Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000690954
Ethics application status
Approved
Date submitted
24/01/2020
Date registered
22/06/2020
Date last updated
22/06/2020
Date data sharing statement initially provided
22/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindful Parenting and Child Emotional Well-being
Scientific title
Mindfulness in parenting and parental emotion regulation, beliefs and behaviours: A pilot randomised controlled trial
Secondary ID [1] 300324 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental distress 315934 0
Parental emotion regulation 315935 0
Parental beliefs and behaviours 315936 0
Child emotional well-being 315937 0
Condition category
Condition code
Mental Health 314205 314205 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants attend a mindful parenting program. The program is delivered over 8 consecutive weeks, with 8 x 2 hour sessions (one session per week). The program is delivered face-to-face, in small groups of 8-15 participants, at the University of Sydney psychology clinic. The program is facilitated by a registered Clinical Psychologist and a Clinical Psychology Registrar. Each session involves mindfulness practices, including body scans and sitting meditations, group inquiry, and exploration of challenging parenting situations.
Intervention code [1] 316604 0
Treatment: Other
Comparator / control treatment
A no treatment waitlist control group will be used. The waitlist control group will receive the mindful parenting intervention approximately 5 months after the intervention group. The intervention group is run within Australian school term 1 of 2020, There is then an 8-week follow up period, The waitlist group is then run within school term 3.
Control group
Active

Outcomes
Primary outcome [1] 322592 0
Participant recruitment rate: (i) the % of potential participants who enrolled in the research program after engaging with the study's Facebook advertisement; (ii) % of potential participants who enrolled in the program after being contacted by email; and (iii) % of potential participants who enrolled in the program after registering their interest online on the study’s expression of interest page.
Timepoint [1] 322592 0
Immediately prior to the randomisation or participants into treatment and control groups.
Primary outcome [2] 322615 0
Participant attendance rate: (i) average attendance rate of participants across 8 sessions; and (ii) % of participants who attended at least 6 out of 8 sessions, both assessed by audit of participant attendance log.
Timepoint [2] 322615 0
Immediately following completion of the program.
Primary outcome [3] 322618 0
Participant drop-out rate: (i) % of participants withdrawing from the program; and (ii) % of participants failing to complete at least 4 sessions, assessed by audit of participant attendance log.
Timepoint [3] 322618 0
Immediately following completion of the program.
Secondary outcome [1] 379045 0
Change in parental experiential avoidance - measured with the Parental Acceptance and Action Questionnaire (PAAQ)
Timepoint [1] 379045 0
Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion.

Secondary outcome [2] 379046 0
Change in parental emotion regulation strategies - using the Cognitive Emotion Regulation Questionnaire (CERQ),

Timepoint [2] 379046 0
Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion.
Secondary outcome [3] 379047 0
Change in parental anxiety-related beliefs and behaviours - using the Parental Attitudes, Beliefs and Understanding of Anxiety Questionnaire (PABUA) & the Parental Accommodation Scale (PAS),
Timepoint [3] 379047 0
Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion.
Secondary outcome [4] 379048 0
Change in mindfulness in parenting - (i) using Interpersonal Mindfulness in Parenting (IMP) questionnaire; and (ii) using a specifically designed in-session questionnaire.
Timepoint [4] 379048 0
(i) Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion, using the IMP; and (ii) weekly in-session, using the in-session questionnaire..
Secondary outcome [5] 379050 0
Change in parenting stress: using the Parenting Stress Scale.
Timepoint [5] 379050 0
Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion.
Secondary outcome [6] 379052 0
Change in parental distress: using the DASS-21.
Timepoint [6] 379052 0
Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion.
Secondary outcome [7] 379053 0
Change in child functioning - using Internalising and Externalising scales of the Child Behaviour Checklist (CBCL).
Timepoint [7] 379053 0
Immediately prior to the program, 4 weeks after commencement of program, immediately following completion of program and 2 months after completion.

