ISRCTN ISRCTN79430721
DOI https://doi.org/10.1186/ISRCTN79430721
Secondary identifying numbers 4409
Submission date
19/07/2012
Registration date
01/08/2012
Last edited
01/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Ms Kylee Trevillion
Scientific

South London and Maudsley NHS Trust
Section of Women's Mental Health
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Email kylee.trevillion@kcl.ac.uk

Study information

Study designNon-randomised interventional and observational trial
Primary study designObservational
Secondary study designOther
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleLinking Abuse and Recovery through Advocacy: an observational study
Study acronymLARA
Study objectivesHigh 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(s)The Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 01 November 2007 ref: 07/H0807/66
Health condition(s) or problem(s) studiedMental Health Research
InterventionFive 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 typeOther
Primary outcome measureTo explore the feasibility of a future larger study of domestic violence advocacy
Secondary outcome measuresTo 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 study start date01/04/2008
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUK Sample Size: 112; Description: Sample size for qualitative study is 40. Pilot trial sample size yet to be determined.
Key inclusion criteria1. Service users in contact with Community Mental Health Teams (CMHTs)
2. Male & female participants
3. Aged 18 - 65 years
Key exclusion criteriaService users deemed by clinicians to be too unwell to enter the study
Date of first enrolment01/04/2008
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

South London and Maudsley NHS Trust (UK)
Hospital/treatment centre

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

Website http://www.slam.nhs.uk/
ROR logo "ROR" https://ror.org/015803449

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/06/2010 Yes No
Results article resultsl 01/03/2011 Yes No
Results article results 01/03/2014 Yes No

Editorial Notes

01/10/2018: Publication reference added.