Free From Abuse: The Booster Project

November 4, 2020 updated by: University of Sheffield

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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);
  2. 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);
  3. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • Sheffield, United Kingdom
        • The University of Sheffield

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Free From Abuse
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.
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.
Other: Technology and crime
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks
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
baseline, immediately post intervention - an average of 1 hour, 1 week, 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sheffield

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Huddersfield

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Agata Debowska, PhD, University of Sheffield

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 031298

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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