Clinical trial NCT06592872: Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students
Official title: Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bullying
Cyberbullying
Smoking
Keywords: bullying
cyberbullying
elementary school
videogame
educational games
Lead sponsor: National Health Promotion Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-09-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Bullying and cyberbullying are highly prevalent forms of aggressive behavior among youth of all ages and have a wide variety of negative social and mental health consequences. Bullying in all its forms involves persistent and intentional threatening, aggressive or verbally abusive behavior directed toward others at relative disadvantage. These behaviors share a similar set of risk and protective factors with early-stage substance use, therefore a single intervention approach may efficiently address both behaviors. Indeed, a fruitful way to extend the benefits of evidence-based prevention is to adapt the most effective interventions so they address shared and unique risk and protective factors for multiple related behaviors. The proposed SBIR Fast-Track application requests funding to develop and evaluate a multicomponent intervention to prevent bullying behavior by adapting the evidence-based Life Skills Training (LST) elementary school program. LST teaches youth personal self-management skills, social skills, drug refusal skills, and other life skills needed to successfully navigate key developmental tasks, increase resilience, and facilitate healthy psychosocial development. The LST program has been extensively tested and found to effectively prevent substance use in a series of randomized controlled trials with behavioral effects reported in over 30 peer-reviewed publications. The intervention for the proposed SBIR will teach young people how to respond to in-person and online bullying from the perspectives of perpetrator, victim, and bystander. We propose to develop: (1) bullying-specific classroom sessions to supplement the existing LST elementary school program; (2) an immersive serious (educational) video game to provide opportunities for students to apply life skills in preventing bullying and other high-risk situations in a gamified format; and, (3) e-learning modules that provide parents with strategies and resources to support anti-bullying lessons taught in school; and (4) e-learning modules for educators and support professionals that emphasize the importance of a school-wide anti-bullying approach that teaches prosocial behavior and encourages respect for peers. In Phase I, we will develop prototypes of bullying-specific classroom sessions, a video game level, and teacher and parent training materials to test them for feasibility, usability, and overall appeal. In Phase II, we will complete the development of all program materials and conduct a rigorous randomized controlled trial (RCT) of the prevention program. Elementary schools (N=30) will be randomized to either an intervention group that receives the prevention program or a treatment-as-usual control group that receives existing school health education. At the end of the initial intervention period, and at one- and two-year follow-ups, we will compare both groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding bullying, cyberbullying, and substance use behavior.

Phase II Specific Aims

1. Develop the complete multicomponent primary prevention curriculum materials to prevent bullying and cyberbullying among elementary school students;
2. Conduct a rigorous RCT that randomizes 30 elementary schools into either an intervention or treatment-as-usual control condition to test the effectiveness of the intervention;
3. Analyze outcome data to assess the impact of the intervention on behaviors, norms, attitudes, and knowledge regarding bullying, cyberbullying, and substance use at the end of the initial intervention period, and at 12- and 24-month follow-up assessments;
4. Conduct a process evaluation to document and monitor all Phase II project activities;
5. Disseminate research findings to the scientific and practice communities;
6. Create a provider training mechanism to promote dissemination and sustainability of the intervention;
7. Based on our commercialization plan, implement a marketing strategy for the new primary prevention program aimed at elementary schools across the country.

Eligibility criteria: Inclusion Criteria: All students are eligible to participate in the intervention and complete the surveys.

Exclusion Criteria: All students are eligible to participate in the intervention and complete the surveys. Survey data will be excluded from the analysis for participants with significant cognitive impairment or severe learning disabilities, as designated by school personnel.

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Primary outcomes:
measure: Bullying/cyberbullying, norms, and attitudes at posttest
timeFrame: Posttest (within 2 weeks of completing final classroom session/videogame module)
measure: Bullying and cyberbullying, norms, and attitudes at 24-month followup
timeFrame: 24-month followup (within 24-25 months of completing the final classroom session and videogame module)
measure: Bullying/cyberbullying, norms, and attitudes at baseline
timeFrame: Pretest (prior to participation in the first classroom session and videogame module of intervention)
measure: Bullying and cyberbullying, norms, and attitudes at 12-month followup
timeFrame: 12-month followup (within 12-13 months of completing final classroom session and videogame module
Secondary outcomes:
measure: Bullying and cyberbullying, norms, and attitudes at pretest (prior to participating in the first classroom session and videogame module)
timeFrame: Pretest (prior to participation in the first classroom session and videogame module of intervention)
measure: Bullying and cyberbullying, norms, and attitudes at posttest (within 2 weeks of completing final classroom session and videogame module)
timeFrame: Posttest (within 2 weeks of completing final classroom session and videogame module)
measure: Bullying and cyberbullying, norms, and attitudes at 12-month followup
timeFrame: 12-month followup (within 12-13 months of completing final classroom session and videogame module
measure: Bullying and cyberbullying, norms, and attitudes at 24-month followup
timeFrame: 24-month followup (within 24-25 months of completing final classroom session and videogame module
Other outcomes:
Locations:
Study officials:
affiliation: National Health Promotion Associates
name: Christopher Williams, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: