Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000981426
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
26/07/2016
Date last updated
26/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minding Young Minds: The impact of a school based intervention targeting perfectionism and self-compassion on children’s psychological health
Scientific title
Minding Young Minds: The impact of a school based intervention targeting perfectionism and self-compassion on children’s psychological health
Secondary ID [1] 289725 0
nil
Universal Trial Number (UTN)
Trial acronym
MYM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perfectionism 299564 0
well being, 299565 0
self-compassion 299587 0
Condition category
Condition code
Mental Health 299536 299536 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The perfectionism intervention was informed by Shafran and colleagues’ (2002) model of clinical perfectionism within a cognitive-behavioural framework. The content was adapted for children and designed to be highly engaging, involving different communication media, and short but targeted activities. It consisted of three lessons (each of 40 minutes duration), administered once a week, during normal class lessons, by a trainee clinical psychologist, Lesson 1 content incorporated a description of perfectionism (differentiating between perfectionism that causes problems from ‘trying your best’), the good and the bad aspects of mistakes, finishing with a message challenging over-dependence of self-evaluation on the determined pursuit of personally demanding standards e.g., “You are more than your achievements”. Lesson 2, delivered one week after the initial lesson, focused on developing skills related to dealing with self-criticism and paying attention to, and celebrating, successes. Lesson 3 focused on self-compassion.
Intervention code [1] 295363 0
Prevention
Intervention code [2] 295368 0
Behaviour
Comparator / control treatment
The control group receive class lessons as usual.
Control group
Active

Outcomes
Primary outcome [1] 299016 0
The Warwick-Edinburgh Mental Well-being Scale
Timepoint [1] 299016 0
3-month post final MYM lesson
Secondary outcome [1] 325865 0
Self-oriented perfectionism from the Child and Adolescent Perfectionism Scale
Timepoint [1] 325865 0
3-month post final MYM lesson

Eligibility
Key inclusion criteria
no inclusion criteria, all children in the classroom eligible
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
21/08/2015
Date of last data collection
Anticipated
31/03/2016
Actual
31/03/2016
Sample size
Target
206
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294104 0
University
Name [1] 294104 0
Flinders University
Country [1] 294104 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology,
Flinders University
GPO Box 2100,
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 292940 0
None
Name [1] 292940 0
Address [1] 292940 0
Country [1] 292940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295520 0
Flinders Social and Behavioural Research Ethics Committee
Ethics committee address [1] 295520 0
Flinders University
GPO Box 2100,
Adelaide, SA, 5001
Ethics committee country [1] 295520 0
Australia
Date submitted for ethics approval [1] 295520 0
04/03/2015
Approval date [1] 295520 0
01/05/2015
Ethics approval number [1] 295520 0
6332

Summary
Brief summary
The proposed study aims to evaluate the impact of an intervention targeting perfectionism and self-compassion on children’s psychological health. It will further develop Fairweather-Schmidt and Wade’s (2015) pilot study, by having greater power, one more lesson that the previous protocol (i.e., 3 instead of 2), having a longer follow up period, and aim to include schools with lower SES to increase generalisability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67594 0
Prof Tracey Wade
Address 67594 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 67594 0
Australia
Phone 67594 0
+61 8 8201-3736
Fax 67594 0
Email 67594 0
[email protected]
Contact person for public queries
Name 67595 0
Prof Tracey Wade
Address 67595 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 67595 0
Australia
Phone 67595 0
+61 8 8201-3736
Fax 67595 0
Email 67595 0
[email protected]
Contact person for scientific queries
Name 67596 0
Prof Tracey Wade
Address 67596 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 67596 0
Australia
Phone 67596 0
+61 8 8201-3736
Fax 67596 0
Email 67596 0
[email protected]

No information has been provided regarding IPD availability


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.