- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04681495
Translating an In-Person Brief, Bystander Bullying Intervention (STAC) to a Technology-Based Intervention (STAC)
June 22, 2021 updated by: Klein Buendel, Inc.
School interventions to reduce bullying can be effective but also require substantial time and resources.
Online technologies have the potential to deliver effective bullying interventions to a large number of middle schools for less cost.
The feasibility of delivering the effective STAC bullying intervention through a mobile web app will be tested using a needs analysis with school administrators, focus groups with middle school students, and development and usability testing of a prototype.
Study Overview
Detailed Description
While studies support the efficacy of comprehensive, school-wide interventions in reducing bullying, these types of programs can require significant time and financial resources for implementation, resulting in barriers to providing school-based bullying prevention, especially in low-income and rural communities.
Additionally, although training bystanders to act as "defenders" on behalf of targets of bullying is an important intervention component, few programs include this as part of their comprehensive strategy.
Brief programs that focus on bystander training and require fewer resources are needed to reduce bullying and its negative consequences.
The PI (Dr.
Midgett) developed STAC, a brief, stand-alone bullying bystander intervention for middle school students, to reduce bullying and mental health risks for bystanders.
Brief, in-person programs, however, still pose implementation barriers such as training school personnel, providing external support, and not allowing for large groups of students to be trained at the same time.
For this project, we propose to develop a technology-based STAC intervention (STAC-T) that will allow students to customize their experience by selecting avatars and bullying scenarios based on our previous studies conducted in a range of middle schools, including those in low-income and rural communities.
The innovative, user-centered design proposed will be inherently sensitive to cultural needs of students and identify personally-appropriate strategies.
The specific aims of this application include conducting a needs analysis to determine product need, building a system prototype leveraging prior work and expertise of an external advisory board, and usability and effectiveness testing with middle school students and stakeholders to evaluate feasibility.
This proposal is designed to document proof of concept and finalizing design and content of the system which will be developed and tested in a subsequent randomized controlled trial.
The technology-based platform will increase the overall reach, impact, and sustainability of the STAC intervention for bullying prevention.
It will substantially reduce cost to increase reach and its interactivity and algorithms can tailor program content to adapt it further for students attending low-income and rural schools.
Thus, this low-cost, easy to disseminate technology-based bullying bystander intervention has the potential to have a substantial impact on the problem of bullying and the negative associated consequences for both students who are targets and bystanders in middle school when the problem of bullying peaks.
There is a large market for the STAC-T intervention with approximately 100,000 public and private schools with middle-school grades in the United States.
Globally, the online education market is growing at 10% a year and the digital health market exceeds $220 billion annually.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Golden, Colorado, United States, 80401
- Klein Buendel, Inc
-
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Idaho
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Boise, Idaho, United States, 83712
- Boise State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria (Students):
- Enrolled in grades 6, 7, 8, or 9 in a middle/junior high school in Idaho.
- Have a desire to make a positive difference at school, be mature, and have ability to positively engage socially with peers and adults as judged by school personnel.
- Speaks and reads English
- Parent consents and students assents for participation
Inclusion Criteria (School Personnel)
- Employed in a middle/junior high school in Idaho with grades 6, 7, 8, and/or 9.
- Employed as a principal, teacher, or school counselor
- Speaks and reads English
- Consents to participate
Exclusion Criteria (Students):
- Participated in a previous study on STAC
- Speaks and reads only a language other than English
- Does not consent/assent
Exclusion Criteria (School Personnel):
- Participated in a previous study on STAC
- Speaks and reads only a language other than English
- Does not consent/assent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Usability of Bullying Prevention Online Application
This intervention has a single arm.
It consists of conducting focus groups and usability testing of a bullying prevention online application for middle-school-aged students.
|
STAC is a brief, stand-alone bullying bystander intervention for middle school students, to reduce bullying and mental health risks for bystanders.
The primary outcome will be showing usability for the technology-based program (STAC-T) prototype.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Questionnaire
Time Frame: The SUS will be completed one time immediately following usability testing. The usability testing will last one hour and will be conducted in months 9 through 11 of the study..
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Participant perspective of program feasibility and bullying prevention promotion.
The System Usability Scale (SUS) is a reliable tool for measuring the usability of technologies.
It consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100.
Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.
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The SUS will be completed one time immediately following usability testing. The usability testing will last one hour and will be conducted in months 9 through 11 of the study..
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aida Midgett, PhD, LPC, Boise State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Midgett A, Doumas DM, Myers VH, Moody S, Doud A. Technology-Based Bullying Intervention for Rural Schools: Perspectives on Needs, Challenges, and Design. Rural Ment Health. 2021 Jan;45(1):14-30. doi: 10.1037/rmh0000151.
- Doumas DM, Midgett A, Myers V, Buller MK. Usability of a Technology-Based Bystander Bullying Intervention for Middle School Students in Rural, Low-Income Communities: Mixed Methods Study. JMIR Form Res. 2021 Oct 26;5(10):e32382. doi: 10.2196/32382.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2019
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
February 28, 2021
Study Registration Dates
First Submitted
December 11, 2020
First Submitted That Met QC Criteria
December 18, 2020
First Posted (Actual)
December 23, 2020
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 22, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 325
- 1R41MD014943-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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