- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171206
Free From Abuse: The Booster Project
A Brief Internet-delivered Intervention to Promote Healthy Relationships Among Young Adults: A Randomised Placebo-controlled Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
1. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sheffield, United Kingdom
- The University of Sheffield
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participants will not be eligible to enrol in the trial if they have visual and/or auditory deficits with regards to watching video clips.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Free From Abuse
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.
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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.
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|
Placebo Comparator: Technology and crime
This is a brief internet-delivered placebo intervention designed to inform participants about how the development of technology could affect crime.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
|
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Change in acceptance of myths about domestic violence
Time Frame: baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
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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
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baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in abuse perpetration
Time Frame: baseline, 4 weeks
|
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
|
baseline, 4 weeks
|
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Change in abuse victimisation
Time Frame: baseline, 4 weeks
|
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
|
baseline, 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Agata Debowska, PhD, University of Sheffield
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 031298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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