Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000556246
Ethics application status
Approved
Date submitted
6/04/2018
Date registered
13/04/2018
Date last updated
13/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Compassionate Mind Training to Improve Parent Wellbeing and Child Behaviour
Scientific title
Randomised Controlled Trial of Compassionate Mind Training to Improve Parent Self-Criticism, Wellbeing, and Child Behaviour
Secondary ID [1] 294512 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-criticism 307285 0
Condition category
Condition code
Mental Health 306402 306402 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compassion-Focused Therapy aims to help individuals with self-criticism and emotional distress (Gilbert, 2014). Previous research suggests that even brief programs may be effective in helping alleviate stress and suffering and promoting wellbeing (Leaviss & Uttley, 2015; Gilbert & Maratos, 2017). Compassion-focused therapy (CFT) was developed by Professor Paul Gilbert from the Centre for Compassion Research and Training at the University of Derby, UK. The theoretical underpinning of CFT draws upon evolutionary psychology, attachment theory, and applied psychology processes from neuroscience and social psychology.

The Compassionate Mind Training (CMT) program is comprised of one brief 2-hour seminar, which will focus on practices including: (1) a soothing rhythm breathing practice ; (2) a practice focused on creating friendly facial expressions and voice tones as part of compassion; (3) a practice aimed to develop mindfulness and increase attention to one's current mental state; (4) a practice aimed to develop the sense of a compassionate self that is based upon feelings of wisdom, strength and commitment to be supportive and helpful to self and others; (5) an imagery practice aimed to develop a compassionate image of another mind that has caring intent towards the self; and (6) a practice aimed to develop a compassionate self that has caring intent towards the self and how to use compassion focusing to work with self-criticism and life difficulties.

Ultimately, the proposed research will establish whether such a brief 2-hour intervention is beneficial to participants in terms of their wellbeing, parenting style, and child's behaviour (in comparison to a wait-list control sample drawn from the same population). The brief nature of the CMT intervention is significantly more cost-effective compared to manualised parenting and/or therapeutic interventions; thus, allowing the possibility of dissemination to greater numbers of parents at any given time, and opens up the possibility of population-level effects that are consistent with the public health model of prevention, in addition to treatment.

The CMT group seminar will be delivered in-person by Dr James Kirby (Clinical Psychologist and UQ lecturer) at facilities provided by UQ's School of Psychology, St Lucia (Brisbane). At the group seminar, all participants will be provided with workbooks and access to audio recorded meditations to help facilitate independent practice of CMT. A practice diary will also need to be completed, which asks participants to reflect on their experience in the 2 weeks after attending the seminar.
Intervention code [1] 300815 0
Treatment: Other
Intervention code [2] 300816 0
Lifestyle
Intervention code [3] 300817 0
Behaviour
Comparator / control treatment
All participants enrolled in this research will be offered a place in a 2-hour workshop on Compassion-Focused Training; however, the timing will vary. Following completion of the initial online questionnaire, participants will be randomly allocated to either the Immediate CFT intervention or the wait-list condition. Participants allocated to the CFT intervention will receive CFT training once enough parents/caregivers have enrolled to fulfil the minimum number required for the group workshop. Participants randomly allocated to the wait-list condition will be offered a separate session of CFT approximately 1 month after participants in the Immediate CFT intervention group.
Control group
Active

Outcomes
Primary outcome [1] 305415 0
Participant self-report of self-criticism as assessed by The Forms of Self-Criticising/Attacking and Self-Reassuring Scale and The Functions of Self-Criticising/Self-Attacking Scale
Timepoint [1] 305415 0
All participants will be asked to complete an online questionnaire taking 20 minutes on two occasions, the first being immediately after enrolling in the study (baseline), and the second two weeks after the attending the workshop (primary timepoint). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up.
Primary outcome [2] 305416 0
Participant self-report of compassion as assessed by The Compassionate Engagement and Action Scales and The Fears of Compassion Scales
Timepoint [2] 305416 0
All participants will be asked to complete an online questionnaire taking 20 minutes on two occasions, the first being immediately after enrolling in the study (baseline), and the second two weeks after the attending the workshop (primary timepoint). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up.
Primary outcome [3] 305417 0
Participant self-report of parenting as assessed by The Parenting Scale
Timepoint [3] 305417 0
All participants will be asked to complete an online questionnaire taking 20 minutes on two occasions, the first being immediately after enrolling in the study (baseline), and the second two weeks after the attending the workshop (primary timepoint). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up.
Secondary outcome [1] 345115 0
Psychosocial adjustment as assessed by The Depression Anxiety Stress Scale (DASS-21) and The Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [1] 345115 0
All participants will be asked to complete an online questionnaire taking 20 minutes on two occasions, the first being immediately after enrolling in the study (baseline), and the second two weeks after the attending the workshop (secondary timepoint). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up.
Secondary outcome [2] 345213 0
Parental report of external shame as assessed by the Other as Shamer Scale
Timepoint [2] 345213 0
All participants will be asked to complete an online questionnaire taking 20 minutes on two occasions, the first being immediately after enrolling in the study (baseline), and the second two weeks after the attending the workshop (secondary timepoint). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up.
Secondary outcome [3] 345214 0
Parental report of child behaviour as assessed using the Strengths and Difficulties Questionnaire
Timepoint [3] 345214 0
All participants will be asked to complete an online questionnaire taking 20 minutes on two occasions, the first being immediately after enrolling in the study (baseline), and the second two weeks after the attending the workshop (secondary timepoint). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria for participants will be that parents/caregivers must:

- Have at least one child between the ages of 3 and 9 years.
- Demonstrate a level of self-criticism towards their own parenting style.
- Be concerned about their child's social, emotional, and/or behavioural functioning.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will be:

- An inability to attend the 2-hour session.
- Experiencing or affected by severe mental illness.
- Not willing to complete questionnaires or be randomised.
- Parents who have accessed or completed a parenting program within the previous 6 months.
- Parents who have previously completed the "Mindful Self-Compassion" program (Germer & Neff).
- Parents who do not meet the minimum threshold for self-reported self-criticism towards their parenting, and level of concern about their child's social, emotional, and/or behavioural functioning.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The project will be a randomised controlled trial with a mixed 2 (between groups: Compassionate Mind Training (CMT) vs. Wait-list Control) x 2 (repeated measures: Times) design. Randomisation will occur using a random number generator for all consenting participants who have completed assessment Time 1. All participants will complete assessment at two separate time points: T1 = pre-randomisation; T2 = post-program or wait-list period (2 weeks later). Participants in the CMT intervention condition will be asked to complete the questionnaire again at 3-months follow-up. The effectiveness of the CMT program will be evaluated in terms of the effect size changes in measures over time.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The random allocation of participants to the two conditions is designed to produce matched sub-samples from the general population of parents/families. We will check this by statistically comparing baseline variables between the two groups (using chi squared tests for categorical variables, and t-tests or ANOVAs for continuous variables). The hypotheses will be tested using a MANOVAs with condition (CMT vs. wait-list control) as the between-groups factor, and assessment time-point as the within-groups factor (T1 vs. T2).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2018
Actual
Date of last participant enrolment
Anticipated
31/05/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
100
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 299138 0
University
Name [1] 299138 0
University of Queensland
Country [1] 299138 0
Australia
Primary sponsor type
Individual
Name
Dr James Kirby
Address
School of Psychology
McElwain Building
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 298397 0
Individual
Name [1] 298397 0
Norman Ramos
Address [1] 298397 0
School of Psychology
McElwain Building
University of Queensland
St Lucia QLD 4072
Country [1] 298397 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300069 0
University of Queensland School of Psychology Ethics Review Committee
Ethics committee address [1] 300069 0
Ethics committee country [1] 300069 0
Australia
Date submitted for ethics approval [1] 300069 0
13/03/2018
Approval date [1] 300069 0
16/03/2018
Ethics approval number [1] 300069 0
18-PSYCH-MP-07-AH

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

Contacts
Principal investigator
Name 82462 0
Dr James Kirby
Address 82462 0
School of Psychology
McElwain Building
University of Queensland
St Lucia QLD 4072
Country 82462 0
Australia
Phone 82462 0
+61 7 3365 6802
Fax 82462 0
Email 82462 0
[email protected]
Contact person for public queries
Name 82463 0
Norman Ramos
Address 82463 0
School of Psychology
McElwain Building
University of Queensland
St Lucia QLD 4072
Country 82463 0
Australia
Phone 82463 0
+61 7 3365 6802
Fax 82463 0
Email 82463 0
[email protected]
Contact person for scientific queries
Name 82464 0
James Kirby
Address 82464 0
School of Psychology
McElwain Building
University of Queensland
St Lucia QLD 4072
Country 82464 0
Australia
Phone 82464 0
+61 7 3365 6802
Fax 82464 0
Email 82464 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
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