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Clinical Trials/NCT03205059
NCT03205059UnknownNot Applicable

An Evidence-based Approach for Bullying Prevention

National Health Promotion Associates, Inc.1 site in 1 country3,000 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
3,000
Locations
1
Primary Endpoint
Change in bullying/cyberbullying perpetration in the past two years

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
11 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Middle school aged-youth

Exclusion Criteria

  • •Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites

Arms & Interventions

LST MS curriculum+ Bullying/Cyberbullying serious game

Experimental

Intervention: LST MS curriculum+ Bullying/Cyberbulling serious game (Behavioral)

LST MS curriculum

Active Comparator

Intervention: LST MS curriculum (Behavioral)

Outcomes

Primary Outcomes

Change in bullying/cyberbullying perpetration in the past two years

Time Frame: Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Principal Investigator
Principal Investigator

Christopher Williams

Senior Vice President

National Health Promotion Associates, Inc.

Study Sites (1)

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