NCT06019429

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.

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

August 1, 2023

Last Update Submit

October 5, 2023

Conditions

Keywords

prosocial behavioranxietyself esteemclassroom peer contextattention deficit hyperactivity disorder

Outcome Measures

Primary Outcomes (1)

  • Prosocial behavior

    The Strengths and Difficulties Questionnaire (SDQ) is a self-report and third-party informant (parent and teacher) screening instrument for psychosocial functioning of children and adolescents (Goodman, 1997); Dutch version (Widenfelt, Goedhart, Treffers, \& Goodman, 2003). For 8 to 13 year old participants, both the self-report and parent version is used. For 4-7 year old participants only the parent version is used. The SDQ is comprised of five subscales: (a) emotional symptoms, (b) conduct problems, (c) hyperactivity/ inattention, (d) peer relationship problems, and (e) prosocial behavior. All subscales consist of five items using a 3-point Likert scale (ranging from 0 = ''not true'' to 2 = ''very true'' The SDQ is a reliable and valid screener of psychological difficulties across social-emotional domains (Muris, Meesters, \& Van den Berg, 2003; Van Rooy, Veenstra, Clench-Aas, 2008).

    Up to 11 months

Secondary Outcomes (1)

  • Self-esteem

    Up to 11 months

Other Outcomes (2)

  • Anxiety and emotional problems

    Up to 11 months

  • Classroom Peer Context Questionnaire (CPCQ)

    Up to 11 months

Study Arms (3)

HiRO plus judo

EXPERIMENTAL

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

Behavioral: HiRO +judo

HiRO

EXPERIMENTAL

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

Behavioral: HiRO

School as usual

ACTIVE COMPARATOR

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

Behavioral: School as usual

Interventions

HiROBEHAVIORAL

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.

HiRO
HiRO +judoBEHAVIORAL

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 plus judo
School as usualBEHAVIORAL

Any amount of classes offered to promote social-emotional development

School as usual

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All primary school children

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University

Leiden, South Holland, 1500, Netherlands

RECRUITING

MeSH Terms

Conditions

AltruismAnxiety DisordersAttention Deficit Disorder with Hyperactivity

Interventions

Schools

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

  • Bianca Boyer, PhD

    Leiden University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Rongen, MSc

CONTACT

Marije Kuijper, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Schools who partake in this study decide the type of program they will receive: HiRO without judo, HiRO with judo, school-as-usual
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 31, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations