Sexual AssaultNCT03820609
Interactive Digital Intervention to Prevent Violence Among Young Adults
A study testing Digital Intervention in people with Sexual Assault, run by Happy People Games, LLC at 2 sites in United States.
Trial summary
The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault
- What is being tested?
- Digital Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2018to 15 Aug 2018
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 24
- Enrolled as a student at one of the study sites
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clemson University
Clemson, South Carolina, 29634
Community College of Rhode Island
Warwick, Rhode Island, 02886
About this study
The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.
Read the detailed description
Sexual assault (SA) is prevalent among students at 2- and 4-year colleges. The rate of SA among college students is three times greater than the rate in the general population, making prevention on college campuses a public health priority. There are no college SA prevention programs that document reductions in SA in a rigorous research design. Digital applications that use the theory and strategies of serious games integrate proven theories of behavior change (social cognitive theory, self-determination theory) to produce sustained, measurable behavioral outcomes, and are effective for promoting change in a range of health behaviors. Digital applications have high market potential in light of widespread use of mobile devices among young adults. Problematically, there are no commercially-available digital applications for SA prevention with efficacy in reducing SA. Accordingly, in this proposal, the Interactive Digital Intervention to Prevent Violence among Young Adults team will design, create and pilot the Make a Change digital application. Make a Change is a universal prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building. This team consists of experts in SA prevention, commercial videogame production, the development and testing of serious games for health, and business development and marketing. The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.
- Conditions
- Sexual Assault
- Being tested
- Digital Intervention
- Keywords
- Sexual Assault, Digital Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital InterventionBehavioural
This digital application for sexual assault prevention can be completed on a tablet computer.
| Study group | Role | What they receive |
|---|---|---|
| Digital Intervention | Experimental | Make a Change is a universal sexual assault (SA) prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building. Receives: Behavioral: Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual aggression
Assessed via the Sexual Experiences Survey - Revised
Measured: 1-month follow-up
Sexual victimization
Assessed via the Sexual Experiences Survey - Revised
Measured: 1-month follow-up
Bystander intervention
Assessed via the Bystander Attitudes Survey
Measured: 1-month follow-up
Secondary outcomes (7)
Rape supportive beliefs
Assessed via the Short-Form Illinois Rape Myth Acceptance Scale
Measured: 1-month follow-up
Perception of peer support for sexual aggression
Assess through items from Boeringer's Social Norms Measure and Clemson's Peer Pressure Measure
Measured: 1-month follow-up
Perceived peer norms
Change in the accuracy in perception of peer norms (assessed via responses to in-app questions)
Measured: 1-month follow-up
Bystander intervention confidence
Assessed via the Bystander Efficacy Scale from ARC-3
Measured: 1-month follow-up
Communication of consent
Assessed via the Consent Experiences Scale
Measured: 1-month follow-up
Self-protective behavior
Assessed via the Alcohol Use Self-Protective Behavior Scale
Measured: 1-month follow-up
Psychological barriers to resistance
Assessed via the Psychological Barriers to Resistance Instrument
Measured: 1-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 posted29 Jan 2019
- Study start5 Jun 2018
- Primary completion15 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AssaultStudies 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
- Model description
- A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happy People Games, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University
- Responsible party
- Sponsor
- Investigators
- Sharon Wood, Principal investigator, Happy People Games
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820609
- Sponsor's protocol ID
- HappyPeopleGames
- Status last verified
- Apr 2019
- First submitted
- 30 Oct 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Digital Intervention to Prevent Violence Among Young Adults
- ClinicalTrials.gov ID
- NCT03820609
- Acronym / sponsor ID
- HappyPeopleGames
- Conditions
- Sexual Assault
- Keywords
- Sexual Assault, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Happy People Games, LLCUniversity, hospital or other
- Collaborators
- Clemson University
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 29 Jan 2019 (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.
The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.
Detailed description
Sexual assault (SA) is prevalent among students at 2- and 4-year colleges. The rate of SA among college students is three times greater than the rate in the general population, making prevention on college campuses a public health priority. There are no college SA prevention programs that document reductions in SA in a rigorous research design. Digital applications that use the theory and strategies of serious games integrate proven theories of behavior change (social cognitive theory, self-determination theory) to produce sustained, measurable behavioral outcomes, and are effective for promoting change in a range of health behaviors. Digital applications have high market potential in light of widespread use of mobile devices among young adults. Problematically, there are no commercially-available digital applications for SA prevention with efficacy in reducing SA. Accordingly, in this proposal, the Interactive Digital Intervention to Prevent Violence among Young Adults team will design, create and pilot the Make a Change digital application. Make a Change is a universal prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building. This team consists of experts in SA prevention, commercial videogame production, the development and testing of serious games for health, and business development and marketing. The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal.
| Arm | Type | Receives |
|---|---|---|
| Digital Intervention | Experimental | Behavioral: Digital InterventionMake a Change is a universal sexual assault (SA) prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18 and 24
- Enrolled as a student at one of the study sites
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Digital InterventionThis digital application for sexual assault prevention can be completed on a tablet computer. | Behavioural | Digital Intervention |
Primary outcome
Sexual aggression
Time frame: 1-month follow-up
Assessed via the Sexual Experiences Survey - Revised
Sexual victimization
Time frame: 1-month follow-up
Assessed via the Sexual Experiences Survey - Revised
Bystander intervention
Time frame: 1-month follow-up
Assessed via the Bystander Attitudes Survey
7 secondary outcomes
Rape supportive beliefs
Time frame: 1-month follow-up
Perception of peer support for sexual aggression
Time frame: 1-month follow-up
Perceived peer norms
Time frame: 1-month follow-up
Bystander intervention confidence
Time frame: 1-month follow-up
Communication of consent
Time frame: 1-month follow-up
Self-protective behavior
Time frame: 1-month follow-up
Psychological barriers to resistance
Time frame: 1-month follow-up
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 3 Apr 2019.
- Individual participant dataSharing planned: No. There is no IPD sharing plan.
Related trials for Sexual Assault
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
Active, not recruiting
uSafeUS+ App Pilot Testing
Alcohol Consumption, Sexual Assault
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.
Sharon Wood principal investigator
Happy People Games
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention in people with Sexual Assault, run by Happy People Games, LLC 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 2 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: finished, as of the sponsor's last update on 3 Apr 2019. 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?
Sexual aggression (time frame: 1-month follow-up). The study lists 3 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 3 Apr 2019.