Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001038381
Ethics application status
Approved
Date submitted
16/06/2017
Date registered
17/07/2017
Date last updated
19/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of a brief mental health crisis intervention for adolescents
Scientific title
Evaluation of the efficacy of a brief community-based intervention for adolescents presenting in crisis to public mental health service
Secondary ID [1] 292210 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal thoughts and behaviours 303701 0
Self harm 303792 0
Condition category
Condition code
Mental Health 303073 303073 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research project aims to evaluate the effectiveness of a Brief Crisis Intervention for Adolescents who present to the Monash Health Early in Life Mental Health Service (ELMHS) with recent suicidal behaviour/plan or deliberate self-harm (within the past 2 weeks). This intervention is offered to young people and their parents/carers as part of routine mental health care by mental health clinicians within the ELMHS Intake, Assessment, Consultation and brief Treatment (iACT) team at the ELMHS Dandenong site - Community Services Building.

All mental health clinicians within the iACT Team are health practitioners who have training and experience in assessment and treatment of mental health conditions in children, adolescents and youth, including mental health crisis presentations. These clinicians include certified psychologists, social workers, occupational therapists, medical practitioners, and consultant psychiatrists who are at a Grade 2 category of employment or higher.

Young people (aged 12 to 18 years) and their parents/carers who agree to participate in the Brief Crisis Intervention for Adolescents as part of the young person’s routine care, will also be invited to participate in this research study.

The primary treatment goals of the intervention are: To reduce reoccurrence of suicidal/self-harm behaviour and to increase coping with stressors that can trigger suicidal crises.

The iACT brief crisis intervention is provided over a total of 4-5 sessions, with sessions ideally administered on a weekly basis. This intervention consists of initial, middle and end phases of acute treatment. Each session commences with a risk assessment and broad review, so that revisions may be made to the crisis plan as required.

Sessions will generally be allocated in the following order:
1. Assessment Session (90-120 mins)
2. Initial Treatment phase (1-2 sessions – 60-90 mins)
3. Middle Treatment Phase (2-3 sessions – 60 mins)
4. End Treatment Phase (1 session – 60 mins)

Each phase consists of the following core tasks:
1. Initial Treatment Phase – Psychoeducation, safety planning and shared narrative/case formulation
2. Middle Treatment Phase – Selective individual skill building modules and family intervention modules.
3. End Treatment Phase – Relapse prevention

The iACT brief crisis intervention is a semi-structured treatment. Thus, individual and family modules are collaboratively chosen by the individual, family and clinician at the end of the initial treatment phase. Selection of the modules is based on relevance to the individual formulation and predicted effectiveness regarding risk reduction.

Individual skill building treatment modules from the middle phase of treatment can include: self monitoring skills; emotional regulation skills; problem solving skills (around identified stressors); mobilising social supports; behavioural activation; communication skills; thought-based strategies and goal setting skills. Family treatment modules include: enhancing parental emotional reflection skills; strengthening family relationships; and family communication skills.

The relapse prevention focus of the final stage of treatment involves: reviewing the crisis event; reviewing the crisis event with skills learned through current treatment; reviewing future high-risk scenarios and engaging in planning around how these may be most effectively managed; debriefing around the therapy experience and engaging in planning around recommended follow up supports.

Family involvement in all aspects of the young person's treatment can be flexibly planned. Therefore, parents may join the young person for parts of their treatment sessions or participate in entire sessions with the young person at the clinician’s discretion. Additional family phone ‘check ins’ (5-15 minutes per/week) may be offered at clinician’s discretion. These will not be considered as treatment sessions.

Treatment Fidelity/Adherence Measures:
Mental Health Clinicians providing this brief crisis intervention to young people and their carers, as part of the young person's routine mental health care, will have had orientation to the 'Treatment Fidelity ­Guiding Document'. This guideline aims to define the minimum therapeutic tasks that should be covered in each treatment stage and selected treatment module to support consistency of the intervention. This aims to ensure that the treatment is implemented as planned and that each component is delivered in a comparable manner to all participants

Clinicians who are providing this routine brief crisis intervention package to young people who have consented to participate in the current research evaluation project will complete a Treatment Fidelity Session Checklist at end of each session that helps document therapeutic tasks covered each session.

Clinicians will also be required to have several of their client’s full series of therapy sessions audio recorded, where a research investigator will rate these recorded sessions in relation to treatment adherence. A random selection method will be utilised for selecting clinician’s clients within the study to request consent for this audio-taping process. The number of sessions recorded will equate to 15-20% of the total number of treatment sessions delivered to all participants group. This recording process is voluntary. If a participant does not want their treatment sessions to be recorded, they do not have to be.
Intervention code [1] 298366 0
Treatment: Other
Intervention code [2] 298455 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302452 0
Study Hypotheses:

Change in the frequency and severity of suicidal thoughts and behaviour, assessed using the Colombian Suicide Severity Rating Scale (C-SSRS).

Outcome will be measured with the Colombian Suicide Severity Rating Scale (C-SSRS) - 'Baseline-Screening' Version at Timepoint 1 and the C-SSRS- 'Since Last Session' Version at subsequent time points
Timepoint [1] 302452 0
Timepoints:

1. Before starting the Brief Crisis Intervention for Adolescents (baseline),
2. At their final treatment session
3. Phone review completed two months after completing the intervention.
Primary outcome [2] 302760 0
Change in the frequency and severity of deliberate self-harm behaviour, assessed using the Colombian Suicide Severity Rating Scale (C-SSRS).

Outcome will be measured with the Colombian Suicide Severity Rating Scale (C-SSRS) - 'Baseline-Screening' Version at Timepoint 1 and the C-SSRS- 'Since Last Session' Version at subsequent time points
Timepoint [2] 302760 0
Timepoints:

1. Before starting the Brief Crisis Intervention for Adolescents (baseline),
2. At their final treatment session
3. Phone review completed two months after completing the intervention.
Secondary outcome [1] 336061 0
Study Hypothesis:

Change in suicide related resilience and coping skills, assessed using the Suicide Resilience Inventory (SRI-25).
Timepoint [1] 336061 0
Timepoints:
1. Before starting the Brief Crisis Intervention for Adolescents (baseline)
2. At their final treatment session
3. Phone review completed two months after completing the intervention.

Eligibility
Key inclusion criteria
Inclusionary criteria:
• Youth aged in between 12-18 years
• Following recent suicide attempt or deliberate self-harm within last 2 weeks
• May present with suicidal ideation and plan
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General exclusion considerations:
• Psychiatric inpatient admission required
• Significant psychotic component to presentation
• Severe and chronic substance dependence/abuse that is a primary component of presentation
• Severe personality disorder – where brief treatment is not indicated
• Where the carer’s capacity/availability to engage in intervention with young person is compromised or severe parent-carer relational discord where a brief family-based intervention is contraindicated.

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)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Justification of Sample Size

A power analysis was performed to determine the sample size required to detect significant differences across time on the primary outcomes measures. Results from a Daniel Soper ‘a priori’ sample size calculator indicated that a sample size of approximately 64 participants would be adequate, with a medium effect size (Cohen’s d) = 0.5, desired statistical power = 0.8 and a = 0.05. This study will aim to recruit 65-75 young people and their parents/carers.

2. Data Analysis

A one-way repeated measures Analysis of Variance (ANOVA) will be utilized to assess for significant change in the three outcome variables (suicidal thoughts/behaviours severity, self-harm behaviours severity and suicide-related resilience levels) across the three time-points (beginning of treatment, end of treatment and at 2 month post review).
A mixed-model ANOVA with a 3x2x3 design will also be used to identify any confounding group effects of age, gender or socio-economic status variables on the results.




Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/08/2017
Actual
30/08/2017
Date of last participant enrolment
Anticipated
16/03/2018
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
70
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16450 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 296751 0
Self funded/Unfunded
Name [1] 296751 0
Country [1] 296751 0
Primary sponsor type
Government body
Name
Early in Life Mental Health Service, Monash Health
Address
145 Cleeland Street, Dandenong VIC 3175
Country
Australia
Secondary sponsor category [1] 295724 0
Other
Name [1] 295724 0
The Cairnmillar Institute
Address [1] 295724 0
993 Burke Road, Camberwell VIC 3123
Country [1] 295724 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297975 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 297975 0
Ethics committee country [1] 297975 0
Australia
Date submitted for ethics approval [1] 297975 0
21/06/2017
Approval date [1] 297975 0
20/07/2017
Ethics approval number [1] 297975 0
Monash Health Ref: RES-17-0000-352A, NMA SSA Reference Number: SSA/17/MonH/333

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

Contacts
Principal investigator
Name 75638 0
Dr David Moseley
Address 75638 0
Intake, Assessment, Consultation and Brief Treatment (iACT) Team
Early in Life Mental Health Service (ELMHS), Monash Health
Community Services Building
145-151 Cleeland Street, Dandenong VIC 3175
Country 75638 0
Australia
Phone 75638 0
+61 3 9767 8274
Fax 75638 0
Email 75638 0
[email protected]
Contact person for public queries
Name 75639 0
David Moseley
Address 75639 0
Early in Life Mental Health Service, Monash Health
Community Services Building
145-151 Cleeland Street, Dandenong VIC 3175
Country 75639 0
Australia
Phone 75639 0
+61 3 9767 8274
Fax 75639 0
+61 3 9767 8244
Email 75639 0
[email protected]
Contact person for scientific queries
Name 75640 0
David Moseley
Address 75640 0
Early in Life Mental Health Service, Monash Health
Community Services Building
145-151 Cleeland Street, Dandenong VIC 3175
Country 75640 0
Australia
Phone 75640 0
+61 3 9767 8274
Fax 75640 0
+61 3 9767 8244
Email 75640 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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