An Evidence-based Approach for Bullying Prevention

Substance Abuse Clinical Trial

Official title:

An Evidence-based Approach for Bullying Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03205059
• Other study ID #: R44HD074319-02
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 2020

Study information

• Verified date: January 2019
• Source: National Health Promotion Associates, Inc.
• Contact: Christopher Williams
• Phone: 9144212525
• Email: cwilliams[@]nhpamail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• Middle school aged-youth

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bullying
• Cyberbullying
• Substance Abuse
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• LST MS curriculum+ Bullying/Cyberbulling serious game
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.
• LST MS curriculum
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.

Locations

Country	Name	City	State
United States	National Health Promotion Associates	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Health Promotion Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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