Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000444280
Ethics application status
Approved
Date submitted
18/03/2018
Date registered
28/03/2018
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Learning successfully for study and life ("Life"): Teaching gifted young adolescents about minimising the impact of perfectionism on successful learning.
Scientific title
Learning successfully for study and life ("Life"): Teaching gifted young adolescents about minimising the impact of perfectionism on successful learning.
Secondary ID [1] 294370 0
Nil known
Universal Trial Number (UTN)
U1111-1211-0513
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 307099 0
Anxiety 307100 0
Psychological Wellbeing 307101 0
Perfectionism 307102 0
Condition category
Condition code
Mental Health 306210 306210 0 0
Anxiety
Mental Health 306211 306211 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3 session perfectionism programme "LIFE" will be delivered weekly to Year 8 students (Mean age 13.5) who are in a gifted stream at an Adelaide public secondary school.
Lesson duration is 50 minutes, delivered face to face to students in their usual classroom by external facilitators (postgraduate psychology students)., with their usual classroom teacher also present. Lesson format consists of short oral or video presentations on key concepts, together with group discussion and worksheets to apply ideas to real life scenarios. Lesson 1 covers unhelpful perfectionism versus the pursuit of excellence, lesson 2 looks at good learning (taking time out will improve your performance; making mistakes and failing is an essential part of success; celebration of success), and lesson 3 focuses on self-compassion: How to respond to when things don’t go so well.
Intervention code [1] 300673 0
Prevention
Intervention code [2] 300674 0
Treatment: Other
Comparator / control treatment
Waitlist control - students will undertake lessons as usual before receiving the LIFE programme after 3 month follow-up data is collected
Control group
Active

Outcomes
Primary outcome [1] 305221 0
Perfectionism (Almost Perfect Scale - Revised)
Timepoint [1] 305221 0
One week prior to the intervention, one week post intervention, 3 months after the baseline (primary endpoint).
Secondary outcome [1] 344532 0
Academic motivation (Academic motivation scale)
Timepoint [1] 344532 0
One week prior to the intervention, one week post intervention, 3 months after the baseline
Secondary outcome [2] 344533 0
Academic satisfaction (one item VAS)
Timepoint [2] 344533 0
One week prior to the intervention, one week post intervention, 3 months after the baseline
Secondary outcome [3] 344534 0
Anxiety (DASS-21 subscale)
Timepoint [3] 344534 0
One week prior to the intervention, one week post intervention, 3 months after the baseline
Secondary outcome [4] 344535 0
Self compassion (Self-compassion scale - short form)
Timepoint [4] 344535 0
One week prior to the intervention, one week post intervention, 3 months after the baseline
Secondary outcome [5] 344546 0
Depression (DASS-21 subscale)
Timepoint [5] 344546 0
One week prior to the intervention, one week post intervention, 3 months after the baseline
Secondary outcome [6] 344547 0
Wellbeing (Warwick Edinburgh Mental Wellbeing Scale)
Timepoint [6] 344547 0
One week prior to the intervention, one week post intervention, 3 months after the baseline

Eligibility
Key inclusion criteria
Enrolled in a selected school in Year 8 (Gifted stream) with passive consent from parent and active assent from student
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
No. Schools will nominate pairs of classes to take part which will then be randomly allocated to intervention/control groups offsite by the primary researcher
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel randomisation with a priori rules regarding allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power analysis shows that to detect a Cohen's d effect size of 0.30 with a power level of 0.80, and attition of 5% at each time point, 110 participants per group are required (Hedeker, Gibbons, & Waternaux, 1999). This pilot study will therefore not be fully powered, as 50 participants per group are available within school constraints. Data will be analysed via Linear Mixed Modelling, adjusting for baseline levels of each outcome variable.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2018
Actual
1/05/2018
Date of last participant enrolment
Anticipated
28/09/2018
Actual
1/05/2018
Date of last data collection
Anticipated
10/12/2018
Actual
30/09/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 22092 0
5064 - Glenunga

Funding & Sponsors
Funding source category [1] 299011 0
University
Name [1] 299011 0
Flinders University
Country [1] 299011 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 298237 0
None
Name [1] 298237 0
Address [1] 298237 0
Country [1] 298237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299948 0
Social and Behavioural Sciences Research Ethics Committee, Flinders University
Ethics committee address [1] 299948 0
Ethics committee country [1] 299948 0
Australia
Date submitted for ethics approval [1] 299948 0
15/01/2018
Approval date [1] 299948 0
23/03/2018
Ethics approval number [1] 299948 0
7901
Ethics committee name [2] 299949 0
SA Department of Education and Child Development
Ethics committee address [2] 299949 0
Ethics committee country [2] 299949 0
Australia
Date submitted for ethics approval [2] 299949 0
16/01/2018
Approval date [2] 299949 0
27/03/2018
Ethics approval number [2] 299949 0
2018-0003

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

Contacts
Principal investigator
Name 82050 0
Prof Tracey Wade
Address 82050 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 82050 0
Australia
Phone 82050 0
+618 8201 3736
Fax 82050 0
Email 82050 0
[email protected]
Contact person for public queries
Name 82051 0
Tracey Wade
Address 82051 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 82051 0
Australia
Phone 82051 0
+618 8201 3736
Fax 82051 0
Email 82051 0
[email protected]
Contact person for scientific queries
Name 82052 0
Tracey Wade
Address 82052 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 82052 0
Australia
Phone 82052 0
+618 8201 3736
Fax 82052 0
Email 82052 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
sensitivity of children's data


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 374748-(Uploaded-01-03-2019-10-37-06)-Basic results summary.docx
Plain language summaryNo The purpose of this study was to evaluate a 3-less... [More Details]

Documents added automatically
No additional documents have been identified.