Back to resultsBullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
Primary Purpose
Bullying
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BullyDown
Attention-matched control
Sponsored by
About this trial
This is an interventional prevention trial for Bullying
Eligibility Criteria
Inclusion Criteria: 7th or 8th grade English speaking Own their own cell phone Home internet Provide informed assent Exclusion Criteria: Non-English speakers Unable to read the screener Know someone else in the RCT Know they are not on an unlimited text messaging plan
Sites / Locations
- Center for Innovative Public Health ResearchRecruiting
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BullyDown intervention
Healthy lifestyle control
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of the intervention
Recruitment and enrollment rates
Acceptability of the intervention
Positive program appraisal
Secondary Outcome Measures
Full Information
NCT ID
NCT06017050
First Posted
August 16, 2023
Last Updated
August 25, 2023
Sponsor
Center for Innovative Public Health Research
Collaborators
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT06017050
Brief Title
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
Official Title
Developing a Bullying Prevention Program That Transcends Physical Boundaries
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovative Public Health Research
Collaborators
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullying
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Youth will be randomized to either the intervention or control group.
Masking
Participant
Masking Description
Youth assigned to the control group will receive message written to seem as if it is intervention content (i.e., address bullying behaviors).
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BullyDown intervention
Arm Type
Experimental
Arm Title
Healthy lifestyle control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
BullyDown
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention-matched control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the intervention
Description
Recruitment and enrollment rates
Time Frame
Through study completion, anticipated to be 1 year
Title
Acceptability of the intervention
Description
Positive program appraisal
Time Frame
Intervention end, 8 weeks after program enrollment
Other Pre-specified Outcome Measures:
Title
Relatively lower rates of bullying perpetration in the intervention versus control group
Description
Bullying other youth the same age
Time Frame
In the past 30 days at 3-months post-randomzied controlled trial (RCT) end
Title
Relatively lower rates of aggressive behavior in the intervention versus control group
Description
Youth who report aggressive acts that do not meet the definition of bullying
Time Frame
In the past 30 days at 3-months post-RCT end
Title
Relatively higher rates of bystanding behavior in the intervention versus control group
Description
Intervening when a youth sees others being bullied as measured by the University of Illinois Willingness to Intervene scale
Time Frame
In the past 30 days at 3-months post-RCT end
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
7th or 8th grade
English speaking
Own their own cell phone
Home internet
Provide informed assent
Exclusion Criteria:
Non-English speakers
Unable to read the screener
Know someone else in the RCT
Know they are not on an unlimited text messaging plan
Facility Information:
Facility Name
Center for Innovative Public Health Research
City
San Clemente
State/Province
California
ZIP/Postal Code
92672-6745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele L Ybarra, MPH PhD
Phone
877-302-6858
Ext
801
Email
Michele@InnovativePublicHealth.org
First Name & Middle Initial & Last Name & Degree
Michele L Ybarra, MPH PhD
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-2100
Country
United States
Individual Site Status
Completed
12. IPD Sharing Statement
Learn more about this trial
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
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