ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12626000834358

Ethics application status

Approved

Date submitted

2/07/2026

Date registered

10/07/2026

Date last updated

10/07/2026

Date data sharing statement initially provided

10/07/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

A trial examining the feasibility, acceptability and efficacy of a psychologist-supported digital program for anxiety and risky drinking in mothers

Scientific title

A pilot randomised controlled trial examining the feasibility, acceptability and preliminary efficacy of a psychologist-supported digital program to reduce anxiety and risky drinking in mothers during the first 1000 days postpartum

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

U1111-1343-2753

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Risky drinking

Anxiety

Depression

Condition category

Condition code

Mental Health

Addiction

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention group will receive the 6-week psychologist-supported digital Healthy Mum, Healthy Bub program, comprised of:

i) THE DIGITAL PROGRAM

The digital program includes 6 sequential modules, which were co-developed with mothers with lived experience of anxiety and risky drinking during early motherhood. Each module includes a 45-minute audio component that follows the therapeutic journey of a fictional mother seeking support for anxiety and alcohol use during early motherhood. Through conversations with her therapist, evidence-based skills and strategies are introduced and demonstrated in a relatable, real-world context. Each audio component is accompanied by a corresponding digital Learn and Apply interactive worksheet (15-30 minutes to complete), which provides the opportunity for participants to consolidate, apply, and practice the skills introduced in the audio content in their own life.

The content of each module is founded on the evidence-based principles of Cognitive Behavioural Therapy (CBT) and motivational interviewing. The key content of each module (both audio and the Learn and Apply worksheet) is outlined below:
• Module 1: Psychoeducation about alcohol, anxiety and their interrelationship, understanding patterns and reasons for alcohol use, emotion regulation, and goal setting.
• Module 2: introduction to cognitive therapy and application to anxious thoughts (i.e., Challenging negative/unhelpful thoughts), understanding drinking triggers, and psychoeducation on child emotional wellbeing and connection.
• Module 3: Anticipating difficult moments and proactive problem-solving, CBT strategies for sticking to drinking limits and cognitive therapy targeting positive alcohol expectancies i.e. “Drinking Thinking”, alcohol moderation strategies including ‘Delay, Distract, Decide’ method, and introduction of Parent-Child Interaction Therapy skills.
• Module 4: Gradually facing fears through behavioural experiments assertive communication, managing lapses in drinking.
• Module 5: Developing supportive social connections, planning ahead for social drinking triggers, changes in identity.
• Module 6: Longer-term goal-setting, ongoing relapse prevention, and understanding drinking healthy vs. unhealthy drinking behaviours.

Modules will be released sequentially (one per week) regardless of whether the previous module has been completed. Participants will receive regular, automated emails and SMS notifying them when a new module becomes available, as well as reminders that encourage module completion by emphasising the key skills to be learnt each week.

At the beginning of each module, participants will be asked to complete a brief symptom “check-in” about how they have been feeling over the past week. This includes brief questions about symptoms of anxiety and low mood, any thoughts of suicide, and recent alcohol use. After each week, they will receive tailored feedback based on their responses within the Learn & Apply worksheet (generated using rule-based response algorithms), and suggestions to encourage practice of the skills in daily life. The program will also provide a summary of skills learnt in each module and a collection of additional resources addressing related areas of maternal health (e.g., postnatal depression, sleep difficulties, breastfeeding issues, maternal guilt).

ii) PSYCHOLOGICAL SUPPORT DELIVERED VIA TELEHEALTH

The intervention group will also have access to two telehealth sessions with a trained, registered psychologist on the team. Participants will be contacted by one of the psychologists during week 1 and week 4 of the intervention period for a brief (up to 30-minute) phone conversation. The primary purpose of these calls will be to support program engagement by providing motivational enhancement, troubleshooting any difficulties using the program, and guide participants in practising key skills from the modules. This may include working together to personalise behavioural experiments and cognitive therapy exercises, so they are relevant to the participant’s own goals and circumstances. The calls will be semi-structured in nature and will cover key topic areas; however, they will be flexible and tailored to individual need.

Any concerns about the participants’ or their child’s wellbeing, symptom deterioration, or indication of risk (e.g., active suicidal intent, interpersonal violence, emergence of new symptoms that are likely to interfere with treatment), detected within the module responses or during the telehealth sessions will be managed by the team psychologists, who will ensure appropriate referral to alternative alcohol/mental health/postnatal services. Clinical supervision will be provided during the intervention period by a board approved supervisor to discuss cases and risk assessment processes. For urgent or emergency support, participants will be encouraged to contact 24-hour crisis services and will be provided with a list of options.

