Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000857202
Ethics application status
Approved
Date submitted
2/05/2018
Date registered
22/05/2018
Date last updated
31/05/2019
Date data sharing statement initially provided
31/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Brief Psychoeducational Workshop for High-school students
Scientific title
Brief Self-compassion and CBT Psychoeducational Program for High-school students: a Cohort-Controlled trial Assessing Stress, Perfectionism and Self Compassion
Secondary ID [1] 294649 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked with two prior studies. The original 2016 trial investigated the efficacy of an intervention which included ACT, CBT and Self-compassion based approaches (ACTRN12616000543482). The subsequent 2017 trial investigated the efficacy of an intervention which included ONLY CBT and Self-compassion based approaches (ACTRN12617000875303). The current trial is a follow-up which shortens the intervention from 8 to 4 weeks.

Health condition
Health condition(s) or problem(s) studied:
Mental Health 307681 0
Condition category
Condition code
Mental Health 306747 306747 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A psychoeducational program called Compassionate Brain (1 X 80min session per week for 4 weeks) will be run for middle school students. The Compassionate Mind program has been developed within a Cognitive Behavioral Therapy (CBT) and Self-Compassion framework. The program seeks to provide psychoeducation about thoughts, emotions and behavior as well as encourage the development of skills such as mindfulness, self-compassion and helping thinking styles. Adherence to the program will be monitored through recording attendance at each session.

The program will be delivered by a registered psychologist face-to-face and involve both lectures and small group work. The intervention will be delivered over 4 weeks and the sessions will be conducted at the school the students are currently attending. Content will include psycho-education delivery, experiential exercises, mindfulness practice, in addition to individual pair and group-based activities. Informational material will include powerpoint slides, short video clips and role plays. Finally, a series of questionnaires will be administered to measure outcomes prior to the program starting, 4 weeks later at the end of the program and a follow-up set of questionnaires will be administered approximately 3-4months later post-program completion.
Intervention code [1] 301079 0
Behaviour
Intervention code [2] 301218 0
Treatment: Other
Comparator / control treatment
Year 6 students attending the same school as the year 7 students will be the control group. They will recieve the equivalent of "treatment as usual", with an internal school pastoral care program.
Control group
Active

Outcomes
Primary outcome [1] 305738 0
The Stress Subscale of the Depression and anxiety scale for youth (DASS-Y, Szabo, unpublished) to measure stress symptoms
Timepoint [1] 305738 0
Primary outcome data will be collected at baseline, 4 weeks later at post [primary timepoint], and 3 - 4 months post program completion.
Primary outcome [2] 305739 0
Almost Perfect Scale (Slaney, Rice, Mobley, Trippi, & Ashby, 2001) to measure perfectionistic levels.
Timepoint [2] 305739 0
Primary outcome data will be collected at baseline, 4 weeks later at post [primary timepoint], and 3 - 4 months post program completion.
Primary outcome [3] 305740 0
The self-compassion scale (Neff, 2003b) to measure self-compassion levels
Timepoint [3] 305740 0
Primary outcome data will be collected at baseline, 4 weeks later at post [primary timepoint], and 3 - 4 months post program completion.
Secondary outcome [1] 346340 0
Difficulties in Emotion Regulation Scale Short Form
(DERS-SF): to measure emotion regulation skill
Timepoint [1] 346340 0
This outcome data will be collected at baseline, 4 weeks later at post, and 3 - 4 months post program completion.
Secondary outcome [2] 346965 0
Anxiety subscale of the Depression and anxiety scale for youth (DASS-Y, Szabo, unpublished) to measure depression, anxiety and stress symptoms
Timepoint [2] 346965 0
This outcome data will be collected at baseline, 4 weeks later at post, and 3 - 4 months post program completion.
Secondary outcome [3] 346966 0
Depression subscale of the Depression and anxiety scale for youth (DASS-Y, Szabo, unpublished) to measure depression, anxiety and stress symptoms
Timepoint [3] 346966 0
This outcome data will be collected at baseline, 4 weeks later at post, and 3 - 4 months post program completion.

Eligibility
Key inclusion criteria
Year 6 and 7 students attending a specific Sydney-based secondary school.
Minimum age
10 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not providing consent or not being enrolled in the specific school.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
cohort-controlled trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Correlation, Regression, t-test, ANOVA, Mediation, Moderation

Differences between groups will be examined using hierarchical mixed models containing random intercept and random slope terms as well as fixed effects for treatment received. We are also interested in further investigating self compassion and mindfulness as potential mediating variables in predicting outcomes such as depression, anxiety, stress and perfectionism.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/05/2018
Actual
24/05/2018
Date of last participant enrolment
Anticipated
24/05/2018
Actual
24/05/2018
Date of last data collection
Anticipated
24/10/2018
Actual
24/09/2018
Sample size
Target
150
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22570 0
2135 - Strathfield

Funding & Sponsors
Funding source category [1] 299379 0
University
Name [1] 299379 0
Australian Catholic University
Country [1] 299379 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
25A Barker Rd Strathfield 2135 NSW
Country
Australia
Secondary sponsor category [1] 298658 0
University
Name [1] 298658 0
University of Sydney
Address [1] 298658 0
School of Psychology
88 Mallett Street - Building F
Camperdown
The University of Sydney 2050
Country [1] 298658 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300179 0
Human Research Ethics Committee at Australian Catholic University
Ethics committee address [1] 300179 0
Ethics committee country [1] 300179 0
Australia
Date submitted for ethics approval [1] 300179 0
Approval date [1] 300179 0
03/04/2018
Ethics approval number [1] 300179 0
2016-44H

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

Contacts
Principal investigator
Name 82810 0
Dr Madeleine Ferrari
Address 82810 0
Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 82810 0
Australia
Phone 82810 0
+61297014726
Fax 82810 0
Email 82810 0
[email protected]
Contact person for public queries
Name 82811 0
Madeleine Ferrari
Address 82811 0
Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 82811 0
Australia
Phone 82811 0
+61297014726
Fax 82811 0
Email 82811 0
[email protected]
Contact person for scientific queries
Name 82812 0
Madeleine Ferrari
Address 82812 0
Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 82812 0
Australia
Phone 82812 0
+61297014726
Fax 82812 0
Email 82812 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
Clinical data will only be reported in aggregate group form, consistent with ACU Human Research Ethics Committee approval


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.