NCT07098559

Brief Summary

This research is a randomized controlled experimental study. The research aims to evaluate the effectiveness of creative drama workshops based on the bystander intervention model on middle school students' bystander intervention and empathy levels. The research population consists of sixth and seventh grade students. The research sample will consist of at least 42 middle school students, 21 in the intervention group and 21 in the control group. The sample will be selected through randomization. The students in the intervention group will receive 10 sessions of creative drama intervention. The research aims to answer the following questions: Is there a difference between the intervention group and the control group in terms of bystander intervention levels? Is there a difference between the intervention group and the control group in terms of empathy levels toward the victim of peer bullying?

Trial Health

63
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Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress91%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

July 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 24, 2025

Last Update Submit

August 3, 2025

Conditions

Keywords

creative dramamiddle school studentspeer bullyingbystander interventionbystander intervention modelbystander roleemphatynursing

Outcome Measures

Primary Outcomes (1)

  • Bystander Intervention Scale in Bullying

    The scale aims to evaluate individuals' reactions and attitudes towards bullying incidents they witness and was created based on the Bystander Intervention Model. The scale, consisting of 16 items in total, consists of five sub-dimensions: Noticing the incident, interpreting the incident as a situation requiring immediate help, accepting the responsibility to help, deciding how to intervene, and implementing the intervention decision. The scale, structured as a 5-point Likert-type scale, is applied by rating from "Strongly Disagree" to "Strongly Agree." The overall Cronbach's Alpha reliability coefficient of the scale was calculated as 0.88. The Cronbach's Alpha reliability coefficients for the sub-dimensions are, respectively; 0.60 for recognizing the event, 0.78 for interpreting the event as emergency aid, 0.67 for accepting the responsibility to help, 0.75 for deciding on the intervention method, and 0.78 for implementing the intervention decision

    3 months

Secondary Outcomes (1)

  • Empathy Scale for Peer Bullying Victims

    3 months

Study Arms (2)

Creative drama group

EXPERIMENTAL

Participants will be given ten sessions of creative drama intervention training in creative drama workshops reviewed by experts.

Behavioral: Creative drama

Control group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Creative dramaBEHAVIORAL

This intervention is unique in its integration of the Bystander Intervention Model with creative drama techniques to enhance empathy, self-efficacy, and active intervention behaviors among middle school students witnessing peer bullying. Unlike traditional anti-bullying programs that rely on lectures or cognitive-based approaches, this study uses experiential learning and role-playing scenarios to simulate real-life bullying situations and encourage emotional engagement and behavioral change.

Creative drama group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being in 6th or 7th grade,
  • Having parental consent, and
  • Voluntary participation in the study

You may not qualify if:

  • Difficulty in reading and writing Turkish, and
  • Having a physical/mental disability or illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Central Study Contacts

Şeyma Nur Hepokur Yıldırım, PhD Candidate

CONTACT

Yeter Kitiş, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, it is impossible to blind the researcher implementing the intervention and the participants. A pre-test will be administered before randomization to prevent bias in the study. The study's data collection and statistical process are planned to be blinded. The assignment of students to the intervention and control groups will be made by a statistician independent of the study. The researcher and the students will not know which group they are in until the application begins. After administering the follow-up tests, the independent researcher will code the data as groups A and B and transfer it to SPSS. With this method, the statistician plans to perform analysis and reporting without knowing which group is the intervention group and which is the control group. The codes of the groups are intended to be disclosed after the analysis and reporting of the data. In this way, detection bias, statistical bias, and reporting bias will be prevented.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized study with experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 1, 2025

Study Start

September 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

IPD sharing is restricted by data confidentiality, participant privacy, and applicable ethics rules and legislation. Sharing data with third parties may require relevant ethics committee approval, institutional permissions, and explicit consent from participants. If these conditions are not met, IPD sharing may not be possible.

Locations