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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000699369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
21/05/2026
Date registered
Help: Date registered
11/06/2026
Date last updated
Help: Date last updated
25/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
eHUGS: A Randomised Controlled Trial of an Online Program to Support Infant Mental Health and Mother–Infant Relationships Following Postnatal Depression
Scientific title
Evaluating an e-Intervention to Mitigate the Impact of Postnatal Depression on Infant Mental Health: A Randomised Controlled Trial
Additional trial identifiers [1] 317343 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 342002 0
Condition category
Condition code
Mental Health 338084 338084 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
eHUGS online intervention:
Participants allocated to the intervention will receive access to the eHUGS online program, a primarily self-guided digital intervention with minimal human support. eHUGS is designed to target modifiable aspects of the mother–infant relationship in mothers who have experienced postnatal depression, including maternal communication, observation, responsiveness, and cognitive distortions.

The program consists of four sequential online modules, completed over four weeks (one module per week). Module 1 (Let's Play!) uses guided activities and play to promote connection and enjoyment of parenting. Module 2 (Observing Baby) focuses on observing and responding to infant cues. Module 3 (Your Feelings) explores how past experiences and thoughts and feelings can interfere with parenting and mother-infant interactions. Module 4 (Putting it all together) reinforces key messages for enhancing mother-infant interactions. Each module takes approximately 30 minutes to complete and includes psychoeducation delivered through text and video, as well as guided activities undertaken with the infant, promoting interactions known to strengthen the mother–infant relationship. These activities are play-based and provide a natural context for reestablishing interactions. Participants are encouraged to complete all modules (see below).

Modules are released weekly to support progressive skill development. In addition, brief supplementary content related to module topics and program use is available at any time via the eHUGS library (each page requires less than 5 minutes to read).

Participants will receive automated SMS messages (10 messages over four weeks; approximately 2–3 per week) to reinforce key content and encourage practice. Following randomisation, participants will receive a single engagement phone call (20–30 minutes) to introduce the eHUGS program, support initial use, and answer any questions.

Program usage data will be collected unobtrusively via website analytics and database tracking, including number and duration of logins and modules completed.
Intervention code [1] 334134 0
Treatment: Other
Description of the comparator or control
Waitlist control:
Participants allocated to the waitlist control will receive links via SMS to publicly available online parenting resources, including Raising Children Network, Perinatal Anxiety and Depression Australia (PANDA), Karitane, Parenting SA, Kidsafe, Parentline Pregnancy and Babies Information Hub. Messages will be sent weekly over a 4-week period (6 messages over four weeks; approximately 1–2 messages per week).

The resources provide general parenting educational information and do not include alternative treatment programs.

Following randomisation, participants will receive a single engagement phone call to inform them of their group allocation and answer any questions about participation.

Following completion of follow-up assessments, participants in the waitlist control condition will be offered access to the eHUGS program.
Control group
Active

Outcomes
Primary outcome [1] 345481 0
Infant social–emotional functioning
Timepoint [1] 345481 0
Baseline, post-intervention (4-weeks post-randomisation), 3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [1] 461820 0
Mother–infant relationship functioning
Timepoint [1] 461820 0
Baseline, post-intervention (4-weeks post-randomisation), 3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [2] 461821 0
Perceptions of child temperament and behaviour
Timepoint [2] 461821 0
Baseline, post-intervention (4-weeks post-randomisation), 3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [3] 461822 0
Parenting self-efficacy
Timepoint [3] 461822 0
Baseline, post-intervention (4-weeks post-randomisation), 3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [4] 461823 0
Program skills and satisfaction
Timepoint [4] 461823 0
Post-intervention (4 weeks post-randomisation)
Secondary outcome [5] 461881 0
Program usage
Timepoint [5] 461881 0
3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [6] 461882 0
Maternal depression
Timepoint [6] 461882 0
Post-intervention (4-weeks post-randomisation) and 3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [7] 462666 0
Maternal anxiety
Timepoint [7] 462666 0
Post-intervention (4-weeks post-randomisation) and 3 months post-intervention (16 weeks post-randomisation)
Secondary outcome [8] 462667 0
Maternal stress
Timepoint [8] 462667 0
Post-intervention (4-weeks post-randomisation) and 3 months post-intervention (16 weeks post-randomisation)

