Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001262695
Ethics application status
Approved
Date submitted
20/11/2014
Date registered
3/12/2014
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Date results provided
4/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minding Young Minds: The impact of interventions targeting perfectionism and self-compassion on psychological health and body image among pre-adolescent children
Scientific title
Evaluating the impact of a perfectionism and self-compassion intervention on mental health in pre-adolescent children
Secondary ID [1] 285700 0
Nil
Universal Trial Number (UTN)
Trial acronym
MYM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body image problems 293558 0
Maladaptive perfectionism 293559 0
Low self-compassion 293560 0
Condition category
Condition code
Mental Health 293845 293845 0 0
Eating disorders
Mental Health 293846 293846 0 0
Depression
Mental Health 293847 293847 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maladaptive Perfectionism intervention: primary school children (aged 10-12, co-ed) initially complete baseline questionnaires, then received two intervention lessons (each 45 minutes in length) delivered once per week over 2 weeks by a skilled study team member in a school classroom setting. Lessons focussed on identifying/defining perfectionism; and the difference between adaptive and maladaptive perfectionism; and, and the value in making mistakes and being willing to give something a 'go'. Developmentally appropriate individual and group-based activities and media were specifically developed for the study. Post-intervention questionnaires were completed within the week of the second intervention lesson. A final assessment, using the same questionnaire as per baseline and post-intervention, was undertaken one month post intervention.

Promoting Self-Compassion intervention: primary school children (aged 10-12, co-ed) initially complete baseline questionnaires, then received two intervention lessons (each 45 minutes in length) delivered once per week over 2 weeks by a skilled study team member in a school classroom setting. Lessons focussed on identifying/defining self-compassion; being compassionate (self and others), understanding that everyone makes mistakes, being kind to oneself to support resilience. Developmentally appropriate individual and group-based activities and media were specifically developed for the study. Post-intervention questionnaires were completed within the week of the second intervention lesson. A final assessment, using the same questionnaire as per baseline and post-intervention, was undertaken one month post intervention.
Intervention code [1] 290644 0
Prevention
Intervention code [2] 290709 0
Behaviour
Comparator / control treatment
Control group undertook their normal school program, but completed baseline, post-intervention and follow-up questionnaires
Control group
Active

Outcomes
Primary outcome [1] 293625 0
Strengths and Difficulties Questionnaire (SDQ) change in total score
Timepoint [1] 293625 0
1 month follow-up
Primary outcome [2] 293626 0
Child and Adolescent Perfectionism Scale (CAPS) change in total score
Timepoint [2] 293626 0
1-month follow-up
Primary outcome [3] 293627 0
Self-Compassion Scale (short form) change in total score
Timepoint [3] 293627 0
1-month follow-up
Secondary outcome [1] 311489 0
McKnight Body Image Concerns - change in score
Timepoint [1] 311489 0
1-month follow-up

Eligibility
Key inclusion criteria
Age inclusion criteria only
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
primary school classes < year 5

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)
Using a computer-generated randomisation process (i.e., central randomisation by computer), classes were randomly allocated a condition. Participants were enrolled into one of three conditions (perfectionism, self-compassion, control) based on membership within a given school class.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a computer-generated randomisation process (i.e., central randomisation by computer), classes were randomly allocated a condition. Participants were enrolled into one of three conditions (perfectionism, self-compassion, control) based on membership within a given school class.
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
Linear mixed modelling: A mixed within-between 3 (group: intervention 1 or intervention 2 or control) x 2 (time: post-intervention, 1-month follow-up) design was used, controlling for baseline measures. Age and gender moderators will be tested.
This intervention is a pilot study; data from this pilot will assist planning for a properly powered study, including assisting effect size estimation/calculation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/10/2014
Actual
21/10/2014
Date of last participant enrolment
Anticipated
31/10/2014
Actual
31/10/2014
Date of last data collection
Anticipated
Actual
9/12/2014
Sample size
Target
150
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8941 0
5162 - Morphett Vale
Recruitment postcode(s) [2] 8942 0
5073 - Tranmere
Recruitment postcode(s) [3] 8947 0
5076 - Athelstone

Funding & Sponsors
Funding source category [1] 290276 0
Charities/Societies/Foundations
Name [1] 290276 0
Butterfly Foundation
Country [1] 290276 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 289035 0
Charities/Societies/Foundations
Name [1] 289035 0
Butterfly Foundation
Address [1] 289035 0
(Sydney Office) 103 Alexander Street Crows Nest NSW 2065
Country [1] 289035 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291974 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 291974 0
Ethics committee country [1] 291974 0
Australia
Date submitted for ethics approval [1] 291974 0
26/11/2013
Approval date [1] 291974 0
06/03/2014
Ethics approval number [1] 291974 0
6332

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

Contacts
Principal investigator
Name 52890 0
Dr Kate Fairweather-Schmidt
Address 52890 0
School of Psychology
Faculty of Social and Behavioural Sciences
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 52890 0
Australia
Phone 52890 0
+61-8-8201-2318
Fax 52890 0
Email 52890 0
[email protected]
Contact person for public queries
Name 52891 0
Tracey Wade
Address 52891 0
School of Psychology
Faculty of Social and Behavioural Sciences
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 52891 0
Australia
Phone 52891 0
+61-8-8201-3736
Fax 52891 0
Email 52891 0
[email protected]
Contact person for scientific queries
Name 52892 0
Tracey Wade
Address 52892 0
School of Psychology
Faculty of Social and Behavioural Sciences
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 52892 0
Australia
Phone 52892 0
+61-8-8201-3736
Fax 52892 0
Email 52892 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
funding not available to do the work


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.