Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592872
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N30 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None