Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000282280
Ethics application status
Approved
Date submitted
9/02/2018
Date registered
23/02/2018
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Date results provided
5/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A school-based evaluation of Therapeutic Storytelling Intervention (TSI) to promote young people's mental health and wellbeing
Scientific title
A school-based cluster-randomised controlled trial to determine the effectiveness of Therapeutic Storytelling Intervention (TSI) in promoting young people's mental health and wellbeing
Secondary ID [1] 294006 0
Nil known
Universal Trial Number (UTN)
U1111­1192­4533
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychopathology 306519 0
Condition category
Condition code
Mental Health 305627 305627 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 305674 305674 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic storytelling intervention (TSI) is an innovative form of psychotherapy developed by Ron Phillips in 1989 based on his book “Gem of First Water” (Phillips, 1989). “Gem of First Water” is the story of a boy on a journey of discovery and adventure in a mythical land called ‘confusion’. Along the way the hero is faced with challenges and dilemmas that reflect the common adolescent struggles, such as poor impulse control, making connections between decisions and feeling, working through grief, drug and alcohol use and peer and parent relationship issues. TSI has now been developed as a class room intervention for young people and is currently being delivered in schools in South Auckland.

The intervention involves 12 weekly sessions of TSI delivered to each selected class by a counsellor. Students will receive the book, a student workbook and the teacher will receive a talking book to allow for students to catchup any sessions they may have missed. The duration of TSI is approximately 30 minutes plus 30 minutes of discussion and workbook exercises.

Week 1 - Introduction to the story, introduces elements of thoughts, feelings and behaviours, the golden rule.
Week 2 - Discusses being stuck and change. Related these to thoughts, feelings and behaviours
Week 3 - Mastering anger
Week 4 - Honesty and forgiveness
Week 5 - Self care and empathy for others, Mind triage
Week 6 - Golden rule of relationships, Insight and knowing self.
Week 7 - Courage, Deep decisions, Lessons in life.
Week 8 - Relationship between decisions and feelings. Habit rule for managing life
Week 9 - How bad choices evolve
Week 10 - Model for facing fears
Week 11 - Understanding who you are, Identity and who you are.
Week 12 - Model of identity, Coming home.

The workbooks contain a variety of exercises that gets students to reflect on aspects of the story and how relates to their lives. The workbook is divided in to chapters that relate to the chapters of the story. These exercises are designed to reinforce messages during the class sessions and some independent exercises for students that can be completed outside of the 12 weekly sessions.

Teachers will receive a 2 hour training session before the intervention. Teachers are not expected to deliver the intervention themselves, but to support key messages in classes outside of the intervention sessions. Teachers will receive a copy of the story, workbook, and a summary of key messages and models delivered in the intervention sessions.

Fidelity will be assessed by student attendance and completion of workbooks by a research assistant. Any issues will be identified through discussions and feedback from teachers and resolved in collaboration with the school and researchers.
Intervention code [1] 300277 0
Prevention
Comparator / control treatment
Matched by year, classrooms not receiving TSI
Control group
Active

Outcomes
Primary outcome [1] 304738 0
Emotional symptoms, conduct problems, hyperactivity/ inattention, peer relationship problems, and prosocial behaviour. This will be assessed using the The Strength’s and Difficulties Questionnaire (SDQ), a short 25-item behavioural questionnaire for children and adolescents
Timepoint [1] 304738 0
Baseline, at the end of the 12 weeks intervention period and 6 months following the end of the intervention (primary endpoint)
Secondary outcome [1] 342987 0
Emotional Health will be assessed using the Social Emotional Health Survey–Primary (SEHS–P), a 20 item questionnaire that measures covitality, and has been validated for use in children aged between 10 and 13 years.
Timepoint [1] 342987 0
Students will complete the SEHS-P at baseline, 12 weeks and 6 months following the end of the intervention

Eligibility
Key inclusion criteria
All students in classes in year 7 and year 8 from participating intermediate schools.
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Streamed classes (these are classes for high achieving students) due to system differences from other classes.

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)
Allocation of classes will be by an independent statistician not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer generation of random sequence..
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Masking of participants/ classes to allocation arm is not possible.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcome analyses will use the follow-up data as the dependent variables. All analyses will be conducted according to the principle of intention-to-treat (ITT) by replacing missing data from the baseline assessment. Dependent variables with non-normal distributions will be either log- or square-root transformed. The primary analyses will compare differences between the intervention and control groups on the outcome variables (SDQ, SEHS-P) using analysis-of-covariance models, controlling for baseline outcome measures as well as age, sex, and ethnicity. Differences between control and intervention groups will be considered statistically significant at P<0.05. Analyses will take into account clustering of students from the same classroom through random effects models

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/02/2018
Date of last participant enrolment
Anticipated
1/03/2018
Actual
23/02/2018
Date of last data collection
Anticipated
30/11/2018
Actual
30/11/2018
Sample size
Target
480
Accrual to date
Final
436
Recruitment outside Australia
Country [1] 9572 0
New Zealand
State/province [1] 9572 0

Funding & Sponsors
Funding source category [1] 298632 0
University
Name [1] 298632 0
University Of Auckland
Country [1] 298632 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Population Health
Private Bag 92019
Auckland 1142
New Zealand.
Country
New Zealand
Secondary sponsor category [1] 297797 0
None
Name [1] 297797 0
Address [1] 297797 0
Country [1] 297797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299591 0
Health and Disability Ethics Committees
Ethics committee address [1] 299591 0
Ethics committee country [1] 299591 0
New Zealand
Date submitted for ethics approval [1] 299591 0
09/03/2017
Approval date [1] 299591 0
29/05/2017
Ethics approval number [1] 299591 0
17/CEN/50

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

Contacts
Principal investigator
Name 80950 0
A/Prof Simon Denny
Address 80950 0
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country 80950 0
New Zealand
Phone 80950 0
+64212388089
Fax 80950 0
Email 80950 0
[email protected]
Contact person for public queries
Name 80951 0
Simon Denny
Address 80951 0
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country 80951 0
New Zealand
Phone 80951 0
+64212388089
Fax 80951 0
Email 80951 0
[email protected]
Contact person for scientific queries
Name 80952 0
Simon Denny
Address 80952 0
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country 80952 0
New Zealand
Phone 80952 0
+64212388089
Fax 80952 0
Email 80952 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
Not part of consent process


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 374473-(Uploaded-05-06-2019-10-10-37)-Basic results summary.docx
Plain language summaryNo There was no evidence of effectiveness of therapeu... [More Details]

Documents added automatically
No additional documents have been identified.