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An Evidence-based Approach for Bullying Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03205059
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : January 7, 2019
Information provided by (Responsible Party):
Christopher Williams, National Health Promotion Associates, Inc.

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.

Condition or disease Intervention/treatment Phase
Bullying Cyberbullying Substance Use Substance Abuse Behavioral: LST MS curriculum+ Bullying/Cyberbulling serious game Behavioral: LST MS curriculum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Evidence-based Approach for Bullying Prevention
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: LST MS curriculum+ Bullying/Cyberbullying serious game 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.

Active Comparator: LST MS curriculum Behavioral: 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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03205059

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Contact: Christopher Williams 9144212525

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United States, New York
National Health Promotion Associates Recruiting
White Plains, New York, United States, 10604
Contact: Christopher Williams    914-421-2525   
Sponsors and Collaborators
National Health Promotion Associates, Inc.

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Responsible Party: Christopher Williams, Senior Vice President, National Health Promotion Associates, Inc. Identifier: NCT03205059     History of Changes
Other Study ID Numbers: R44HD074319-02 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms