Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000683639
Ethics application status
Approved
Date submitted
6/06/2023
Date registered
26/06/2023
Date last updated
26/06/2023
Date data sharing statement initially provided
26/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An anchor in the storm: the effectiveness of a flexible perspective-taking intervention in supporting the transition to motherhood
Scientific title
An anchor in the storm: the effectiveness of a flexible perspective-taking intervention in supporting the transition to motherhood
Secondary ID [1] 309831 0
None
Universal Trial Number (UTN)
U1111-1293-3819
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health among mothers of infants 330258 0
Alcohol use in pregnancy 330259 0
Condition category
Condition code
Mental Health 327122 327122 0 0
Anxiety
Mental Health 327123 327123 0 0
Depression
Mental Health 327124 327124 0 0
Other mental health disorders
Reproductive Health and Childbirth 327125 327125 0 0
Childbirth and postnatal care

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. Particpants 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] 326264 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] 334995 0
Post-traumatic stress symptoms, as measured using the Impact of Event Scale - Revised
Timepoint [1] 334995 0
6 weeks and 4 months post expected date of delivery
Primary outcome [2] 334996 0
Depressive symptoms, as measured using the Depression Anxiety Stress Scales
Timepoint [2] 334996 0
6 weeks and 4 months post expected date of delivery
Primary outcome [3] 334997 0
Anxiety symptoms, as measured using the Depression Anxiety Stress Scales
Timepoint [3] 334997 0
6 weeks and 4 months post expected date of delivery
Secondary outcome [1] 422654 0
Stress symptoms, as measured using the Depression Anxiety Stress Scales
Timepoint [1] 422654 0
6 weeks and 4 months post expected date of delivery
Secondary outcome [2] 422655 0
Alcohol consumption as assessed using the Alcohol Use and Disorders Identification Test (AUDIT-C)
Timepoint [2] 422655 0
6 weeks and 4 months post expected date of delivery
Secondary outcome [3] 422656 0
Psychological flexibility, as measured using the CompACT
Timepoint [3] 422656 0
6 weeks and 4 months post expected date of delivery
Secondary outcome [4] 422657 0
Self-as-context, as measured using the Self-As-Context Scale
Timepoint [4] 422657 0
6 weeks and 4 months post expected date of delivery
Secondary outcome [5] 422658 0
Birth satisfaction, as measured using the Perception of Labour and Delivery Scale
Timepoint [5] 422658 0
6 weeks post expected date of delivery
Secondary outcome [6] 422659 0
Breastfeeding satisfaction, as measured using the Maternal Breastfeeding Evaluation Scale
Timepoint [6] 422659 0
6 weeks and 4 months post expected date of delivery
Secondary outcome [7] 422660 0
Feasibility of the intervention, as indicated by rate of participant recruitment and particpant retention (assessed via data from participant tracking database)
Timepoint [7] 422660 0
At study completion
Secondary outcome [8] 422661 0
Emotional availability, as assessed on the Emotional Availability - Self-Report
Timepoint [8] 422661 0
4 months post expected date of delivery
Secondary outcome [9] 423112 0
Acceptability of the intervention, as indicated by a series of items (Likert scales, open-ended questions) developed for use in this study
Timepoint [9] 423112 0
6 weeks post expected date of delivery

Eligibility
Key inclusion criteria
Participants will be women aged 18 years and over, who are currently at least 20 weeks pregnant, 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)
Particpants 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
26/06/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/07/2024
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] 25579 0
New Zealand
State/province [1] 25579 0

Funding & Sponsors
Funding source category [1] 314015 0
University
Name [1] 314015 0
The University of Queensland
Country [1] 314015 0
Australia
Primary sponsor type
Individual
Name
Dr Koa Whittingham
Address
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 315905 0
None
Name [1] 315905 0
Address [1] 315905 0
Country [1] 315905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313152 0
The University of Queensland Human Research Ethics Committees (HRECs)
Ethics committee address [1] 313152 0
Ethics committee country [1] 313152 0
Australia
Date submitted for ethics approval [1] 313152 0
08/05/2023
Approval date [1] 313152 0
16/06/2023
Ethics approval number [1] 313152 0
2023/HE000719

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

Contacts
Principal investigator
Name 127174 0
Dr Koa Whittingham
Address 127174 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 127174 0
Australia
Phone 127174 0
+61 0409260428
Fax 127174 0
Email 127174 0
[email protected]
Contact person for public queries
Name 127175 0
Koa Whittingham
Address 127175 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 127175 0
Australia
Phone 127175 0
+61 0409260428
Fax 127175 0
Email 127175 0
[email protected]
Contact person for scientific queries
Name 127176 0
Koa Whittingham
Address 127176 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 127176 0
Australia
Phone 127176 0
+61 0409260428
Fax 127176 0
Email 127176 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.