Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000085279p
Ethics application status
Submitted, not yet approved
Date submitted
29/12/2017
Date registered
19/01/2018
Date last updated
19/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving care for adolescents during an inpatient admission following self-harm and suicidal acts
Scientific title
A pilot randomised trial of standard care versus structured care during an inpatient admission following self-harm and suicidal acts in adolescents
Secondary ID [1] 293699 0
The Royal Children's Hospital Foundation Proposal ID: 2014-419
Universal Trial Number (UTN)
U1111-1207-0848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 306033 0
Self-harm 306034 0
Condition category
Condition code
Mental Health 305180 305180 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Young people allocated to structured care will receive all the usual benefits associated with standard adolescent inpatient care during their admission, with the addition of structured sessions for both the young person and their parent/guardian, with the content of these sessions clearly defined.

The young person will attend two sessions during their inpatient admission following the principles of Therapeutic Assessment (as outlined by Ougrin, Ng, and Low (2008)). Therapeutic Assessment (TA) is a structured safety-planning approach that utilises the principles of cognitive behaviour therapy (Beck, 2011) and cognitive analytic therapy (Ryle & Kerr, 2003). These psychological approaches aim to work alongside the individual and support them to accept the need for change and implement required adjustments. These sessions will be individually delivered as a face-to-face intervention, with each session lasting approximately 60 minutes. There will be a minimum of two days between session one and session two. A registered mental health nurse has been recruited specifically for the trial and will be trained in TA by the Principal Investigator.

Furthermore, the parent/guardian of young people allocated to structured care will also attend two sessions during the adolescent’s inpatient admission. These sessions will draw on the principles of task one of Attachment Based Family Therapy (Diamond, Diamond, & Levy, 2014; Diamond & Stern, 2003). This task aims to assess family functioning and provide attachment informed psycho-education and crisis management strategies. These two sessions will be provided by the PI, a Consultant Psychiatrist.

Due to the pilot nature of this trial, strategies to monitor adherence to the interventions will not be included.
Intervention code [1] 299953 0
Treatment: Other
Intervention code [2] 300019 0
Behaviour
Comparator / control treatment
Young people and their parents/guardian allocated to standard care will receive the usual benefits associated with standard adolescent inpatient care during their admission. In keeping with standard practice, the ward provides the least restrictive environment possible while remaining compatible with the needs and safety of young people and staff. It also aims to promote community management wherever possible.
Standard care may also include individual sessions with the young person and/or parent support/meetings. While these are recognised as important elements of standard adolescent inpatient care, within current clinical practice on the ward their practice is variable and occurs on an ad hoc basis depending on the young person’s risk, assessed needs, and requests for support. Furthermore, though individual sessions with the young person and offering parent support are recognised as good clinical practice on the ward, guidance around the content of this support is not clearly outlined.
Control group
Active

Outcomes
Primary outcome [1] 304337 0
Attendance at first and subsequent community mental health appointments following discharge from Banksia ward. As previously defined by Ougrin et al (2008), attendance at subsequent appointments will be operationalised as attendance at 50% or more of the appointments offered (excluding cancellations).
Timepoint [1] 304337 0
1 and 3 months follow-up following discharge from Banksia ward.
Secondary outcome [1] 341627 0
Parental protective factors in supporting the young person when in crisis. This questionnaire has been developed specifically for the pilot study to assess parental protective factors in supporting their child when they are experiencing thoughts of hurting themselves or ending their life. The measure has been based on the External Protective factor of the SRI-25 and adapted for a parent’s perspective. Items are rated on a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree).
Timepoint [1] 341627 0
Baseline and prior to discharge from Banksia ward
Secondary outcome [2] 341628 0
Adolescent suicide-related resilience as assessed with the 3 factors of the Suicide-Resilience Inventory-25 (SRI-25; Osman et al., 2004).
Timepoint [2] 341628 0
Baseline and prior to discharge from Banksia ward
Secondary outcome [3] 341629 0
Young person satisfaction with inpatient admission with the adapted Experience of Service Questionnaire.
Timepoint [3] 341629 0
Prior to discharge from Banksia ward
Secondary outcome [4] 341630 0
Level of clinician-rated engagement in community mental health support using the Engagement Measure (Hall, 2001). Responses are combined to form a single measurement of engagement, with higher scores reflecting higher levels of engagement.
Timepoint [4] 341630 0
1 and 3 months follow-up following discharge from Banksia ward.
Secondary outcome [5] 341631 0
Number of re-admissions to the Royal Children's Hospital adolescent inpatient mental health ward (Banksia ward)
Timepoint [5] 341631 0
1 and 3 months follow-up following discharge from Banksia ward.
Secondary outcome [6] 341905 0
Parent satisfaction with inpatient admission with the adapted Experience of Service Questionnaire
Timepoint [6] 341905 0
Prior to discharge from Banksia ward
Secondary outcome [7] 341906 0
Number of re-presentations to the Royal Children's Hospital Emergency Department
Timepoint [7] 341906 0
1 and 3 months follow-up following discharge from Banksia ward.

