BullyingNCT06592872
Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students
A study testing Bullying prevention in people with Bullying and Cyberbullying, run by Christopher Williams.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying, Cyberbullying, Smoking
- What is being tested?
- Bullying prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Develop the complete multicomponent primary prevention curriculum materials to prevent bullying and cyberbullying among elementary school students;
- 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;
- 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;
- Conduct a process evaluation to document and monitor all Phase II project activities;
- Disseminate research findings to the scientific and practice communities;
- Create a provider training mechanism to promote dissemination and sustainability of the intervention;
- Based on our commercialization plan, implement a marketing strategy for the new primary prevention program aimed at elementary schools across the country.
- Conditions
- Bullying, Cyberbullying, Smoking
- Being tested
- Bullying prevention
- Keywords
- bullying, cyberbullying, elementary school, videogame, educational games
- Medical subject headings
- Bullying, Cyberbullying, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bullying preventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding substance use and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 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)
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 control group.
Measured: Posttest (within 2 weeks of completing final classroom session and videogame module)
Bullying and cyberbullying, norms, and attitudes at 12-month followup
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding substance use and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 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
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding substance use and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 24-month followup (within 24-25 months of completing final classroom session and videogame module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BullyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Williams
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Christopher Williams, National Health Promotion Associates, Inc.
- Investigators
- Christopher Williams, PhD, MPH, Principal investigator, National Health Promotion Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592872
- Sponsor's protocol ID
- R44HD114361
- Other IDs
- R44HD114361
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students
- ClinicalTrials.gov ID
- NCT06592872
- Acronym / sponsor ID
- R44HD114361
- Conditions
- Bullying, Cyberbullying, Smoking
- Keywords
- bullying, cyberbullying, elementary school, videogame, educational games
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Christopher WilliamsIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Develop the complete multicomponent primary prevention curriculum materials to prevent bullying and cyberbullying among elementary school students;
- 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;
- 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;
- Conduct a process evaluation to document and monitor all Phase II project activities;
- Disseminate research findings to the scientific and practice communities;
- Create a provider training mechanism to promote dissemination and sustainability of the intervention;
- Based on our commercialization plan, implement a marketing strategy for the new primary prevention program aimed at elementary schools across the country.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LifeSkills for Elementary School (Intervention) | Experimental | Behavioral: Bullying preventionApproximately 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. |
| 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bullying preventionThe 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. | Behavioural | LifeSkills for Elementary School (Intervention) |
Primary outcome
Bullying/cyberbullying, norms, and attitudes at posttest
Time frame: Posttest (within 2 weeks of completing final classroom session/videogame module)
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.
Bullying and cyberbullying, norms, and attitudes at 24-month followup
Time frame: 24-month followup (within 24-25 months of completing the final classroom session and videogame module)
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.
Bullying/cyberbullying, norms, and attitudes at baseline
Time frame: Pretest (prior to participation in the first classroom session and videogame module of intervention)
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.
Bullying and cyberbullying, norms, and attitudes at 12-month followup
Time frame: 12-month followup (within 12-13 months of completing final classroom session and videogame module
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.
4 secondary outcomes
Bullying and cyberbullying, norms, and attitudes at pretest (prior to participating in the first classroom session and videogame module)
Time frame: 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)
Time frame: Posttest (within 2 weeks of completing final classroom session and videogame module)
Bullying and cyberbullying, norms, and attitudes at 12-month followup
Time frame: 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
Time frame: 24-month followup (within 24-25 months of completing final classroom session and videogame module
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Williams, PhD, MPH principal investigator
National Health Promotion Associates
Questions about this trial
What is this clinical trial studying?
A study testing Bullying prevention in people with Bullying and Cyberbullying, run by Christopher Williams.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Williams, PhD, MPH (914-421-2525 ext. 204, cwilliams@nhpamail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bullying/cyberbullying, norms, and attitudes at posttest (time frame: Posttest (within 2 weeks of completing final classroom session/videogame module)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.