Condition category
Mental and Behavioural Disorders
Date applied
14/03/2019
Date assigned
30/09/2019
Last edited
30/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Domestic violence and abuse (DVA) is a serious public and clinical health problem. Programmes for men who perpetrate DVA exist but they vary widely in what they cover, how long they last and who delivers it. There is a lack of evidence of how and if they work for the men or the victims/survivors of DVA and whether they are cost effective.
We consulted DVA experts and researchers to develop a group domestic violence perpetrator programme (DVPP) to be delivered by facilitators from third sector organisations and lasting 23 weeks. This was tested in a small pilot study of 36 men and their partners or ex-partners and shown to be feasible. The aim of this study is to test on a larger scale whether a group DVPP can help men and their partners/ex-partners.

Who can participate?
In this study, we aim to recruit 366 male perpetrators of DVA from four regions (Bristol, Somerset, Wiltshire and South Wales). The study will be advertised within GP practices, social services, police, domestic abuse helplines and helplines for men. To participate, men must 21 years old or over and have used abusive behaviour in their current or previous relationships with women. They must have contact with that abused partner/ex-partner within the last 3 months at the time of recruitment. They must be able to complete questionnaires (this can be with the help of a researcher) and be able to participate in an english-speaking group setting. However potential male participants will be excluded if they are court mandated to attend a perpetrator programme, have ongoing private court cases or criminal justice investigations, are deemed too high risk (eg previous violence or aggression towards professionals), are not willing to engage with the intervention, are unable to engage or consent to participation or are unwilling to provide their partner/ex-partner contact details.
The partners or ex-partners of participating men will also be invited to take part in the study.

What does the study involve?
Men will be individually randomised such that for every three men, two will be allocated to the DVPP intervention and one will get usual care, which does not stop them from accessing other support. The participant's partners or ex-partners will be contacted to inform them of their participation, intervention ex-/partners will be offered dedicated support and all will be invited to take part in the study. The DVPP intervention men will be invited to attend 23-week group course of weekly DVPP sessions with 2 facilitators and occasional one-to-one sessions. All participants will be followed up for 12 months and asked to complete questionnaires at 4, 8 and 12 months after recruitment.
A subgroup of male and female participants (from intervention and control arms) and also facilitators delivering the intervention will be asked to take part in an interview substudy to explore their experiences and acceptability of the study/intervention. We will monitor how well the intervention is implemented (by observing the sessions as part of a process evaluation). We will also run a cost-effectiveness analysis.

What are the possible benefits and risks of participating?
The possible benefits of participating are that men have a two-thirds chance of getting a place on a group programme for men who are concerned about their behaviour in relationships with women. This will provide a supportive environment, working through a structured programme to help men change their behaviours. Taking part in the study will provide evidence of whether these programmes are helpful to men. It may be of wider benefit to other men and aims improve the safety for women and children. Other possible benefits are that partners or ex-partners will have dedicated support from a women’s safety worker.
The disadvantages of taking part are that participants have to commit to attending a weekly 23-week domestic violence group programme. People may find it hard to talk in a group about their feelings and circumstances, but everyone will be in a similar situation. Participants in the control group may be disappointed if they are not allocated to the intervention group. All participants will be asked to complete questionnaires over a 12 month period which may take some time and ask some difficult questions about their behaviours.
Given the nature of domestic violence, there is a risk concerning the safety of the participant, their partner/ex-partner and possibly their children. Safeguarding of all parties is of paramount importance.

Where is the study run from?
The study is run from the University of Bristol in partnership with RESPECT, Splitz Support services (Trowbridge, Wiltshire), Nextlink (Bristol), Barnados (Taunton, Somerset), and Phoenix Domestic Abuse Services (Blaina, Gwent).

When is the study starting and how long is it expected to run for?
April 2019 to August 2021

Who is funding the study?
National Institute of Health Research (NIHR) (UK)

Who is the main contact?
Dr Mei-See Man
mei-see.man@bristol.ac.uk

Trial website

http://www.bristol.ac.uk/primaryhealthcare/researchthemes/reprovide/group-intervention-for-men/

Contact information

Type

Scientific

Primary contact

Dr Mei-See Man

ORCID ID

http://orcid.org/0000-0003-4948-5670

Contact details

Population Health Sciences
Medical school
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+441173314506
mei-see.man@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41244

Study information

Scientific title

The effectiveness and cost-effectiveness of a group programme for men who are concerned about their abusive behaviour in relationships with women: A randomised controlled trial

Acronym

RCTofDVPP

Study hypothesis

Hypothesis: a 23-week weekly community based domestic violence perpetrator programme (DVPP) will reduce men's abusive behaviour against their partners or ex-partners and improve their health and wellbeing.
The primary objective is to determine the efficacy of the domestic violence perpetrator programme (DVPP) intervention.
The secondary objectives are:
1. Assess the effect of the perpetrator intervention on measures of DVA, health and wellbeing of the male participant, plus reports of police incidents.
2. Assess the effect of the intervention on measures of experience of DVA, health and wellbeing of female partners and ex-partners
3. To compare the costs and consequences of the intervention from the NHS and Personal Social Services (PSS), public and societal perspectives
4. Determine acceptability of the intervention to perpetrators, victims/survivors and professionals working with perpetrators and with victims/survivors
5. Through mixed methods process evaluation (interviews and routine data), to explore the extent to which the intervention was implemented, fidelity to the intervention, how and why the intervention was or was not beneficial.

Ethics approval

IRAS number 261128
REC ref 19/SC/0171
South Central - Oxford B REC
Booked onto REC meeting on 09/04/2019

Study design

Pragmatic parallel group individually randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Perpetrators and victims of domestic violence and abuse

Intervention

The Domestic Violence Perpetrator Programme (DVPP) intervention is a complex behavioural group intervention for men. It consists of a weekly 23-week group programme with at least three one-to-one individual sessions, and an optional monthly relapse prevention group (RPG) for an additional 6 months following completion of the programme. The group sessions will be run by two experienced DVPP facilitators (preferably one male and one female) trained on the intervention manual.

The weekly group sessions will cover themes including: goal identification and goal setting; recognising abuse; denial and minimisation; intents of violence; basic anger management; identifying urges to perpetrate abuse and cooling-down strategies; basic CBT; effects of DVA on partners and children; participant’s own childhood experiences; impacts on children; active listening; conflict resolution; masculinity; beliefs and expectations; sexual respect; attachment styles; building empathy; loving relationships; emotional abuse; and accountability.
Individual sessions will be tailored for participants’ needs following the initial and ongoing assessment. Possible individual interventions might include deconstructing specific incidents of abuse; accountability letters or planning discussions with partner or children; relaxation or emotional regulation work. The delivery team may refer or signpost to other specialist services (eg drug or alcohol services), as part of their service.

Women's intervention: Women partners or ex-partners of men who are allocated to the intervention arm will be contacted by a designated women’s safety worker as part of the intervention. It is the woman’s decision whether she engages with the women’s safety worker. Women can engage with the women’s safety worker and decline to take part in the research, or they can take part in the research and decline the women’s safety worker supporter, or they can accept or decline both.
Women’s safety workers offer support to women regardless of their situation eg if they do or do not want to leave their abusive partner, if they need to go to a safehouse etc. Practical and emotional support is given to help victims keep safe, help connect them with their communities and planning for the future.

Usual Care Control arm: Men who are allocated to the usual care control arm will not receive any intervention or referrals from the research team, however they are free to access any other services available to them as part of their usual care. The research team may signpost to other appropriate services (e.g. mental health services) if it is felt to be appropriate and/or necessary.
All women regardless of their partners’ allocation will be signposted to women’s support services.

Randomisation is by an automated computer system run by the Bristol Randomised Trial Collaboration-Bristol Trials Centre. After consent and baseline data collection, participants will be randomly allocated on a 2:1 ratio to the intervention or control arm. The randomisation algorithm will include stratification by site (4 sites) and minimisation by relationship status (whether or not they are still in a relationship with the abused partner). The participant will be told immediately of the allocation and the next steps involved. Certain members of the research team (statistician and health economist) will be blinded to the allocation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Men's self report of abuse, as measured by the revised Abusive Behaviour Inventory (ABI-R) at 12 months post randomisation

