Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000089730
Ethics application status
Approved
Date submitted
14/12/2021
Date registered
24/01/2022
Date last updated
28/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The MotherCare Project: A Brief Online Values Intervention for Mothers of Infants
Scientific title
The MotherCare Project: Impact of a Brief Online Values Intervention on the Mental Health of Mothers of Infants
Secondary ID [1] 305961 0
Nil known.
Universal Trial Number (UTN)
U1111-1272-4095
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Mental health among mothers of infants. 324560 0
Condition category
Condition code
Mental Health 322026 322026 0 0
Anxiety
Mental Health 322027 322027 0 0
Depression
Mental Health 322028 322028 0 0
Other mental health disorders
Reproductive Health and Childbirth 322093 322093 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete an online survey (requiring approximately 20-30 minutes) asking details about their birth and breastfeeding experiences and psychological symptoms (e.g., anxiety, depression, post-traumatic stress). Mothers in the intervention group will be given access to online resources as follows. The online resources comprise (i) a brief web-based informational video (eight minutes long), that begins with a psychoeducation component on values (a component of Acceptance and Commitment Therapy) and relevance to mothers of infants (from birth to 23 months), followed by simple strategies to prompt engagement with their values in daily life (e.g., encouraging participants to create a list of the activities they can do to live out their values while being a mum, and providing examples of different types of activities) ; (ii) an audio-guided values meditation (nine minutes long), which women will be encouraged to listen to and use to guide their own values meditation practice for short periods (e.g. 2-5 minutes) each day for the next month; 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. After eight weeks, all participants will complete a second online survey that is distinct from the first survey (requiring approximately 20 minutes) asking about their birth and breastfeeding experiences and psychological symptoms (e.g., anxiety, depression, post-traumatic stress). The second survey includes questions about the utility and acceptability of the values intervention resources and the website will monitor how far participants progress through the resources.
Intervention code [1] 322350 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 Time 2 questionnaire, 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] 329801 0
Depression (measured on the Depression, Anxiety, Stress Scale - 21)
Timepoint [1] 329801 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Primary outcome [2] 329802 0
Trauma symptoms (measured on The Impact of Event Scale - Revised)
Timepoint [2] 329802 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Primary outcome [3] 329803 0
Psychological flexibility (measured on the CompACT)
Timepoint [3] 329803 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Secondary outcome [1] 403881 0
Breastfeeding difficulties (measured on the Breastfeeding Experience Scale)
Timepoint [1] 403881 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Secondary outcome [2] 403882 0
Obsessive Compulsive Disorder Symptoms (measured on Florida Obsessive-Comulsive Inventory)
Timepoint [2] 403882 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Secondary outcome [3] 404046 0
Anxiety (measured on the DASS-21)
Timepoint [3] 404046 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Secondary outcome [4] 404047 0
Stress (measured on the DASS-21)
Timepoint [4] 404047 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)
Secondary outcome [5] 404048 0
Breastfeeding satisfaction (measured on the Maternal Breastfeeding Evaluation Scale)
Timepoint [5] 404048 0
Time 1 Survey (baseline)
Time 2 (8 weeks post-T1 survey)

Eligibility
Key inclusion criteria
Participants will be women aged 18 years and over, who have given birth to a child in the past two years, and are currently living in Australia or New Zealand.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age. Not living in Australia or New Zealand. Not having given birth to a child in the past two years.

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 will be concealed and the Qualtrics survey (on a computer) will randomly allocate participants.
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 survey 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
The study is a micro-randomised control trial due to trialling the values and committed action components of Acceptance Commitment Therapy (ACT), not the whole treatment intervention.
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 size of approximately 120 participants will be required. This sample size has been deemed reasonable given previous trials (Lennard, Mitchell, & Whittingham, 2020).

Descriptive statistics (i.e., mean, standard deviation, and percentages) will describe the demographic data and intervention participants’ use of the resources and summarise participants’ scores for study variables. One-way analysis of covariance (ANCOVA) models will explore differences between the intervention and waitlist-control groups in the outcome variables at post- intervention, controlling for pre-intervention scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
1/05/2022
Actual
Date of last data collection
Anticipated
31/07/2022
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310302 0
University
Name [1] 310302 0
The University of Queensland
Country [1] 310302 0
Australia
Primary sponsor type
Individual
Name
Koa Whittingham
Address
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 311419 0
None
Name [1] 311419 0
Address [1] 311419 0
Country [1] 311419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309965 0
The University of Queensland Human Research Ethics Committees (HRECs)
Ethics committee address [1] 309965 0
Ethics committee country [1] 309965 0
Australia
Date submitted for ethics approval [1] 309965 0
21/11/2021
Approval date [1] 309965 0
18/01/2022
Ethics approval number [1] 309965 0
2021/HE002529

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

Contacts
Principal investigator
Name 116010 0
Dr Koa Whittingham
Address 116010 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 116010 0
Australia
Phone 116010 0
+61 0409260428
Fax 116010 0
Email 116010 0
[email protected]
Contact person for public queries
Name 116011 0
Koa Whittingham
Address 116011 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 116011 0
Australia
Phone 116011 0
+61 0409260428
Fax 116011 0
Email 116011 0
[email protected]
Contact person for scientific queries
Name 116012 0
Koa Whittingham
Address 116012 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 116012 0
Australia
Phone 116012 0
+61 0409260428
Fax 116012 0
Email 116012 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14379Ethical approval  [email protected]
14380Informed consent form  [email protected]



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.