ClinicalTrials.gg
CompletedNCT06017050Updated Dec 5, 2025Results posted

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

An interventional study of BullyDown and Attention-matched control in Bullying, sponsored by Center for Innovative Public Health Research. Completed at 2 sites in United States. Open to participants aged 12 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
12 Years to 14 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Bullying

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03

In context

Bullying

57 studies on the registry are indexed under Bullying; 9 are open to participants now.

This study's enrollment of 138 is below the median of 228 across 51 interventional studies indexed under Bullying.

Browse Bullying studies →

Lead sponsor

Center for Innovative Public Health Research is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    BullyDown intervention

    Behavioral: BullyDown

  • Placebo comparator
    Healthy lifestyle control

    Behavioral: Attention-matched control

Interventions

  • BehavioralBullyDown

    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.

  • BehavioralAttention-matched control

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Recruitment period

  2. 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.

    Time frame: Intervention end, 9 weeks after program enrollment

  3. Feasibility: Retention at 3-month Follow-up

    A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility

    Time frame: 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.

    Time frame: 9 weeks post-randomization

Other outcomes

  1. Rates of Bullying Perpetration in the Intervention Versus Control Group

    Bullying behaviors towards other youth the same age 3 or more times in the past 30 days

    Time frame: Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program

  2. Rates of Aggressive Behavior in the Intervention Versus Control Group

    Youth who report aggressive acts towards others 1-2 times in the past 30 days

    Time frame: Reported aggressive behavior in the past 30 days at the end of the 9 week program

  3. Scores of Bystanding Behavior in the Intervention Versus Control Group

    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.

    Time frame: Responses provided at the program end survey, 9 weeks after they were randomized

07

Results

Posted Dec 5, 2025

Participant flow

Participant flow — Overall Study
MilestoneBullyDown interventionHealthy lifestyle control
Started7167
Completed6966
Not completed21

Outcome measures

PrimaryFeasibility: 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.

Time frame:
Recruitment period
Reported as:
Count of participants · Participants
Feasibility: Recruitment Rate
ParticipantsOverall Number of Participants Recruited
Feasibility: Recruitment Rate202
PrimaryAcceptability 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.

Time frame:
Intervention end, 9 weeks after program enrollment
Reported as:
Mean · Average score on a 5-point likert scale
Acceptability of the Intervention
Average score on a 5-point likert scaleBullyDown interventionHealthy lifestyle control
Acceptability of the Intervention3.7 ± 1.13.6 ± 1.0
PrimaryFeasibility: Retention at 3-month Follow-up

A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility

Time frame:
21 weeks post-randomization, 3 months after the 9-week program ended
Reported as:
Count of participants · Participants
Feasibility: Retention at 3-month Follow-up
ParticipantsBullyDown interventionHealthy lifestyle control
Feasibility: Retention at 3-month Follow-up4849
SecondaryFeasibility: Retention Rate at Program End

A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility.

Time frame:
9 weeks post-randomization
Reported as:
Count of participants · Participants
Feasibility: Retention Rate at Program End
ParticipantsBullyDown interventionHealthy lifestyle control
Feasibility: Retention Rate at Program End5956
Other pre-specifiedRates of Bullying Perpetration in the Intervention Versus Control Group

Bullying behaviors towards other youth the same age 3 or more times in the past 30 days

Time frame:
Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program
Reported as:
Count of participants · Participants
Rates of Bullying Perpetration in the Intervention Versus Control Group
ParticipantsBullyDown interventionHealthy lifestyle control
Rates of Bullying Perpetration in the Intervention Versus Control Group77
Other pre-specifiedRates of Aggressive Behavior in the Intervention Versus Control Group

Youth who report aggressive acts towards others 1-2 times in the past 30 days

Time frame:
Reported aggressive behavior in the past 30 days at the end of the 9 week program
Reported as:
Count of participants · Participants
Rates of Aggressive Behavior in the Intervention Versus Control Group
ParticipantsBullyDown interventionHealthy lifestyle control
Rates of Aggressive Behavior in the Intervention Versus Control Group1514
Other pre-specifiedScores of Bystanding Behavior in the Intervention Versus Control Group

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.

Time frame:
Responses provided at the program end survey, 9 weeks after they were randomized
Reported as:
Mean · units on a scale
Scores of Bystanding Behavior in the Intervention Versus Control Group
units on a scaleBullyDown interventionHealthy lifestyle control
Scores of Bystanding Behavior in the Intervention Versus Control Group14.7 ± 2.915.0 ± 3.1

Adverse events

Collected over Each participant was followed for 21 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BullyDown intervention0/71 (0%)0/71 (0%)0/71 (0%)
Healthy lifestyle control0/67 (0%)0/67 (0%)0/67 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)BullyDown InterventionHealthy Lifestyle ControlTotal
<=18 years7167138
Between 18 and 65 years000
>=65 years000
Sex/Gender, Customized
Sex/Gender, Customized(Participants)BullyDown InterventionHealthy Lifestyle ControlTotal
Boys211637
Girls384179
Nonbinary youth4610
Declined to answer8412
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BullyDown InterventionHealthy Lifestyle ControlTotal
Hispanic or Latino5450104
Not Hispanic or Latino171431
Unknown or Not Reported033
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BullyDown InterventionHealthy Lifestyle ControlTotal
American Indian or Alaska Native213
Asian303
Native Hawaiian or Other Pacific Islander000
Black or African American9817
White414182
More than one race369
Unknown or Not Reported131124
Bullying perpetration
Bullying perpetration(Participants)BullyDown InterventionHealthy Lifestyle ControlTotal
Count of participants91120
Aggression perpetration
Aggression perpetration(Participants)BullyDown InterventionHealthy Lifestyle ControlTotal
Count of participants242246
Bystander behavior
Bystander behavior(units on a scale)BullyDown InterventionHealthy Lifestyle ControlTotal
Mean14.7 ± 2.415.3 ± 2.715.0 ± 2.5
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Study locations

2 sites
  • Center for Innovative Public Health Research
    San Clemente, California 92672-6745, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599-2100, United States
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06017050
Lead sponsor
Center for Innovative Public Health Research
Responsible party
Sponsor
First posted
Aug 30, 2023
Start date
Aug 15, 2023
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024
Results posted
Dec 5, 2025
Last update
Dec 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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