Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000492853
Ethics application status
Approved
Date submitted
12/02/2021
Date registered
28/04/2021
Date last updated
28/04/2021
Date data sharing statement initially provided
28/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development, implementation and evaluation of a new trauma-informed model of youth treatment for substance use disorders.
Scientific title
Development, implementation and evaluation of a new trauma-informed model of treatment for people aged 18-35 with substance use disorders.
Secondary ID [1] 302230 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use disorders 318929 0
Comorbid post-traumatic stress disorder (PTSD) 318930 0
Condition category
Condition code
Mental Health 316905 316905 0 0
Addiction
Mental Health 318899 318899 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase one: Development.
The new trauma-informed model will be co-developed with Lives Lived Well staff and will build on the existing literature on TIC for adult outpatients model of care, in addition to incorporating existing evidence-based programs (Grit, Healthy Recovery) delivered alongside the new model. It will also incorporate one-to-one trauma-focused therapy for clients with PTSD delivered by a trained clinician (provisional psychologist supervised by a board-approved, endorsed clinical psychologist) on a weekly to fortnightly basis, over 6-8 weeks, with 90-minute sessions. The service environment (climate) and therapeutic milieu, as well as the existing therapeutic group programs will also be revised to be both more trauma-informed and strengths-focused, emphasising personal strengths in clients, rewarding positive behaviour, and creating a ‘shared language’ between clients and staff. The duration of the development phase is approximately 8-months to ensure all components of the new model are developed and ready to be implemented.

Phase two: Implementation.
Staff will undergo training the new trauma-informed model via a two day workshop, in addition to other facets of trauma-informed care. This training will be delivered face-to-face by a specialist clinical psychologist who developed and implemented adult outpatient models of TIC. The training will involve psychoeducation, experiential practice, short videos, and group discussion with staff. Following this training, staff will receive trauma-informed clinical supervision to assist with understanding events with clients from a trauma-informed perspective, and how to talk about trauma with clients. Staff will also have the opportunity to refer eligible clients who have a trauma history to receive trauma-focused therapy (submitted as a separate trial). A trauma-informed approach by staff will be used throughout client screening/assessment, one-to-one case management, and therapeutic group programs. The training will educate staff on the content of the new model, the proposed benefits for both staff and clients, how to implement the model, and how to refer clients to further treatment. It will also address barriers to delivering the model in the residential settings. The training will be organised and co-facilitated by the researchers. Implementation of other aspects of the model, such as revisions and changes to the service environment and therapeutic group programs, will be implemented following the staff training. Within the program, seven therapeutic group sessions are delivered to clients per week, equating to 42 sessions over the 6-week program. The implementation of trauma-informed adaptations to these therapeutic groups will be phased, and measures of adherence (among other service outcomes) will be collected when the client and service evaluation phase begins. The duration of the implementation phase is 18-months due to ongoing supervision and referrals to trauma-informed care. This phase will overlap with the development phase by 6-months since supervision will commence immediately following training in TIC. It will also overlap with the evaluation phase for 12-months, since supervision will continue until the end of the evaluation outcomes.

Phase three: Evaluation.
An evaluation of the staff training, client, and service outcomes will be conducted. The impact of the staff training on their knowledge, attitudes, skills and confidence in delivering trauma-informed feedback will be evaluated at baseline, 1, 3, 6 and 12 months follow up. For evaluation of client outcomes, all clients accessing participating residential treatment services will have the opportunity to take part in a survey, alongside their routine treatment. Client outcomes on alcohol and other drug (AOD) and mental health (trauma, depression, anxiety) symptoms will be evaluated at baseline, 6 weeks, 3 and 6 months follow up. To evaluate service outcomes, we will assess: the number of clients admitted/discharged; number of PTSD screens/trauma-informed feedback sessions/referrals to trauma-informed treatment completed; organisational TIC climate; number of groups/case management sessions delivered/attended, length of stay/treatment episodes completed; staff satisfaction and retention. These measures will be collected by the research team. All questionnaires will be administered and collected by the research team using an online survey platform, except for outcome measures that are routinely collected by the organisation. The duration of the evaluation phase will be 24-months in total which will incorporate the staff, client, and service outcomes. Staff outcomes will be collected in the first 12-months and will start in the weeks prior to the staff training in the new model (baseline), and follow ups will commence immediately after. This will overlap with the model development (Phase 1) for 6-months where other parts of the model (such as adaptations to the therapeutic groups) are implemented. Once these are fully implemented, client and service outcomes that will be collected and will continue for 18-months. Baseline client data will only be collected for the first 12-months, and the latter 6-months will only be collecting the client follow up data. Service outcomes will be collected for the 18-months.

