Bullying BehaviorNCT07261397
Nurse-Led ROOTS-Soft Skills Intervention for Bullying Prevention
A study testing Nurse-Led ROOTS Program and Soft Skills Training in people with Bullying Behavior and Emotional Regulation Difficulties, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effect of a nurse-led intervention combining the ROOTS program and soft skills training on emotional regulation and bullying prevention among high school students in Bandung, Indonesia. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Bullying Behavior, Emotional Regulation Difficulties, Adolescent Mental Health
- What is being tested?
- Nurse-Led ROOTS Program and Soft Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2025to 5 Oct 2025
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 14-18 years
- Enrolled in participating secondary schools
- Willing to provide assent, with parental/guardian consent
- Able to understand and communicate in the local language (e.g., Indonesian or English)
- Identified as having mild to moderate difficulties in emotional regulation or at risk for anxiety/depression based on school screening Exclusion Criteria
- Severe psychiatric conditions requiring immediate clinical intervention (e.g., psychosis, severe depression with suicidal intent)
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- Currently receiving structured psychological or psychiatric treatment for emotional regulation or mental health conditions
- Cognitive or developmental disabilities that would prevent meaningful participation in group activities
- Non-consent from parent/guardian or the participant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
SMA Al Marwah and MAN Kota Bandung
Bandung, West Java, 40184
About this study
Official title: The Effect of the Nurse-Led ROOTS Program and Soft Skills Training on Emotional Regulation to Prevent Bullying in High School Students in Bandung City: A Quasi-Experimental
This study aims to evaluate the effect of a nurse-led intervention combining the ROOTS program and soft skills training on emotional regulation and bullying prevention among high school students in Bandung, Indonesia. Bullying remains a major concern in schools and is closely linked to emotional difficulties, poor coping skills, and limited empathy. Strengthening students' emotional regulation is an evidence-based strategy to reduce aggressive behaviors and promote safer school environments.
In this study, trained school nurses will deliver an integrated intervention consisting of sessions on identifying emotions, managing stress, developing empathy, communicating effectively, and resolving conflicts. The program is designed to help students better understand their emotions, control impulsive reactions, and build positive relationships with peers. These skills are expected to reduce the risk of bullying-both as perpetrators and as victims.
Read more
The research uses a quasi-experimental design involving two high schools in Bandung. One school will receive the nurse-led intervention, while the comparison school will continue routine school activities. Students who meet inclusion criteria and provide consent/assent will participate in pre- and post-intervention assessments. The primary outcome is improvement in emotional regulation scores. Secondary outcomes include bullying behavior, empathy, and student perceptions of the school climate.
All activities will follow ethical guidelines, including confidentiality, voluntary participation, and the right to withdraw at any time. The study seeks to provide evidence on how nurses can contribute to mental health promotion in schools and support sustainable, school-based bullying prevention strategies.
Read the detailed description
This study investigates a structured, nurse-led intervention that integrates the ROOTS program with soft skills training to enhance emotional regulation as a strategy to prevent bullying among adolescents. The intervention consists of multiple structured sessions delivered over several weeks, focusing on emotional awareness, stress management, empathy development, communication strategies, and problem-solving skills. The program was adapted for Indonesian high school students and aligned with the role of school nurses in mental health promotion.
A quasi-experimental non-randomized design will be used. Two high schools in Bandung will participate: one serving as the intervention site and the other as the comparison site. Participants will be students in grades 10-11 who consent to join the study. Pre-intervention assessments will measure emotional regulation (primary outcome) and bullying behaviors, empathy, and school climate (secondary outcomes). After the intervention sessions are completed, the same measures will be reassessed.
The study aims to generate evidence on the feasibility and effectiveness of a nurse-led emotional and social skills program delivered in school settings. Findings are expected to inform future mental health strategies, support the integration of nurses into school-based preventive services, and contribute practical recommendations for bullying prevention policies.
- Being tested
- Nurse-Led ROOTS Program and Soft Skills Training
- Keywords
- Bullying Prevention, Emotional Regulation, Empathy, High School Students, Nurse-Led Intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led ROOTS Program and Soft Skills TrainingBehavioural
A structured, eight-week program delivered once per week (60-90 minutes/session) by the school nurse and supported by teachers. Core components include:
Program orientation and group norms
Peer leadership and assertive communication
Emotional awareness and labeling
Expression management and self-control
Cognitive reappraisal exercises
Empathy and perspective-taking
Peer-led positive values campaign
Reflection, feedback, and skill consolidation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive the Nurse-Led ROOTS Program combined with Soft Skills Training. This eight-week program, facilitated by the school nurse and a teacher, includes peer-led leadership activities, emotion regulation exercises, assertive communication, cognitive reappraisal, and empathy training to prevent bullying and improve emotional regulation. Receives: Behavioral: Nurse-Led ROOTS Program and Soft Skills Training |
| Control Group | No intervention | Participants in this arm will receive standard care provided at the school without additional psychological intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Regulation
Emotional regulation ability is measured using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA), a 10-item instrument rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher total scores indicating better overall emotional regulation ability. Changes in the total ERQ-CA score from pre-intervention (week 0) to post-intervention (week 8) are used to evaluate the extent to which the intervention improves participants' capacity to manage and express their emotions adaptively.
