Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students

NCT06592872 | Not Yet Recruiting DMC

• 1 other identifier: R44HD114361
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project is designed to address the urgent need for an effective primary prevention approach to the problem of bullying and cyberbullying among elementary school students. The project involves developing, feasibility testing, and testing for the effectiveness an innovative new approach to the primary prevention of bullying utilizing both a serious (educational) videogame and facilitator-led, interactive class sessions. Using a cluster randomized controlled trial, the intervention will teach students how to respond to in-person and online bullying from the perspectives of perpetrator, victim, and bystander. The intervention enhances personal self-management skills, social skills, refusal skills, and other life skills needed to successfully navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development. At the end of the initial intervention period, and at one- and two-year follow-ups, we will compare outcomes of students in the intervention and control groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding bullying, cyberbullying, and substance use behavior.

Conditions

Bullying; Cyberbullying; Smoking

Keywords

bullying; cyberbullying; elementary school; videogame; educational games

Outcome Measures

Primary Outcomes (4)

• Bullying/cyberbullying, norms, and attitudes at posttest

  The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding bullying and cyberbullying and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.

  Posttest (within 2 weeks of completing final classroom session/videogame module)

• Bullying and cyberbullying, norms, and attitudes at 24-month followup

  The investigtors will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding bullying and cyberbullying and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and control group.

  24-month followup (within 24-25 months of completing the final classroom session and videogame module)

• Bullying/cyberbullying, norms, and attitudes at baseline

  The investigators will asess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding bullying and cyberbullying and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.

  Pretest (prior to participation in the first classroom session and videogame module of intervention)

• Bullying and cyberbullying, norms, and attitudes at 12-month followup

  The investigators will assess key study variables including behaviors, norms, attitudes, and knowledge regarding bullying and cyberbullying and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.

  12-month followup (within 12-13 months of completing final classroom session and videogame module

Secondary Outcomes (4)

• Bullying and cyberbullying, norms, and attitudes at pretest (prior to participating in the first classroom session and videogame module)

  Pretest (prior to participation in the first classroom session and videogame module of intervention)

• Bullying and cyberbullying, norms, and attitudes at posttest (within 2 weeks of completing final classroom session and videogame module)

  Posttest (within 2 weeks of completing final classroom session and videogame module)

• Bullying and cyberbullying, norms, and attitudes at 12-month followup

  12-month followup (within 12-13 months of completing final classroom session and videogame module

• Bullying and cyberbullying, norms, and attitudes at 24-month followup

  24-month followup (within 24-25 months of completing final classroom session and videogame module

Study Arms (2)

LifeSkills for Elementary School (Intervention)

EXPERIMENTAL

Approximately 1500 students in the 3rd grade (100 students per school) will complete pre-tests, post-tests, and 12- and 24-month follow-ups. Students whose school is randomized to the intervention condition (15 schools) will receive the LifeSkills Training standard curriculum plus bullying/cyberbullying classroom and serious game.

Behavioral: Bullying prevention

LifeSkills for Elementary School (Control)

NO INTERVENTION

Approximately 1500 students in the 3rd grade (100 students per school) will complete pre-tests, post-tests, and 12- and 24-month follow-ups. Students whose school is randomized to the control condition (12 schools) will not receive the LifeSkills Training intervention, but will receive the health education content normally provided by their schools.

Interventions

Bullying prevention BEHAVIORAL

The intervention utilizes a serious (educational) videogame and teacher-led, interactive class sessions. Students exposed to the intervention will learn to respond to in-person and online bullying from the perspectives of perpetrator, victim, and bystander. The intervention enhances personal self-management skills, social skills, refusal skills, and other life skills needed to successfully navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development.

LifeSkills for Elementary School (Intervention)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Christopher Williams: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Bullying; Cyberbullying; Smoking

Condition Hierarchy (Ancestors)

Aggression; Behavioral Symptoms; Behavior; Harassment, Non-Sexual; Social Behavior

Study Officials

• Christopher Williams, PhD, MPH

  National Health Promotion Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Williams, PhD, MPH

CONTACT

914-421-2525; cwilliams@nhpamail.com

Nina Daley, BS

CONTACT

914-421-2525; ndaley@nhpamail.com

Study Design

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

Model Details: The intervention will consist of a suite of serious (educational) videogames and interactive teacher-led classroom sessions. The intervention is designed to address the urgent need for an effective primary prevention approach to the problem of bullying and cyberbullying among elementary school students. The intervention enhances personal self-management skills, social skills, refusal skills, and other life skills needed to successfully navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share