Condition category
Mental and Behavioural Disorders
Date applied
19/07/2012
Date assigned
01/08/2012
Last edited
31/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Mental health service users report higher rates of domestic violence than other healthcare service users and the general population. However, when mental health service users disclose domestic violence, the response of mental health services is frequently thought to be inadequate. Despite increasing evidence of community and primary healthcare treatments in improving outcomes for victims of domestic violence, there are few treatments for victims in contact with secondary mental health services. We developed and conducted a pilot study for a future larger study of a domestic violence advocacy treatment in community mental health services.

Who can participate?
This pilot study aimed to recruit mental health professionals caring for service users, and approximately 75-80 male and female service users (aged 18-65 years) who disclosed domestic violence in the past 12 months across five community mental health services in London, England.

What does the study involve?
Of the five participating community-based outpatient mental health services, three were allocated as intervention groups and two were allocated as control groups. The three intervention groups received domestic violence education to improve clinicians’ competencies in addressing domestic violence (this consisted of two 2-hour training sessions on how to identify and respond to domestic violence, followed by regular team meetings with domestic violence advisors who provided ongoing advice, education and assistance to professionals), education of advocates about mental health services and service users, and a direct referral pathway to an advocacy treatment for male and female mental health service users experiencing domestic violence. Advocacy involved outreach work, support, advice and information, including work to increase personal safety. The two control groups received treatment as usual.

What are the possible benefits and risks of participating?
For participating mental health professionals, benefits may include improvements in knowledge and competence in responding to domestic violence experienced by service users; no risks have been identified. For service users, benefits may include improvements in quality of life, reduction in unmet needs, decreased abuse and improvement in mental symptoms. Risks may include increasing abuse if perpetrator knows the abuse has been disclosed and that the service user is receiving advocacy; and emotional distress when disclosing abuse and receiving advocacy. Therefore, a standard operating procedure and safety protocol aimed to minimise the risk for service users. Additionally, no written information about the study was taken away by service users, unless it was safe for them to do so, and all participants (including those in control teams) were provided with information about support services.

Where is the study run from?
Institute of Psychiatry, Kings College London (UK).

When is it starting and how long is it expected to run from?
The two-year study started in May 2009 and finished in May 2011

Who is funding the study?
The project was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit Programme.

Who is the main contact?
Dr Louise M. Howard, Professor in Women’s Mental Health

Trial website

Contact information

Type

Scientific

Primary contact

Ms Kylee Trevillion

ORCID ID

Contact details

South London and Maudsley NHS Trust
Section of Women's Mental Health
16 De Crespigny Park
London
SE5 8AF
United Kingdom
kylee.trevillion@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4409

Study information

Scientific title

Linking Abuse and Recovery through Advocacy: an observational study

Acronym

LARA

Study hypothesis

High rates of domestic violence are experienced by mental health service users but most domestic violence is undetected by mental health services and when disclosure occurs, the response of services is often inadequate. Domestic violence advocates can reduce abuse, and improve quality of life, in the general population but there are no studies examining advocacy for mental health service users. This intervention will be developed for mental health services after carrying out relevant qualitative studies examining the experiences of service users and professionals when domestic violence is disclosed. A pilot randomised controlled trial will then examine the feasability of a future larger trial to evaluate this intervention.

Ethics approval

The Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 01 November 2007 ref: 07/H0807/66

Study design

Non-randomised interventional and observational trial

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Mental Health Research

Intervention

Five community-based outpatient mental health services were allocated to the intervention (n=3) and control (n=2) groups. As this was a pilot study we did not randomly allocate services and instead determined allocation by grouping services that shared the same building (to avoid problems of contamination). Intervention and control groups were followed up over two years.

The three intervention groups received:
1. Two 2 hour sessions of domestic violence training for mental health professionals (on entry to study), illustrating how to identify, respond and document domestic violence
2. Domestic violence manual for mental health professionals (developed by the research team), which included guidelines for good practice and details of local and national domestic violence services.
3. Direct referral pathway to a domestic violence advocacy intervention for service users identified by clinicians as experiencing violence.
4. Provision of integrated domestic violence advocacy for service users (delivered by two named domestic violence advisors who received mental health training). Advocacy incorporated specialist emotional and practical support, including safety planning and referrals to other agencies
5. Regular attendance by domestic violence advisors at staff meetings, to discuss clinical cases and provide ongoing domestic violence education.
6. Information campaign in CMHTs (posters and leaflets in the waiting room and toilets) highlighting the problem of domestic violence and support available.

The two control groups receive treatment as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To explore the feasibility of a future larger study of domestic violence advocacy

Secondary outcome measures

To pilot cost measures and outcomes, including professionals’ knowledge, attitudes and behaviours towards domestic violence and service users experience of domestic violence, use of safety behaviours, unmet needs and quality of life.

Overall trial start date

01/04/2008

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Service users in contact with Community Mental Health Teams (CMHTs)
2. Male & female participants
3. Aged 18 - 65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 112; Description: Sample size for qualitative study is 40. Pilot trial sample size yet to be determined.

Participant exclusion criteria

Service users deemed by clinicians to be too unwell to enter the study

Recruitment start date

01/04/2008

Recruitment end date

01/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Trust
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

South London and Maudsley NHS Trust (UK)

Sponsor details

Michael Rutter Centre for Children
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.slam.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19891808
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21160053

Publication citations

  1. Protocol

    Howard LM, Trevillion K, Khalifeh H, Woodall A, Agnew-Davies R, Feder G, Domestic violence and severe psychiatric disorders: prevalence and interventions., Psychol Med, 2010, 40, 6, 881-893, doi: 10.1017/S0033291709991589.

  2. Protocol

    Rose D, Trevillion K, Woodall A, Morgan C, Feder G, Howard L, Barriers and facilitators of disclosures of domestic violence by mental health service users: qualitative study., Br J Psychiatry, 2011, 198, 3, 189-194, doi: 10.1192/bjp.bp.109.072389.

Additional files

Editorial Notes