Healthy Clinical Trial
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. 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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 13 Years |
Eligibility | Inclusion Criteria: All primary school children Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University | Leiden | South-Holland |
Lead Sponsor | Collaborator |
---|---|
Universiteit Leiden |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anxiety and emotional problems | The Youth Anxiety Measure for the Diagnostic and Statistical Manual of Mental Disorders (YAM-5) is a self- and parent-report questionnaire to assess anxiety disorder symptoms in children and adolescents. Part one, used in this study, consists of 28 items and measures the 5 major anxiety disorders including separation anxiety disorder, selective mutism, social anxiety disorder, panic disorder, and generalized anxiety disorder. The five subscales consist of four to seven items using a 4-point Likert scale (ranging from 0 = ''never'' to 3 = 'always''. Higher scores indicate higher levels of anxiety. A validation study demonstrated that the measure was easy to complete by youngsters, support was found for the psychometric qualities of the measure: that is, the internal consistency was good for both parts, as well as for most of the subscales, the parent-child agreement appeared satisfactory, and there was also evidence for the validity of the scale. | Up to 11 months | |
Other | Classroom Peer Context Questionnaire (CPCQ) | The Classroom Peer Context Questionnaire (CPCQ) is a self-report questionnaire that can be used to assess the self-perceived peer context in the classroom. The questionnaire consists of 20 items belonging to 5 scales; comfort, cooperation, conflict, cohesion and isolation.Confirmatory factor analyses supports these 5 dimensions. Good reliability, validity, and stability for each dimension has been demonstrated. | Up to 11 months | |
Primary | 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 | 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. | Up to 11 months |
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