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Trial registered on ANZCTR


Registration number
ACTRN12619000439145
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
18/03/2019
Date last updated
25/02/2020
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a Critical-Time Intervention (CTI) for mentally ill prisoners exiting custody, to improve mental health and criminal justice outcomes
Scientific title
A pilot study of a Critical-Time Intervention (CTI) for mentally ill prisoners exiting custody, to improve mental health and criminal justice outcomes
Secondary ID [1] 297413 0
NSW Health Translational Research Grant Scheme H18/1636
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 311203 0
Mood disorders 311205 0
Condition category
Condition code
Mental Health 309823 309823 0 0
Schizophrenia
Mental Health 309824 309824 0 0
Depression
Mental Health 309825 309825 0 0
Suicide
Mental Health 309826 309826 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed low-intensity ‘critical-time’ intervention (the critical time being the transition period before and after release from prison) will involve the following:

1. The research worker (trained and experienced mental health clinician) will identify the community mental health key worker (community mental health clinician assigned as the lead or coordinating clinician for the individual) and make early contact by phone to inform the key worker about the participants involvement in the trial

2. Development of an individualized care plan for post-release mental health care: The researchers (trained and experienced mental health clinicians) will develop an individualized care plan informed by the results of prison screening that is routinely undertaken on entry to prison and on any subsequent mental health assessment/treatment in prison (by the existing mental health services in custody). The research workers will provide the individualised care plan (in the form of a completed proforma document covering the results of mental health screening and assessment undertaken in prison, mental health diagnoses made in prison, treatment provided in prison, clinical recommendations for post-release care) and provide it to the participant's community mental health team key worker following release from custody.

3. Post-release contact: The research worker will contact the key worker from the identified community mental health team by phone within two weeks of the participant's release from prison to determine if the participant has been in contact with the mental health service as planned; if offender has not made contact the researcher worker will then phone the participant to encourage contact, including by informing/reminding the participant of the contact details for the key worker

Fidelity to the intervention will be assessed by audit of the individualised care plans developed by researchers and by audit of the spreadsheet to be used by researchers to document the nature and timing of all contacts made with the participant, key worker and others for each participant. The assessment will be undertaken twice monthly during the trial.
Intervention code [1] 313430 0
Treatment: Other
Intervention code [2] 313804 0
Prevention
Comparator / control treatment
The control group will receive treatment-as-usual (i.e. treatment currently provided by custodial mental health services within Justice Health and Forensic Mental Health Network (NSW) and treatment provided by secondary mental health services in the community following release, including clinician-initiated attempts to transfer care between services in the community and prison). Early contact with community mental health service staff will occur for the control group participants in order to confirm details, inform staff about the study and plans for post-release study follow-up but no individualised care plan will be provided prior to release and no post-release contact will be made.
Control group
Active

Outcomes
Primary outcome [1] 318783 0
Proportion of released prisoners in each group (intervention and control) who make contact with community mental health team, and number of contacts made in the three months post-release from custody. The information will be gathered directly from the community mental health team key worker via telephone interview and from the participant also by phone interview (the participant will be interviewed in person if they have returned to custody)
Timepoint [1] 318783 0
3 months following participant release from prison
Primary outcome [2] 318790 0
Mental health status as measured by a questionnaire developed for the study and designed to screen for current/recent (1 month) symptoms of major mental illness. The questionnaire has been adapted from a too (the Prison Mental Health Screening Tool Stage 1)l used to screen individuals entering prison in order to identify those who require further mental health assessment and treatment. Mental health status in the two groups (intervention and control) will be measured by both comparing the total score derived from the questionnaire as well as comparing the proportion in both groups who meet a pre-specified threshold for mental health services referral (determined by the results of a previous predictive validity study, augmented with prison mental health clinical input; the threshold is defined by an algorithm depending on responses to various domains covered by the tool, including the presence of active/recent symptoms of serious mental illness, a history of antipsychotic treatment prior to imprisonment, etc)
Timepoint [2] 318790 0
The questionnaire will be administered to the participant via telephone interview at 3 months following release from prison (or in person if the participant has returned to prison)
Secondary outcome [1] 366043 0
Post-release level of functioning as assessed by questions adapted from the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) - self report and collateral information gathered from community mental health team key worker (telephone interview)
Timepoint [1] 366043 0
At 3 months following the participant's release from prison
Secondary outcome [2] 366044 0
Rates of criminal offences and re-incarceration during the 3-months following release from custody, through checking for each participant whether any offences have been committed for which they have been charged/convicted (using Corrective Services NSW's Offender Information and Management System).
Timepoint [2] 366044 0
At 3 months post-release from custody
Secondary outcome [3] 366172 0
Health specific outcomes (prevalence of substance use and medication compliance) as measured by self-report on interview and collection of collateral information from community mental health team key worker (phone interview) in the form of a composite secondary outcome
Timepoint [3] 366172 0
At 3 months post release from custody

Eligibility
Key inclusion criteria
New prison entrants at Metropolitan Remand and Reception Centre (MRRC) who completed Reception Screening Assessment in the last 24-48 hours.
Possess physical and mental capacity to provide written informed consent in English language.
Referred to custodial mental health team by reception screening nursing staff
Charged with non-indictable offence (if on remand) or with sentence less than 6 months remaining (including parole period)
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
At risk of aggression during interview.
Charged with strictly indictable offences.
Non-parole period greater than 6 months or likely to remain in custody longer than 6 months.
Lacking capacity to consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through central randomization (computer program)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
On average, over 100 men enter prison at the Metropolitan Remand and Reception
Centre (MRRC) in Sydney each week. We
would expect 30 prisoners to reach the validated mental health threshold on screening
(i.e. that established by the Screening Study based on diagnostic thresholds for severe
mental illness and/or referred to secondary mental health care) and thus be eligible for recruitment each week. Assuming a
conservative refusal/incapacity rate of 20%, 24 participants could be successfully
recruited each week, comfortably above the likely interview completion rate of 18 per
week for two research assistants. The proposed interview rate (2 per day) is half that
of the Screening Study on the basis that time for recruitment will need to be balanced
by time for the intervention to occur in parallel in the current project. Over nine months,
two research assistants would be thus able to recruit approximately 700 prisoners (350
in each group). Assuming attrition of 20% by the end of the follow-up period (including
those not released by the end of the study period), a total sample size of 560 would be
expected. It is important to note that health and justice records will be accessed for all
participants, providing at least some follow-up data for those lost to interview-based
follow-up. A previous study of low-intensity case management for released prisoners in
Queensland reported a mental health service contact rate of 15% in the control group
at 3 months but this study involved an unselected group of sentenced prisoners. We
would expect a much higher rate of contact in our sample selected at baseline for
mental health needs and with no exclusion of remand prisoners. A conservative
doubling of this rate to 30% would mean that a sample size of 560 will provide 80%
power (at the 0.05 probability level, two-tailed) to detect a meaningful difference
between the groups, corresponding to a relative increase in the proportion making
successful contact with community mental health services, within 3 months of release,
for those in the intervention group of 50%.

Following descriptive statistical analysis of the baseline profiles (socio-demographic,
clinical and forensic) of the two groups to assess any failure of randomisation, the
primary and secondary research questions will be pursued, using an intention to treat
analysis in the first instance (followed by an a priori per-protocol analysis excluding
those in the intervention group who did not actually receive the intervention for any
reason).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25452 0
2128 - Silverwater

Funding & Sponsors
Funding source category [1] 300910 0
Government body
Name [1] 300910 0
NSW Health Translational Research Grants Scheme
Address [1] 300910 0
Locked Mail Bag 961
North Sydney NSW 2059
Country [1] 300910 0
Australia
Primary sponsor type
Government body
Name
Justice Health and Forensic Mental Health Network
Address
Justice Health and Forensic Mental Health Network
Roundhouse, Long Bay Complex
1300 Anzac Parade
Malabar
NSW 2036
Country
Australia
Secondary sponsor category [1] 301760 0
None
Name [1] 301760 0
Address [1] 301760 0
Country [1] 301760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301679 0
Justice Health and Forensic Mental Health Network Human Research Ethics Committee
Ethics committee address [1] 301679 0
1300 Anzac Parade
Matraville
NSW 2036
Ethics committee country [1] 301679 0
Australia
Date submitted for ethics approval [1] 301679 0
01/06/2015
Approval date [1] 301679 0
21/09/2015
Ethics approval number [1] 301679 0
JH File No G185/14
Ethics committee name [2] 302447 0
Aboriginal Health & Medical Research Council Human Research Ethics Committee
Ethics committee address [2] 302447 0
Level 3, 66 Wentworth Avenue
Surry Hills
NSW 2010
Ethics committee country [2] 302447 0
Australia
Date submitted for ethics approval [2] 302447 0
21/10/2015
Approval date [2] 302447 0
29/02/2016
Ethics approval number [2] 302447 0
1137/15
Ethics committee name [3] 302448 0
Corrective Services New South Wales Ethics Committee
Ethics committee address [3] 302448 0
Level 5, Henry Deane Building
20 Lee Street
Sydney
NSW 2001
Ethics committee country [3] 302448 0
Australia
Date submitted for ethics approval [3] 302448 0
11/12/2015
Approval date [3] 302448 0
06/04/2016
Ethics approval number [3] 302448 0
Not provided by the ethics committee
Ethics committee name [4] 305457 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [4] 305457 0
Research Office, Level 2, REN Building
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [4] 305457 0
Australia
Date submitted for ethics approval [4] 305457 0
17/10/2018
Approval date [4] 305457 0
18/02/2019
Ethics approval number [4] 305457 0
AU RED LNR/18/WMEAD/461

Summary
Brief summary
The proposed research project will focus intervening in the prison-to-community transition period to improve post-release mental health and other outcomes. Our research will specifically test whether an early and individualised critical-time intervention for prisoners released into the community is feasible locally and whether it can, firstly, increase contact with community mental health services and, secondly, whether there is any consequent benefit for mental health status, functioning or reoffending.

It will utilise a randomised controlled trial (RCT) design, with longitudinal multi-source follow-up to assess the feasibility and efficacy of a novel ‘critical-time’ intervention. The intervention is to be implemented during the prison-to-community transition period. As part of the intervention, the research team will identify prisoners entering custody who have severe mental illness, have committed relatively minor offences, and are likely to benefit from ongoing community mental health team input on release. The research team will identify the appropriate CMHT for the participant early in their custodial episode and make contact with the key worker. In collaboration with custodial mental health clinicians involved in treating the prisoner, we will develop an individualised care plan for each participant which will be forwarded to the Community Mental Health Team (CMHT) as part of the project. We will follow-up with the key worker and the participant to encourage ongoing community mental health engagement following the participant’s release from custody.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87762 0
Prof Kimberlie Dean
Address 87762 0
Justice Health and Forensic Mental Health Network
Roundhouse, Long Bay complex
1300 Anzac Parade
Matraville
NSW 2036
Country 87762 0
Australia
Phone 87762 0
+61 2 9700 3854
Fax 87762 0
Email 87762 0
k.dean@unsw.edu.au
Contact person for public queries
Name 87763 0
Dr Daria Korobanova
Address 87763 0
Justice Health and Forensic Mental Health Network
Roundhouse, Long Bay complex
1300 Anzac Parade
Matraville
NSW 2036
Country 87763 0
Australia
Phone 87763 0
+61 2 9700 3830
Fax 87763 0
Email 87763 0
daria.korobanova@health.nsw.gov.au
Contact person for scientific queries
Name 87764 0
Prof Kimberlie Dean
Address 87764 0
Justice Health and Forensic Mental Health Network
Roundhouse, Long Bay complex
1300 Anzac Parade
Matraville
NSW 2036
Country 87764 0
Australia
Phone 87764 0
+61 2 9700 3854
Fax 87764 0
Email 87764 0
k.dean@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results