Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000290493
Ethics application status
Approved
Date submitted
31/03/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
MotherCare: An Anchor in the Storm - the effectiveness of a flexible perspective-taking intervention to improve psychological adjustment for mothers of babies under 24 months
Scientific title
MotherCare: An Anchor in the Storm - the effectiveness of a flexible perspective-taking intervention to improve psychological adjustment for mothers of babies under 24 months
Secondary ID [1] 314090 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health among mothers of infants 336868 0
Condition category
Condition code
Mental Health 333339 333339 0 0
Other mental health disorders
Mental Health 333338 333338 0 0
Depression
Mental Health 333337 333337 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mothers in the intervention group will be given access to online resources specifically designed for use in this study: (i) a brief web-based informational video (approx. 7 mins) that begins with a psychoeducation component on flexible perspective taking (self-as-context, a component of Acceptance and Commitment Therapy [ACT]) and relevance to mothers of infants (from birth to 23 months), drawing on ACT methaphors for enhancing a transcndent sense of self; (ii) an audio-guided experiential exercise on flexible perspective taking tailored to pregnant and new mothers (approx. 9 mins), which women will be encouraged to listen to and use to guide their own meditation practice; and (iii) a simple tip sheet (designed specifically for this study) summarising key points that will be made available to participants to download and print. Resource use will be monitored using website analytics. Participants will have access to the resources for the full duration of the study and extending to 12 months from the time of enrolment.
Intervention code [1] 330666 0
Treatment: Other
Comparator / control treatment
The control group will be a 'care as usual' group; that is, no active treatment or intervention will be made available to these participants. The control group will still have access to mental health support from their GP and other mental health professionals. Following the completion of the final online survey, all control participants will be offered access to the online intervention resources through a link emailed to them.
Control group
Active

Outcomes
Primary outcome [1] 340912 0
Post-traumatic stress symptoms
Timepoint [1] 340912 0
Baseline and 8 weeks post-intervention
Primary outcome [2] 340914 0
Anxiety symptoms
Timepoint [2] 340914 0
Baseline and 8 weeks post-intervention
Primary outcome [3] 340913 0
Depressive symptoms
Timepoint [3] 340913 0
Baseline and 8 weeks post-intervention
Secondary outcome [1] 445435 0
Parental self-efficacy
Timepoint [1] 445435 0
Baseline and 8 weeks post-intervention
Secondary outcome [2] 445427 0
Stress symptoms
Timepoint [2] 445427 0
Baseline and 8 weeks post-intervention
Secondary outcome [3] 445430 0
Birth satisfaction
Timepoint [3] 445430 0
Baseline and 8 weeks post-intervention
Secondary outcome [4] 445434 0
Acceptability of the intervention
Timepoint [4] 445434 0
8 weeks post-intervention
Secondary outcome [5] 445433 0
Emotional availability
Timepoint [5] 445433 0
Baseline and 8 weeks post-intervention
Secondary outcome [6] 445432 0
Feasibility of the intervention
Timepoint [6] 445432 0
At study completion
Secondary outcome [7] 445428 0
Psychological flexibility
Timepoint [7] 445428 0
Baseline and 8 weeks post-intervention
Secondary outcome [8] 445431 0
Breastfeeding satisfaction
Timepoint [8] 445431 0
Baseline and 8 weeks post-intervention
Secondary outcome [9] 445429 0
Self-as-context
Timepoint [9] 445429 0
Baseline and 8 weeks post-intervention

Eligibility
Key inclusion criteria
Participants will be women aged 18 years and over, who are currently mothers of a baby under 24 months and living in Australia or New Zealand.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised automatically via Qualtrics at completion of the baseline questionnaire, and will be notified of their group allocation via a email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by computer software (Qualtrics will randomly allocate to intervention or waitlist control groups).
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
To obtain a medium effect size (Cohen’s d = 0.5), it is estimated that a sample of approximately 128 participants will be required (64 per group). Allowing for up to 40% attrition over the follow-up period (estimated from our three previous anonymous, online RCTs of brief psychological interventions with perinatal women), we will aim to recruit 214 women.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/04/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
214
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26922 0
New Zealand
State/province [1] 26922 0

Funding & Sponsors
Funding source category [1] 318598 0
University
Name [1] 318598 0
The University of Queensland
Country [1] 318598 0
Australia
Primary sponsor type
Individual
Name
Dr Koa Whittingham, The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320998 0
None
Name [1] 320998 0
Address [1] 320998 0
Country [1] 320998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317200 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 317200 0
Ethics committee country [1] 317200 0
Australia
Date submitted for ethics approval [1] 317200 0
11/12/2024
Approval date [1] 317200 0
14/03/2025
Ethics approval number [1] 317200 0
2024/HE002494

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

Contacts
Principal investigator
Name 140318 0
A/Prof Koa Whittingham
Address 140318 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 140318 0
Australia
Phone 140318 0
+61 0409260428
Fax 140318 0
Email 140318 0
[email protected]
Contact person for public queries
Name 140319 0
Koa Whittingham
Address 140319 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 140319 0
Australia
Phone 140319 0
+61 0409260428
Fax 140319 0
Email 140319 0
[email protected]
Contact person for scientific queries
Name 140320 0
Koa Whittingham
Address 140320 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 140320 0
Australia
Phone 140320 0
+61 0409260428
Fax 140320 0
Email 140320 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.