Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001254886
Ethics application status
Approved
Date submitted
29/04/2021
Date registered
16/09/2021
Date last updated
29/07/2024
Date data sharing statement initially provided
16/09/2021
Date results provided
29/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
I’ll be OK In Year 7: Effects of the 8 week transition programs on Year 6 students' psychological well-being and successful transition to Year 7, during the COVID-19 pandemic.
Scientific title
I’ll be OK In Year 7: Effects of the 8 week transition programs on adolescents' mental health, well-being and transition to high-school, during the COVID-19 pandemic (Stage 1 )
Secondary ID [1] 304049 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
SBTIMH - Stage 1
School Based Transition Intervention & Mental Health
Linked study record
This study is the pilot to a larger study prospectively registered as ACTRN12621001485820

Health condition
Health condition(s) or problem(s) studied:
anxiety 321689 0
depression 321690 0
stress 321691 0
Condition category
Condition code
Mental Health 319430 319430 0 0
Anxiety
Mental Health 319431 319431 0 0
Depression
Mental Health 319444 319444 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SBTIMH Stage 1 is a two arm intervention trial with no control group, involving 2 intervention groups (A & B). 300 Year 6 students from 6 primary schools will be exposed to 2 different interventions.
Group A (n=150) will participate in the 8 week (one-hour), school based - Resilience Focused Transition Program (RFTP); delivered by provisional psychologists under supervision of the registered psychologist /Board of Psychology' approved supervisor.
Group B (n=150) will participate in 8 week (one-hour), school based - Mindfulness Focused Transition Program (MFTP), delivered by provisional psychologists under supervision of the applicant, who, in addition to psychology, is also a certified mindfulness facilitator.
Children/Year 6 students will participate in 8 one-hour per week sessions, during school term, delivered in their own class, with their classroom teacher present. The activities will involve skill development, role plays, discussion and completing quizzes and questionnaires.
Session attendance checklists will be used to monitor adherence to the intervention.
Sessions will be delivered face to face or via Zoom, subject to current COVID -19 restrictions.
The following contents will be included in the proposed programs:
Program A
"I'll be OK in Year 7" Resilience Focused Transition Program- Proposed Outline (2021)
Week 1 (90 min) Introduction to the Program
- Introducing the program, presenters and participants
- Discussing goals of the program & group rules
- Exploring feelings about transition to High School
- Completion of Year 6 Surveys- Homework
Week 2 (60 min) Coping with changes
- What is transition stress
- Discussing how to cope with change, and building resilience
- Stress reduction activity
Week 3 (60 min) Time Management and Problem Solving
- Discussing how to balance responsibilities and ways to manage competing priorities
- Introducing skills such as activity scheduling, and time management
- Introducing problem solving strategies (for both interpersonal and practical problems)
- Introducing the importance of self-care and how to improve wellbeing
Week 4 (60 min) Assertive Communication
- Building and increasing emotion vocabulary to facilitate effective communication
- Introducing assertiveness and discussing and role-playing assertive, passive and aggressive approaches to communication
- Discussing how to give feedback respectfully and constructively, and how to receive feedback
Week 5 (60 min) Maintaining Friendships & Making Friends
- Discussing opportunities available in high school and where it could lead to
- Difficulties that children may experience such as changing friendship groups
- Practicing social skills training
- Practicing conversational skills
Week 6 (60 min) Self-care and how to improve wellbeing
- Difficulties with being the small fish in a big pond
- Introducing self-compassion, and talking about self-esteem
- Exploring mindfulness /Making a self-care plan
- Homework
Week 7 (60 min) Bullying and Cyber-safety
- Understanding bullying behavior and the effects of bullying
- How to respond to bullying in high school, and resources available for help
- Discussing cyber safety and social media use
- How to engage in safe behaviours online, and managing your privacy
- How to handle cyber bullying, and your online presence (respecting others online)
Week 8 (90 min) Final session
- Review of the program
- Feedback and discussion
- Presentation of Certificates
- Completion of Year 6 (post) surveys
Program B
“I’ll be OK in Year 7” Mindfulness Based Stress Reduction - Proposed Outline (2021)
Week 1 (90 min) Introduction to the Program
• Introductions and welcomes
• “I’ll be OK in Year 7” – Overview of the Program
• Exploring Feelings about Transition
• Your bucket of emotions
• Q & A Session
• (Pre) Survey Completion
Week 2 (60 min) Coping with Transition Stress
• Establishing goals and group rules
• What is Transition Stress?
• In-class Activity (5 senses)
• Summary
Week 3 (60 min) Introduction to Mindfulness
• Icebreaker exercises and Review of Week 2
• What is Mindfulness?
• Mindfulness Breathing -Activity
• Summary and homework
Week 4 (60 min) Staying Focused
• Mindful Moment
• Review of previous week
• Attention Training and Basic Neuroscience
• Mindfulness Activity (Staying Focused)
• Summary
Week 5 (60 min) Coping with Unhelpful Thoughts?
• Mindful Moment
• Review of previous week
• Mindfulness of Thoughts
• Mindfulness Activity (Unhelpful Thoughts)
• Summary and homework
Week 6 (60 min) Coping with Difficult Emotions
• Mindful Moment
• Review of previous week
• Mindfulness of Emotions
• Mindfulness Activity (Difficult Emotions)
• Summary
Week 7 (60 min) Mindful Communication
• Mindful Moment
• Review of previous week
• Mindfulness of Listening & Communication
• Activity (Self-care Plan)
• Summary and homework
Week 8 (90 min) Final Session & Self Care
• Mindful Moment
• Review of Week 7
• Looking after yourself /Self Care Activity
• Review of program – survey’s completion
• Certificates Presentation
• Final conclusions, Q&A and good byes




Intervention code [1] 320370 0
Behaviour
Intervention code [2] 320371 0
Prevention
Comparator / control treatment
'The study will compare 2 different interventions with the Mindfulness Focused Transition Program as the comparator
Control group
Active

Outcomes
Primary outcome [1] 327292 0
Composite Mental Health Outcomes (anxiety, depression, stress) measured by DASS-Y
Youth Depression, Anxiety and Stress Scale -DASS-Y scores
The DASS -Y is an unpublished child/adolescent adaptation of DASS-21 a widely used and validated measure of depression, anxiety and stress symptoms in general Australian populations.
Timepoint [1] 327292 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] 327293 0
Child Behaviour measured by scores on Strength and Difficulties Questionnaire (SDQ-P), completed by a parent.
Timepoint [2] 327293 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] 394504 0
Composite Well-being Outcomes (Resilience &Self-Esteem scores) measured by a 20 item questionnaire, combining Aiena's Resilience and Rosenberg's Self-Esteem Scales:
Resilience Scale for Children - RS10 (Aiena et al 2012)
Rosenberg’s Self Esteem Scale (RSES-10)
Timepoint [1] 394504 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] 397966 0
Successful transition/adjustment to Year 7, measured by a composite of
attendance rate e.g % of days attended (AR) derived from Year 7 school reports. and academic achievement (AA), measured by GPA derived from Year 7 school reports.
Timepoint [2] 397966 0
Secondary timepoint -12 month post-completion of intervention

Eligibility
Key inclusion criteria
Participants will include 300 Year 6 students (age 11-12) from 6 mainstream primary schools; (public and non-public schools) located in Sydney Inner West..
Participants need to be enrolled in Year 6 in 2023
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 allocated to Group A, B using sealed envelopes with the name of each school, which will be placed in boxes - labelled as A or B
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Selected schools will paired (based on their size, SES, source of funding, gender, NAPLAN profile). Simple random order generation using coin-tossing procedure will be used to allocate each school to Group A or B
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be statistically analyzed using SPSS statistical computing platform. The effect of participating in the program on the outcome measures will be analysed by performing a repeated ANOVA two-way mixed design; 2 groups (Intervention A and Intervention B) X 3 times (pre-intervention/baseline, post-intervention/week 10 and long-term/12 months post intervention).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/06/2023
Actual
21/09/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
30/09/2023
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
300
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308432 0
Government body
Name [1] 308432 0
Australian Government Research Training Program/PhD
Country [1] 308432 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
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] 309264 0
None
Name [1] 309264 0
Address [1] 309264 0

Country [1] 309264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308390 0
ACU Higher Research Ethics Committee
Ethics committee address [1] 308390 0
Ethics committee country [1] 308390 0
Australia
Date submitted for ethics approval [1] 308390 0
16/12/2020
Approval date [1] 308390 0
28/10/2021
Ethics approval number [1] 308390 0
2020-233H

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

Contacts
Principal investigator
Name 110550 0
Dr Baljinder K. Sahdra
Address 110550 0
Institute for Positive Psychology and Education
Level 9, 33 Berry Street, North Sydney, NSW 2060
PO Box 968, North Sydney, NSW 2059
Country 110550 0
Australia
Phone 110550 0
+61 2 9701 4669
Fax 110550 0
NIL
Email 110550 0
[email protected]
Contact person for public queries
Name 110551 0
Ewa Geba
Address 110551 0
Australian Catholic University
Mary Aikenhead Clinic
Room 641.G.02 /163-167 Albert Road, Strathfield NSW 2135
Country 110551 0
Australia
Phone 110551 0
+61297014715
Fax 110551 0
NIL
Email 110551 0
[email protected]
Contact person for scientific queries
Name 110552 0
Baljinder Sahdra
Address 110552 0
Institute for Positive Psychology and Education
533 Caroline Chisholm House, 33 Berry Street, North Sydney, NSW 2060
Country 110552 0
Australia
Phone 110552 0
+61 422 890 578
Fax 110552 0
NIL
Email 110552 0
[email protected]

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 deidentified individual participant data of published results will be available as per Participants Information Letter and Consent Forms
When will data be available (start and end dates)?
1 July 2025 - 31 October 2026
Available to whom?
Available to researchers upon an email request
Available for what types of analyses?
To be decided
How or where can data be obtained?
by emailing [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Documents were uploaded by study researchers but have since been removed.

Documents added automatically
No additional documents have been identified.