Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000373471p
Ethics application status
Submitted, not yet approved
Date submitted
1/04/2025
Date registered
28/04/2025
Date last updated
28/04/2025
Date data sharing statement initially provided
28/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Group interventions for parent-child dyads impacted by parental disturbances of self organisation: A Bayesian Adaptive trial.
Scientific title
Comparing group intervention outcomes for parental mental health and the parent-child relationship for parent-child dyads impacted by parental disturbances of self organisation (DSO): A Bayesian Adaptive Trial..
Secondary ID [1] 313525 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex Posttraumatic Stress Disorder 336001 0
Borderline Personality Disorder 336999 0
Disturbances of Self Organisation 337000 0
Depression 337001 0
Anxiety 337002 0
Posttraumatic stress disorder 337003 0
Emotional Dysregulation 337004 0
Parent-child relationship difficulties 337005 0
Attachment difficulties 337006 0
Condition category
Condition code
Mental Health 332583 332583 0 0
Psychosis and personality disorders
Mental Health 332584 332584 0 0
Depression
Mental Health 332585 332585 0 0
Anxiety
Mental Health 333331 333331 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either
1, Postnatal Depression and Anxiety group (control) OR
2. Parent-Child Nurture and Regulation group (treatment)

The treatment group is a 10-week x 2.5-hour community-based group intervention which is provided face to face at Tresillian sites. It is based on dialectical behaviour therapy (DBT, biosocial theory), trauma theory and attachment theory. The group can accept up to 8 participants, and it is facilitated by two group facilitators.

The intervention focuses on reducing parental disturbances of self organisation and improving the parent-child relationship by providing psychoeducation on the trauma response (trauma theory), and skills training in mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness (DBT skills). In addition it focusses on building mindful awareness and responsiveness to the child's cues (DBT and attachment theory).

The group is provided by tertiary level educated mental health clinicians trained in psychology, social work, occupational therapy or mental health nursing.
Further facilitators have undergone a two day fidelity training workshop to ensure standardisation of the intervention across sites. The facilitators will receive fortnightly supervision for one hour to support their clinical practice.

Each participant receives a pre group assessment before being accepted into the group. At this assessment prospective participants are provided information on the trauma response and biosocial theory. The participant is asked to consider what skills they think they need to improve, and what behaviours they wish to reduce. Their commitment to changing behaviour is emphasised as key to the intervention.

Each participant receives a manual at the first group session which outlines each week’s content as per below. Each group session begins with a mindfulness exercise, then moves to a review of prior skills learnt, and finishes with teaching new skills. The manual has been designed specifically for this study.

• Week 1: Introduction to Group, Mindfulness, the trauma response and Distress Tolerance
• Week 2: Distress Tolerance continued
• Week 3: Mindfulness review and Introduction to Emotion Regulation
• Week 4 - 6: Emotion Regulation continued
• Week 7: Mindfulness review and Introduction to Interpersonal Effectiveness
• Week 8 - 9: Interpersonal Effectiveness
• Week 10: Mindfulness, Reflections and Final Skills

The participants are encouraged to practise skills taught between sessions and to share their experience in their new learning at the beginning of the following week's session.
Intervention code [1] 330122 0
Treatment: Other
Intervention code [2] 330204 0
Behaviour
Comparator / control treatment
Participants will be randomised to either the Parent-Child Nurture and Regulation group, or the Postnatal Depression and Anxiety group. The Postnatal Depression and Anxiety group is the control group, whilst the former is the intervention.

The Postnatal Depression and Anxiety group is an 8 week outpatient 2 hour group for parent-child dyads where the parent is struggling with mental health concerns. It has an additional partner's night and reunion session. It is based on cognitive behaviour therapy, attachment theory and narrative therapy and utilises a strengths based perspective to support participant's confidence.

In routine practice, the PNDA group is facilitated by two trained clinicians - a mental health clinician and a trained child and family health nurse. The mental health clinician will have tertiary education in a mental health related discipline such as psychology or social work. Facilitators can only provide the intervention when they have attended a two day training program for the group.

Interested participants register on their interest on the website. They are then contacted to for a pre-group interview, where they receive a mental health assessment and review of the group to see if it is suitable for them and they can attend.

The participants attend the group weekly face to face at the Tresillian site they registered for. Free childcare is available on site. Each weekly session lasts 2 hours. Their partners can attend a partners' only session about halfway through the group - this occurs in the evening. The group covers the following topics each week:

• Session 1-Overview of postnatal mental health disorders and treatment options
• Session 2-Mood Management
• Session 3-What we need and effective communication of these needs
• Session 4-Journey of the Self
• Session 5-Life Journey
• Session 6-Reconnecting to my child’s partner
• Session 7-Parent-Infant Relationship
• Session 8-Change is Recovery
• Partner Session - participants do not attend this
• Reunion Session occurs approximately a month after the final group session.

The adaptive design will use response-adaptive randomization to the treatment and control arms, where the probability of assignment to the treatment group depends on the probability that the treatment is superior to the control.

The chosen randomization protocol, generalized Thompson sampling, balances the benefits to current trial participants with information gain to benefit future treatment users. When early evidence in favour of the treatment or the control is strong, response-adaptive randomization uses this information to benefit the participants, while continuing to test the early evidence with additional data.

In practice, changing the randomization probabilities will be implemented in one of three ways

• Allocating more or fewer seats to study participants in a treatment or control group
• Expanding or contracting the number of participants in each group (6-10 participants per group is considered optimal)
• Adding or removing groups. Adding a PCNR group would need a 2-3 month lead time to secure facilitators and facilities.
Control group
Active

Outcomes
Primary outcome [1] 340092 0
Change in Disturbances of Self Organisation score
Timepoint [1] 340092 0
This outcome will be measured at the initial group session, the final group session and at 6 weeks follow up.
Primary outcome [2] 340093 0
Change in parental empathy score
Timepoint [2] 340093 0
The Composite Caregivinng Questionnaire scores will be assessed at the beginning of the group, the final session of the group and at 6 weeks follow up
Primary outcome [3] 341038 0
Change in parental hostility score
Timepoint [3] 341038 0
The Composite Caregivinng Questionnaire scores will be assessed at the beginning of the group, the final session of the group and at 6 weeks follow up
Secondary outcome [1] 442634 0
Change in depression scores
Timepoint [1] 442634 0
This will be assessed at the first group session, the final group session and at 6 weeks follow up
Secondary outcome [2] 443430 0
Change in posttraumatic stress disorder (PTSD) scores
Timepoint [2] 443430 0
This will be assessed at the first and last group session and at 6 weeks follow up.
Secondary outcome [3] 443431 0
Complex Posttraumatic stress disorder (cPTSD) status and scores
Timepoint [3] 443431 0
This will be measured at the first and last group session and at 6 weeks follow up
Secondary outcome [4] 443432 0
Changes in Borderline Personality Disorder symptoms and diagnosis
Timepoint [4] 443432 0
This will be measured at the first and last group session and at 6 weeks follow up
Secondary outcome [5] 443433 0
Changes in emotion regulation
Timepoint [5] 443433 0
This will be measured at the first and last group session and at 6 weeks follow up.
Secondary outcome [6] 443434 0
Parental adverse childhood experiences.
Timepoint [6] 443434 0
The parent's Adverse Childhood Experiences scale score will be measured approximately two weeks before the first group session.
Secondary outcome [7] 445405 0
Group participants' perception of the feasibility of the intervention.
Timepoint [7] 445405 0
This will be tested at the final group session and at 6 weeks follow up. Additionally, for those who opt in to the brief interview, this will occur within a month of completing the final group session.
Secondary outcome [8] 445912 0
Group participants' perception of the acceptability of the group interventions.
Timepoint [8] 445912 0
Free text responses will be collected in the data collection after the final group session and at 6 weeks follow up. Interview transcripts will be collected via opt in interviews within a month of the final group session.
Secondary outcome [9] 446482 0
Change in parent-child contingency score
Timepoint [9] 446482 0
The NCAST contingency score will be collected two weeks before the first group session, and two weeks after the final group session
Secondary outcome [10] 446483 0
Change in anxiety score
Timepoint [10] 446483 0
This will be measured at the first and last group session and at 6 weeks follow up

Eligibility
Key inclusion criteria
Parents who:
1. Are the legal guardian of a child aged 0 – 3 years
2. Are seeking group intervention at Tresillian due to mental health concerns
3. Screen positively to difficulties managing emotions and/or behaviour
4. Have willingness and capacity to provide informed consent
5. Have willingness and capacity to participate and comply with the study requirements
6. Are 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents who:
1. Cannot commit to working towards safety for themselves or others
2. Do not endorse difficulties with emotion regulation or impulsive behaviour
3. Are not able to commit to attending the group regularly
4. Are not able to communicate easily in English

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)
Yes. The personnel who recruit to the trial will not be aware at the time of recruitment or consent of which group the participant will be allocated to.

Once someone has enrolled and consented to the trial randomisation will occur. Randomization will be conducted using stratified block randomization. Participants will be divided into strata based on location, with the study involving three Tresillian locations. These locations differ significantly in the socio-economic profiles of their surrounding communities, which could influence the characteristics of potential participants. Stratified randomization will ensure a balanced representation of socio-economic backgrounds across the treatment and control arms. Within each stratum, participants will be randomized in blocks of four to twelve, maintaining balance within each location.

The randomisation sequence will not be fully disclosed to the research personnel who are recruiting and consenting participants to the trial and they will not be aware of the next allocation seat whilst discussing the research with a potential new participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes. Randomisation will occur via block randomisation stratified by location of the intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Bayesian Adaptive Trial

The study will be structured as a Bayesian Adaptive Trial (BAT). The Bayesian methodology provides a direct measure of the probability that a hypothesis H is true given the data, which we denote by Pr(H|D), where D denotes some data.
We consider the primary hypothesis that:
• H: the change in the mean DSO between the treatment and control is greater than 0.

Sample Size:

The study expects to recruit approximately 200 participants across treatment and control arms.

BATs can deliver valuable insights for a relative effect (treatment vs. control) of any size. Power analysis is, strictly speaking, not applicable in the Bayesian setting. Bayesian analysis can help guide decision-making based on any number of available data points. As an example, an ``inconclusive'' result that a novel treatment has a 50% chance of performing better than an established treatment is still valuable. In this case, it may be worth investing in further testing and/or refining the novel treatment since the marginal returns of investing in optimizing an established treatment are likely to be lower.

Statistical analysis plan:

The study will recruit participants in 7 - 8 sequential cohorts. Interim analyses will be conducted at the end of treatment for every two cohorts. These analyses will use accumulated data to update the probability that the treatment arm is more effective than the control arm.

At each interim analysis at time t the probability Pr(H|Dt) will be updated for the accumulated trial data up to time t. Final study analysis will be the estimate of the probability Pr(H|DT ) at the end of the study at time T.

Based on the results of interim analyses, the following pre-planned trial adaptations may be made:
• Response adaptive randomization
• Stopping for toxicity or futility
• Estimating location/SES effects once sufficient data is collected
• Adding treatment variations once efficacy sufficiently established

Although initially structured as a two-arm trial, the study aligns with the ethos of a platform trial. Platform trials focus on a condition or disease rather than a specific intervention, leveraging accumulating trial data to adaptively assign participants to treatments most likely to benefit them. Treatments found to be ineffective or harmful can be replaced, while highly effective interventions may become the new standard. Consequently, while the study's current duration is 2.5 years, with additional funding, it has the potential to continue indefinitely, focusing on identifying the most effective treatments within settings like Tresillian.

Interim Analysis:

Each interim analysis will include several parts:
• Descriptive statistics
• Examination of the distributions of observed DSO, CCQ Hostility, CCQ Empathy, NCAST PCI-T Contingency scores; tests of normality
• Examination of data for evidence of potential toxicity. The study will define toxicity as over 40% of participants in a treatment arm experiencing a deterioration in DSO scores.
• Updating the posterior probability that the effect of the treatment on DSO is greater than that of the control, given all the available data. This analysis will be used for updating response-adaptive randomization probabilities.
• Updating posterior predictive probability that the effect of treatment on DSO will be greater than that of the control, once all planned trial data are collected. This analysis will be used to test for futility defined as less than 10% probability at the end of the study that the treatment is more effective than the control at reducing DSO symptoms.
• Updating posterior predictive probability that the effect of treatment on DSO will be greater than that of the control separately for each participating location, once all planned trial data are collected. This analysis will be used to test for futility defined as less than 10% probability at the end of the study that the treatment is more effective than the control at reducing DSO symptoms.
• Updating the posterior probability that the effect of the treatment on CCQ Hostility and Empathy and NCAST PCI-T Contingency scores is greater than that of the control, given all the available data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
15/09/2027
Actual
Date of last data collection
Anticipated
18/02/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27380 0
Tresillian Nepean Family Care Centre - Kingswood
Recruitment hospital [2] 27381 0
Tresillian Wollstonecraft Family Care Centre - Wollstonecraft
Recruitment hospital [3] 27382 0
Tresillian Family Care Centre - Belmore - Belmore
Recruitment postcode(s) [1] 43478 0
2747 - Kingswood
Recruitment postcode(s) [2] 43479 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 43480 0
2192 - Belmore

Funding & Sponsors
Funding source category [1] 317977 0
Charities/Societies/Foundations
Name [1] 317977 0
Paul Ramsay Foundation
Country [1] 317977 0
Australia
Funding source category [2] 317992 0
Charities/Societies/Foundations
Name [2] 317992 0
Tresillian Family Care Centres
Country [2] 317992 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Tresillian Family Care Centres
Address
Country
Australia
Secondary sponsor category [1] 320317 0
Charities/Societies/Foundations
Name [1] 320317 0
Paul Ramsay Foundation
Address [1] 320317 0
Country [1] 320317 0
Australia
Other collaborator category [1] 283321 0
University
Name [1] 283321 0
University of Technology Sydney
Address [1] 283321 0
Country [1] 283321 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316648 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316648 0
Ethics committee country [1] 316648 0
Australia
Date submitted for ethics approval [1] 316648 0
27/01/2025
Approval date [1] 316648 0
Ethics approval number [1] 316648 0

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

Contacts
Principal investigator
Name 138530 0
Dr Alice Dwyer
Address 138530 0
Tresillian Family Care Centres, Mc Kenzie Street, Belmore 2192 NSW
Country 138530 0
Australia
Phone 138530 0
+61439622072
Fax 138530 0
Email 138530 0
[email protected]
Contact person for public queries
Name 138531 0
Anne-Marie Maxwell
Address 138531 0
Tresillian Family Care Centres, Mc Kenzie Street, Belmore 2192 NSW
Country 138531 0
Australia
Phone 138531 0
+61455 274 864
Fax 138531 0
Email 138531 0
[email protected]
Contact person for scientific queries
Name 138532 0
Alice Dwyer
Address 138532 0
Tresillian Family Care Centres, Mc Kenzie Street, Belmore 2192 NSW
Country 138532 0
Australia
Phone 138532 0
+61439622072
Fax 138532 0
Email 138532 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?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Requests can be addressed to Tresillian's Governance and Risk Committee on [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24591Data dictionary  [email protected]
24592Ethical approval  [email protected]
24593Statistical analysis plan  [email protected]
24594Study protocol  [email protected]


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.