Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000863538
Ethics application status
Approved
Date submitted
27/06/2024
Date registered
12/07/2024
Date last updated
12/07/2024
Date data sharing statement initially provided
12/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cultivating self-compassion in parents of autistic children: Examining the effects of an online workshop
Scientific title
Randomised controlled trial of the effect of Compassionate Mind Training on self-reported self-compassion levels in parents of autistic children
Secondary ID [1] 312417 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-compassion 334236 0
Condition category
Condition code
Mental Health 330901 330901 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 330962 330962 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Compassionate Mind Training (CMT) program is comprised of one brief 2-hour seminar, consisting of psychoeducation and various compassion-based practices: (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.

A previous randomised controlled trial (RCT) on the CMT program in parents of children aged 3 to 9 found that this program significantly reduces levels of parental self-criticism and child emotional and peer problems (ACTRN12618000556246).

The CMT group workshops will be delivered online by Dr James Kirby (Clinical Psychologist and UQ lecturer) and Dr Ru Ying Cai (Research Fellow). The approximate group size is 8 to 10 parents. The workshop will be interactive, with numerous opportunities for parents to engage in group discussions. After the group workshop, all participants will be provided with access to audio-recorded meditations to help facilitate independent practice of CMT (via links emailed to participants). No specific post-workshop instructions regarding independent practice of CMT will be provided.

Participants can also volunteer to be interviewed (via Zoom, phone, or email) two weeks post-workshop attendance. Semi-structured interviews using a study-specific questionnaire will be used. A member of the research team will conduct the interviews, which is approximately 30 minutes. The interviews will be audio-recorded for transcription prior to data analyses.
Intervention code [1] 328924 0
Treatment: Other
Intervention code [2] 328925 0
Lifestyle
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 (multiple workshops will be made available for parents to select the most suitable time). Following completion of the suitability online questionnaire to assess eligibility, participants will be randomly allocated to either the CFT intervention or the control condition (block randomisation). Once parents have selected their chosen workshop time, parents in the control condition will be asked to complete the Time 1 and Time 2 online surveys prior to attending their selected workshop. Both participants in the CFT intervention and the control condition will be attending the same workshops.
Control group
Active

Outcomes
Primary outcome [1] 338658 0
Participant self-report of self-compassion.
Timepoint [1] 338658 0
All participants will be asked to complete this scale on two occasions, the first being immediately after enrolling in the study and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [1] 436882 0
Participant self-report of self-criticism. This will be assessed as a composite outcome.
Timepoint [1] 436882 0
All participants will be asked to complete this scale on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [2] 436883 0
Participant self-report of mental well-being #1. This will be assessed as a composite outcome.
Timepoint [2] 436883 0
All participants will be asked to complete these scales on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [3] 436884 0
Participant self-report of parental warmth. This will be assessed as a composite outcome.
Timepoint [3] 436884 0
All participants will be asked to complete this scale on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [4] 436885 0
Participant self-report of positive affect
Timepoint [4] 436885 0
All participants will be asked to complete this scale on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [5] 436886 0
Participant self-report of emotion regulation
Timepoint [5] 436886 0
All participants will be asked to complete this scale on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [6] 436887 0
Participant report of children’s emotional, social and behavioural outcomes. This will be assessed as a composite outcome.
Timepoint [6] 436887 0
All participants will be asked to complete this scale on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [7] 437213 0
Participant self-report of mental well-being #2
Timepoint [7] 437213 0
All participants will be asked to complete these scales on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).
Secondary outcome [8] 437214 0
Participant self-report of negative affect.
Timepoint [8] 437214 0
All participants will be asked to complete this scale on two occasions, the first being after workshop selection and the second either two weeks after attending the workshop (CMT intervention condition) or right before attending the workshop (control condition).

Eligibility
Key inclusion criteria
Inclusion criteria for participants will be that parents must:
1) Have at least one autistic child aged between 3 and 17 years
2) Score low to moderate on the Self-Compassion Scale
3) Have access to the required technology: stable internet connection, computer/laptop/tablet and audio outlet (the ability to watch an online workshop)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) An inability to attend a 2-hour workshop
2) Not willing to complete questionnaires or be randomised.

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)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The random allocation of participants to the two conditions is designed to produce matched sub-samples of parents of autistic children. 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. control) as the between-groups factor, and assessment time-point as the within-groups factor (T1 vs. T2).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/04/2024
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
60
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316830 0
Charities/Societies/Foundations
Name [1] 316830 0
Autism Spectrum Australia
Country [1] 316830 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Edwards
Address
Country
Australia
Secondary sponsor category [1] 319061 0
None
Name [1] 319061 0
Address [1] 319061 0
Country [1] 319061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315598 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 315598 0
Ethics committee country [1] 315598 0
Australia
Date submitted for ethics approval [1] 315598 0
13/02/2024
Approval date [1] 315598 0
08/04/2024
Ethics approval number [1] 315598 0
GU Ref No: 2024/101

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

Contacts
Principal investigator
Name 135198 0
Dr Chris Edwards
Address 135198 0
Autism Spectrum Australia, Level 5, Tower B, The Zenith, 821 Pacific Highway Chatswood NSW 2067
Country 135198 0
Australia
Phone 135198 0
+61 423354654
Fax 135198 0
Email 135198 0
[email protected]
Contact person for public queries
Name 135199 0
Ru Ying Cai
Address 135199 0
Autism Spectrum Australia, Level 5, Tower B, The Zenith, 821 Pacific Highway Chatswood NSW 2067
Country 135199 0
Australia
Phone 135199 0
+61402437928
Fax 135199 0
Email 135199 0
[email protected]
Contact person for scientific queries
Name 135200 0
Ru Ying Cai
Address 135200 0
Autism Spectrum Australia, Level 5, Tower B, The Zenith, 821 Pacific Highway Chatswood NSW 2067
Country 135200 0
Australia
Phone 135200 0
+61402437928
Fax 135200 0
Email 135200 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


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.