Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001485820
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
1/11/2021
Date last updated
18/04/2023
Date data sharing statement initially provided
1/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
I'll be OK in Year 7: Effects of the school based transition programs on Year-6 students' mental health, wellbeing and successful transition to Year 7
Scientific title
I'll be OK in Year 7: Effects of the school based transition programs on adolescents' mental health, well-being and transition to high-school - a Randomised Control Trial (Stage 2)
Secondary ID [1] 304712 0
None
Universal Trial Number (UTN)
NIl
Trial acronym
SBTIMH - Stage 2 (RCT)
School Based Transition Intervention & Mental Health
Linked study record
This study will be a follow up of a Pilot Study / Stage 1 (ACTRN12621001254886)

Health condition
Health condition(s) or problem(s) studied:
anxiety 322729 0
depression 322730 0
stress 322731 0
Condition category
Condition code
Mental Health 320318 320318 0 0
Anxiety
Mental Health 320319 320319 0 0
Depression
Mental Health 320320 320320 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SBTIMH - Stage 2 intervention will take place in 2024-2025 (Term 2 and 4).
This trial is an interventional RCT with control group, designed as a continuation of Stage 1 (2-arm interventional study with no control group) trial, scheduled to be completed in Term 4/ 2021, registered as ACTRN12621001254886
Participants will include 600 Year 6 students from 12 local schools. The schools will be randomly allocated to 1. intervention or 2. control group:
1. Intervention Group (n=300), will consist of Year 6 students, who will participate in the 8 week school based intervention program (A or B) identified as the most effective in Stage 1 (See Registration ACTRN12621001254886 for more details).
Sessions will be delivered during school term/time by provisional psychologists (ACU Clinical Psychology Masters students, completing their placement at the ACU Strathfield Psychology Clinic in 2022/23), under supervision of the applicant Ewa Geba, who is an AHPRA registered clinical psychologist and the PBA approved supervisor.

The 8 week resilience program covers topics including coping with changes, time management and problem solving, assertive communication, maintaining friendships and making friends, self-care and how to improve wellbeing, difficulties with being the small fish in a big pong, self compassion, self esteem and mindfulness, etc. A complete breakdown of this is available in record ACTRN12621001254886.
Sessions will be delivered face to face on-site or via Zoom. Session attendance checklist will be used to monitor adherence to the intervention. Additional details regarding the number and duration of sessions, the content of each session and the total duration of the intervention will be updated once Stage 1 is complete.
Intervention code [1] 321135 0
Behaviour
Comparator / control treatment
2. Control Group (n=300) will consists of Year 6 students, who will participate in the 2 hour introductory session; the session will cover basic introduction to the topic of transition to high- school; including transition stress and coping strategies. Year 6 students will be provided with a list of resources, including hotlines (Kids Helpline 1800 55 1800) and websites (www.kidshelpline.com.au; www.headspace.org.au). In addition, this session will be delivered by provisional psychologists under supervision of a clinical psychologist. The session will be delivered as a one-off event, face to face or via Zoom, to a group of no more than 20 participants. Session attendance checklist will be used to monitor adherence to the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 328221 0
Composite Mental Health Outcomes (anxiety, depression and stress), measured by DASS-Y
Timepoint [1] 328221 0
T-1 Pre-intervention (Week 1)
T-2 Post-intervention (Week 8) - primary timepoint
T-3 Follow up (12 month post completion of intervention)
Primary outcome [2] 328222 0
Child Behaviour measured by scores on the Strength and Difficulties Questionnaire (SDQ-P), completed by the parents.
Timepoint [2] 328222 0
T-1 Pre-intervention (Week 1)
T-2 Post-intervention (Week 8) - primary timepoint
T-3 Follow up (12 month post completion of intervention)
Secondary outcome [1] 398132 0
Composite Well-being Outcomes (Resilience & Self-Esteem Scores), measured by a 2- item questionnaire, combining Aiena's Resilience and Rozenberg's Self-Esteem Scales.
Timepoint [1] 398132 0
T-1 Pre-intervention (Week 1)
T-2 Post-intervention (Week 8)
T-3 Follow up (12 month post completion of intervention)
Secondary outcome [2] 398133 0
Successful transition to Year 7, measured by
-. Attendance rate (AR) - e.g % of days attended, derived from Year 7 school reports
Timepoint [2] 398133 0
12 month post-completion of intervention
Secondary outcome [3] 400849 0
Successful transition to Year 7 will be measured by
-Academic Achievement (AA) - measured by GPA derived from Year 7 school reports
Timepoint [3] 400849 0
12 months post intervention

Eligibility
Key inclusion criteria
Participants will include 600 Year 6 students and their parents from 12 mainstream primary schools (public and non-public), located in Sydney Inner West Metropolitan Area.
Child participants must be enrolled in Year 6 in 2023 or 2024
Parent participants (1 per child) must be must be proficient in English, at the level allowing them to complete the questionnaires.
Minimum age
11 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No participants will be excluded, unless parents/guardians do not consent.
Selective schools will not be included.

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)
Participating schools will be randomly allocated to Group 1 (intervention) or Group 2 (control), using sealed envelopes with the name of the school inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Selected schools will be paired (based on their size, SES, source of funding, single gender/co-ed status, NAPLAN profile).
Simple random order generation using coin-tossing procedure will be used to allocate each school to Group 1 or Group 2
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
Data will be statistically analysed using R-Studio statistical computing platform (Allaire, 2018). The effect of participating in group 1 or 2 on the outcome measures will be analysed by performing a repeated ANOVA two-way mixed design: 2 groups (intervention and control) X 3 time-points (pre-intervention/baseline, post intervention and follow up/12 month post intervention).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
29/12/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309082 0
Government body
Name [1] 309082 0
Australian Government Research Training Program/PhD
Country [1] 309082 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Institute for Positive Psychology and Education (Funding Recipient)
Australian Catholic University
Level 9, 33 Berry Street, North Sydney, NSW 2060
PO Box 968, North Sydney, NSW 2059
Country
Australia
Secondary sponsor category [1] 310028 0
None
Name [1] 310028 0
Address [1] 310028 0
Country [1] 310028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308956 0
ACU Higher Research Ethics Committee
Ethics committee address [1] 308956 0
Ethics committee country [1] 308956 0
Australia
Date submitted for ethics approval [1] 308956 0
16/12/2020
Approval date [1] 308956 0
28/10/2021
Ethics approval number [1] 308956 0
2020-233H

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

Contacts
Principal investigator
Name 112466 0
Dr Baljinder K. Sahdra
Address 112466 0
Institute for Positive Psychology and Education
Level 9, 33 Berry Street. North Sydney, NSW 2060
PO Box 968, North Sydney, NSW 2059
Country 112466 0
Australia
Phone 112466 0
+61 2 9701 4669
Fax 112466 0
Email 112466 0
baljinder.sahdra@acu.edu.au
Contact person for public queries
Name 112467 0
Baljinder K. Sahdra
Address 112467 0
Institute for Positive Psychology and Education
Level 9, 33 Berry Street. North Sydney, NSW 2060
PO Box 968, North Sydney, NSW 2059
Country 112467 0
Australia
Phone 112467 0
+61 2 9701 4669
Fax 112467 0
Email 112467 0
baljinder.sahdra@acu.edu.au
Contact person for scientific queries
Name 112468 0
Baljinder K. Sahdra
Address 112468 0
Institute for Positive Psychology and Education
Level 9, 33 Berry Street. North Sydney, NSW 2060
PO Box 968, North Sydney, NSW 2059
Country 112468 0
Australia
Phone 112468 0
+61 2 9701 4669
Fax 112468 0
Email 112468 0
baljinder.sahdra@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only de-identified individual participant data of published results will be available
When will data be available (start and end dates)?
1/07/2024 - 31/06/2025
Available to whom?
To any researchers upon an email request
Available for what types of analyses?
To be determined
How or where can data be obtained?
by emailing ewa.geba@acu.edu.au


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.