Phase four: Sustainability
The sustainability of TIC service outcomes will be assessed once client recruitment to the trial has ceased. The duration of the sustainability phase is 6-months, which will overlap with the final 6-months of the evaluation phase where we will be collecting client follow ups (but not recruiting any new clients entering the program).
Intervention code [1] 318519 0
Treatment: Other
Intervention code [2] 318525 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325012 0
Client drug and/or alcohol involvement measured via the WHO The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).
Timepoint [1] 325012 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Primary outcome [2] 325013 0
Client PTSD symptoms. Measured by the Primary Care PTSD Screen for DSM-5 and the PTSD Checklist.
Timepoint [2] 325013 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Primary outcome [3] 326839 0
Client drug and/or alcohol use measured via the Australian Treatment Outcomes Profile and Quality of Life (ATOP) questionnaire.
Timepoint [3] 326839 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Secondary outcome [1] 386541 0
Client depression as measured by the Patient Health Questionnaire.
Timepoint [1] 386541 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Secondary outcome [2] 386542 0
Client anxiety as measured by the Generalised Anxiety Disorder Scale (GADS),
Timepoint [2] 386542 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Secondary outcome [3] 391819 0
Client resilience as measured by the Resilience Evaluation Scale
Timepoint [3] 391819 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Secondary outcome [4] 392855 0
Client emotion regulation will also be assessed via the Distress Tolerance Scale.
Timepoint [4] 392855 0
Once at baseline, and once each at 1 month, 3 months, and 6 months after treatment commencement.
Secondary outcome [5] 392856 0
Staff perceptions of trauma informed care using a Trauma-informed Care Survey (which meaures commitment to TIC, support for TIC, self-efficacy to implement TIC, beliefs about trauma in the workplace, and foundational knowledge about trauma)
Timepoint [5] 392856 0
Once at baseline (before the staff training), and once again at 3 months, 6 months and 12 months after the staff training.
Secondary outcome [6] 392857 0
Staff perceptions on the 5-values of trauma informed care within the service as measured by the Trauma-Informed Climate Scale-10.
Timepoint [6] 392857 0
Once at baseline (before the staff training), and once again at 3 months, 6 months and 12 months after the staff training.
Secondary outcome [7] 392858 0
Staff workplace and satisfaction as measured by the Professional Quality of Life Scale, version 5 (ProQOL)
Timepoint [7] 392858 0
Once at baseline (before the staff training), and once again at 3 months, 6 months and 12 months after the staff training.
Secondary outcome [8] 392859 0
Service outcome for adherence to staff supervision, which will be measured by staff attendance for supervision per week (n and %) and recorded by the research psychologist each week.
Timepoint [8] 392859 0
Collected each week following the staff training.
Secondary outcome [9] 392862 0
Service outcome for adherence for therapeutic groups, which will be measured by the number of therapeutic groups (n and %) successfully ran within each 6-week program cycle, which will be assessed using audits of the service client management system.
Timepoint [9] 392862 0
Collected every 6 weeks post-implementation of the model (reflecting one entire cycle of the intervention).
Secondary outcome [10] 392863 0
Service outcome for adherence for therapeutic group attendance, which will be measured by the number of clients attending each therapeutic group assessed using audits of the service client management system.
Timepoint [10] 392863 0
Collected every 6 weeks post-implementation (reflecting one entire cycle of the intervention).
Secondary outcome [11] 392864 0
Service outcome for tolerability as measured by average client length of stay assessed using audits of the service client management system.
Timepoint [11] 392864 0
Collected per client enrolled into the evaluation phase.
Secondary outcome [12] 392865 0
Service outcome for retention as measured by number of 6-week client treatment completions. These outcomes will be measured using audits of the service client management system.
Timepoint [12] 392865 0
Collected every 6 weeks post-implementation (reflecting one entire cycle of the intervention).

Eligibility
Key inclusion criteria
For the trial, Lives Lived Well Clients aged between 18-35 years who are admitted to the participating residential service will receive the new TIC model as part of their routine treatment. Data on the TIC intervention will only be collected from those who consent to partake in the study feedback and follow up measurements.
For the trauma-therapy, Clients attending Lives Lived Well TIC services with a provisional DSM-5 Diagnosis of PTSD on the PTSD Checklist (PCL-5) may be offered Cognitive Processing Therapy (submitted as a separate feasibility trial).

All staff at the residential facility will be invited to take part in the training and evaluation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For clients: Outside the ages of 18-35, not receiving residential treatment for a substance use disorder at the participating residential facility.

Staff: No exclusion criteria. Staff must be an employee fo the participating residential facility and have regular client contact.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To indicate changes in primary and secondary outcomes over time, we will use within-subject changes using repeated measures ANOVA’s, as well as looking at mean differences, confidence intervals and effect sizes. This form of analysis is particularly important for the staff outcomes, where the sample size is likely to be small. We will also use Bayesian methods to assess potential changes, as this form of analyses is less reliant on p-value testing.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
177
Accrual to date
33
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306651 0
Government body
Name [1] 306651 0
Australian Government Department of Health
Country [1] 306651 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Psychology,
McElwain Building
The University of Queensland
St Lucia, QLD, 4072
Australia
Country
Australia
Secondary sponsor category [1] 307200 0
None
Name [1] 307200 0
Address [1] 307200 0
Country [1] 307200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306833 0
University of Queensland Human Research Ethics Committee (A, B, and LNR).
Ethics committee address [1] 306833 0
Ethics committee country [1] 306833 0
Australia
Date submitted for ethics approval [1] 306833 0
Approval date [1] 306833 0
09/07/2020
Ethics approval number [1] 306833 0
2020000949

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105170 0
Prof Leanne Hides
Address 105170 0
School of Psychology
The University of Queensland
St Lucia, Qld 4072 Australia
Country 105170 0
Australia
Phone 105170 0
+61 7 336 56398
Fax 105170 0
Email 105170 0
[email protected]
Contact person for public queries
Name 105171 0
Leanne Hides
Address 105171 0
School of Psychology
The University of Queensland
St Lucia, Qld 4072 Australia
Country 105171 0
Australia
Phone 105171 0
+61 7 336 56398
Fax 105171 0
Email 105171 0
[email protected]
Contact person for scientific queries
Name 105172 0
Molly Carlyle
Address 105172 0
School of Psychology
The University of Queensland
St Lucia, Qld 4072 Australia
Country 105172 0
Australia
Phone 105172 0
+61 7 3443 2569
Fax 105172 0
Email 105172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified baseline and follow up data collected
When will data be available (start and end dates)?
Within 12 months of the conclusion of the study
No end date specified
Available to whom?
Only researchers who provide a methodologically sound proposal will be provided with access to the data on a case-by-case basis
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
via University of Queensland Research Data Management System website
https://rdm.uq.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9053Study protocol  [email protected]
10650Informed consent form  [email protected]
10651Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders.2023https://dx.doi.org/10.3389/fpsyt.2023.1169794
N.B. These documents automatically identified may not have been verified by the study sponsor.