Prosocial BehaviorNCT06019429
Promoting Social-emotional Development and Self-esteem in Primary School Students
A study testing HiRO, HiRO +judo and School as usual in people with Prosocial Behavior and Anxiety Disorders and Symptoms, run by Universiteit Leiden at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosocial Behavior, Anxiety Disorders and Symptoms, Attention Deficit Hyperactivity Disorder
- What is being tested?
- HiRO, HiRO +judo and School as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All primary school children
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University
Leiden, South Holland, 1500
Bianca Boyer, PhD
About this study
Official title: A Non-randomized Trial Testing the Efficiency of a Universal School-based Intervention Promoting Social-emotional Development and Self-esteem in Primary School Students
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.
Read more
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.
Read the 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
- Being tested
- HiRO, HiRO +judo, School as usual
- Keywords
- prosocial behavior, anxiety, self esteem, classroom peer context, attention deficit hyperactivity disorder
- Medical subject headings
- Altruism, Anxiety Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiROBehavioural
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 +judoBehavioural
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.
School as usualBehavioural
Any amount of classes offered to promote social-emotional development
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HiRO +judo |
| HiRO | Experimental | In this condition, students receive weekly classes aimed to promote social-emotional development. Receives: 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. Receives: Behavioral: School as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 11 months
Secondary outcomes (1)
Self-esteem
The child version of the Rosenberg's Self Esteem Scale (CRSES; Wood, Griffin, Barton, Sandercock, 2021) has been developed to assess self esteem in children aged 7-12 years. The CRSES comprises five positive and five negative statements each with four possible responses scored from one to four. Scoring is reversed for responses to negative items so that a higher score indicates better overall self esteem. A validation study has tested the internal consistency, convergent validity, and factor structure of the CRSES. A unidimensional factor structure provided an adequate fit, and total scores were related to life satisfaction. As the sample also consists of children aged 4-7 years of age, a 10-item parent version of the Rosenberg Self Esteem Scale (RSES) was developed that will be validated using the pre-treatment assessment of this trial.
Measured: Up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosocial BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Schools who partake in this study decide the type of program they will receive: HiRO without judo, HiRO with judo, school-as-usual
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca Boyer, Universiteit Leiden
- Investigators
- Bianca Boyer, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019429
- Sponsor's protocol ID
- 158765324
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Trial Testing the Efficiency of a Universal School-based Intervention Promoting Social-emotional Development and Self-esteem in Primary School Students
- ClinicalTrials.gov ID
- NCT06019429
- Acronym / sponsor ID
- 158765324
- Conditions
- Prosocial Behavior, Anxiety Disorders and Symptoms, Attention Deficit Hyperactivity Disorder, Healthy, Emotional Problem, Self Esteem
- Keywords
- prosocial behavior, anxiety, self esteem, classroom peer context, attention deficit hyperactivity disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Schools who partake in this study decide the type of program they will receive: HiRO without judo, HiRO with judo, school-as-usual
| Arm | Type | Receives |
|---|---|---|
| HiRO plus judo | Experimental | Behavioral: HiRO +judoIn this condition, students receive weekly classes aimed to promote social-emotional development. In addition, they will receive 6 judo classes. |
| HiRO | Experimental | Behavioral: HiROIn this condition, students receive weekly classes aimed to promote social-emotional development. |
| School as usual | Active comparator | Behavioral: School as usualIn this condition, students receive any amount of classes organized by their school to promote social-emotional development. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All primary school children
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HiROHiRO 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. | Behavioural | HiRO |
| HiRO +judoIn 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. | Behavioural | HiRO plus judo |
| School as usualAny amount of classes offered to promote social-emotional development | Behavioural | School as usual |
Primary outcome
Prosocial behavior
Time frame: Up to 11 months
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).
1 secondary outcome
Self-esteem
Time frame: Up to 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bianca Boyer, PhD principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiRO, HiRO +judo and School as usual in people with Prosocial Behavior and Anxiety Disorders and Symptoms, run by Universiteit Leiden at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Rongen, MSc (0031611740033, anne@hiro.school), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosocial behavior (time frame: Up to 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.