None listed
Conditions
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).
Interventions
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
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed