Trial Outcomes & Findings for BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth (NCT NCT06017050)
NCT ID: NCT06017050
Last Updated: 2025-12-05
Results Overview
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 status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
Recruitment period
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
BullyDown intervention
BullyDown: 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.
|
Healthy lifestyle control
Attention-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.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
67
|
|
Overall Study
COMPLETED
|
69
|
66
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
Baseline characteristics by cohort
| Measure |
BullyDown Intervention
n=71 Participants
BullyDown: 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.
|
Healthy Lifestyle Control
n=67 Participants
Attention-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.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
71 Participants
n=37 Participants
|
67 Participants
n=37 Participants
|
138 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Sex/Gender, Customized
Boys
|
21 Participants
n=37 Participants
|
16 Participants
n=37 Participants
|
37 Participants
n=74 Participants
|
|
Sex/Gender, Customized
Girls
|
38 Participants
n=37 Participants
|
41 Participants
n=37 Participants
|
79 Participants
n=74 Participants
|
|
Sex/Gender, Customized
Nonbinary youth
|
4 Participants
n=37 Participants
|
6 Participants
n=37 Participants
|
10 Participants
n=74 Participants
|
|
Sex/Gender, Customized
Declined to answer
|
8 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=37 Participants
|
50 Participants
n=37 Participants
|
104 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=37 Participants
|
14 Participants
n=37 Participants
|
31 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
17 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=37 Participants
|
41 Participants
n=37 Participants
|
82 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=37 Participants
|
6 Participants
n=37 Participants
|
9 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=37 Participants
|
11 Participants
n=37 Participants
|
24 Participants
n=74 Participants
|
|
Bullying perpetration
|
9 Participants
n=37 Participants
|
11 Participants
n=37 Participants
|
20 Participants
n=74 Participants
|
|
Aggression perpetration
|
24 Participants
n=37 Participants
|
22 Participants
n=37 Participants
|
46 Participants
n=74 Participants
|
|
Bystander behavior
|
14.7 units on a scale
STANDARD_DEVIATION 2.4 • n=37 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 2.7 • n=37 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 2.5 • n=74 Participants
|
PRIMARY outcome
Timeframe: Recruitment periodPopulation: 474 youth were identified as eligible.
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.
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=474 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
Attention-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.
|
|---|---|---|
|
Feasibility: Recruitment Rate
|
202 Participants
|
—
|
PRIMARY outcome
Timeframe: Intervention end, 9 weeks after program enrollmentPopulation: Youth who provided data at the program end survey were included in the analyses.
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.
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=59 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
n=56 Participants
Attention-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.
|
|---|---|---|
|
Acceptability of the Intervention
|
3.7 Average score on a 5-point likert scale
Standard Deviation 1.1
|
3.6 Average score on a 5-point likert scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 21 weeks post-randomization, 3 months after the 9-week program endedA retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=71 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
n=67 Participants
Attention-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.
|
|---|---|---|
|
Feasibility: Retention at 3-month Follow-up
|
48 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 9 weeks post-randomizationA retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility.
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=71 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
n=67 Participants
Attention-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.
|
|---|---|---|
|
Feasibility: Retention Rate at Program End
|
59 Participants
|
56 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Reported bullying perpetration behavior in the past 30 days at the end of the 9 week programPopulation: Youth who provided data at the program end survey were included in the analyses.
Bullying behaviors towards other youth the same age 3 or more times in the past 30 days
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=59 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
n=56 Participants
Attention-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.
|
|---|---|---|
|
Rates of Bullying Perpetration in the Intervention Versus Control Group
|
7 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Reported aggressive behavior in the past 30 days at the end of the 9 week programPopulation: Youth who provided data at the program end survey were included in the analyses.
Youth who report aggressive acts towards others 1-2 times in the past 30 days
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=59 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
n=56 Participants
Attention-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.
|
|---|---|---|
|
Rates of Aggressive Behavior in the Intervention Versus Control Group
|
15 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Responses provided at the program end survey, 9 weeks after they were randomizedPopulation: Youth who provided data at the program end survey were included in the analyses.
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.
Outcome measures
| Measure |
Overall Number of Participants Recruited
n=59 Participants
Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study
|
Healthy lifestyle control
n=56 Participants
Attention-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.
|
|---|---|---|
|
Scores of Bystanding Behavior in the Intervention Versus Control Group
|
14.7 units on a scale
Standard Deviation 2.9
|
15.0 units on a scale
Standard Deviation 3.1
|
Adverse Events
BullyDown intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy lifestyle control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michele Ybarra
Center for Innovative Public Health Research
Phone: 8773026858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place