Eligibility
Key inclusion criteria
Parents of a child currently aged between 3 and 18 years of age, who have concerns about their child’s emotional well-being (eg. believe their child tends to worry, or be nervous, sensitive, anxious or shy).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants are:
1. Inadequate mastery of the English language.
2. Engaging in another psychological therapy aimed at managing parent anxiety, parenting difficulties or child behaviour;
3. Organic brain damage.
4. Current or past psychosis or bipolar disorder.
5. Current or recent (within last 12 months) substance dependence.
6. Current moderate to high risk of self-harm or suicide
7. Significant interpersonal difficulties
8. Current safeguarding concerns about children in the family
9. Child intellectual disability.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed as was done using online computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation was done using a computer program to generate 2 randomly allocated groups of participants.
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
Sample size of 20-40 participants was determined for this pilot study, based on recommendations by Whitehead, Julious, Cooper, and Campbell (2016) for an 80% powered main trial with two-sided 5% significance, where the standardised effect sizes are expected to be small to medium.

The purpose of this pilot study is primarily to test the feasibility of conducting a future full clinical trial. However, effect sizes of assessed outcomes will be calculated in order to provide estimates of the likely effect sizes and required sample sizes in a later full clinical trial. These will include effect sizes for:
a. Correlations between measured outcomes;
b. Changes in pre-program to post-program scores for parents’ mindful parenting (IMP), emotion regulation strategies (CERQ), experiential avoidance (PAAQ), anxiety-related beliefs (PABUA), and accommodation behaviours (PAS), distress (DASS-21) and parenting stress (PSS) scores, and in child functioning (CBCL);
c. Between-group differences for intervention vs control group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/01/2020
Date of last participant enrolment
Anticipated
3/07/2020
Actual
Date of last data collection
Anticipated
24/11/2020
Actual
Sample size
Target
40
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304750 0
University
Name [1] 304750 0
University of Sydney
Country [1] 304750 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
94 Mallett Street
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 305064 0
None
Name [1] 305064 0
Address [1] 305064 0
Country [1] 305064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305169 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 305169 0
The University of Sydney
SYDNEY NSW 2001
Ethics committee country [1] 305169 0
Australia
Date submitted for ethics approval [1] 305169 0
13/09/2019
Approval date [1] 305169 0
28/11/2019
Ethics approval number [1] 305169 0
2019/793

Summary
Brief summary
The study is a pilot randomised controlled trial of a mindful parenting program for community-recruited parents who have concerns about their child’s emotional well-being.
The study is being conducted to investigate (1) the feasibility of the program, as a way to improve child emotional well-being by assisting parents to manage their own emotions and anxiety-related beliefs and behaviours; and (2) the acceptability of the program to parents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99474 0
Dr Marianna Szabo
Address 99474 0
School of Psychology
The University of Sydney
Sydney NSW 2006
Country 99474 0
Australia
Phone 99474 0
+61 2 9351 5147
Fax 99474 0
Email 99474 0
[email protected]
Contact person for public queries
Name 99475 0
Ms Virginia Burgdorf
Address 99475 0
Clinical Psychology Unit
School of Psychology
Brain and Mind Centre
94 Mallett St
Camperdown NSW 2050
Country 99475 0
Australia
Phone 99475 0
+61 0458 638 728
Fax 99475 0
Email 99475 0
[email protected]
Contact person for scientific queries
Name 99476 0
Ms Virginia Burgdorf
Address 99476 0
Clinical Psychology Unit
School of Psychology
Brain and Mind Centre
94 Mallett St
Camperdown NSW 2050
Country 99476 0
Australia
Phone 99476 0
+61 0458 638 728
Fax 99476 0
Email 99476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data only.
When will data be available (start and end dates)?
Start: 30/1/2022
End: no end date determined.
Available to whom?
Researchers collaborating with the PhD Researcher involved in this study.
Available for what types of analyses?
Any analyses.
How or where can data be obtained?
Data will be made available by emailing the PhD Researcher on this study ([email protected]).


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.