Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001420730
Ethics application status
Approved
Date submitted
18/10/2022
Date registered
7/11/2022
Date last updated
7/11/2022
Date data sharing statement initially provided
7/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of a therapeutic assessment intervention on engagement in aftercare services for young people who present to the emergency department for deliberate self-harm
Scientific title
Effectiveness of a therapeutic assessment intervention on engagement in aftercare services for young people who present to the emergency department for deliberate self-harm
Secondary ID [1] 308342 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
deliberate self harm 327954 0
suicide attempt 327955 0
suicidal ideation 327956 0
Emergency medicine 328132 0
Condition category
Condition code
Mental Health 325020 325020 0 0
Suicide
Emergency medicine 325183 325183 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will involve the delivery of a brief collaborative intervention called the Therapeutic Assessment (TA) to young people aged 12-17 years who present to the emergency department (ED) for deliberate self-harm (DSH) at the following sites:
1) Perth Children’s Hospital ED
2) Albany Health Campus ED
3) Geraldton Regional Hospital ED

The TA is a brief psychological intervention that has been designed to make the assessment of young people who have engaged in DSH behaviour more therapeutic (Ougrin et al., 2011). TA builds upon standard clinical assessment to identify factors that drive and maintain DSH behaviour. TA involves brief recovery-focused problem-solving therapy to identity the young person’s strengths and uses this to encourage help-seeking behaviours.

The major components of Therapeutic Assessment are as follows:
1) Standard psychosocial history and risk assessment (approximately 1 hr) completed by Psychiatric Liason Nurses (PLN) 4-hours of presentation to the ED per the Child and Adolescent Mental Health Services (CAMHS) protocol.
2) A 45 min intervention completed bt the PLN nurse within 7-days of presenting to the ED for DSH. Participants will be given the option to attend the assessment at the hospital or online through teleconferencing.

The TA intervention includes:
a) Joint construction of a diagram aiming to capture the vicious cycles that maintain DSH.
b) Identifying a target problem contributing to the patients DSH.
c) Considering and enhancing motivation for change.
d) Exploring potential ‘exits’ (i.e., ways of breaking the cycles of DSH identified during the intervention).
e) Describing the diagram and the exits in an ‘understanding letter’ which the clinician is required to prepare based on the initial assessment. The understanding letter outlines the primary concerns identified by the young person during the TA intervention. It includes a copy of the diagram including the coping strategies identified during the TA. The understanding letter is a tool that the young person can draw on during their recovery and offers a secondary source of support to the young person.

The study will occur over 34-months and will be split into two time periods with a two-month gap at months 11-12 to allow for training of staff at each participating trial site.
Period 1 comprises months 1-10. Participants who present to participating trial sites during Period 1 will be enrolled into Group 1 and will receive standard clinical care. Each participant will receive follow-up at 6-months and 12 months.

During the training period (months 11-12) staff will be trained in the TA assessment at each participating trial site. During the training period there will be no further recruitment of participants. Young people who present to participating EDs during this time for an index event of DSH will not be eligible to participate in the study.

Period 2 comprised months 13-22. Participants who present to participating trial sites during Period 2 will be enrolled into Group 2 and will receive the TA intervention. Each participant will receive follow-up at 6-months and 12 months from their index presentation.

Training
The training package for TA will be based upon the two-full day routinely delivered training package, delivered in person via face-to-face workshops by a trained clinical psychologist. Training will consist of 5 half-day seminars including theoretical background, viewing clinical videos of TA being delivered, followed by completing two TA interventions directly supervised by PI Pedro with agreeable, eligible but non-participating patients within the final two weeks of the Training and Implementation Phase. Ongoing clinical supervision will allow for continuity of support. Clinical supervision will occur weekly for 1.5 hours for the duration of the trial.

Model Fidelity
Model fidelity will be based on the procedures used by Ougrin and colleagues for the clinical trial of TA (Ougrin et al., 2011). Initial fidelity will be established during the final two weeks of the training phase. Post-completion of the training package and directly supervised interventions on two occasions, clinicians will complete a further two interventions with agreeable, eligible but non-participating patients during the Training and Implementation phase.

Standard clinical delivery of TA requires written transcript of the interview, including co-construction of the model and 'Exits' on a standardised proforma. These written transcripts and the accompanying 'Therapeutic Letter' will be de-identified and submitted for external review against the Therapeutic Assessment quality assurance tool (TAQAT).
Fidelity audits will be completed by a combination of an external auditor, a participant and the clinician delivering the intervention. Audit outcomes will be reviewed during clinical supervision. Fidelity will also be supported via weekly clinical supervision sessions.
Ongoing fidelity will be monitored throughout the intervention via monthly audits of randomly selected, de-identified transcripts and Therapeutic Letters. Fidelity will also be supported via weekly clinical supervision sessions.
Intervention code [1] 324663 0
Treatment: Other
Intervention code [2] 324789 0
Behaviour
Comparator / control treatment
During Period 1, (months 1-10) participants will receive standard clinical care but will be asked to provide consent to participate in the study. At all times, participants in the study will be encouraged to engage in their existing treatments. This project does not impact on existing sub-acute treatments.

