NCT07261397

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 22, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Bullying PreventionEmotional RegulationEmpathyHigh School StudentsNurse-Led Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-intervention (week 0) and post-intervention (week 8)

Study Arms (2)

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.

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.

Interventions

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

Intervention Group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Severe psychiatric conditions requiring immediate clinical intervention (e.g., psychosis, severe depression with suicidal intent)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMA Al Marwah and MAN Kota Bandung

Bandung, West Java, 40184, Indonesia

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Iyus Yosep

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and school staff are aware of group allocation, but outcome assessors are blinded to minimize measurement bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 3, 2025

Study Start

July 1, 2025

Primary Completion

September 30, 2025

Study Completion

October 5, 2025

Last Updated

December 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations