Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000875303
Ethics application status
Approved
Date submitted
13/06/2017
Date registered
15/06/2017
Date last updated
1/11/2019
Date data sharing statement initially provided
1/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Compassionate Brain: Evaluation of a psychoeducational workshop program for middle school students
Scientific title
Compassionate Brain: Evaluation of a psychoeducational workshop program for middle school students
Secondary ID [1] 291893 0
Nil
Universal Trial Number (UTN)
Trial acronym
CBP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional Regulation Difficulties 303233 0
Negative Affect 303234 0
Perfectionism 303675 0
Condition category
Condition code
Mental Health 302662 302662 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Compassionate Brain Program is a novel psycho-educational workshop series that has been developed for middle school students. This study is a controlled trial seeking to evaluate the effectiveness of this program and to also better understand the relationships between emotional regulation, perfectionism, low mood, anxiety, stress and self-compassion in an adolescent population.

The Compassionate Brain program has been developed within a Cognitive Behavioral Therapy 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. Content will be interactive, including experiential exercises, role plays, and mindfulness practice.

The program will be delivered by a registered clinical psychologist face-to-face and involve both lectures and small group work. School teachers will be involved in assisting the small group work. The intervention will be delivered over a total of 8 sessions for the intervention group. The duration of each session will be approximately one hour, conducted at the school the students are currently attending. Dependent on school timetabling, the sessions will be run either once a week or once a fortnight. Thus total duration of the intervention will be 8-16 weeks.

A series of questionnaires will be administered to measure outcomes prior to the program starting, at the end of the program and a follow-up set of questionnaires will be administered approximately 3-4months later post-program completion. The primary outcomes to be measured are difficulties in emotional regulation, perfectionism, low mood, stress, and anxiety. Intervention adherence will also be assessed by recording attendance of students during each session.
Intervention code [1] 298037 0
Prevention
Comparator / control treatment
This is a cohort-controlled trial. The control group will be a year cohort either above or below the intervention group. The control group will receive the same questionnaire administered to the intervention group. At the same time as the Compassionate Brain Program received by the intervention group, the control group will be receiving the equivalent of "treatment as usual", with an internal school pastoral care program.
Control group
Active

Outcomes
Primary outcome [1] 302063 0
The primary objective of the project is to evaluate the efficacy of the Compassionate Brain program in relation to difficulties in emotional regulation.
Scale: the 18-item short version of the Difficulties in Emotion Regulation Scale (DERS-18; Victor & Klonsky, 2016).
Timepoint [1] 302063 0
Primary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.
Primary outcome [2] 302064 0
Negative Affect
Scale: the 21-item Depression, Anxiety Stress Scales, (DASS-21-Y; Szabo, unpublished scale).
Timepoint [2] 302064 0
Primary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.
.
Primary outcome [3] 302065 0
Perfectionism
Scale: the 23-item Almost Perfect Scale (APC; Slaney, Mobley, Trippi, Ashby & Johnson, 1996).
Timepoint [3] 302065 0
Primary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.
Secondary outcome [1] 335930 0
Self-compassion
Scale: Self-compassion Short Scale (Raes, Pommier, Neff & Van Gucht, 2011).
Timepoint [1] 335930 0
Secondary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.
Secondary outcome [2] 335931 0
Open-ended qualitative reports of how helpful or unhelpful students found the program
Timepoint [2] 335931 0
This secondary outcome data will be collected at post; at the conclusion of the intervention,


Eligibility
Key inclusion criteria
Middle school students
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not providing consent or not being enrolled in the specific middle schools involved in the study .

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur at the school level. After consenting to be involved in the study, middle school grades 6 and 7 will be randomly allocated to either intervention or control groups. Allocation will be concealed through the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used
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
This study will involve two groups: an intervention and control group. 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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
8/05/2017
Date of last participant enrolment
Anticipated
8/05/2019
Actual
17/05/2017
Date of last data collection
Anticipated
1/12/2019
Actual
15/12/2017
Sample size
Target
500
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16418 0
2135 - Strathfield

Funding & Sponsors
Funding source category [1] 296723 0
University
Name [1] 296723 0
Australian Catholic University
Country [1] 296723 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
25A Barker Rd Strathfield
Australian Catholic University
NSW 2135
Country
Australia
Secondary sponsor category [1] 295337 0
University
Name [1] 295337 0
University of Sydney
Address [1] 295337 0
Mallett Street Campus,
The University of Sydney,
NSW 2006
Country [1] 295337 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297624 0
Human Research Ethics Committee at Australian Catholic University
Ethics committee address [1] 297624 0
Ethics committee country [1] 297624 0
Australia
Date submitted for ethics approval [1] 297624 0
29/03/2017
Approval date [1] 297624 0
07/04/2017
Ethics approval number [1] 297624 0
2016-44H

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

Contacts
Principal investigator
Name 74630 0
Dr Madeleine Ferrari
Address 74630 0
Australian Catholic University.
Office 640.G.02, Edward Clancy Building,
25A Barker Road, Strathfield, NSW 2135
Country 74630 0
Australia
Phone 74630 0
+61297014726
Fax 74630 0
Email 74630 0
[email protected]
Contact person for public queries
Name 74631 0
Madeleine Ferrari
Address 74631 0
Australian Catholic University.
Office 640.G.02, Edward Clancy Building,
25A Barker Road, Strathfield, NSW 2135
Country 74631 0
Australia
Phone 74631 0
+61297014726
Fax 74631 0
Email 74631 0
[email protected]
Contact person for scientific queries
Name 74632 0
Madeleine Ferrari
Address 74632 0
Australian Catholic University.
Office 640.G.02, Edward Clancy Building,
25A Barker Road, Strathfield, NSW 2135
Country 74632 0
Australia
Phone 74632 0
+61297014726
Fax 74632 0
Email 74632 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 form


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.