An Evidence-based Approach for Bullying Prevention

January 3, 2019 updated by: Christopher Williams, National Health Promotion Associates, Inc.
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • White Plains, New York, United States, 10604
        • Recruiting
        • National Health Promotion Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Middle school aged-youth

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Promotion Associates, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44HD074319-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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