Condition category
Mental and Behavioural Disorders
Date applied
30/06/2010
Date assigned
30/06/2010
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Hill

ORCID ID

Contact details

Room 3.305
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6283

Study information

Scientific title

Evaluation of the RESETTLE project (formerly Community Risk Assessment and Management Service) for Released High Risk Prisoners

Acronym

RESETTLE

Study hypothesis

To establish whether a co-ordinated community psychosocial provision for personality disordered offenders is effective in producing both beneficial changes in individuals and reducing social exclusion and reducing risk and thus increasing public protection.

Case participants will be randomly allocated to the Resettle project, formerly known as CRACMS (Community Risk Assessment and Case Management Service). The Resettle intervention will involve the offender spending time on a regular basis on the Resettle site. During this time they will be interacting in a social therapy environment.

Please note that as of 13/06/2013, the following changes were made to the trial record:
1. The anticipated end date was updated from 01/04/2010 to 31/05/2013
2. The target number of participants was updated from 60 to 72

Ethics approval

MREC approved (ref: 08/H0903/11)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Service Delivery; Disease: Not Applicable

Intervention

1. Control participants: released to the usual post-release good quality support offered following release from prison.
2. Resettle: regular group activities, specific psychosocial treatments and risk management. The intervention will be delivered by Resettle sociotherapists.

Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 13/06/2013:
1. Reoffending data:
1.1. Police Records: Police National Computer (PNC)
1.2. Probation records

Previous primary outcome measures until 13/06/2013:
Personality functioning:
1. International Personality Disorder Evaluation (IPDE)
2. Hare Psychopathy Checklist Screening Version (PCL-SV)
3. Revised Adult Personality Disorder Functioning Assessment (RAPFA)
4. The Inventory of Interpersonal Problems
5. Behavioural Inhibition System (BIS)

Secondary outcome measures

Current secondary outcome measures as of 13/06/2013:
1. Antisocial behaviour
1.1. Self-report delinquency scale (SRD)
2. Personality functioning
2.1. Inventory of Interpersonal Problems (IIP)
2.2. Barratt Impulsivity Scale (BIS)
3. Psychiatric illness/symptom and substance abuse/dependency
3.1. Structured Clinical Interview for DSM-IV (SCID I)
3.2. Symptom Check List (SCL-90-R)

Previous secondary outcome measures until 13/06/2013:
1. Antisocial behaviour:
1.1. Self-Reported Delinquency (SRD)
1.2. LIVA
2. Psychiatric illness/symptoms and substance abuse/dependence:
2.1. Structured Clinical Interview for DSM-IV (SCID I)
2.2. Symptom Check List (SCL-90-R)

Overall trial start date

01/04/2008

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men being released from prison establishments to the Merseyside Probation Area
2. Some formal or informal diagnosis/indication of 'personality disorder'
3. Supervised via the Multi-Agency Public Protection Arrangements (generally a Level 2 or 3 classifiation)

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

Planned sample size: 72

Participant exclusion criteria

1. Active mental health difficulties that are un-treated
2. Men being released to an area other than Merseyside Probation Area

Recruitment start date

01/04/2008

Recruitment end date

31/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room 3.305
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health (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

Publication citations

Additional files

Editorial Notes

24/06/2016: No publications found, verifying study status with principal investigator.