Bullying of ChildSTACNCT04681495
Translating an In-Person Brief, Bystander Bullying Intervention (STAC) to a Technology-Based Intervention
A study testing STAC in people with Bullying of Child and Bullying, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying of Child, Bullying
- What is being tested?
- STAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Sep 2019to 28 Feb 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Participated in a previous study on STAC
- Speaks and reads only a language other than English
- Does not consent/assent
- Participated in a previous study on STAC
- Speaks and reads only a language other than English
- Does not consent/assent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boise State University
Boise, Idaho, 83712
Klein Buendel, Inc
Golden, Colorado, 80401
About this study
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.
Read the 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.
- Conditions
- Bullying of Child, Bullying
- Being tested
- STAC
- Keywords
- Bullying, Bullying Prevention, Technology
- Medical subject headings
- Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STACBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usability of Bullying Prevention Online Application | Other | 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. Receives: Behavioral: STAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Questionnaire
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.
Measured: 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..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start24 Sep 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bullying of ChildStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Boise State University
- Responsible party
- Sponsor
- Investigators
- Aida Midgett, PhD, LPC, Principal investigator, Boise State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681495
- Sponsor's protocol ID
- 325
- Other IDs
- 1R41MD014943-01
- Acronym
- STAC
- Status last verified
- Jun 2021
- First submitted
- 11 Dec 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33777286Doumas 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.
PubMed 34582355
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating an In-Person Brief, Bystander Bullying Intervention (STAC) to a Technology-Based Intervention
- ClinicalTrials.gov ID
- NCT04681495
- Acronym / sponsor ID
- STAC / 325
- Conditions
- Bullying of Child, Bullying
- Keywords
- Bullying, Bullying Prevention, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Boise State University
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 Dec 2020 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability of Bullying Prevention Online Application | Other | Behavioral: STACThis 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. |
Who may qualify
- Ages
- 11 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Employed in a middle/junior high school in Idaho with grades 6, 7, 8, and/or 9.
Key exclusion criteria (6 listed)
- Participated in a previous study on STAC
- Speaks and reads only a language other than English
- Does not consent/assent
- Participated in a previous study on STAC
- Speaks and reads only a language other than English
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 |
|---|---|---|
| STACSTAC 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. | Behavioural | Usability of Bullying Prevention Online Application |
Primary outcome
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..
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Background: PubMed 33777286Midgett 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.
- Derived from this study: PubMed 34582355Doumas 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.
- 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.
Aida Midgett, PhD, LPC principal investigator
Boise State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAC in people with Bullying of Child and Bullying, run by Klein Buendel, Inc. at 2 sites 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04681495, which also lists 2 linked publications.
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 23 Jun 2021.