NCT06017050

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

August 16, 2023

Results QC Date

June 13, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    21 weeks post-randomization, 3 months after the 9-week program ended

Secondary Outcomes (1)

  • Feasibility: Retention Rate at Program End

    9 weeks post-randomization

Other Outcomes (3)

  • Rates of Bullying Perpetration in the Intervention Versus Control Group

    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

    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

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

Study Arms (2)

BullyDown intervention

EXPERIMENTAL
Behavioral: BullyDown

Healthy lifestyle control

PLACEBO COMPARATOR
Behavioral: Attention-matched control

Interventions

BullyDownBEHAVIORAL

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.

BullyDown intervention

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.

Healthy lifestyle control

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Center for Innovative Public Health Research

San Clemente, California, 92672-6745, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-2100, United States

Location

MeSH Terms

Conditions

Bullying

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Results Point of Contact

Title
Michele Ybarra
Organization
Center for Innovative Public Health Research

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Youth assigned to the control group will receive message written to seem as if it is intervention content (i.e., address bullying behaviors).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Youth will be randomized to either the intervention or control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 30, 2023

Study Start

August 15, 2023

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

December 5, 2025

Results First Posted

December 5, 2025

Record last verified: 2025-07

Locations