Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000858493p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2025
Date registered
8/08/2025
Date last updated
8/08/2025
Date data sharing statement initially provided
8/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a social support intervention for perinatal women.
Scientific title
A social support intervention for perinatal women: A pilot randomized controlled trial of the Bamboo Perinatal Program.
Secondary ID [1] 314690 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 337858 0
Perinatal anxiety 337859 0
Maternal-infant bonding 337860 0
Maternal parenting self-efficacy 337861 0
Anhedonia 338284 0
Loneliness 338285 0
Condition category
Condition code
Mental Health 334191 334191 0 0
Depression
Mental Health 334192 334192 0 0
Anxiety
Public Health 334193 334193 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention (Bamboo) arm will be provided with access to the Bamboo WebApp, where they will indicate whether they prefer to nominate a support person from their existing social network or request for the platform's algorithm to pair them with a volunteer support person (a community-dwelling mother). All support persons will be trained in social support provision via an online training video. The training addresses a variety of principles related to types of social support, types of coping strategies, rapport building, trust building, autonomy support, active listening, cultural sensitivity, and reinforcement of support boundaries. The training will last approximately 30 minutes. WebApp analytics will capture information on the amount of time each support person spent on the training platform. Support people will check a box to indicate that they have completed the training before progressing in the trial.

Once paired, participants and their supporters will be invited to engage in interactive activities on the Bamboo WebApp. These interactive activities include support expectation and planning exercises, discussion topic prompts, and text-based dialogue opportunities. These activities will be non-compulsory, and requirements for frequency and nature of pair-based interactions will not be specified. As such, engagement with the WebApp and volume of support interactions will vary between pairs. Supporters and participants will provide details (volume; nature) of support interactions at assessment times. WebApp analytics will also capture information on engagement with the online materials.

Each week, a prompt will be provided on the WebApp to encourage shared planning and support around mental/physical health and parenting. The activities will encourage positive discussions around a range of topics relating to self-care, infant care, and relationships. The WebApp's resource center (containing podcasts, articles and meditations) will be leveraged to identify key principles for healthy and adaptive parenting. These resources will be designed specifically for the trial and program. Participants will have indefinite access to the WebApp.

Participants will be eligible to join the trial at any point from the start of their third trimester of pregnancy (28 weeks) through to 1-month postpartum. Pair-matching will take place immediately after allocation to the intervention group, or as soon as possible thereafter. Participation in the trial will continue until 6-months postpartum (i.e., maximum trial duration of approximately 9 months).
Intervention code [1] 331344 0
Treatment: Other
Intervention code [2] 331345 0
Lifestyle
Intervention code [3] 331346 0
Behaviour
Comparator / control treatment
Participants in the control condition will have full access to existing professional services as well as unrestricted access to other community-based mental (and physical) health services (e.g., midwives, child health nurse, peer support groups).
Control group
Active

Outcomes
Primary outcome [1] 341944 0
Number of interactions between participants and support people
Timepoint [1] 341944 0
3-months postpartum and 6-months postpartum
Primary outcome [2] 341945 0
Social support from paired support person
Timepoint [2] 341945 0
3-months postpartum and 6-months postpartum
Primary outcome [3] 341946 0
Participants' satisfaction with WebApp resources
Timepoint [3] 341946 0
3-months postpartum and 6-months postpartum.
Secondary outcome [1] 449110 0
Depression
Timepoint [1] 449110 0
3-months postpartum and 6-months postpartum
Secondary outcome [2] 449111 0
Anxiety
Timepoint [2] 449111 0
3-months postpartum and 6-months postpartum.
Secondary outcome [3] 449112 0
Anhedonia
Timepoint [3] 449112 0
3-months postpartum and 6-months postpartum
Secondary outcome [4] 449113 0
Maternal parenting self-efficacy
Timepoint [4] 449113 0
3-months postpartum and 6-months postpartum
Secondary outcome [5] 449114 0
Maternal-infant bonding
Timepoint [5] 449114 0
3-months postpartum and 6-months postpartum.
Secondary outcome [6] 449115 0
Loneliness
Timepoint [6] 449115 0
3-months postpartum and 6-months postpartum
Secondary outcome [7] 450162 0
Volunteer perceptions of training videos
Timepoint [7] 450162 0
Immediately after training.
Secondary outcome [8] 450205 0
Volunteer benefits of caregiving
Timepoint [8] 450205 0
When the (paired) new mother is at 3 months postpartum and 6 months postpartum.
Secondary outcome [9] 450523 0
Feasibility
Timepoint [9] 450523 0
When participant reaches 6-months postpartum
Secondary outcome [10] 450524 0
Acceptability
Timepoint [10] 450524 0
When participant reaches 6-months postpartum
Secondary outcome [11] 450525 0
Preliminary effectiveness
Timepoint [11] 450525 0
When participant reaches 6-months postpartum

