Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001348448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/11/2025
Date registered
Help: Date registered
2/12/2025
Date last updated
Help: Date last updated
15/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
2/12/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Preparing for motherhood: a one-day group antenatal workshop to support postpartum adjustment for first-time mothers.
Scientific title
Using the Multiphase Optimisation Strategy to develop a one-day antenatal group intervention for first-time mothers targeting postpartum psychological adjustment: a feasibility and acceptability pilot study
Additional trial identifiers [1] 315949 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Postpartum psychological maladjustment 339780 0
Postpartum Depression 339909 0
Postpartum Anxiety 339910 0
Postpartum Stress 339911 0
Condition category
Condition code
Mental Health 336010 336010 0 0
Depression
Mental Health 336011 336011 0 0
Anxiety
Mental Health 336012 336012 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 336013 336013 0 0
Health promotion/education
Reproductive Health and Childbirth 336140 336140 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Brief Name: The First 90 Days: a one-day group antenatal group workshop to support the psychological adjustment to motherhood.

Materials:
-A scripted facilitator manual
-Participant workbooks that included summaries of core workshop content, worksheets completed during the workshop related to ACT processes, self-compassion, and parental self-efficacy (e.g. mindfulness prompts, values identification worksheets, psychoeducation material on bonding and attachment, support seeking resources).
-A take-home A3 fourth trimester coping plan (populated by participants throughout the workshop with personally chosen adaptive coping strategies and support resources).
-Powerpoint slides with visual representation of key content
-Audio recordings of quotes from mothers from qualitative research (actor voiceovers)
-Props including ACT finger traps to represent creative hopelessnesss and surrender, self-compassion flash cards.

Procedures:
-ACT-consistent group facilitation (collaborative, compassionate, non-judgmental stance) with open group discussion, experiential exercises, and brief psychoeducation didactic information.
-The manualised intervention included 5 modules to be completed over the course of 5 hours (with ~1 hrs of breaks include taken as needed to ensure participant comfort). The structure is as follows: Introduction: group safety and security, concept of the fourth trimester and establishing fourth trimester expectations, introduction to the approach (ACT based, self-compassion, self-as expert, head-heart-hands mindfulness approach). Module 1: relationship with self including identifying mothering values, strategies to support psychological flexibility and self compassion, and building self-efficacy. Module 2: Relationship with baby focused on psychoeducation around bonding and attachment, attunement and mindful parenting, emotional regulation, acceptance, and building parental self-efficacy. Module 3: practical tools focused on finalising personalised coping and social support plans. Conclusion: Summary.

Who provided the intervention:
The facilitator is an AHPRA-registered clinical psychologist experienced in ACT, compassion-focused therapy, perinatal mental health, and group facilitation.

Mode and format:
-Small groups of 3-6 participants (3 cohorts)
-Facilitator guided via scripted manual but with open group discussions and individual workbooks and coping plans completed during the workshop.

Strategies for monitoring adherence:
a) Participant adherence:
-Session attendance checklist
b) Fidelity adherence:
-Fidelity checklist - summarised whether each planned component delivered, session dose and timing, adaptations, overall adequacy of delivery .
-Facilitator log - qualitative reflections on delivery, adaptations, group dynamics, engagement/challenges/deviations.

Number, Schedule, and Dose:
A single session 5 hour workshop (~4 hours of content once breaks considered) attended during participants' third trimesters (28 weeks - 40 weeks gestation) of pregnancy. Workshop scheduled when >3 participants identified as eligible.

Location:
The workshop was held at a private midwifery centre group room with AV access. Sunshine Coast, Queensland.
Intervention code [1] 332566 0
Behaviour
Intervention code [2] 332567 0
Prevention
Intervention code [3] 332568 0
Treatment: Other
Description of the comparator or control
Participant receive routine antenatal care without restrictions on access to any services or materials. No one-day antenatal workshop provided.
Control group
Active

Outcomes
Primary outcome [1] 343553 0
Feasibility. This will be assessed as a composite outcome.
Timepoint [1] 343553 0
Recruitment, consent, reach, screening, eligibility, randomisation: end of recruitment period. Attendance (adherence): recorded day of workshop Retention and data completeness: (baseline T1, immediately post workshop T2, ~6 weeks post partum T3, ~12 weeks postpartum T4). Fidelity: facilitator logs/checklist/competence rating/timing tolerance completed after each workshop (3 cohorts). Safety: monitored continuously. Will be summarised at end of data collection.
Primary outcome [2] 343554 0
Acceptability. This will be assessed as a composite outcome.
Timepoint [2] 343554 0
-Aim and 6 open box questions completed immediately post intervention on the day (pen and paper). -Long qualitative questions completed at T4 (~12 weeks postpartum).
Secondary outcome [1] 454744 0
Depression
Timepoint [1] 454744 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [2] 454745 0
Adaptive Coping
Timepoint [2] 454745 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [3] 454746 0
Psychological Flexibility
Timepoint [3] 454746 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [4] 454747 0
Parental Self-Efficacy
Timepoint [4] 454747 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [5] 454748 0
Self-Compassion
Timepoint [5] 454748 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [6] 454749 0
Bonding and attachment. This will be assessed assessed as a composite outcome.
Timepoint [6] 454749 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [7] 455266 0
Anxiety
Timepoint [7] 455266 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.
Secondary outcome [8] 455267 0
Stress
Timepoint [8] 455267 0
baseline T1, immediately post-worksop T2, ~6 weeks postpartum T3, ~12 weeks postpartum T4.

Eligibility
Key inclusion criteria
-18 years old or over
-No clinical mental health presentation or significant clinical history in the past 12 months (subclinical scores on the prodromal questionnaire 16 and mental health inventory 5 at screening).
-Mother pregnant with first living child
-English speaking
-Available to attend a one day workshop if randomised to intervention group
-In third trimester of pregnancy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
Yes
Key exclusion criteria
-Clinical threshold mental health symptoms, diagnosis in the past 12 months, or significant clinical mental health history.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation with 1:1 allocation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/05/2025
Date of last participant enrolment
Anticipated
Actual
4/10/2025
Date of last data collection
Anticipated
14/04/2026
Actual
10/04/2026
Sample size
Target
27
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 320559 0
University
Name [1] 320559 0
University of the Sunshine Coast (internal HDR research budget)
Country [1] 320559 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
Country
Australia
Secondary sponsor category [1] 323174 0
None
Name [1] 323174 0
Address [1] 323174 0
Country [1] 323174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319100 0
University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [1] 319100 0
Ethics committee country [1] 319100 0
Australia
Date submitted for ethics approval [1] 319100 0
14/02/2025
Approval date [1] 319100 0
14/03/2025
Ethics approval number [1] 319100 0
S252059

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

Contacts
Principal investigator
Name 146254 0
Mrs Christy Manning
Address 146254 0
UniSC, School of Health, 90 Sippy Downs Drive, Sippy Downs Queensland, 4556.
Country 146254 0
Australia
Phone 146254 0
+61 422146507
Fax 146254 0
Email 146254 0
[email protected]
Contact person for public queries
Name 146255 0
Christy Manning
Address 146255 0
UniSC, School of Health, 90 Sippy Downs Drive, Sippy Downs Queensland, 4556.
Country 146255 0
Australia
Phone 146255 0
+61 422146507
Fax 146255 0
Email 146255 0
[email protected]
Contact person for scientific queries
Name 146256 0
Christy Manning
Address 146256 0
UniSC, School of Health, 90 Sippy Downs Drive, Sippy Downs Queensland, 4556.
Country 146256 0
Australia
Phone 146256 0
+61 422146507
Fax 146256 0
Email 146256 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.