NCT03205059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

June 28, 2017

Last Update Submit

January 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

LST MS curriculum+ Bullying/Cyberbullying serious game

EXPERIMENTAL
Behavioral: LST MS curriculum+ Bullying/Cyberbulling serious game

LST MS curriculum

ACTIVE COMPARATOR
Behavioral: LST MS curriculum

Interventions

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+ Bullying/Cyberbullying serious game

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.

LST MS curriculum

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Middle school aged-youth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Promotion Associates

White Plains, New York, 10604, United States

RECRUITING

MeSH Terms

Conditions

BullyingCyberbullyingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial BehaviorChemically-Induced DisordersMental Disorders

Central Study Contacts

Christopher Williams

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Vice President

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

June 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations