Condition category
Mental and Behavioural Disorders
Date applied
21/10/2005
Date assigned
08/12/2005
Last edited
03/03/2015
Prospective/Retrospective
Prospectively 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

Dr Mairead Dolan

ORCID ID

Contact details

Research Department
Edenfield Centre
Bury New Road
Manchester
M25 3BL
United Kingdom
+44 (0)161 772 3619
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pilot evaluation of a randomised controlled trial (RCT) of Enhanced Thinking Skills versus Treatment as Usual in antisocial personality disordered offenders in the community

Acronym

Study hypothesis

In community-based antisocial personality disordered offenders who are in contact with forensic/other NHS services or criminal justice (probation), Enhanced Thinking Skills (ETS) will lead to a reduction in criminal attitudes, improvements in problem solving ability, a reduction of risk scores on dynamic measures of risk and a reduction in antisocial and offending behaviour compared with Treatment As Usual (TAU).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Antisocial Personality Disorder

Intervention

Enhanced Thinking Skills Cognitive Training versus Treatment as Usual

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Number of criminal offences during follow-up, change in antisocial personality traits, change in antisocial attitudes, change in measures of risk.

Secondary outcome measures

Participants engagement in and satisfaction with the Enhanced Thinking Skills Therapy

Overall trial start date

01/01/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female participants meeting the criteria for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) antisocial personality disorder with a history of offending behaviour
2. Aged 18-50 years
3. Participants will be recruited from the NHS and Greater Manchester Probation Service
4. Participants will have a history of antisocial behaviour and/or offending behaviour particularly violent offences

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 participants in the ETS group and 60 in the TAU group

Participant exclusion criteria

1. Current Axis I disorder (schizophrenia, depression, anxiety disorders) (Schedule Clinical Interview for DSM-IV Axis I disorder, First et al, 1996)
2. IQ less than 70 on the National Adult Reading Test (Nelson et al, 1978)
3. Previously undergone a cognitive skills intervention

Recruitment start date

01/01/2006

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Research Department
Manchester
M25 3BL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 6000
timothy.stibbs@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Forensic Mental Health R&D Programme

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