BullyingNCT06017050

BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth

A study testing BullyDown in people with Bullying, run by Center for Innovative Public Health Research at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Bullying
What is being tested?: BullyDown
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 2 sitesUnited States
Study dates: 15 Aug 2023to 3 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 14 years
All sexes
Healthy volunteers accepted
Child

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-2100
Center for Innovative Public Health Research
San Clemente, California, 92672-6745

Other trials in United States

About this study

Official title: 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.

Conditions: Bullying
Being tested: BullyDown, Attention-matched control
Medical subject headings: Bullying

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BullyDownBehavioural
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.
Attention-matched controlBehavioural
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.

Study groups in NCT06017050
Study group	Role	What they receive
BullyDown intervention	Experimental	Not described Receives: Behavioral: BullyDown
Healthy lifestyle control	Placebo comparator	Not described Receives: Behavioral: Attention-matched control

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: Recruitment Rate
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.
Measured: Recruitment period
Acceptability of the Intervention
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.
Measured: Intervention end, 9 weeks after program enrollment
Feasibility: Retention at 3-month Follow-up
A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility
Measured: 21 weeks post-randomization, 3 months after the 9-week program ended

Secondary outcomes (1)

Feasibility: Retention Rate at Program End
A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility.
Measured: 9 weeks post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20233 Jun 2024

First posted30 Aug 2023
Study start15 Aug 2023
Primary completion3 Jun 2024
Study completion3 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BullyingStudies 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: Randomised
Intervention model: Parallel groups
Model description: Youth will be randomized to either the intervention or control group.
Masking: Single blind
Who is masked: Participant
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06017050
Sponsor's protocol ID: R21HD104369
Other IDs: R21HD104369
Status last verified: Jul 2025
First submitted: 16 Aug 2023
Last updated: 5 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bullying trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing a Bullying Prevention Program That Transcends Physical Boundaries
ClinicalTrials.gov ID: NCT06017050
Acronym / sponsor ID: R21HD104369
Conditions: Bullying
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Center for Innovative Public Health ResearchUniversity, hospital or other
Collaborators: University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 15 Aug 2023 (actual)
Primary completion: 3 Jun 2024 (actual)
Study completion: 3 Jun 2024 (actual)
First posted: 30 Aug 2023 (actual)
Results: Posted 5 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Youth will be randomized to either the intervention or control group.

Arm	Type	Receives
BullyDown intervention	Experimental	Behavioral: BullyDown
Healthy lifestyle control	Placebo comparator	Behavioral: Attention-matched control

Who may qualify

Ages: 12 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

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
BullyDownBullyDown 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.	Behavioural	BullyDown intervention
Attention-matched controlThe 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.	Behavioural	Healthy lifestyle control

Primary outcome

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.
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.
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

1 secondary outcome

Feasibility: Retention Rate at Program End
Time frame: 9 weeks post-randomization

Results and safety

Results posted to the registry on 5 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BullyDown intervention	71	69
Healthy lifestyle control	67	66

Primary outcome: Feasibility: Recruitment Rate

Time frame: Recruitment period. Count of participants. Unit: Participants

Measure	Overall Number of Participants Recruited n = 474
Value	202

Population analysed: 474 youth were identified as eligible.

Primary outcome: Acceptability of the Intervention

Time frame: Intervention end, 9 weeks after program enrollment. Mean (Standard Deviation). Unit: Average score on a 5-point likert scale

Measure	BullyDown intervention n = 59	Healthy lifestyle control n = 56
Value	3.7 (1.1)	3.6 (1.0)

Population analysed: Youth who provided data at the program end survey were included in the analyses.

Primary outcome: Feasibility: Retention at 3-month Follow-up

Time frame: 21 weeks post-randomization, 3 months after the 9-week program ended. Count of participants. Unit: Participants

Measure	BullyDown intervention n = 71	Healthy lifestyle control n = 67
Value	48	49

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each participant was followed for 21 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BullyDown intervention	0 of 71 (0%)	0 of 71 (0%)	0 of 71
Healthy lifestyle control	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BullyDown in people with Bullying, run by Center for Innovative Public Health Research at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 5 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 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility: Recruitment Rate (time frame: Recruitment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017050.

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 5 Dec 2025.