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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06017050
Other study ID # R21HD104369
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2023
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Center for Innovative Public Health Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Center for Innovative Public Health Research San Clemente California

Sponsors (2)

Lead Sponsor Collaborator
Center for Innovative Public Health Research University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Relatively lower rates of bullying perpetration in the intervention versus control group Bullying other youth the same age In the past 30 days at 3-months post-randomzied controlled trial (RCT) end
Other Relatively lower rates of aggressive behavior in the intervention versus control group Youth who report aggressive acts that do not meet the definition of bullying In the past 30 days at 3-months post-RCT end
Other Relatively higher rates of bystanding behavior in the intervention versus control group Intervening when a youth sees others being bullied as measured by the University of Illinois Willingness to Intervene scale In the past 30 days at 3-months post-RCT end
Primary Feasibility of the intervention Recruitment and enrollment rates Through study completion, anticipated to be 1 year
Primary Acceptability of the intervention Positive program appraisal Intervention end, 8 weeks after program enrollment
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