BullyingNCT03205059
An Evidence-based Approach for Bullying Prevention
A study testing LST MS curriculum+ Bullying/Cyberbulling serious game and LST MS curriculum in people with Bullying and Cyberbullying, run by National Health Promotion Associates, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying, Cyberbullying, Substance Use
- What is being tested?
- LST MS curriculum+ Bullying/Cyberbulling serious game and LST MS curriculum
- 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
- 1 siteUnited States
- Study dates
- 1 Jun 2017to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Middle school aged-youth
Who cannot join
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Health Promotion Associates
White Plains, New York, 10604
Christopher Williams, 914-421-2525, cwilliams@nhpamail.com
About this study
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.
- Conditions
- Bullying, Cyberbullying, Substance Use, Substance Abuse
- Being tested
- LST MS curriculum+ Bullying/Cyberbulling serious game, LST MS curriculum
- Medical subject headings
- Bullying, Cyberbullying, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LST MS curriculum+ Bullying/Cyberbulling serious gameBehavioural
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 curriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LST MS curriculum+ Bullying/Cyberbullying serious game | Experimental | Not described Receives: Behavioral: LST MS curriculum+ Bullying/Cyberbulling serious game |
| LST MS curriculum | Active comparator | Not described Receives: Behavioral: LST MS curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jun 2017
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (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
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Promotion Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Christopher Williams, National Health Promotion Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205059
- Sponsor's protocol ID
- R44HD074319-02
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2017
- Last updated
- 7 Jan 2019
- 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 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence-based Approach for Bullying Prevention
- ClinicalTrials.gov ID
- NCT03205059
- Acronym / sponsor ID
- R44HD074319-02
- Conditions
- Bullying, Cyberbullying, Substance Use, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Health Promotion Associates, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 2 Jul 2017 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Middle school aged-youth
Key exclusion criteria (1 listed)
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
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 |
|---|---|---|
| LST MS curriculum+ Bullying/Cyberbulling serious gameThe 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. | Behavioural | LST MS curriculum+ Bullying/Cyberbullying serious game |
| LST MS curriculumThe 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. | Behavioural | LST MS curriculum |
Primary outcome
Change in bullying/cyberbullying perpetration in the past two years
Time frame: Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LST MS curriculum+ Bullying/Cyberbulling serious game and LST MS curriculum in people with Bullying and Cyberbullying, run by National Health Promotion Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Williams (9144212525, cwilliams@nhpamail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bullying/cyberbullying perpetration in the past two years (time frame: Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up). 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 7 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.