Standard clinical care involves:
1) Triage by ED Nurse (<5 minutes)
2) Assessment and treatment where required by an ED doctor (<15 minutes)
3) Mental health assessment conducted by a Clinical Nurse Specialist – Mental Health Nurse (Child Adolescent Specialist Training), Psychiatric Liaison Nurse or Clinical Nurse specialist (30 minutes)
4) Risk assessment (including risk and protective factors) to inform a Risk Management Plan, as per CAMHS Risk Assessment and Management Plan. (10 minutes)
5) Care Plan (discharge plan) that may include (15-20 minutes):
a) Admission to the mental health ward (5A) for further risk containment.
b) Discharge to community services for aftercare, where standard procedure includes a follow-up sub-acute appointment within one-week at a community mental health clinic OR mental health clinician in the private sector.
c) Referral to aftercare support.
Control group
Active

Outcomes
Primary outcome [1] 332839 0
Adherence with aftercare treatment, defined as rate of attendance at mental health treatment appointments following the index presentation for DSH over a 12-month period.
Recorded from medical records and PSOLIS (ED electronic records).
Timepoint [1] 332839 0
6-month follow up post-index presentation
12-month follow up post-index presentation
Secondary outcome [1] 414835 0
Rates of re-presentation for DSH- defined as the number of presentations for DSH to a WA emergency department within a 12 -month period.

Recorded from medical records audit and PSOLIS.
Timepoint [1] 414835 0
6-month follow up post-index presentation for participants in both group 1 and group 2.
12-month follow up post-index presentation for participants in both group 1 and group 2.
Secondary outcome [2] 414836 0
Repeat episodes of DSH (with and without suicidal intent),
Measured using the Modified Self-Injurious Thoughts and Behaviours Interview (SITBI)- Short Form. A modified version of the SITBI (comprising interview items from the suicide attempt and non-suicidal self-injury) sections (20 items in total). The questions have been adapted to assess behaviours in the past 6-months, corresponding with the study follow-up period.
Timepoint [2] 414836 0
6-month follow up post-index presentation for participants in both group 1 and group 2.
12-month follow up post-index presentation for participants in both group 1 and group 2.
Secondary outcome [3] 414837 0
Medical seriousness of DSH at index presentation and at each recurrent presentation over a 12-month period (if applicable). Measured using the Medical Lethality Scale of the K-SADS (Scale 4d.) – revised: (1= no medical damage; 2= subthreshold, superficial cuts; 3= threshold indicating medical intervention, significant cut with bleeding); clinician rated.
Timepoint [3] 414837 0
6-month follow up post-index presentation for participants in both group 1 and group 2.
12-month follow up post-index presentation for participants in both group 1 and group 2.
Secondary outcome [4] 414838 0
Potential lethality of DSH at index presentation and at each recurrent presentation. Measured using the Potential Lethality Scale; (1 = certain survival; 2 = <50% chance of death; 3. >50% chance of death; 4 = certain death); clinician rated.
Timepoint [4] 414838 0
Recurrent presentation to the ED for DSH or suicidal ideation. This outcome will be assessed at the index presentation and then at each recurrent presentation to the ED for DSH or suicidal ideation for up to 12 months post-index presentation for participants in both group 1 and group 2.
Secondary outcome [5] 414839 0
Suicidal Ideation. Measured using the The Beck Scale for Suicidal Ideation (BSSI) is a 21-item self-rated questionnaire.
Timepoint [5] 414839 0
Recurrent presentation to the ED for DSH or suicidal ideation. This outcome will be assessed at the index presentation and then at each recurrent presentation to the ED for DSH or suicidal ideation for up to 12 months post-index presentation for participants in both group 1 and group 2.

Eligibility
Key inclusion criteria
Young people aged 12-17 years of age who attend Perth Children’s Hospital, Albany Health Campus or Geraldton Regional Hospital EDs for DSH (defined as intentional self-injury or poisoning, irrespective of suicidal intent) OR young people who present for suicidal ideation with a history of DSH.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) The young person presents with suicidal ideation but has no current or historical DSH behaviour.
2) Current psychosis as documented in Department of Health Progress notes or reported by parents/carer or clinicians.
3) Intellectual disability (IQ score <70) as documented in Department of Health Progress notes or reported by parents/carers.
4) Parent/carer lack of consent.
5) Patient lack of verbal consent (patient chooses not to participate).
6) Lack of concordance for consent between parent/carer and patient.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A two-group phased approach will be used. Participants who present to participating EDs during the first 10-months of the trial will receive Standard Clinical Care (Group 1). A two-month training period will commence during months 11-12 where participating EDs will receive training in the TA intervention. During the training period, recruitment will be paused. Once training is complete, all participants who present to participating EDs between months 13-22 will receive the TA intervention (Group 2) in addition to Standard Clinical Care.Participants in Group 1 and Group 2 will be recruited during the same calendar months, exactly 12-months apart. This approach will account for potential temporal trends in ED presentations that are observed at different time periods throughout the calendar year.

The phased approach is used in the study design for the following reasons:
1) TA is an entirely novel intervention and has not yet been used in CAHS, CAMHS or WA Country Health Service at Albany Health Campus or Geraldton Regional Hospital. As such, clinical staff at these locations are entirely naive to the model.
2) It is not practical to train staff to deliver the TA intervention and request that they not apply their training to clinical cases they are exposed to (which often involve significant need and distress). Doing so would be very difficult and would introduce significant bias.
3) A two-phase approach allows staff to be trained at the same time across trial sites, ensuring greater model fidelity prior to implementing the intervention.

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on review of clinical data from Perth Children’s Hospital ED Department for 2019, there are on average, 100 presentations per month to Perth Children’s Hospital for DSH, 17 per month to Albany Health Campus ED and 11 per month to Geraldton Regional Hospital ED. Review of past data indicates approximately 30% of these are a first-time presentation and 70% are a recurrent presentation. Assuming a 60% consent rate amongst patients who are eligible for recruitment, and that the percentage of total presentations who are both recurrent and eligible (i.e., haven’t been recruited previously) reduces from 70% to 34% over the 10-month recruitment period we estimate at least 400 participants per period (model of care with /without TA) will be recruited to the study.

Application of a generalized linear (Poisson) mixed-effects model, with random effects corresponding to outcome clustered by model of care/site/month, indicates we will have more than 90% power to detect the expected 20% decrease in re-presentation rates by inclusion of TA into standard clinical care, and 80% power to detect a 17% reduction in re-presentation rates.
TOTAL: 394

Demographic characteristics (age, gender, presentation type) and outcome measures (re-presentations and appointment attendance rates will be summarized descriptively for each site and treatment group.

Adherence to aftercare will be analysed by examining attendance rates at scheduled mental health treatment appointments. Adherence will be analysed by regression of a binary attendance indicator variable within a generalised linear mixed model (GLMM) framework.

Rates of re-presentation to ED for a mental health crisis will be analysed by application of a hierarchical regression model (GLMM) appropriate for count data i.e., a Poisson model or alternatively a negative binomial model if over-dispersion is evident. An exposure variable (time) may be considered if there are differing exposure periods for subjects.

The Medical Seriousness Scale (discrete values from 1-3) and Potential Lethality Scale (discrete value from 1-4) and Suicide Intent Scale (discrete value from 1-4), collected at presentation to ED, will each be analysed by ordinal regression within a cumulative link mixed model framework to accommodate multiple measures per person.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
394
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23383 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 23384 0
Albany Hospital - Albany
Recruitment hospital [3] 23385 0
Geraldton Hospital - Geraldton
Recruitment postcode(s) [1] 38780 0
6009 - Nedlands
Recruitment postcode(s) [2] 38781 0
6330 - Albany
Recruitment postcode(s) [3] 38782 0
6530 - Geraldton

Funding & Sponsors
Funding source category [1] 312461 0
Charities/Societies/Foundations
Name [1] 312461 0
Suicide Prevention Australia
Country [1] 312461 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
15 Hospital Ave, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 314046 0
None
Name [1] 314046 0
Address [1] 314046 0
Country [1] 314046 0
Other collaborator category [1] 282457 0
Government body
Name [1] 282457 0
Child Adolescent Mental Health Service
Address [1] 282457 0
Level 2, 52-54 Monash Avenue, Nedlands, WA 6009
Country [1] 282457 0
Australia
Other collaborator category [2] 282458 0
Government body
Name [2] 282458 0
Child Adolescent Health Service
Address [2] 282458 0
15 Hospital Ave, Nedlands, WA 6009
Country [2] 282458 0
Australia
Other collaborator category [3] 282459 0
University
Name [3] 282459 0
University of Western Australia
Address [3] 282459 0
35 Stirling Hwy, Crawley WA 6009
Country [3] 282459 0
Australia
Other collaborator category [4] 282460 0
Government body
Name [4] 282460 0
WA Country Health Service
Address [4] 282460 0
189 Wellington St, Perth, WA 6000
Country [4] 282460 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311806 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311806 0
Ethics committee country [1] 311806 0
Australia
Date submitted for ethics approval [1] 311806 0
Approval date [1] 311806 0
24/08/2022
Ethics approval number [1] 311806 0

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

Contacts
Principal investigator
Name 122430 0
Prof Ashleigh Lin
Address 122430 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands, WA 6009
Country 122430 0
Australia
Phone 122430 0
+61 8 6319 1291
Fax 122430 0
Email 122430 0
[email protected]
Contact person for public queries
Name 122431 0
Ashleigh Lin
Address 122431 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands, WA 6009
Country 122431 0
Australia
Phone 122431 0
+61 8 6319 1291
Fax 122431 0
Email 122431 0
[email protected]
Contact person for scientific queries
Name 122432 0
Ashleigh Lin
Address 122432 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands, WA 6009
Country 122432 0
Australia
Phone 122432 0
+61 8 6319 1291
Fax 122432 0
Email 122432 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?
Individual participant data underlying published results only, after de-identification.
When will data be available (start and end dates)?
Immediately following publication of main results, no end date.
Available to whom?
Only researchers from academic research institutions who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
IPD meta-analyses only.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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