- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017050
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
December 2, 2025 updated by: Center for Innovative Public Health Research
Developing a Bullying Prevention Program That Transcends Physical Boundaries
Given the limited impact of existing school-based interventions and the time associated with implementing them during school time, more efficient and effective intervention methods are needed.
Programs that can be delivered to middle school youth irrespective of whether they are attending school physically or virtually may be especially relevant as school boundaries become more fluid.
BullyDown addresses this critical need by providing a scalable program that could be quickly and cost-effectively disseminated nationally.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Clemente, California, United States, 92672-6745
- Center for Innovative Public Health Research
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-2100
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Participants will: be enrolled in one of our partner schools, be in middle school (i.e., 7th or 8th grade) or between the ages of 12-14 years of age, be English-speaking, own their own cell phone, intend to have the same cell phone number for at least 3 months (this may or may not apply, depending on the number of youth who meet this criterion), and provide informed written assent.
Non-English speakers and youth who do not have the reading ability to complete the screener are not eligible.
Youth recruited from schools will also be required to have parental permission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BullyDown intervention
|
BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth.
Message content is based upon the social-emotional learning model.
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Placebo Comparator: Healthy lifestyle control
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The attention-matched control will receive the messages for the same number of days as the intervention.
Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Recruitment Rate
Time Frame: Recruitment period
|
If at least 75% of eligible participants assent to participate, this will be supportive of a hypothesis of feasibility.
Note that a youth could assent and not be randomized if they did not complete the baseline survey.
|
Recruitment period
|
|
Acceptability of the Intervention
Time Frame: Intervention end, 9 weeks after program enrollment
|
Youth were asked: "How likely are you to recommend BullyDown to other people your age?" Answers were collected on a 5-point Likert scale.
The response option ranged from 1-5, with higher values reflecting greater acceptability.
An average score of 4 or higher was deemed supportive of program acceptability.
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Intervention end, 9 weeks after program enrollment
|
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Feasibility: Retention at 3-month Follow-up
Time Frame: 21 weeks post-randomization, 3 months after the 9-week program ended
|
A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility
|
21 weeks post-randomization, 3 months after the 9-week program ended
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Retention Rate at Program End
Time Frame: 9 weeks post-randomization
|
A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility.
|
9 weeks post-randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of Bullying Perpetration in the Intervention Versus Control Group
Time Frame: Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program
|
Bullying behaviors towards other youth the same age 3 or more times in the past 30 days
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Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program
|
|
Rates of Aggressive Behavior in the Intervention Versus Control Group
Time Frame: Reported aggressive behavior in the past 30 days at the end of the 9 week program
|
Youth who report aggressive acts towards others 1-2 times in the past 30 days
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Reported aggressive behavior in the past 30 days at the end of the 9 week program
|
|
Scores of Bystanding Behavior in the Intervention Versus Control Group
Time Frame: Responses provided at the program end survey, 9 weeks after they were randomized
|
Bystander intentions are measured using the 5-item University of Illinois Willingness to Intervene scale.
Each of the items is measured on a 4-point Likert scale, resulting in a sum that ranges from 5 - 20.
A higher score reflects a greater willingness to intervene.
|
Responses provided at the program end survey, 9 weeks after they were randomized
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2023
Primary Completion (Actual)
June 3, 2024
Study Completion (Actual)
June 3, 2024
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 25, 2023
First Posted (Actual)
August 30, 2023
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
December 2, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21HD104369 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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