of Experiential lessons for each class. Experiential learning is the guiding principle of the program, with a strong foundation based on the values upheld in judo. The learning cycle forms the basis for each experiential lesson within HiRO, and focusses on concrete experience, reflective observation, conceptualization, and practice.

Intervention Type: BEHAVIORAL

HiRO +judo

In the condition HiRO with judo, students receive the same treatment as offered in the HiRO condition. In addition, they receive physical judo classes that are designed to translate the above-mentioned values to the behavioral level.

Intervention Type: BEHAVIORAL

School as usual

Any amount of classes offered to promote social-emotional development

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

All primary school children

Exclusion Criteria

None

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiteit Leiden

OTHER

Sponsor Role: lead

Responsible Party

Bianca Boyer

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bianca Boyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University

Locations

Leiden University

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Anne Rongen, MSc

Role: CONTACT

anne@hiro.school

0031611740033

Marije Kuijper, MSc

Role: CONTACT

marije@hiro.school

0031611105556

Facility Contacts

Bianca Boyer, PhD

Role: primary

Other Identifiers

158765324

Identifier Type: -

Identifier Source: org_study_id