Secondary outcome measures

1. Revised Abusive Behaviour Inventory (ABI-R) at baseline, 4 and 8 months
2. Communications Patterns Questionnaire - short form (CPQ-SF) at baseline, 4, 8 and 12 months
3. Propensity for Abusiveness Scale (PAS) at baseline, 4, 8 and 12 months
4. Adapted Intimate Partner Violence Responsibility Attribution Scale (IPVRAS) at baseline 4, 8 and 12 months
5. Patient Health Questionnaire (PHQ-9) at baseline, 4, 8 and 12 months
6. Generalised Anxiety Disorder assessment (GAD-7) at baseline 4, 8, and 12 months
7. Primary Care PTSD screen (PC-PTSD) at baseline, 4, 8 and 12 months
8. Health related quality of life (EQ-5D-5L) at baseline 4, 8 and 12 months
9. ICEpop CAPability measure for adults (ICECAP-A) at baseline, 4, 8 and 12 months
10. Alcohol Use Disorders Identification Test (AUDIT-C) at baseline and 12 months
11. Drug Use Disorders Identification Test (DUDIT) at baseline and 12 months
12. Short Form health questionnaire - 12 (SF-12) at baseline and 12 months
13. Child health utility (CHU-9D) at baseline, 4, 8 and 12 months for female participants only
14. Use of health services (questionnaire measures) at baseline, 4, 8 and 12 months
15. Police reports of DV incidents at 12 months prior to participation and during 12-month study
16. Cost effectiveness, measured as cost per QALY at 12 months
17. Reflective Functioning Questionnaire at baseline and 12 months

Overall trial start date

01/04/2019

Overall trial end date

31/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria for male participants:
1. > 21 years of age
2. Use of abusive behaviour in current or previous relationships with women partner(s) or ex-partner(s) and concerned about that behaviour
3. Ability to complete outcome questionnaires with or without the assistance of the researcher
4. Need to be able to understand and participate in an English-speaking group setting
5. Must have contact with an abused partner or ex-partner within the last three months at the time of recruitment

Inclusion criteria for partners or ex-partners:
1. Female partners or ex-partners of men using violence/abuse in their relationships
2. Age > 18 years
3. Ability to complete outcome questionnaires with or without the assistance of the researcher

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

366 male participants and up to 220 female (ex-) partners (England – 274 males, 165 females, Wales – 92 males, 55 females)

Participant exclusion criteria

Exclusion criteria for male participants:
1. Court mandated referral to perpetrator programme
2. Men who are deemed too high risk as assessed by a programme co-ordinator or by the research team
3. Men who are deemed by the programme coordinator as not willing to engage with the intervention.
4. Men with known previous violence or aggression towards professionals
5. Participants who cannot understand the English language sufficiently well to give informed consent and to complete the questionnaires (with or without assistance) or to participate in a group setting.
6. Participants unable to consent to and engage with a group programme (this may include, and is not limited to, persons with a serious mental health difficulty, serious learning disability or unstable substance misuse difficulties)
7. Men who have private court cases ongoing regarding child custody / access
8. Men who have ongoing criminal justice investigations for a DVA incident towards a partner or ex-partner (i.e. waiting to hear if will be going to court or waiting for a court date)
9. Men who are unwilling or unable to provide partner / ex-partner details to enable the research team to contact them.
10. Men who fall outside the catchment areas (for the purposed of collecting data on police records).

Exclusion criteria for partners/ex-partners:
1. Participants who cannot understand English sufficiently well to give informed consent and to complete the questionnaires (with or without assistance).
2. Women who are deemed (by the women’s safety worker, DVPP coordinator or research team) to be put at greater risk if they take part in the study.

Recruitment start date

21/10/2019

Recruitment end date

31/07/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Population Health Sciences Medical school Canynge Hall 39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

University of Bristol
One Cathedral Square
Bristol BS1 5DD
Bristol
Bristol BS1 5DD
United Kingdom
44 117 428 4011
research-governance@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bristol.ac.uk

Funders

Funder type

Not defined

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists intend to publish the main findings in high-impact peer-reviewed journals, and a longer report in the NIHR journals library within a year of project completion.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository

The anonymised datasets generated and analysed during the current study will be stored in a publically available repository, https://data.bris.ac.uk/data/ , as .csv, .doc, .txt etc files, depending on whether this is survey or interview data and how it is exported/collated, for a minimum of 20 years from the date of publication. The data will be available to bona fide researchers, for research purposes, by application and assessment by the University of Bristol's Data Access Committee, and subject to a Data Access Agreement, as consented by participants. Direct identifiers/dates of birth/study group/dates/place names etc will be removed and the data anonymised before depositing in the repository. The research is currently under ethical review by South Central-Oxford B REC.

Intention to publish date

31/07/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes