Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000508572
Ethics application status
Approved
Date submitted
18/03/2024
Date registered
24/04/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial evaluating the Study Without Stress plus Social Connectedness (SWoS-Social) Program among Australian high school students
Scientific title
Effectiveness of an enhanced Study Without Stress program (SWoS-Social) on stress and social connectedness among Australian high school students completing their final exams
Secondary ID [1] 311739 0
Nil
Universal Trial Number (UTN)
Trial acronym
SWoS-Social RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 333219 0
Anxiety 333220 0
Depression 333221 0
Condition category
Condition code
Mental Health 329909 329909 0 0
Anxiety
Mental Health 329910 329910 0 0
Depression
Mental Health 329911 329911 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
The intervention is an enhanced version of the Study Without Stress program (i.e., SWoS-social). The original SWoS program includes strategies such as time management, thought challenging, problem solving and relaxation. The enhanced version of the SWoS program integrates peer connectedness, providing psychoeducation about the importance of peer connectedness as well as examples of how to apply the skills learned through the program to connect with peers.
The SWoS program includes 8 face to face sessions (50 minutes each) with one session conducted each week for 8 consecutive weeks.
Number of attendees per session will be monitored by facilitators, no other attendance or adherence will be monitored.

Materials:
Participants will be provided with work books within which to practice skills learned and revise program content. The completion of this work book is integrated into the 8 sessions that are 50 minutes in duration. The students may complete one of two activities as homework, approximately 5-10 minutes per week). Facilitators will also have a manual with detailed session plans.

Participants:
Participants will include students completing Year 11/12 at a public high school in the Greater Sydney Metropolitan area. In the first study phase, students will be randomised by English class by an independent allocation system, and the school notified. Approximately 120 students will take part in the trial i.e., 60 students completing SWoS and 60 students completing the active control in the experimental phase. These groups will be counterbalanced in the second phase of the study.

Half of the participants will be administered the SWoS program in Phase 1, whereas the other half will be administered the SWoS program in Phase 2. The SWoS program will be administered in the same way in the treatment condition phase 1 and in the treatment condition phase 2. Participants will complete surveys pre and post phase 1, and pre and post phase 2, to examine change in symptoms following the SWoS program. Additionally, there will be approximately 1 month between the end of Phase 1 and the start of Phase 2.

Facilitators:
Facilitators will include school personnel such as school counsellors, student support officers, and teachers trained to use the SWoS program. The facilitators will complete a 6-hour online training program that has been created specifically for the SWoS program. This will be followed by a 1 hour online meeting with one of the Chief Investigators to discuss questions and ensure the facilitators understand the content.

Location: The students will complete SWoS sessions at school during class time.

Intervention code [1] 328198 0
Behaviour
Comparator / control treatment
Active Control:
The active control condition will be a study skills program targeting study skills and practice, developed by the school in consultation with the research team. This study skills control will be run at the same time (i.e., during class) and for the same duration (8 sessions in total, 1 per week, approximately 50 minutes long) as the SWoS-Social program. Sessions will be conducted face to face.

Materials:
Participants will be provided with work sheets to set goals for study, practice skills learned such as structuring time, summarising notes and tips for how to memorise class/textbook content. These work sheets will vary in length (approximately 15-20mins to complete). Students will also bring their own text books and computers to practice the study skills learned on actual course work. Students will also complete practice exams and essay questions with which they can practice exam technique and essay writing skills after discussing these skills.

Participants:
Participants will include students completing Year 11/12 at a public high school in the Greater Sydney Metropolitan area. These will be the students allocated to the control condition, with half of the students completing the study skills control in Phase 1, and the other half in Phase 2. Adherence will only be monitored by the number of attendees per session, and this will be recorded each session by facilitators.

Facilitators:
Facilitators will include school personnel such as school counsellors, student support officers, and teachers. Facilitators will be given a manual with session plans, but no formal training.

Location: The students will complete study skills sessions at school during class time.
Control group
Active

Outcomes
Primary outcome [1] 337680 0
Stress
Timepoint [1] 337680 0
Immediately pre and post Phase 1 (primary time point), and immediately pre and post Phase 2 (counterbalancing).
Primary outcome [2] 337683 0
Social connectedness - peers
Timepoint [2] 337683 0
Immediately pre and post Phase 1 (primary time point), and immediately pre and post Phase 2 (counterbalancing)
Primary outcome [3] 337684 0
Anxiety
Timepoint [3] 337684 0
Immediately pre and post Phase 1 (primary time point), and immediately pre and post Phase 2 (counterbalancing)
Secondary outcome [1] 432817 0
Social connectedness - primary outcome
Timepoint [1] 432817 0
Immediately pre and post Phase 1, and immediately pre and post Phase 2 (counterbalancing)
Secondary outcome [2] 432818 0
Depression - primary outcome
Timepoint [2] 432818 0
Immediately pre and post Phase 1, and immediately pre and post Phase 2 (counterbalancing)
Secondary outcome [3] 432820 0
Test anxiety - primary outcome
Timepoint [3] 432820 0
Immediately pre and post Phase 1, and immediately pre and post Phase 2 (counterbalancing)
Secondary outcome [4] 432821 0
Self efficacy
Timepoint [4] 432821 0
Immediately pre and post Phase 1, and immediately pre and post Phase 2 (counterbalancing)
Secondary outcome [5] 432936 0
Skills used to manage stress, with focus on skills taught in the SWoS-Social program
Timepoint [5] 432936 0
Immediately pre and post Phase 1, and immediately pre and post Phase 2 (counterbalancing)

Eligibility
Key inclusion criteria
Students at a government run high school in Sydney who are completing the Higher School Certificate in 2025.
Minimum age
16 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Safety concerns i.e., self-harm, raised by the student themselves, parents or teachers.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation by student class
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A conservative approach was taken, and the sample size was calculated assuming independent groups analyses. We calculated effect size using G*Power, with a medium effect size, p-value of 0.05 and 80% power, and this resulted in 64 participants per group.
Analyses will include repeated measures with both within and between groups effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316071 0
University
Name [1] 316071 0
Macquarie University
Country [1] 316071 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318264 0
None
Name [1] 318264 0
None
Address [1] 318264 0
Country [1] 318264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314886 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 314886 0
Ethics committee country [1] 314886 0
Australia
Date submitted for ethics approval [1] 314886 0
04/11/2023
Approval date [1] 314886 0
24/11/2023
Ethics approval number [1] 314886 0
Ethics committee name [2] 314920 0
State Education Research Applications Process (SERAP)
Ethics committee address [2] 314920 0
Ethics committee country [2] 314920 0
Australia
Date submitted for ethics approval [2] 314920 0
29/01/2024
Approval date [2] 314920 0
Ethics approval number [2] 314920 0

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

Contacts
Principal investigator
Name 133062 0
Dr Jessica Belcher
Address 133062 0
Australian Hearing Hub, Macquarie University, Balaclava Road, North Ryde, NSW 2109
Country 133062 0
Australia
Phone 133062 0
+61 2 9850 1464
Fax 133062 0
Email 133062 0
[email protected]
Contact person for public queries
Name 133063 0
Jessica Belcher
Address 133063 0
Australian Hearing Hub, Macquarie University, Balaclava Road, North Ryde, NSW 2109
Country 133063 0
Australia
Phone 133063 0
+61 2 9850 1464
Fax 133063 0
Email 133063 0
[email protected]
Contact person for scientific queries
Name 133064 0
Jessica Belcher
Address 133064 0
Australian Hearing Hub, Macquarie University, Balaclava Road, North Ryde, NSW 2109
Country 133064 0
Australia
Phone 133064 0
+61 2 9850 1464
Fax 133064 0
Email 133064 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
Risk of identification of participants sensitive data


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.