Measured: Pre-intervention (week 0) and post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullying 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Students are assigned to either the intervention group receiving the ROOTS and Soft Skills sessions or a control group receiving school-as-usual activities. The intervention lasts 8 weeks with pre- and post-assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iyus Yosep, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261397
- Sponsor's protocol ID
- NURS-202511.01
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The dataset contains sensitive mental health information from adolescents, and institutional policies prohibit the release of such de-identified data to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Nurse-Led ROOTS Program and Soft Skills Training on Emotional Regulation to Prevent Bullying in High School Students in Bandung City: A Quasi-Experimental
- ClinicalTrials.gov ID
- NCT07261397
- Acronym / sponsor ID
- NURS-202511.01
- Keywords
- Bullying Prevention, Emotional Regulation, Empathy, High School Students, Nurse-Led Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 3 Dec 2025 (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 study aims to evaluate the effect of a nurse-led intervention combining the ROOTS program and soft skills training on emotional regulation and bullying prevention among high school students in Bandung, Indonesia. Bullying remains a major concern in schools and is closely linked to emotional difficulties, poor coping skills, and limited empathy. Strengthening students' emotional regulation is an evidence-based strategy to reduce aggressive behaviors and promote safer school environments.
In this study, trained school nurses will deliver an integrated intervention consisting of sessions on identifying emotions, managing stress, developing empathy, communicating effectively, and resolving conflicts. The program is designed to help students better understand their emotions, control impulsive reactions, and build positive relationships with peers. These skills are expected to reduce the risk of bullying-both as perpetrators and as victims.
The research uses a quasi-experimental design involving two high schools in Bandung. One school will receive the nurse-led intervention, while the comparison school will continue routine school activities. Students who meet inclusion criteria and provide consent/assent will participate in pre- and post-intervention assessments. The primary outcome is improvement in emotional regulation scores. Secondary outcomes include bullying behavior, empathy, and student perceptions of the school climate.
All activities will follow ethical guidelines, including confidentiality, voluntary participation, and the right to withdraw at any time. The study seeks to provide evidence on how nurses can contribute to mental health promotion in schools and support sustainable, school-based bullying prevention strategies.
Detailed description
This study investigates a structured, nurse-led intervention that integrates the ROOTS program with soft skills training to enhance emotional regulation as a strategy to prevent bullying among adolescents. The intervention consists of multiple structured sessions delivered over several weeks, focusing on emotional awareness, stress management, empathy development, communication strategies, and problem-solving skills. The program was adapted for Indonesian high school students and aligned with the role of school nurses in mental health promotion.
A quasi-experimental non-randomized design will be used. Two high schools in Bandung will participate: one serving as the intervention site and the other as the comparison site. Participants will be students in grades 10-11 who consent to join the study. Pre-intervention assessments will measure emotional regulation (primary outcome) and bullying behaviors, empathy, and school climate (secondary outcomes). After the intervention sessions are completed, the same measures will be reassessed.
The study aims to generate evidence on the feasibility and effectiveness of a nurse-led emotional and social skills program delivered in school settings. Findings are expected to inform future mental health strategies, support the integration of nurses into school-based preventive services, and contribute practical recommendations for bullying prevention policies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Students are assigned to either the intervention group receiving the ROOTS and Soft Skills sessions or a control group receiving school-as-usual activities. The intervention lasts 8 weeks with pre- and post-assessments.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Nurse-Led ROOTS Program and Soft Skills TrainingParticipants receive the Nurse-Led ROOTS Program combined with Soft Skills Training. This eight-week program, facilitated by the school nurse and a teacher, includes peer-led leadership activities, emotion regulation exercises, assertive communication, cognitive reappraisal, and empathy training to prevent bullying and improve emotional regulation. |
| Control Group | No intervention | –Participants in this arm will receive standard care provided at the school without additional psychological intervention. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Adolescents aged 14-18 years
- Enrolled in participating secondary schools
- Willing to provide assent, with parental/guardian consent
- Able to understand and communicate in the local language (e.g., Indonesian or English)
- Identified as having mild to moderate difficulties in emotional regulation or at risk for anxiety/depression based on school screening Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nurse-Led ROOTS Program and Soft Skills TrainingA structured, eight-week program delivered once per week (60-90 minutes/session) by the school nurse and supported by teachers. Core components include: Program orientation and group norms Peer leadership and assertive communication Emotional awareness and labeling Expression management and self-control Cognitive reappraisal exercises Empathy and perspective-taking Peer-led positive values campaign Reflection, feedback, and skill consolidation | Behavioural | Intervention Group |
Primary outcome
Emotional Regulation
Time frame: Pre-intervention (week 0) and post-intervention (week 8)
Emotional regulation ability is measured using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA), a 10-item instrument rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher total scores indicating better overall emotional regulation ability. Changes in the total ERQ-CA score from pre-intervention (week 0) to post-intervention (week 8) are used to evaluate the extent to which the intervention improves participants' capacity to manage and express their emotions adaptively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The dataset contains sensitive mental health information from adolescents, and institutional policies prohibit the release of such de-identified data to external researchers.
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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.
Iyus Yosep principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led ROOTS Program and Soft Skills Training in people with Bullying Behavior and Emotional Regulation Difficulties, run by Universitas Padjadjaran at 1 site in Indonesia.
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 9 inclusion and 0 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: finished, as of the sponsor's last update on 12 Dec 2025. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Regulation (time frame: Pre-intervention (week 0) and post-intervention (week 8)). 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 12 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.