Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000550808
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
11/05/2021
Date last updated
8/03/2023
Date data sharing statement initially provided
11/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
PCH EXPAAND Nested Intervention: Evaluating Therapeutic Assessment as a brief intervention for children and adolescents who self-harm at the time of a mental health emergency.
Scientific title
PCH EXPAAND Nested Intervention: Evaluating the effect of Therapeutic Assessment on rates of representation to hospital emergency departments in children and adolescents who self-harm at the time of a mental health emergency
Secondary ID [1] 303385 0
nil
Universal Trial Number (UTN)
n/a
Trial acronym
PCH EXPAAND
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Child and Adolescent Mental Health 320669 0
Deliberate Self-Harm 321105 0
Suicide 321106 0
Condition category
Condition code
Mental Health 318514 318514 0 0
Other mental health disorders
Mental Health 318515 318515 0 0
Suicide
Mental Health 318902 318902 0 0
Depression
Mental Health 318903 318903 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Control: treatment as usual

Group 2: Expanded assessment including standardized measures of attentional conditions and difficulties with emotional processing, and the semi-structured diagnostic interview (K-SADS).

Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime Version (K-SADS-PL) is most widely used diagnostic interviews in research. It is a standardized semi-structured interview to measure current and past symptoms of mood, anxiety, psychotic and disruptive behaviour disorders (including ADHD) in children aged 6-18 years old. Administration time is between 45-75 minutes. The K-SADS diagnostic interview takes between 1-2 hours to administer

Group 3: Expanded Assessment with Nested Intervention - Therapeutic Assessment: a brief, manualised psychological assessment technique developed specifically to make the assessment for children and adolescents who have self-harmed more therapeutic

Therapeutic Assessment (TA; Ougrin et al., 2009) is a brief, manualised psychological assessment technique developed specifically to make the assessment for children and adolescents who have self-harmed more therapeutic (Ougrin et al., 2009). TA is a therapeutic intervention where the clinician and patient co-construct a narrative with regards to their DSH / suicidal crisis behaviours within the context of a theoretical model developed by Ougrin and colleagues (2009) over a single 1-hour to 1.5-hour session. The content of this session is then recorded in a ‘therapeutic letter’ and provided to the patient in paper mail form (with an additional electronic form provided if requested.

The intervention will be delivered by a Clinical Psychologist, and/ or masters-level provisionally registered Clinical Psychologists, supervised by a Clinical Psychologist. Therapeutic assessment takes between 1-1.5 hours to complete with the patient.

Both the K-SADS and the Therapeutic Assessment are delivered as a one-off intervention. The intervention is delivered at the Perth Children’s Hospital in an outpatient clinic available to clinical researchers.

Clinicians delivering the interventions receive training and supervision. Output generated from interventions (K-SADS results and Therapeutic Assessment letter) are reviewed by the PI and/ or CPI to ensure correct administration.

Both the K-SADS and Therapeutic Assessment are readily available and have not been modified for use in this study.

Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime Version (K-SADS-PL) is most widely used diagnostic interviews in research.
Ougrin, D., Zundel, T., & Ng, A. V. (2009). Self-harm in young people: A therapeutic assessment manual. CRC Press.
Intervention code [1] 319696 0
Treatment: Other
Intervention code [2] 319996 0
Prevention
Comparator / control treatment
Treatment as usual

All children and adolescents who present to PCH ED with DSH/ Suicidal crisis receive:
• Triage by ED Nurse
• Assessment and treatment where required by ED doctor – usually competed by JMO or RMO. Clinical decisions discussed with ED Consultant Paediatrician on duty.
• Mental Health Assessment by Clinical Nurse Specialist – Mental Health Nurse.
o This involves a psycho-social assessment, including screening for co-morbid mental health conditions such as depression and anxiety.
o Risk assessment (including risk and protective factors) to inform a Risk Management Plan.
o Care Plan (discharge plan)

Control group
Active

Outcomes
Primary outcome [1] 326471 0
Rates of re-presentation to hospital emergency departments for mental health crisis (including deliberate self-harm) within a 6-month period from index presentation.

1. Rates of re-presentation
Number of presentations for a mental health crisis (including DSH) to PCH ED within a 6-month period Medical records/ PSOLIS records.
Timepoint [1] 326471 0
6-months
Secondary outcome [1] 391617 0
1. Acute engagement with treatment - attendance at treatment appointments within two weeks of index presentation to ED.

Rate of attendance at follow-up first follow-up appointment following DSH presentation to PCH ED in the acute time period
Audit of appointments attended (CAMHS-PSOLIS), vs appointments scheduled as per CAMHS clinical guidelines and Risk Management Plans


Timepoint [1] 391617 0
Two weeks
Secondary outcome [2] 391618 0
2. Sub-acute engagement with treatment - rate of attendance at follow-up appointments in sub-acute phase following index presentation to ED for a six-month time-period.

Rate of attendance at follow-up first follow-up appointment following DSH presentation to PCH ED in the sub acute time period
Audit of appointments attended (CAMHS-PSOLIS), vs appointments scheduled as per CAMHS Management Plans and recorded as 'missed' appointment in PSOLIS
Timepoint [2] 391618 0
6-months
Secondary outcome [3] 391619 0
3. Clinical Symptoms - number of deliberate self-harm episodes following index presentation to ED in the acute (2 weeks) and sub-acute (6-months) time periods.

Number of DSH Episodes following presentation in the acute and sub-acute period. Self -and parent-report (structured phone interview) / medical records/ PSOLIS
Timepoint [3] 391619 0
acute: 2 weeks
sub-acute: 6 months
Secondary outcome [4] 391620 0
4. Medical seriousness of presentations for mental health crisis/ DSH behavior to emergency departments within a 6-month time period.

Medical seriousness
Medical seriousness of presentations for mental health crisis/ DSH behaviour within a 6-month period
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

Potential lethality
Potential lethality of presentations for mental health crisis/ DSH behaviour within a 6-month period
Potential Lethality Scale; Haw et al., 2003) (1 = certain survival; 2 = <50% chance of death; 3. >50% chance of death; 4 = certain death); clinician rated

Timepoint [4] 391620 0
6-months

Eligibility
Key inclusion criteria
Children and adolescents aged 10 to17 who attend a hospital emergency department after a mental health crisis (including deliberate self-harm) for the duration of recruitment phase of the project and who give consent.
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Psychosis as documented in Department of Health Progress notes or reported by parents
2, Intellectual disability (IQ score <70) as documented in Department of Health Progress notes or reported by parents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Treatment group allocation for the trial will utilize computer-generated minimisation, that incorporates weighted randomisation, via a local implementation of the MimimPy algorithm (Saghaei & Saghaei, 2011). The minimisation algorithm will ensure balance between intervention groups for several selected patient factors (gender and presentation status).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single site, Randomized, non-blinded control trial with three groups - control, Expanded Assessment and Expanded Assessment + Nested Intervention (Therapeutic Assessment).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is planned to recruit at least 100 in each arm, ensuring at least 90 per group are available for analysis, with this sample size being a pragmatic choice which balances power and feasibility of implementation.

Primary outcome: Based on pilot data we expect that under standard care over 50% of first-time presenters will re-present to ED within 6 months (estimated rate = 0.75 re-presentations/6 mths), and over 75% of recurrent presenters (estimated rate = 1.5 re-presentations/6 mths). Given the combined-sample recruitment of both first-time and recurrent presenters, the power of our planned study was examined via 1000 simulations based on randomly-generated Poisson data defined by these estimated parameters. With recruitment expected to include approximately 90 first-timers and 180 recurrent presenters, and allocation of equal numbers to receive standard care, expanded assessment only or expanded assessment plus intervention, the simulation study has indicated we will have more than 80% power to detect at least a 34% reduction in the re-presentation rates by receipt of the intervention.

For the primary outcome, rates of re-presentation will be analysed by regression modelling appropriate for count data (Poisson, or quasi-Poisson or negative binomial if better suited to the data), with time considered as an exposure variable. Group differences will be examined by contrasts specified in the regression modelling: (1) Separate indicators for Group 2 and Group 3 will compare re-presentation rates with Group 1, as the baseline; (2) Inclusion of one indicator for membership of either Group 2 or 3 and another indicator for Group 3 membership will assess impact of the intervention over and above receipt of the expanded assessment. Presentation type and gender, important prognostic factors, will be included as covariates in the regression model. Analyses will also consider differential assessment group effects across presentation type by inclusion of an interaction term.

Secondary analyses: Logistic regression will be used for analysis of acute and sub-acute engagement with treatment, Poisson regression for counts of reported deliberate self-harm episodes, and ordinal regression for medical seriousness and potential lethality. Where these outcomes measures have been collected on multiple occasions, the analyses will be undertaken within the appropriate mixed-effects regression framework.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
10/12/2021
Date of last data collection
Anticipated
30/06/2022
Actual
30/06/2022
Sample size
Target
300
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18659 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 33026 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 307807 0
Charities/Societies/Foundations
Name [1] 307807 0
Chanel 7 Telethon Trust
Country [1] 307807 0
Australia
Funding source category [2] 307808 0
Charities/Societies/Foundations
Name [2] 307808 0
Perth Children's Hospital Foundation
Country [2] 307808 0
Australia
Primary sponsor type
Hospital
Name
Perth Childrens Hospital
Address
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 308512 0
None
Name [1] 308512 0
Address [1] 308512 0
Country [1] 308512 0
Other collaborator category [1] 281645 0
Charities/Societies/Foundations
Name [1] 281645 0
Telethon Kids Institute
Address [1] 281645 0
Telethon Kids Institute
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS 6009 WA
Country [1] 281645 0
Australia
Other collaborator category [2] 281646 0
University
Name [2] 281646 0
Curtin University
Address [2] 281646 0
Curtin University
Kent Street Bentley
WA 6102
Country [2] 281646 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307813 0
Child Adolescent Health Services Human Research Ethics Committee
Ethics committee address [1] 307813 0
Ethics committee country [1] 307813 0
Australia
Date submitted for ethics approval [1] 307813 0
18/02/2020
Approval date [1] 307813 0
08/07/2020
Ethics approval number [1] 307813 0
EC00268

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

Contacts
Principal investigator
Name 108590 0
Ms Zamia Pedro
Address 108590 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country 108590 0
Australia
Phone 108590 0
+61 08 6456 0203
Fax 108590 0
Email 108590 0
[email protected]
Contact person for public queries
Name 108591 0
Zamia Pedro
Address 108591 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country 108591 0
Australia
Phone 108591 0
+61 08 6456 0203
Fax 108591 0
Email 108591 0
[email protected]
Contact person for scientific queries
Name 108592 0
Zamia Pedro
Address 108592 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country 108592 0
Australia
Phone 108592 0
+61 08 6456 0203
Fax 108592 0
Email 108592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are undecided


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.