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Trial registered on ANZCTR


Registration number
ACTRN12619000630112
Ethics application status
Approved
Date submitted
18/03/2019
Date registered
29/04/2019
Date last updated
28/02/2020
Date data sharing statement initially provided
29/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing resilience and positive mental health strategies in university students
Scientific title
Developing resilience and positive mental health strategies in university students through a Mass Open Online Course
Secondary ID [1] 297737 0
Nil
Universal Trial Number (UTN)
U1111-1230-2570
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
suicide 312066 0
non suicidal self harm 312067 0
Condition category
Condition code
Mental Health 310629 310629 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will build on a previously approved project ('Talk to me' program-building resilience in university students, HREC record number: HRE2019-0402) which included a pilot study of the module 1 and 2 of the MOOC program and focus groups with university staff, students, GP's and mental health policy makers to determine suitability and scope and desired content of a Mass Open Online Course ("Talk-to-Me" MOOC) to support mental health awareness, early detection; interaction and coping skills for undergraduate students.
For this project, we will evaluate the effectiveness of the "Talk-to-me" MOOC developed in the previously approved project ('Talk to me' program-building resilience in university students, HREC record number: HRE2019-0402) in two phases.
Students will complete 6 modules of the MOOC:
• Module 1 – Mental fitness
• Module 2 – Cognitive-behavioural strategies to increase mental fitness
• Module 3 – Non-suicidal self-harm (NSSH)
• Module 4 – Suicidal behaviour in young adults (SBYA)
• Module 5 – Interventions in SBYA
• Module 6 – Gatekeeper Interventions
Phase One
Phase One will include a waitlist RCT to explore and evaluate the effectiveness of the "Talk-to-Me" MOOC. This will include 1) Evaluation of the “Talk-to-Me” MOOC in providing education on mental health and influencing attitudes, stigma, health seeking behaviour and behaviour related to providing support to others experiencing mental health and 2) Exploring changes related to participants own mental health including areas such as self-efficacy, resilience and knowledge about own mental health.

Response to query 4.2.20:
A: A total of 15 hours is allocated to each module. It estimated each module will take between 1-2 hours.
B: The course is completed at the participants own pace over the duration of a semester (February-June 2020, or July- December 2020)
C: There is a quiz at the end of each module. Emails will also be sent out at different points of study to complete pre/post measures.

Intervention code [1] 313975 0
Prevention
Comparator / control treatment
Participants will be recruited and screened for eligibility. Once eligibility is confirmed students will complete baseline measures. Students will then be randomized to receive the "Talk-to-Me" MOOC in Semester One (Group A) or Semester Two (Group B). Students will be randomized at the school level (e.g., all students from the same school will receive the same allocation) to avoid contamination. Following the completion of baseline measures students will be notified of their allocation (Semester One [Group A] or Semester Two [Group B]). For the purposes of this project, Group B is the wait-list group and will therefore act as the control group as per a wait-list design.
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate

Response to query 4.2.20: We have not recruited any participants for the RCT as have not run RCT due to delay in getting ethics approval.
Control group
Dose comparison

Outcomes
Primary outcome [1] 319478 0

Objective Structured Video Examinations (OSVE)
online delivery
likert style responses and open ended responses to observation video
Timepoint [1] 319478 0
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate.
Primary outcome [2] 323074 0
IEQU- Internet Evaluation and Utility Questionnaire.
Timepoint [2] 323074 0
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate
Primary outcome [3] 323075 0
Van Spijker, B.A.J., Batterham, P.J., Calear, A.L., Farrer, L., Christensen, H., Reynolds, J. & Kerkhof, A.J.F.M. (2014). The Suicidal Ideation Attributes Scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation.
Suicide and Life-Threatening Behavior, 44 (4), 408-419.
Timepoint [3] 323075 0
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate
Secondary outcome [1] 368325 0
Whittlesey, V. (2001). Diversity activities for psychology. Boston: Allyn and Bacon, and Fischer, E., and Farina, A. (1995). Attitudes toward seeking psychological Professional help: A shortened form and considerations for research. Journal of
College Student Development, 36, 368-373.]

10 item Attitudes towards seeking help for mental health issues

Used to determine if the MOOC improved building awareness building awareness of mental health promoting activities.
Timepoint [1] 368325 0
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate
Secondary outcome [2] 368327 0
Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user’s portfolio.
Self-Efficacy to Avoid Suicidal Action: domain specific self-report self- efficacy scale. Self-efficacy to avoid suicide action & NSSI
Enhancing resilience, developing skills for managing distress.
Timepoint [2] 368327 0
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate
Secondary outcome [3] 380707 0
Sample Demographic Data
Non validated questions that have been designed specifically for the study including asking questions about previous mental health training experience age, gender, ethnicity, education level, mode of study, area of study. Questions asked via Qualtrics survey
Timepoint [3] 380707 0
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0).
Secondary outcome [4] 380708 0
Bedewy, D., Gabriel, A. (2015). Examining perceptions of academic stress and its sources among university students: The Perception of Academic Stress Scale. Health
Psychology Open, 1-9.

Perception of Academic Stress Scale
18-item likert scale measure to measure perceptions of academic stress and its sources.
User to explore and measure influence and change of academic stress. Inclusion of this mesasure suggested by Scientific Advisory board.
Timepoint [4] 380708 0
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate
Secondary outcome [5] 380709 0
Smith, B.W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., Bernard, J (2008). The brief resilience scale: Assessing ability to bounce back.
6 item likert scale assessment created to assess the ability to bounce back or recover from stress.

Used to determine if the MOOC improved resilience skills and assisted participants to develop skills for managing distress,

All changes made prior to recruitment.
Timepoint [5] 380709 0
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate
Secondary outcome [6] 380710 0
Kessler, R.C., Andrews, G., Colpe, .et al (2002) Short screening scales to monitor population prevalence and trends in non- specific psychological distress.
Psychological Medicine, 32, 959-956

Kessler is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period.
Timepoint [6] 380710 0
Data collection will occur across Semesters One and Two of 2020. Data collection will occur across three time points:
T0 (semester 1, 2020): Participants from both groups (Group A and Group B) will complete baseline measures (Week 0). Participants in Group A will then complete the "Talk-to-Me" MOOC.
T1 (semester 1, 2020): Participants will then complete measures at week 8, directly following Group A completion of training (Both Group A and Group B complete).
T2 (semester 2, 2020): Participants will complete measures at week 8, directly following Group B completion of training (Both Group A and Group B complete).
Prior to Group B beginning the “Talk-to-Me” MOOC, they will be asked to repeat the screening measures to ensure that they have not experienced a decline in mental health and are still eligible to participate

Eligibility
Key inclusion criteria
inclusion criteria: a) aged 18 years and older; b) enrolled in 2nd year, 3rd year or GEM Health Sciences units at Curtin University & UWA. 4) Score below threshold on Suicidal Ideation Attributes Scale. Students will be excluded from the MOOC if they report significant mental distress using tSeverity of suicidal ideation as measured by the Suicidal Ideation Attributes Scale. For the SIDAS, a score of 21 or above is considered high-risk. In addition, students who score 7-10 regarding making an attempt will also be excluded. Scoring above threshold for any of these criteria is grounds for exclusion.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be excluded from the MOOC if they report significant mental distress using the Severity of suicidal ideation as measured by the Suicidal Ideation Attributes Scale. For the SIDAS, a score of 21 or above is considered high-risk. In addition, students who score 7-10 regarding making an attempt will also be excluded. Scoring above threshold for any of these criteria is grounds for exclusion. .

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An online radomizer tool will be used to allocate students in tutorial groups to either early start or delayed start group. Students select which tutorial they attend (unaware of which condition it is in); randomization will occur at the tutorial class level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online radomizer tool will be used to allocate students in tutorial groups to either early start or delayed start group. Students select which tutorial they attend (unaware of which condition it is in); randomization will occur at the tutorial class level.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
wait-list controlled trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
: All Health Science students enrolled in 2nd year, 3rd year or GEM units at Curtin University & UWA will be the offered opportunity to participate (current enrolment in all Health Sciences Faculty ~13,000 students). The research team is in discussion with Curtin extras team so that students will have opportunity to register the training on their academic transcript. Participants will also be offered, upon completion of the training, a completion certificate that they can keep as part of their continuing professional development portfolio. Students will be screened for suitability using an online Qualtrics survey (please refer to appendices for screening measures). This survey will include questions relating to eligibility and will be used to screened for the following inclusion criteria: a) aged 18 years and older; b) enrolled in 2nd year, 3rd year or GEM Health Sciences units at Curtin University; 4) Score below threshold on Suicidal Ideation Attributes Scale. Students will be excluded from the MOOC if they report significant mental distress using tSeverity of suicidal ideation as measured by the Suicidal Ideation Attributes Scale. For the SIDAS, a score of 21 or above is considered high-risk. In addition, students who score 7-10 regarding making an attempt will also be excluded. Scoring above threshold for any of these criteria is grounds for exclusion. Sample size calculations have been based on the anticipated effect of the program on the primary and secondary outcome measures, with power calculations performed in G*Power 3.1. A target sample of 80 participants is based on a relevant effect-size of 0.5 (Cohen's d) suggested by previous findings with alpha=0.05 and power=0.8.

Data analysis:
Quantitative data inclusive of socio-demographic and measures will be entered into SPSS, cleaned and coded for statistical analysis. Differences in the participants' characteristics at baseline will be compared between the Early Start Group (Group A) and the Delayed Start Group (Group B) using either Chi-square tests or independent sample t-tests for categorical and continuous variables, respectively to determine if the randomization process resulted in comparable samples. General linear mixed model analyses will investigate differences between groups across time (e.g., to explore differences between groups at T0, T1 and T2). Comparisons at T1 will be the primary data analysis point. Comparisons at T1 will be compare Group A (who received intervention) to Group B (who did not receive intervention) to determine if the MOOC influenced outcomes. Comparisons at T2 will compare whether the effect size in outcomes observed in Group B (who have now completed the intervention) is similar to the effect size observed in Group A at T1. As Group A is also completing post-test assessments at T2, analysis can also be conducted to explore maintenance effects. Participant will be specified as a random effect on both primary and secondary outcome measures. Prior to fitting this model, the data may be transformed to improve normality if necessary. Expected improvements of outcomes will be calculated by Cohen's d using the pooled standard deviation for weighting the differences of pre-post means. Frequency analysis and t-tests will investigate satisfaction ratings, within the early start intervention group (Group A) and the Delayed Start Intervention Group (Group B). The significance level is set at p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 26029 0
6102 - Bentley
Recruitment postcode(s) [2] 29541 0
6907 - Nedlands

Funding & Sponsors
Funding source category [1] 302264 0
University
Name [1] 302264 0
Curtin university
Address [1] 302264 0
Kent St, Bentley WA 6102
Country [1] 302264 0
Australia
Funding source category [2] 305118 0
Government body
Name [2] 305118 0
Healthway WA
Address [2] 305118 0
38 Station St, Subiaco WA 6008
Country [2] 305118 0
Australia
Funding source category [3] 305119 0
University
Name [3] 305119 0
ANZAHPE
Address [3] 305119 0
ANZAHPE Fee Payment
ANZAHPE, ANZAHPE C/- Health Professional Education, Flinders University, PO Box 852, Renmark, Renmark, South Australia, 5341, Australia
Country [3] 305119 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 302127 0
None
Name [1] 302127 0
Address [1] 302127 0
Country [1] 302127 0
Other collaborator category [1] 280612 0
Individual
Name [1] 280612 0
Dr Viktor Kadic
Address [1] 280612 0
Klinikum Aschaffenburg-Alzenau
Standort Aschaffenburg
Am Hasenkopf 1
63739 Aschaffenburg
Country [1] 280612 0
Germany
Other collaborator category [2] 280619 0
Individual
Name [2] 280619 0
Mr Frank Zimmerman
Address [2] 280619 0
Klinikum Aschaffenburg-Alzenau
Standort Aschaffenburg
Am Hasenkopf 1
63739 Aschaffenburg
Country [2] 280619 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302939 0
Curtin University Health research ethics committe (HREC)
Ethics committee address [1] 302939 0
Kent St, Bentley WA 6102
Ethics committee country [1] 302939 0
Australia
Date submitted for ethics approval [1] 302939 0
03/06/2019
Approval date [1] 302939 0
21/11/2019
Ethics approval number [1] 302939 0

Summary
Brief summary
Suicide is a leading cause of death among young Australians. Historically, high levels of suicide have been recorded in Australian university students, as they transition from high school to university, and experience dramatic changes in personal and social circumstances. The National Suicide Prevention Program in Germany recently developed the “Talk to Me” program, a suicide prevention intervention that facilitates the detection of early symptoms of evolving suicidal behaviour and supports action planning in a potential suicidal crisis situation. This research aims to develop, deliver and test the "Talk-to-Me" Mass online learning content (MOOC) for undergraduate university students, underpinned with strength-based suicide prevention principles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91914 0
Prof Sonya Girdler
Address 91914 0
Curtin University, Kent St, Bentley WA 6102
Country 91914 0
Australia
Phone 91914 0
+61 8 9266 3630
Fax 91914 0
Email 91914 0
sonya.girdler@curtin.edu.au
Contact person for public queries
Name 91915 0
Prof Sonya Girdler
Address 91915 0
Curtin University, Kent St, Bentley WA 6102
Country 91915 0
Australia
Phone 91915 0
+61 8 9266 3630
Fax 91915 0
Email 91915 0
sonya.girdler@curtin.edu.au
Contact person for scientific queries
Name 91916 0
Prof Sonya Girdler
Address 91916 0
Curtin University, Kent St, Bentley WA 6102
Country 91916 0
Australia
Phone 91916 0
+61 8 9266 3630
Fax 91916 0
Email 91916 0
sonya.girdler@curtin.edu.au

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

What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7167 0
Ethical approval
Citation [1] 7167 0
Link [1] 7167 0
Email [1] 7167 0
Other [1] 7167 0
Summary results
No Results