Eligibility
Key inclusion criteria
1. Young person aged 12 – 18 years old with the ability to provide consent
2. Admitted to Banksia Ward at The Royal Children’s Hospital Melbourne following either/both:
a. a suicide attempt (with intent to die and based on lethality)
b. engagement in self harm (without suicidal intent) within 30 days prior to the admission
3. Parent/guardian consent to participate in parenting sessions
4. Proficiency in written and spoken English that is sufficient for participation and questionnaire completion and does not require an interpreter
5. Stable living situation/no immediate plans for out-of-home placement
6. Young person lives within the Western/Metropolitan region
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No suicidal attempts or self harm within 30 days prior to admission
2. Presenting for admission with psychosis or substance dependence
3. A diagnosis of a learning disability and/or autism spectrum condition
4. A disorder that is likely to impair capacity to give informed consent
5. No parent/guardian to participate
6. Direct transfer to medical unit
7. Young person stating that they do not intend to engage in community mental health support following discharge
8. Young person belongs to the Aboriginal or Torres Strait Islanders population

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)
Randomisation will be conducted by a researcher not involved in the study and based within the Clinical Epidemiology and Biostatistics Unit of the Murdoch Children’s Research Institute. A computer-generated block randomisation sequence will be prepared in sealed envelopes. These envelopes will remain concealed until assignment to the two conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by a researcher not involved in the study and based within the Clinical Epidemiology and Biostatistics Unit of the Murdoch Children’s Research Institute. A computer-generated block randomisation sequence will be prepared in sealed envelopes. These envelopes will remain concealed until assignment to the two conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All participants will be recruited during an admission to Banksia ward. A previous feasibility study (Katz et al., 2004) comparing two separate inpatient units using different treatment models with an adolescent inpatient population recruited 62 participants. On this basis, this study aims to recruit at least 31 participants per group to evaluate acceptability and effectiveness. A review of current Banksia admission rates over a one-year period (December 2016 – December 2017) suggests that, on average, the ward accepts 8.2 referrals per week. Young people presenting with suicidal ideation and/or a history of self-harm made up 64% of these referrals, which is equivalent to 5.25 referrals per week. This suggests that the studies aim to recruit 62 participants over 16 weeks will be feasible. Between-group differences will be analysed using chi square, analysis of variance (ANOVA) and t tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/03/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9652 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 18416 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 298316 0
Charities/Societies/Foundations
Name [1] 298316 0
The Royal Children's Hospital Foundation
Country [1] 298316 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Royal Children's Hospital Foundation
Address
50 Flemington Road
Parkville
Victoria 3052
Australia
Country
Australia
Secondary sponsor category [1] 297431 0
None
Name [1] 297431 0
Address [1] 297431 0
Country [1] 297431 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299311 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 299311 0
Research Ethics & Governance
The Royal Children's Hospital
Level 4, South Building
50 Flemington Road
Parkville Vic 3052
Ethics committee country [1] 299311 0
Australia
Date submitted for ethics approval [1] 299311 0
10/01/2018
Approval date [1] 299311 0
Ethics approval number [1] 299311 0

Summary
Brief summary
This pilot study will randomise young people admitted to Banksia ward following a suicide attempt or self-harm to either standard care or structured care. Comparisons will be made in terms of attendance and engagement with community mental health services, parental protective factors in supporting the young person in crisis, self-rated suicide resilience, satisfaction with inpatient services, and readmission rates within 1 and 3 months. Measures will be taken at baseline, discharge from Banksia ward, and 1 and 3 months follow-up. Between-group differences will be analysed using chi square, analysis of variance (ANOVA) and t tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80010 0
Dr Chidambaram Prakash
Address 80010 0
Level 2 East
Clinical Reception K
The Royal Children's Hospital Melbourne
50 Flemington Road
Parkville 3052
Victoria Australia
Country 80010 0
Australia
Phone 80010 0
+61 3 9345 5511
Fax 80010 0
+61 3 9345 6002
Email 80010 0
[email protected]
Contact person for public queries
Name 80011 0
Dr Kirsty James
Address 80011 0
Level 2 East
Clinical Reception K
The Royal Children's Hospital Melbourne
50 Flemington Road
Parkville 3052
Victoria Australia
Country 80011 0
Australia
Phone 80011 0
+61 3 9345 5511
Fax 80011 0
Email 80011 0
[email protected]
Contact person for scientific queries
Name 80012 0
Dr Kirsty James
Address 80012 0
Level 2 East
Clinical Reception K
The Royal Children's Hospital Melbourne
50 Flemington Road
Parkville 3052
Victoria Australia
Country 80012 0
Australia
Phone 80012 0
+61 3 9345 5511
Fax 80012 0
Email 80012 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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