Violence, Gender-BasedNCT04171206
Free From Abuse: The Booster Project
A study testing Free From Abuse and Technology and crime in people with Violence, Gender-Based and Violence, Domestic, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
This project is designed to develop and test a brief internet-delivered intervention to promote healthy relationships among young adults. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence, Gender-Based, Violence, Domestic
- What is being tested?
- Free From Abuse and Technology and crime
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 15 Jul 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be university students aged between 18-24 years, reside in the UK, have access to a computer and internet connection, and be fluent in English.
Who cannot join
- Participants will not be eligible to enrol in the trial if they have visual and/or auditory deficits with regards to watching video clips.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Internet-delivered Intervention to Promote Healthy Relationships Among Young Adults: A Randomised Placebo-controlled Pilot Study
This project is designed to develop and test a brief internet-delivered intervention to promote healthy relationships among young adults.
Read the detailed description
In spite of the fact that young adults are at an increased risk of experiencing and perpetrating intimate partner violence (IPV), there is a lack of universal and widely accessible prevention programmes targeted at this age group. One of the reasons for this may be that it is difficult to deliver a universal prevention to individuals who are not formally grouped through one organisation, such as employed young adults. Those who are formally grouped, such as university students, are unlikely to take part in a lengthy prevention programme which is not a part of an official curriculum. Therefore, there is a need for widely available, accessible, and efficacious IPV prevention programmes that could be appropriate for all young adults regardless of gender. Since many young adults in contemporary Western societies were exposed to some kind of relationship education in schools, it may be that a brief programme will suffice to further boost their awareness of IPV and reduce IPV perpetration and victimisation risk. Therefore, we propose a brief internet-based intervention, Free From Abuse - The Booster Project, to achieve these objectives.
Primary objectives:
- To investigate the acceptability and feasibility of the internet-delivered intervention to university students (determined using the 1 and 4-week follow-up rates, % of participants who correctly answered control questions assessing compliance);
- To assess the acceptability and feasibility of the outcome measures as methods to measure effectiveness of the intervention within a definitive trial (determined using % of missing data);
- To estimate the standard deviation (SD) for the continuous outcomes to inform sample size calculations for a definitive trial.
Secondary objective:
- To evaluate the potential effectiveness of the brief internet-delivered intervention, Free From Abuse - The Booster Project, in increasing recognition of abusive behaviour, as well as reducing acceptance of myths about domestic violence, abuse perpetration, and abuse victimisation among young university students compared with placebo.
- Conditions
- Violence, Gender-Based, Violence, Domestic
- Being tested
- Free From Abuse, Technology and crime
- Keywords
- Interpersonal partner violence, Dating violence, Internet-delivered intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free From AbuseOther
Participants in the treatment arm will watch a 15-minute talk given by an adult female survivor of IPV who tells the story of her abusive relationship. After watching the video, participants will read information on 10 signs of an unhealthy relationship. The intervention will take approximately 25 minutes to complete.
Technology and crimeOther
Participants in the placebo control arm will watch a 19-minute talk on technology development and crime. After watching the video, participants will read 10 facts about cyber security. The intervention will take approximately 25 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Free From Abuse | Experimental | This is a brief internet-delivered intervention designed to boost participants' ability to recognise abusive behaviour, reduce acceptance of myths related to domestic violence and IPV, as well as decrease abuse perpetration and victimisation. Receives: Other: Free From Abuse |
| Technology and crime | Placebo comparator | This is a brief internet-delivered placebo intervention designed to inform participants about how the development of technology could affect crime. Receives: Other: Technology and crime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in recognition of abusive behaviour
Recognition of adolescent relationship abuse (ARA) scale (Rothman, Decker, \& Silverman, 2006); scores on this 12-item self-report scale range from 12 to 60, with higher scores indicating an increased recognition of abusive behaviour
Measured: baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
Change in acceptance of myths about domestic violence
Domestic Violence Myth Acceptance Scale (DVMAS; Peters, 2008); scores on this 18-item self-report scale range from 18 to 108, with higher scores indicating an increased acceptance of myths about domestic violence
Measured: baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
Secondary outcomes (2)
Change in abuse perpetration
Safe Dates - Psychological Abuse Perpetration scale (Foshee et al., 1996, 1998); scores on this 14-item self-report scale range from 14 to 56, with higher scores indicating an increased abuse perpetration
Measured: baseline, 4 weeks
Change in abuse victimisation
14-item Safe Dates - Psychological Abuse Victimisation scale (Foshee et al., 1996, 1998); scores on this 14-item self-report scale range from 14 to 56, with higher scores indicating an increased abuse victimisation
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Dec 2019
- Primary completion15 Mar 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, Gender-BasedStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Huddersfield
- Responsible party
- Sponsor
- Investigators
- Agata Debowska, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171206
- Sponsor's protocol ID
- 031298
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Internet-delivered Intervention to Promote Healthy Relationships Among Young Adults: A Randomised Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04171206
- Acronym / sponsor ID
- 031298
- Conditions
- Violence, Gender-Based, Violence, Domestic
- Keywords
- Interpersonal partner violence, Dating violence, Internet-delivered intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Huddersfield
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 20 Nov 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.
This project is designed to develop and test a brief internet-delivered intervention to promote healthy relationships among young adults.
Detailed description
In spite of the fact that young adults are at an increased risk of experiencing and perpetrating intimate partner violence (IPV), there is a lack of universal and widely accessible prevention programmes targeted at this age group. One of the reasons for this may be that it is difficult to deliver a universal prevention to individuals who are not formally grouped through one organisation, such as employed young adults. Those who are formally grouped, such as university students, are unlikely to take part in a lengthy prevention programme which is not a part of an official curriculum. Therefore, there is a need for widely available, accessible, and efficacious IPV prevention programmes that could be appropriate for all young adults regardless of gender. Since many young adults in contemporary Western societies were exposed to some kind of relationship education in schools, it may be that a brief programme will suffice to further boost their awareness of IPV and reduce IPV perpetration and victimisation risk. Therefore, we propose a brief internet-based intervention, Free From Abuse - The Booster Project, to achieve these objectives.
Primary objectives:
- To investigate the acceptability and feasibility of the internet-delivered intervention to university students (determined using the 1 and 4-week follow-up rates, % of participants who correctly answered control questions assessing compliance);
- To assess the acceptability and feasibility of the outcome measures as methods to measure effectiveness of the intervention within a definitive trial (determined using % of missing data);
- To estimate the standard deviation (SD) for the continuous outcomes to inform sample size calculations for a definitive trial.
Secondary objective:
- To evaluate the potential effectiveness of the brief internet-delivered intervention, Free From Abuse - The Booster Project, in increasing recognition of abusive behaviour, as well as reducing acceptance of myths about domestic violence, abuse perpetration, and abuse victimisation among young university students compared with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free From Abuse | Experimental | Other: Free From AbuseThis is a brief internet-delivered intervention designed to boost participants' ability to recognise abusive behaviour, reduce acceptance of myths related to domestic violence and IPV, as well as decrease abuse perpetration and victimisation. |
| Technology and crime | Placebo comparator | Other: Technology and crimeThis is a brief internet-delivered placebo intervention designed to inform participants about how the development of technology could affect crime. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must be university students aged between 18-24 years, reside in the UK, have access to a computer and internet connection, and be fluent in English.
Key exclusion criteria (1 listed)
- Participants will not be eligible to enrol in the trial if they have visual and/or auditory deficits with regards to watching video clips.
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 |
|---|---|---|
| Free From AbuseParticipants in the treatment arm will watch a 15-minute talk given by an adult female survivor of IPV who tells the story of her abusive relationship. After watching the video, participants will read information on 10 signs of an unhealthy relationship. The intervention will take approximately 25 minutes to complete. | Other | Free From Abuse |
| Technology and crimeParticipants in the placebo control arm will watch a 19-minute talk on technology development and crime. After watching the video, participants will read 10 facts about cyber security. The intervention will take approximately 25 minutes to complete. | Other | Technology and crime |
Primary outcome
Change in recognition of abusive behaviour
Time frame: baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
Recognition of adolescent relationship abuse (ARA) scale (Rothman, Decker, \& Silverman, 2006); scores on this 12-item self-report scale range from 12 to 60, with higher scores indicating an increased recognition of abusive behaviour
Change in acceptance of myths about domestic violence
Time frame: baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
Domestic Violence Myth Acceptance Scale (DVMAS; Peters, 2008); scores on this 18-item self-report scale range from 18 to 108, with higher scores indicating an increased acceptance of myths about domestic violence
2 secondary outcomes
Change in abuse perpetration
Time frame: baseline, 4 weeks
Change in abuse victimisation
Time frame: baseline, 4 weeks
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 6 Nov 2020.
- 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.
Agata Debowska, PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free From Abuse and Technology and crime in people with Violence, Gender-Based and Violence, Domestic, run by University of Sheffield at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 6 Nov 2020. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Change in recognition of abusive behaviour (time frame: baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks). The study lists 2 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 6 Nov 2020.