Adherence will be measured by the percentage of mothers who complete the 6-module protocol and the percentage of mothers who complete the psychologist-delivered telehealth sessions.

Intervention code [1]

Treatment: Other

Description of the comparator or control

Participants in the control group will not receive any active intervention during the study period. They will be placed on a waitlist and offered the opportunity to receive the psychologist-supported digital Healthy Mum, Healthy Bub intervention following completion of the study period (4 months post-baseline). An extensive list of existing support services for postnatal, mental health, alcohol use, and parenting concerns will also be provided at the point of randomisation, and waitlist participants are able to access these (or other support services) without restriction.

At completion of the 4-month follow-up survey, participants will receive a notification via email that they can access the digital Healthy Mum, Healthy Bub intervention, with telehealth sessions delivered by a psychologist (who may be a provisional psychologist or clinical registrar).

Participants in the control group who access the Healthy Mum, Healthy Bub program following the waitlist period will complete an additional brief survey immediately post-intervention (2-months after being given access), to assess primary and key secondary outcomes.

Control group

Active

Outcomes

Primary outcome [1]

Feasibility of the program (engagement/adherence), measured by the % who complete the 6-module protocol (greater than or equal to 50% indicates feasibility)

Timepoint [1]

2-months post-baseline (intervention) & 2-months post-program access (waitlist control)

Primary outcome [2]

Feasibility of the program (engagement/adherence), measured by the number of telehealth support sessions (greater than or equal to 50% engaging in at least one session indicates feasibility)

Timepoint [2]

2-months post-baseline (intervention) & 2-months post-program access (waitlist control)

Primary outcome [3]

Adverse events attributable to the intervention or trial (less than or equal to 5% of participants indicates feasibility)

Timepoint [3]

2-months post-baseline

Secondary outcome [1]

Primary outcome. Feasibility of the research, measured by recruitment and enrolment rates (greater than or equal to 80% of target sample recruited within the planned recruitment window & greater than or equal to 50% who are eligible are enrolled into the trial indicates feasibility)

Timepoint [1]

2-months post-baseline

Secondary outcome [2]

Primary outcome. Feasibility of the research, measured by follow-up rates (greater than or equal to 60% complete at least one survey & greater than or equal to 70% complete primary outcomes in at least one survey indicates feasibility)

Timepoint [2]

2-months post-baseline (primary timepoint) and 4-months post-baseline

Secondary outcome [3]

Primary outcome. Feasibility of the research, measured by withdrawal rates (less than or equal to 10% indicates feasibility)

Timepoint [3]

2-months post-baseline (primary timepoint) and 4-months post-baseline

Secondary outcome [4]

Primary outcome. Acceptability of the program, measured by a customised treatment feedback survey developed by the research team (e.g. participants' perceptions of the relatability, usefulness, and clarity of key program components, including the worksheets, audio content, and personalised feedback.)

Timepoint [4]

2-months post-baseline (intervention) & 2-months post program access (waitlist control)

Secondary outcome [5]

Primary outcome. Acceptability of the program in terms of usability (a score of greater than or equal to 68 is considered above average and indicates acceptability)

Timepoint [5]

2-months post-baseline (intervention) & 2-months post-program access (waitlist control)

Secondary outcome [6]

Primary outcome. Acceptability of the program in terms of user satisfaction (a score of greater than or equal to 26 is considered moderate or greater satisfaction and indicates acceptability)

Timepoint [6]

2-months post-baseline (intervention) & 2-months post-program access (waitlist control)

Secondary outcome [7]

Risky alcohol use

Timepoint [7]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [8]

Alcohol consumption (total standard drinks in the past month and drinks per day)

Timepoint [8]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [9]

Frequency of binge-drinking (past month consumption of 5 or more standard drinks on one occasion)

Timepoint [9]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [10]

Anxiety symptom severity

Timepoint [10]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [11]

Depression symptom severity

Timepoint [11]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [12]

Mother-child attachment

Timepoint [12]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [13]

Parenting stress

Timepoint [13]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Secondary outcome [14]

Parenting self-efficacy

Timepoint [14]

Baseline, 2-months post-baseline, and 4-months post-baseline

Secondary outcome [15]

Maternal guilt

Timepoint [15]

Baseline, 2-months post-baseline, and 4-months post-baseline

Secondary outcome [16]

Family adjustment and relationships

Timepoint [16]

