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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000970347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/07/2026
Date registered
Help: Date registered
7/08/2026
Date last updated
Help: Date last updated
7/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Evaluating training in Psychological First Aid for Birth Trauma for people working in maternity and perinatal care.
Scientific title
Evaluation of Psychological First Aid for Birth Trauma (PFA-B) training for people working in maternity or perinatal care: a randomised waitlist-controlled feasibility study evaluating trauma-informed responses, respectful woman-centred care and compassion fatigue.
Additional trial identifiers [1] 317988 0
Nil Known
Universal Trial Number (UTN)
U1111-1344-4039
Trial acronym
PFA-B
Related trial records

Health condition
Health condition(s) studied:
Birth Trauma 342985 0
Post-traumatic stress disorder (PTSD) 342986 0
Condition category
Condition code
Mental Health 339088 339088 0 0
Other mental health disorders
Reproductive Health and Childbirth 339183 339183 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Psychological First Aid for Birth Trauma (PFA-B) is an evidence-informed, trauma-informed training program designed to equip people working in maternity and perinatal care with the knowledge and practical skills to provide appropriate early psychological support following a difficult or traumatic birth.
The intervention comprises 4 hours of training delivered in a single 4 hour format or two 2-hour sessions. Training is delivered face-to-face or online via videoconferencing in a group format (approximately 10–20 participants).
The training is delivered by Dr Lucy Frankham, a Clinical Psychologist, Accredited EMDR Consultant, birth trauma researcher, and developer of PFA-B, with expertise in perinatal mental health and trauma-informed care.
Participants receive a PFA-B training manual and supporting clinical resources developed specifically for this study, based on current evidence and best-practice guidelines in trauma-informed care, Psychological First Aid, and perinatal mental health. Training includes didactic teaching, clinical examples, facilitated discussion, reflective activities, and practical communication strategies.
The curriculum consists of seven modules:
• Module 1: The evidence for Psychological First Aid for Birth Trauma and why routine psychological debriefing is no longer recommended.
• Module 2: Trauma, post-traumatic stress disorder (PTSD), and birth trauma.
• Module 3: Psychological First Aid for Birth Trauma (PFA-B), including the aims of Psychological First Aid, differences between debriefing and Psychological First Aid, and the principles and characteristics of PFA-B.
• Module 4: Core Skills A: active listening, self-regulation and emotional awareness, validation and empathy, strengths-based practice, and trauma-informed language and communication.
• Module 5: Core Skills B: facilitating appropriate support needs, cultural and contextual competence, perinatal mental health literacy, reproductive grief literacy, and reflective practice and peer support.
• Module 6: Additional clinical considerations when providing Psychological First Aid following birth trauma.
• Module 7: Skills practice through clinical scenarios and discussion.
The intervention is standardised using a facilitator manual, presentation slides and supporting resources. Training is delivered by the same facilitator using standardised materials to maximise intervention fidelity. The content is not individually tailored, although discussion and case examples may be adapted to participants' professional roles while maintaining the standardised curriculum.
Intervention code [1] 334863 0
Prevention
Intervention code [2] 334864 0
Behaviour
Description of the comparator or control
Participants randomised to the waitlist control group will not receive the Psychological First Aid for Birth Trauma (PFA-B) training during the initial study period. During this period, participants will continue with their usual professional education and clinical practice, with no additional training or intervention provided by the study. Outcome measures will be collected at the same time points as the intervention group (baseline, immediately following the intervention group's training, 4 weeks, and 6 months). Following completion of the comparison period, participants allocated to the waitlist control group will receive the identical PFA-B training program.
Control group
Active

Outcomes
Primary outcome [1] 346324 0
Change in self-reported use of Psychological First Aid for Birth Trauma (PFA-B) practices. This will be assessed as a composite outcome.
Timepoint [1] 346324 0
Baseline (pre-training), 4 weeks after baseline, and 6 months after baseline (primary timepoint) for both immediate and waitlist groups.
Primary outcome [2] 346325 0
Change in self-reported woman-centred care.
Timepoint [2] 346325 0
Baseline (pre-training), 4 weeks after baseline, and 6 months after baseline (primary timepoint) for both immediate and waitlist groups.
Primary outcome [3] 346326 0
Change in compassion fatigue symptoms.
Timepoint [3] 346326 0
Baseline (pre-training), 4 weeks after baseline, and 6 months after baseline (primary timepoint) for both immediate and waitlist groups.
Secondary outcome [1] 465415 0
Perceived relevance of the PFA-B training to the participant's role and setting.
Timepoint [1] 465415 0
Immediately following completion of the PFA-B training.
Secondary outcome [2] 465790 0
Self-reported confidence in supporting women following a difficult or distressing birth.
Timepoint [2] 465790 0
Immediately following completion of the PFA-B training.
Secondary outcome [3] 465791 0
Perceived ability to apply PFA-B in day-to-day practice.
Timepoint [3] 465791 0
Immediately following completion of the PFA-B training.
Secondary outcome [4] 465792 0
Perceived impact of the training on supporting women and families.
Timepoint [4] 465792 0
Immediately following completion of the PFA-B training.
Secondary outcome [5] 465793 0
Overall perceived helpfulness and usefulness of the PFA-B training.
Timepoint [5] 465793 0
Immediately following completion of the PFA-B training.

Eligibility
Key inclusion criteria
People aged 18 years and over who are currently working in maternity or perinatal care in Australia (including midwives, obstetricians, nurses, midwifery or nursing students, and allied health professionals)
Able to understand and communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Insufficient English language proficiency to complete the training and study questionnaires.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence
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
An a priori power analysis was conducted using G*Power 3.1.9.7 for a repeated-measures ANOVA examining the within–between interaction in a two-group, four-timepoint design. Assuming a medium effect size (*f* = 0.25), an alpha level of 0.05, power of 0.80, a correlation of 0.50 among repeated measurements, and a nonsphericity correction of 1.00, the analysis indicated that a minimum of 24 participants was required to detect a group-by-time interaction. Allowing for an anticipated attrition rate of 20%, a minimum recruitment sample of 30 participants was required. The planned recruitment target was set at 60 participants to accommodate higher-than-anticipated interest, improve the precision of effect estimates, and minimise the impact of participant attrition.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2026
Actual
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 322537 0
Self funded/Unfunded
Name [1] 322537 0
Country [1] 322537 0
Primary sponsor type
University
Name
University of New England
Address
Country
Australia
Secondary sponsor category [1] 325471 0
None
Name [1] 325471 0
Address [1] 325471 0
Country [1] 325471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321020 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 321020 0
Ethics committee country [1] 321020 0
Australia
Date submitted for ethics approval [1] 321020 0
03/03/2026
Approval date [1] 321020 0
24/04/2026
Ethics approval number [1] 321020 0
HE-2026-2969-5570

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

Contacts
Principal investigator
Name 152390 0
Dr Lucy Frankham
Address 152390 0
University of New England Armidale NSW 2351 Australia
Country 152390 0
Australia
Phone 152390 0
+61401523531
Fax 152390 0
Email 152390 0
[email protected]
Contact person for public queries
Name 152391 0
Lucy Frankham
Address 152391 0
University of New England Armidale NSW 2351 Australia
Country 152391 0
Australia
Phone 152391 0
+61401523531
Fax 152391 0
Email 152391 0
[email protected]
Contact person for scientific queries
Name 152392 0
Lucy Frankham
Address 152392 0
University of New England Armidale NSW 2351 Australia
Country 152392 0
Australia
Phone 152392 0
+61401523531
Fax 152392 0
Email 152392 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.