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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD104369 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BullyDown intervention | Experimental |
| |
| Healthy lifestyle control | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BullyDown | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Retention Rate at Program End | A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility. | 9 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Innovative Public Health Research | San Clemente | California | 92672-6745 | United States | ||
| University of North Carolina at Chapel Hill |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Healthy Lifestyle Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 474 youth were identified as eligible. | Posted | Count of Participants | Participants | Recruitment period |
|
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Each participant was followed for 21 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Ybarra | Center for Innovative Public Health Research | 8773026858 | 801 | michele@innovativepublichealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2023 | Jul 1, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2023 | Aug 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D058445 | Bullying |
| ID | Term |
|---|---|
| D000374 | Aggression |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000071277 | Harassment, Non-Sexual |
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Youth will be randomized to either the intervention or control group.
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Youth assigned to the control group will receive message written to seem as if it is intervention content (i.e., address bullying behaviors).
| Attention-matched control | Behavioral | 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. |
|
Youth who report aggressive acts towards others 1-2 times in the past 30 days |
| 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 | 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 |
| Chapel Hill |
| North Carolina |
| 27599-2100 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Bullying perpetration | Bullying is defined as engaging in at least one of 6 behaviors 3 or more times in the past 30 days. The behaviors include: 1) Hitting, kicking, pushing or shoving someone; 2) Making threatening or aggressive comments to someone; 3) Calling someone mean names; 4) Making fun of someone or teasing someone in a nasty way; 5) Leaving someone out or not letting someone into a group because you were mad at someone or were trying to make someone upset; and 6) Spreading rumors about someone, whether they were true or not. | Count of Participants | Participants |
|
| Aggression perpetration | Aggressive behavior is defined as engaging in at least one of 6 behaviors 1-2 times in the past 30 days. The behaviors include: 1) Hitting, kicking, pushing or shoving someone; 2) Making threatening or aggressive comments to someone; 3) Calling someone mean names; 4) Making fun of someone or teasing someone in a nasty way; 5) Leaving someone out or not letting someone into a group because you were mad at someone or were trying to make someone upset; and 6) Spreading rumors about someone, whether they were true or not. | Count of Participants | Participants |
|
| Bystander behavior | 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. | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| Primary | 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. | Youth who provided data at the program end survey were included in the analyses. | Posted | Mean | Standard Deviation | Average score on a 5-point likert scale | Intervention end, 9 weeks after program enrollment |
|
|
|
| Primary | Feasibility: Retention at 3-month Follow-up | A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility | Posted | Count of Participants | Participants | 21 weeks post-randomization, 3 months after the 9-week program ended |
|
|
|
| Secondary | Feasibility: Retention Rate at Program End | A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility. | Posted | Count of Participants | Participants | 9 weeks post-randomization |
|
|
|
| Other Pre-specified | 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 | Youth who provided data at the program end survey were included in the analyses. | Posted | Count of Participants | Participants | Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program |
|
|
|
| Other Pre-specified | 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 | Youth who provided data at the program end survey were included in the analyses. | Posted | Count of Participants | Participants | Reported aggressive behavior in the past 30 days at the end of the 9 week program |
|
|
|
| Other Pre-specified | 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. | Youth who provided data at the program end survey were included in the analyses. | Posted | Mean | Standard Deviation | units on a scale | Responses provided at the program end survey, 9 weeks after they were randomized |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | 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. | 0 | 67 | 0 | 67 | 0 | 67 |
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| D012919 |
| Social Behavior |