Baseline, 2-months post-baseline, and 4-months post-baseline

Secondary outcome [17]

Child social, emotional and behavioural development

Timepoint [17]

Baseline, 2-months post-baseline, and 4-months post-baseline Also assessed at 2-months post-program access for the waitlist control

Eligibility

Key inclusion criteria

ELIGIBILITY SCREENING SURVEY:
Inclusion criteria
• Female aged 18+ years
• Australian resident
• Biological mother of a child less than 3-years of age, for first or subsequent child
• Risky alcohol use in past month (AUDIT total score greater than or equal to 8),
• Experiencing clinically significant levels of anxiety in past 2 weeks (GAD-7 total score greater than or equal to 5).
• Has internet access
• Willing to provide contact details for a health professional
No exclusions are applied to participants concurrently receiving other psychological support (e.g., counselling, medication).

PSYCHOLOGIST RISK ASSESSMENT TELEHEATH CALL:
Inclusion criteria:
If all inclusion criteria and no exclusion criteria are met, participants may be eligible for the study. They will schedule a time for a registered psychologist from the research team to contact them via phone within the next few days to conduct a risk assessment and ensure the trial provides the right type of support for their needs.The purpose of the call will be to establish rapport with participants and to identify any potential clinical concerns that may not have been detected during the eligibility screening process (e.g., suicide and/or self-harm, severe alcohol withdrawal, interpersonal violence, child neglect). They will conduct the call in accordance with their professional and ethical obligations, including standard duty of care procedures. The psychologists will evaluate whether the person’s clinical concerns can be safely managed within the trial/program, and rate the level of risk as no/low, medium or high. Those at no or low risk may proceed to the baseline survey and trial participation. Those at medium or high rsk (described below) will be excluded from the trial.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Healthy volunteers

Key exclusion criteria

ELIGIBILITY SCREENING SURVEY:
Exclusion criteria:
• Severe alcohol-related risk, defined as an AUDIT score of 4 on items 3, 5, 8, and 9 (indicative of daily binge drinking, inability to fulfil usual responsibilities, and episodes of blackouts or memory loss, as well as alcohol-related injury to self or others within the past 12 months; total score across these items equals 16).
• Insufficient English literacy to understand the materials (score equals 2)
• Active symptoms of psychosis (Psychosis Screening Questionnaire total score greater than or equal to 3)
• Self-identified primary concern is related to trauma symptoms or substance use other than alcohol,
• Significant risk of alcohol withdrawal (indicated by a single yes/no item asking about past experience of severe alcohol withdrawal symptoms such as seizures, hallucinations, or high fever).
• Daily use of cannabis or unprescribed benzodiazepines or weekly use of psychostimulants (assessed by the National Institute on Drug Abuse quick screen).
• Diagnosis of a cognitive impairment or intellectual disability
• Currently pregnant

Following completion of the eligibility screening survey, participants who meet any of the exclusion criteria will be deemed ineligible and will receive a list of relevant referrals to alternative help-seeking options on screen, which will also be emailed to their nominated email address.

PSYCHOLOGIST RISK ASSESSMENT TELEHEATH CALL:
Exclusion criteria:
After completing the psychologist-delivered risk assessment call, a person’s clinical concerns and level of risk will be rated as no/low, medium or high. Those at medium or high risk will not be eligible to participate and will be excluded from the trial.
Those at medium risk will be advised to see a local health professional and/or referred more appropriate, intensive, or in person support services, a safety plan will be developed. Those at high risk will receive immediate action if there is imminent risk to the mother and/or child, a safety plan will be developed, and a mandatory report will be made to child protection services where required.

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)

Randomisation will occur immediately after the baseline survey has been completed.

To avoid bias, participants will be individually randomised on a 1:1 basis to either the intervention (n = 65) or control condition (n = 65) via the trial website, Allocation will be concealed via independent randomisation using computer software.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random allocation will be conducted independently through the trial website using an unpredictable, computer-generated randomisation sequence. This process removes the potential for researcher involvement and ensures the randomisation sequence (not the participant's group allocation) is concealed from all investigators and personnel (blinded).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Due to the pilot nature of the study, a formal power calculation was not conducted. This trial will determine the expected size of effect to inform the sample size of a future definitive RCT. Following guidelines for determining sample sizes for pilot studies, a sample size of 100 mothers was selected to provide sufficient data for the study’s primary aims assessing feasibility and acceptability. Allowing for 30% attrition, based on the team’s past digital RCTs, the total sample to be recruited will be n=130 (65 per arm).

