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An Evidence-based Approach for Bullying Prevention

Primary Purpose

Bullying, Cyberbullying, Substance Use

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LST MS curriculum+ Bullying/Cyberbulling serious game
LST MS curriculum
Sponsored by
National Health Promotion Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bullying

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Middle school aged-youth

Exclusion Criteria:

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

Sites / Locations

  • National Health Promotion AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LST MS curriculum+ Bullying/Cyberbullying serious game

LST MS curriculum

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2017
Last Updated
January 3, 2019
Sponsor
National Health Promotion Associates, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03205059
Brief Title
An Evidence-based Approach for Bullying Prevention
Official Title
An Evidence-based Approach for Bullying Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Promotion Associates, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullying, Cyberbullying, Substance Use, Substance Abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LST MS curriculum+ Bullying/Cyberbullying serious game
Arm Type
Experimental
Arm Title
LST MS curriculum
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
LST MS curriculum+ Bullying/Cyberbulling serious game
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LST MS curriculum
Intervention Description
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 Measure Information:
Title
Change in bullying/cyberbullying perpetration in the past two years
Description
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.
Time Frame
Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Middle school aged-youth Exclusion Criteria: Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Williams
Phone
9144212525
Email
cwilliams@nhpamail.com
Facility Information:
Facility Name
National Health Promotion Associates
City
White Plains
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Williams
Phone
914-421-2525
Email
cwilliams@nhpamail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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An Evidence-based Approach for Bullying Prevention

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