Condition category
Mental and Behavioural Disorders
Date applied
17/06/2015
Date assigned
19/06/2015
Last edited
17/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
Domestic abuse (DA) has major physical and emotional consequences for victims estimated to cost the UK economy £15.7bn per year. One woman in the UK is killed by her partner every five days, and 30% of women and 16% of men are exposed to DA in their lifetime. The health and social consequences for victim survivors and their children negatively affect work and society, and include poor physical health and an increased risk of depression, anxiety disorders, and problems with alcohol and drug abuse. The present study aims to evaluate a new programme for DA perpetrators building on what works with generally violent offenders. Existing DA programmes have not been shown to work, which may because they focus on non-predictive factors such as educating men about power and control dynamics. The National Institute of Clinical Effectiveness (NICE, 2013) Guidelines recommended research to determine the effectiveness of tailored intervention programmes.

Who can participate?
Men that admit they use unhealthy behaviours in their current relationship and want to change these behaviours.

What does the study involve?
Participants are randomly assigned to one of three groups; the programme with risk assessment/monitoring; usual support with risk assessment/monitoring; or usual support without risk assessment/monitoring. Usual support includes referral to mental health or substance misuse services. The study compares the three groups on rates of violence at 12 months as recorded by the police or reported by the partner during the study period.

What are the possible benefits and risks of participating?
The benefit of participating is a change in behaviour in the participants via changes in underpinning thoughts and feelings, leading to improved quality of life for victims. There are no risks to participation other than the theoretical possibility of reduced disclosure by the victim due to wanting his/her partner to remain in treatment. Reassurances will be provided to partners to mitigate this possibility.

Where is the study run from?
Portsmouth City and Hampshire County Council premises (Havant, Gosport, and Fareham).

When is the study starting and how long is it expected to run for?
June 2015 to September 2017

Who is funding the study?
Funding is being sought

Who is the main contact?
Dr Dominic Pearson
dominic.pearson@port.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Dominic Pearson

ORCID ID

Contact details

Department of Psychology
King Henry Building
King Henry I Street
Portsmouth
PO1 2DY
United Kingdom
02392846635
dominic.pearson@port.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of the 'Up2U' domestic abuse perpetrator programme's impact on violence, costs, and quality of life for victims, compared to usual community support.

Acronym

Study hypothesis

To determine whether 'Up2U' will reduce violence by perpetrators and increase quality of life ratings of partners, compared to usual support only, i.e., the standard coordinated agency response, over a 12 month period.

Ethics approval

Department of Psychology Ethics Committee, University of Portsmouth, UK, 28/05/2015

Study design

Interventional open randomised controlled trial with three study branches (to collapse to two, if no difference between the control arms)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Perpetration of violence and abuse against an intimate partner, with physical and mental health consequences for the victim/survivor.

Intervention

Up2U: Creating Healthy Relationships is a modular group-work therapy programme of six to nine months duration delivered in the community to voluntary referrals, supplementing usual support. Up2U was developed by Portsmouth City Council based on the principles of effective practice in offender rehabilitation, including the training and reinforcement of cognitive skills to moderate the associated underpinning dynamic risk factors for violence. The control arms will simply comprise usual community support with risk assessment and monitoring as for the intervention arm, and without assessment and monitoring. If usual support with assessment and monitoring is no different on the primary outcome measures to usual support alone then the two arms will be collapsed to produce a simple two armed trial. Usual support includes fragmented agency support for relevant needs, which may or may not be coordinated by a multi-agency community panel (e.g., MARAC).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Violent re-offending at 12 months as indexed by the frequency of official reports (arrests or cautions), or partner reports (police distress calls).

Secondary outcome measures

1. Partner Quality of Life rated at 6 and 12 months using the SF-12 and the EQ-5D
2. Risk of Re-offending as assessed at 6 and 12 months using the LS/RNR

Overall trial start date

01/06/2015

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. To be eligible for referral a person must accept that they use abusive or unhealthy behaviours in their relationship and want to change these behaviours.
2. Referrals must be adult males or females in a relationship, including same sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Major mental health or substance misuse problems that preclude participation will need to be stabilised prior to assignment to intervention. These clients can be re-screened for inclusion by re-referral via the substance misuse or mental health professional once they have assessed the client as stable.

Recruitment start date

01/07/2015

Recruitment end date

01/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of Portsmouth

Sponsor details

University House
Winston Churchill Avenue
Portsmouth
PO1 2UP
United Kingdom
023 9284 8484
info.centre@port.ac.uk

Sponsor type

University/education

Website

Organisation

University of York

Sponsor details

York Trials Unit
Department of Health Sciences
York
YO10 5DD
United Kingdom
01904 321321
dohs-enquiries@york.ac.uk

Sponsor type

Research organisation

Website

http://www.york.ac.uk/healthsciences/research/trials/

Funders

Funder type

Not defined

Funder name

Being sought

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes