Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000030976
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
20/01/2020
Date last updated
29/06/2021
Date data sharing statement initially provided
20/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a post-training enhancement to the LifeKeepers suicide prevention programme across three training modalities: A randomised control trial.
Scientific title
Evaluating the effectiveness of a post-training enhancement to the LifeKeepers suicide prevention programme across three training modalities: A randomised control trial.
Secondary ID [1] 299425 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial is linked to an inter-related study, which is stage one of the overall research, titled " Evaluating the effectiveness of LifeKeepers suicide prevention programme across three training modalities" . This pre-post study is not registered and does not have a registration number, nor is it published yet. The study has been approved by the University of Auckland ethics committee Protocol number 022441

Health condition
Health condition(s) or problem(s) studied:
suicide prevention 314618 0
Condition category
Condition code
Mental Health 312957 312957 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
A post-training enhancement to LifeKeepers - New Zealand’s national suicide prevention training programme.

There is wide support in the literature demonstrating suicide prevention gatekeeper training programmes increase participants knowledge about suicide and confidence to identify and support someone who may be at risk of suicide immediately post training. However, the observed gains appear to diminish over time.

This study will evaluate the effectiveness of a newly developed enhancement to the LifeKeepers suicide prevention training programmes to maintain participants long-term retention of declarative knowledge about suicide, their self-efficacy (confidence) to apply the skills and their willingness to support someone at risk of suicide (questioning and referral behaviours).

The enhanced programme includes participants engaging in one of the usual LifeKeepers training programmes, but this will be augmented with additional suicide related information provided to participants regularly post-training. The LifeKeepers programme consists of three separate training modalities – a General face-to-face workshop, and Indigenous face-to-face workshop for Maori (Mana Akiaki) and web-based elearning training modules. All three training modalities will be included in the study.

Study participants in the intervention group will receive a 1- 2 page information sheet, designed specifically for this study, reinforcing key messages from the training content.
These 1-2 page information sheets will be sent to participants every two months post training via automated email for a 12-month period. The first information sheet will be sent 8 weeks following the completion of the training. Participants will receive a total of 5 different information sheets over this period:
sheet 1 focuses on common myths and misunderstandings about suicide
sheet 2 examines risk and protective factors
sheet 3 looks at warning signs linked to suicide
sheet 4 reinforces the LifeKeepers C.A.R.E model (connecting, ask, respond and engage)
sheet 5 focus on community supports options available

The automated emails will be administered via Le Va (a Non-Government Organisation) who deliveries the LifeKeepers programmes throughout New Zealand and is funded by the New Zealand Ministry of Health. Participants receive email reminders to encourage completion of post-training assessments.

All three LifeKeepers training programmes consist of 5 modules covering:
1. How to talk responsibly about suicide and understanding the facts related to suicide
2. the risk and protective factors associated with suicide
3. How to identify the warning signs for when someone may be at risk of suicide
4. Learn the skills and build the confidence to intervene safety with individuals at risk of suicide.
5.Learn what to do in an emergency and what services are available.

The face-to-face workshops are a full days training and the 5 online e-learning modules can be completed at the participants own pace and generally take between 2-3 hrs to complete in one sitting.

The trainings are co-facilitated by trained Le Va staff and external contractors. A psychologist or trained mental health professional attends each workshop as a facilitator or support person.
Intervention code [1] 315733 0
Behaviour
Intervention code [2] 316311 0
Prevention
Comparator / control treatment
The Comparator treatment is “Training as usual” in which no further information will be provided to study participants post-training.

The Control treatment involves participants randomly selected into the “Attention control placebo group” receiving additional information, which is not suicide prevention related (a 1-2 page sheet with general health and wellbeing information), every two months via email for a 12-month period post training (5 information sheets in total each consisting of differing health related information).
Control group
Active

Outcomes
Primary outcome [1] 321598 0
Primary outcome 1:
The difference in mean scores of declarative knowledge and skills about suicide from baseline (post-test scores) to 6 months follow-up between the Enhanced LifeKeepers training relative to LifeKeepers training as usual (non-enhanced) and the Attention control placebo group.

The 6 months assessment will require participants to read a case scenario and answer 10 multichoice items with four answer alternatives per question (developed specifically for the study) each pertaining to content presented in the training.
Timepoint [1] 321598 0
Timepoint primary outcome 1:
.
6 months post randomisation
Secondary outcome [1] 375548 0
Secondary outcome 1:
Difference in mean scores for declarative knowledge and skills from baseline to 3 and 12 months follow-up.
The 3 month assessment will require participants to read a case scenario and answer 10 multichoice items with four answer alternatives per question (developed specifically for the study) each pertaining to content presented in the training. The 12 month assessment will require participants to complete a multichoice questionnaire.
Timepoint [1] 375548 0
Timepoint - 3 months and 12 months after randomisation
Secondary outcome [2] 375550 0
Secondary outcome 2:
Difference in self-efficacy (confidence) in identifying and supporting someone at risk of suicide from baseline to 3, 6 and 12 months follow up.
Confidence to detect and engage a person at risk of suicide will be assessed via a slightly modified Morriss Confidence Scale (Capp et al., 2001) involving 2 items..
Timepoint [2] 375550 0
Timepoint secondary outcome 2:

Participants will rate their confidence levels on two items at 3, 6- and 12-months post randomisation
Secondary outcome [3] 375793 0
Secondary outcome 3:
Difference in application of the training (engaging with someone considered at risk, referring them for support or sharing a training resource i.e. behavioural outcome) from baseline to 3, 6 and 12 months follow up. This is measured using a self-report questionnaire designed specifically for this study.
Timepoint [3] 375793 0
Timepoint period for secondary outcome 3:

3, 6 and 12 months post training

Eligibility
Key inclusion criteria
Trainees who have completed either the LifeKeepers General or Maori workshops or the online modules, and who have consented to participate in the research,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The training is not intended for health practitioners who have received more advanced suicide prevention training such as, medical and mental health professionals and they will therefore be excluded from the study.

Training participants who have completed the LifeKeepers training programme but not completed the post-test will be excluded as post-test scores are required for baseline data.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization of participants will be conducted immediately post LifeKeepers training by an independent team support member to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequences are being used in this study to ensure allocation concealment. This will be carried out by an independent statistician.

Participants within each training modality will be randomly assigned to one of the three intervention groups with a 1:1:1 allocation, stratified by training modality and priority group (community members or frontline staff) as per computer generated randomisation sequences to ensure allocation concealment.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The study is designed as a randomized controlled trial (RCT) to evaluate the effectiveness of an enhanced training programme relative to treatment as usual (non-enhanced) and an attention control placebo group. Randomisation of participants will be conducted immediately post LifeKeepers suicide prevention training and be stratified by training modality and priority group (community members or frontline staff).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis
The data analysis for this study will involve quantitative analyses for numeric variables using paired t-tests to compare mean changes from baseline to each follow-up. Standard descriptive statistics will be used to summarise the demographic and presenting features (priority group, modality, previous suicide prevention training) and the values and changes for each outcome at each time point. These will include, means, medians, standard deviations and ranges and frequencies and percentages as appropriate.
The two a-priori comparisons of enhanced LifeKeepers v treatment as usual and enhanced LifeKeepers v Attention control will each be tested using a two-tailed a of 0.025 for each outcome.
The consistency of treatment effects for the primary and secondary outcomes will be tested using ANOVA. These analyses will incorporate treatment, modality and priority groups as factors and the interactions between priority, modality and treatment will be statistically evaluated.

A target sample size of 240 participants (80 per group) is estimated to provide at least 80% power at 5 % level of significance (two-sided, split so there is 2.5% for each of the two treatment comparisons with enhanced treatment for each outcome) to detect a 0.5 difference in the change in mean scores of knowledge and skills about suicide from baseline post-test scores assuming a standard deviation of the change of 1.2 (derived from pilot data) an ICC of 0.02 (derived from pilot data) for the effect of workshop group and allowing for 10% loss to follow up.

However, Le Va is contracted to deliver 24 workshops (12 general and 12 Mana Akiaki) over the period of this study (12 months) with an average of 25 participants per workshop. To date, workshops have been reaching this target. For the e-learning modules Le Va expects to register 500-1000 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
500
Final
Recruitment outside Australia
Country [1] 21906 0
New Zealand
State/province [1] 21906 0

Funding & Sponsors
Funding source category [1] 303936 0
Other
Name [1] 303936 0
Le Va
Country [1] 303936 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Univeristy of Auckland
Department of Psychological Medicine
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 304087 0
None
Name [1] 304087 0
Address [1] 304087 0
Country [1] 304087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304432 0
UNIVERSITY OF AUCKLAND HUMAN PARTICIPANTS ETHICS COMMITTEE
Ethics committee address [1] 304432 0
Ethics committee country [1] 304432 0
New Zealand
Date submitted for ethics approval [1] 304432 0
08/11/2018
Approval date [1] 304432 0
19/12/2018
Ethics approval number [1] 304432 0
Protocol number 022445

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

Contacts
Principal investigator
Name 96934 0
Ms Denise Kingi
Address 96934 0
Harakeke House
15 Ronwood Avenue, PO Box 76536, Manukau City 2241
Country 96934 0
New Zealand
Phone 96934 0
+64 9 261 3476
Fax 96934 0
Email 96934 0
[email protected]
Contact person for public queries
Name 96935 0
Denise Kingi
Address 96935 0
Harakeke House
15 Ronwood Avenue, PO Box 76536, Manukau City 2241
Country 96935 0
New Zealand
Phone 96935 0
+64 9 261 3476
Fax 96935 0
Email 96935 0
[email protected]
Contact person for scientific queries
Name 96936 0
Denise Kingi
Address 96936 0
Harakeke House
15 Ronwood Avenue, PO Box 76536, Manukau City 2241
Country 96936 0
New Zealand
Phone 96936 0
+64 9 261 3476
Fax 96936 0
Email 96936 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
Individual participant data will not be made available only a summary of the results will be made public as part of PhD research.


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.