Eligibility
Key inclusion criteria
a) Women aged >=18 years.
b) Infants aged <=12 months.
c) Has started or completed treatment or support for postnatal low mood or depression since the birth of their most recent baby (counselling, psychological therapy, support group, medication, or an online program).
Minimum age
1 Days
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
a) Women screening positive for low prevalence psychiatric disorders (psychotic or bipolar disorders, substance use).
b) Scores >=20 on the Patient Health Questionnaire (PHQ-9) at baseline, indicating extremely severe depression.
c) Moderate to high suicide risk at baseline (score >=2 on the Edinburgh Postnatal Depression Scale [EPDS] item 10 or PHQ-9 item 9).
d) Significant difficulties with English literacy.

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 concealment will be ensured via central, computer-automated administration, with group assignment concealed from investigators and participants until the point of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An automated permuted blocks (block sizes of 2, 4, and 6) allocation schedule will be pregenerated by a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is powered (.8) to reliably identify clinically meaningful medium effects of f = 0.25 at post-intervention with an alpha level of 0.05 using analysis of covariance; this requires recruitment of 126 participants.

Analyses will be conducted in accordance with CONSORT guidelines using an intention-to-treat approach, with analysts blinded to treatment allocation. Primary analyses will be undertaken using both observed data and datasets derived using imputation to address missing data.

The primary outcome (ASQ:SE) will be analysed using linear mixed-effects models, incorporating repeated measures over time and comparing intervention and control groups. The model will estimate differences in trajectories over time and group differences at the primary endpoint (3 months post-intervention). Models may be extended to include relevant covariates (e.g., maternal anxiety, parenting self-efficacy) where appropriate.

Secondary outcomes will be analysed using mixed-effects modelling approaches consistent with the primary analysis

Clinical significance will be assessed using established methods based on the approach described by Jacobson and Truax (1991).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321914 0
Charities/Societies/Foundations
Name [1] 321914 0
Australian Rotary Health
Country [1] 321914 0
Australia
Primary sponsor type
Other
Name
Parent-Infant Research Institute
Address
Country
Australia
Secondary sponsor category [1] 324776 0
None
Name [1] 324776 0
Address [1] 324776 0
Country [1] 324776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320448 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 320448 0
Ethics committee country [1] 320448 0
Australia
Date submitted for ethics approval [1] 320448 0
Approval date [1] 320448 0
10/03/2026
Ethics approval number [1] 320448 0
HREC/31097/Austin-2025

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

Contacts
Principal investigator
Name 150522 0
Dr Charlene Holt
Address 150522 0
Parent-Infant Research Institute, Heidelberg Repatriation Hospital, Centaur Building, Level 1 300 Waterdale Road, (PO Box 5444) Heidelberg West, Vic 3081
Country 150522 0
Australia
Phone 150522 0
+61 3 9496 4496
Fax 150522 0
Email 150522 0
[email protected]
Contact person for public queries
Name 150523 0
Dr Charlene Holt
Address 150523 0
Parent-Infant Research Institute, Heidelberg Repatriation Hospital, Centaur Building, Level 1 300 Waterdale Road, (PO Box 5444) Heidelberg West, Vic 3081
Country 150523 0
Australia
Phone 150523 0
+61 3 9496 4496
Fax 150523 0
Email 150523 0
[email protected]
Contact person for scientific queries
Name 150524 0
Dr Charlene Holt
Address 150524 0
Parent-Infant Research Institute, Heidelberg Repatriation Hospital, Centaur Building, Level 1 300 Waterdale Road, (PO Box 5444) Heidelberg West, Vic 3081
Country 150524 0
Australia
Phone 150524 0
+61 3 9496 4496
Fax 150524 0
Email 150524 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Health economic analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected] OR [email protected]

Are there extra considerations when requesting access to 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.