An Evidence-based Approach for Bullying Prevention
1 other identifier
interventional
3,000
1 country
1
Brief Summary
This Phase II SBIR project is designed to address the critical public health problem of bullying and cyberbullying among middle school age youth. The project involves developing and testing bullying and cyberbullying prevention materials, including interactive classroom sessions and corresponding serious games, based on the evidence-based substance abuse prevention approach called Life Skills Training. The product has the potential to fill a gap in the intervention tools currently available to schools that can be widely disseminated throughout the country using existing marketing and dissemination channels and decrease the adverse consequences of bullying and cyberbullying as well as substance abuse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJanuary 7, 2019
January 1, 2019
2.9 years
June 28, 2017
January 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in bullying/cyberbullying perpetration in the past two years
The investigators will assess (via questionnaire) key study variables regarding bullying and cyberbullying and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the active comparator group at a post-test assessment and 12-month and 24-month follow-up assessments.
Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up
Study Arms (2)
LST MS curriculum+ Bullying/Cyberbullying serious game
EXPERIMENTALLST MS curriculum
ACTIVE COMPARATORInterventions
The prevention materials for middle school bullying and cyberbullying will (1) utilize both interactive classroom sessions and serious/educational games (digital games used to educate in an entertaining format); (2) positively change social norms surrounding bullying and cyberbulling; (3) challenge positive expectancies about bullying and cyberbullying; (4) enhance protective factors by building social, self-regulation, and relationship skills throughout the interactive learning and behavioral rehearsal; and (5) include booster sessions.
The evidence-based LifeSkills Training program has been successfully used as a universal, school-based substance abuse and violence prevention program for middle school youth. The goals of the LST program are to teach youth the personal self-management skills, social skills, and other life skills needed to successfully resist drug and alcohol use, navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development.
Eligibility Criteria
You may qualify if:
- Middle school aged-youth
You may not qualify if:
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Health Promotion Associates
White Plains, New York, 10604, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Vice President
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
June 1, 2017
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
January 7, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share