Data will be collated and analysed using Stata Statistics/Data Analysis software (StataCorp). Descriptive analyses will be conducted to evaluate all feasibility and acceptability outcomes. These analyses will include the calculation of frequencies, proportions, cross tabulations, and mean/total scores. As this is a pilot trial, the primary purpose of these analyses is to characterise the feasibility of study procedures and the intervention, as well as the acceptability of the intervention.

Efficacy effects on outcome measures will be assessed using multi-level mixed effects analysis for repeated measures, a flexible and rigorous analytic approach for modelling change over time which uses all available data, accommodating missing responses and modelling response attrition using maximum likelihood estimation. Efficacy will be assessed by examining group-by-time interaction effects for each outcome variable across time (from baseline to 2- and 4-month follow-up). Cohen’s D within- and between-group effect sizes will be calculated for each timepoint based on the model-estimated coefficients and standard errors.

The primary analyses will be conducted within an intention-to-treat framework, including all randomised participants in the analysis regardless of completion of the intervention modules or loss to follow-up. A supplementary per-protocol analysis will be conducted among only participants who complete at least one of the six intervention modules (i.e., those who engaged with the program) and the 2-month follow-up assessment.

In addition to the primary intention-to-treat analyses, pooled pre–post effects will be examined across all participants who ultimately receive the intervention (i.e., both the intervention group and the waitlist group once they have been granted access to the program). These pooled analyses will use multilevel mixed-effects models to estimate overall within-person change from pre- to post-intervention, allowing the project team to evaluate the broader impact of the intervention across the full sample.

Additional covariates/mediators/moderators/outcomes that may be included in the analyses include: Psychological and pharmacological treatment (e.g. type of treatment and frequency), Readiness/motivation to change, as assessed via a readiness ruler (e.g., on a scale of 1 to 10, how ready are you to change your anxiety/drinking), Partners drinking (quantity and frequency), Maternal reasons for drinking (Maternal Drinking Motives Scale), Positive alcohol expectancies (Tension Reduction Alcohol Expectancies) and birth trauma (City Birth Trauma-SF, Brief Trauma Questionnaire). These will be measured at baseline, 2-months post-baseline and 4-months post-baseline, as well as 2-months after program access for the waitlist control group.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/08/2026

Actual

Date of last participant enrolment

Anticipated

30/04/2027

Actual

Date of last data collection

Anticipated

29/02/2028

Actual

Sample size

Target

130

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF) 2023 Childhood Mental Health Research Grant (#2036098).

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

from NHMRC 2024 Investigator Grants EL1 (#2034538)

Address [2]

Country [2]

Australia

Funding source category [3]

University

Name [3]

University of Sydney, PREMISE Next Generation NHMRC Centre of Research Excellence in Prevention of Mental Illness and Substance Use

Address [3]

Country [3]

Australia

Funding source category [4]

Government body

Name [4]

National Health and Medical Research Council Centre of Research Excellence in Fetal Alcohol Spectrum Disorder (APP2044613)

Address [4]

Country [4]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.sydney.edu.au/research/research-integrity-and-ethics.html

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/04/2026

Approval date [1]

01/07/2026

Ethics approval number [1]

2026/HE000270

Summary

Brief summary

We are conducting a research study to evaluate the feasibility and acceptability of 'Healthy Mum, Healthy Bub', a psychologist-supported digital support program designed for mothers who experience anxiety and who have concerns about their alcohol use during the first three years of motherhood. The program combines six weekly audio modules combined with two telehealth sessions delivered by a registered psychologist.

We also want to test whether participation in the Healthy Mum, Healthy Bub program leads to greater reductions in anxiety and risky alcohol use, compared to a waitlist control group. Those assigned to the waitlist group will be offered access to the program and psychologist support after completion of the trial period (i.e., 4-month follow-up).

Trial website

https://healthymumhealthybub.org.au/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Katrina Prior

Address

The Matilda Centre Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 8627 9032

Fax

[email protected]

Contact person for public queries

Name

Katrina Prior

Address

The Matilda Centre Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 8627 9032

Fax

[email protected]

Contact person for scientific queries

Name

Katrina Prior

Address

The Matilda Centre Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 8627 9032

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Ethics considerations given the sensitive nature of the data. All data will be de-identified and aggregated at the group level. IPD will not be available.

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Informed consent form		https://healthymumhealthybub.org.au/consent/		Once the trial is actively recruiting, this link w... [More Details]
Ethical approval					HREC decision notification letter_approval.pdf

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.

Trial Review

Documents added manually

Documents added automatically