Eligibility
Key inclusion criteria
Participants will be Australian women (a) aged 18years or older, and (b) between the start of their third trimester of pregnancy and 1-month postpartum, and (c) residing in Northern Queensland, Australia.

Support people will be either nominated partners/family members/friends or volunteer mothers at least 1-year postpartum, aged 18 years or older. Assigned support people will be female and can be foster or adoptive mothers. Nominated support people can be any gender and are not required to be parents. All support people will reside in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for participants are: (a) women who require more intensive intervention due to current self-reported severe mental health disorder (psychosis, substance use dependence, prescribed anti-psychotic medication) or current overt indicators of family violence (self-reported intervention order; court case for family violence).

Exclusion criteria for support people are: (a) people with a self-reported history of criminal activity, and (b) people with self-reported current severe mental health disorder (psychosis, substance use dependence, prescribed anti-psychotic medication).

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)
Allocation concealment will be carried out via central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization. Stratification via time of entry into program (pregnancy v postpartum).
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
We aim to recruit a minimum sample of 150 (50 intervention; 50 support people; 50 control) in accordance with recommendations from Teresi et al., (2022).

Quantitative measures of feasibility and acceptability will be analysed using descriptive statistics (Means, SDs, or proportions) and correlations. Quantitative markers of preliminary effectiveness will be assessed according to effect sizes and confidence intervals in accordance with recommendations from Bell et al., (2018).

Qualitative analyses for feasibility, acceptability, and preliminary effectiveness will be designed and interpreted using an interpretivist approach to enquiry (Denzin & Lincoln, 2013). Transcribed interviews will be analysed using either reflexive thematic analysis (Braun & Clarke, 2019), or content analysis (Krippendorff, 2018), and with consideration of the Saunders, Evans, and Joshi (2005) framework. During the thematic analysis process, prior to finalising themes, members of the research team will assume the role of 'critical friends’ and offer feedback, challenge assumptions, and offer alternative interpretations on the initial coding and identification of themes (Sparkes & Smith, 2013). For interviews, the sample size will be guided by the principles of information power (Malterud et al., 2016) and the concept of pragmatic data saturation.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319239 0
Government body
Name [1] 319239 0
Queensland Mental Health Commission
Country [1] 319239 0
Australia
Funding source category [2] 319314 0
University
Name [2] 319314 0
James Cook University
Country [2] 319314 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Country
Australia
Secondary sponsor category [1] 321791 0
Government body
Name [1] 321791 0
Queensland Mental Health Commission
Address [1] 321791 0
Country [1] 321791 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317817 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 317817 0
Ethics committee country [1] 317817 0
Australia
Date submitted for ethics approval [1] 317817 0
01/05/2025
Approval date [1] 317817 0
Ethics approval number [1] 317817 0

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

Contacts
Principal investigator
Name 142250 0
Prof James Dimmock
Address 142250 0
Department of Psychology, 1 James Cook Drive, James Cook University, Douglas, Qld, 4811
Country 142250 0
Australia
Phone 142250 0
+61 07 4781 4625
Fax 142250 0
Email 142250 0
[email protected]
Contact person for public queries
Name 142251 0
James Dimmock
Address 142251 0
Department of Psychology, 1 James Cook Drive, James Cook University, Douglas, Qld, 4811
Country 142251 0
Australia
Phone 142251 0
+61 07 4781 4625
Fax 142251 0
Email 142251 0
[email protected]
Contact person for scientific queries
Name 142252 0
James Dimmock
Address 142252 0
Department of Psychology, 1 James Cook Drive, James Cook University, Douglas, Qld, 4811
Country 142252 0
Australia
Phone 142252 0
+61 07 4781 4625
Fax 142252 0
Email 142252 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.