Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001034628
Ethics application status
Approved
Date submitted
28/06/2023
Date registered
22/09/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a short-term group intervention for parents with borderline personality disorder symptoms: Lifeboat
Scientific title
Evaluation of a short-term group intervention on emotional dysregulation for parents with borderline personality disorder symptoms: Lifeboat
Secondary ID [1] 309900 0
None
Universal Trial Number (UTN)
Trial acronym
Lifeboat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal borderline personality disorder 330364 0
Borderline personality disorder 330365 0
Condition category
Condition code
Mental Health 327209 327209 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The therapy intervention is an adaptation and combination of two recognised and evidence-based therapies, dialectical behaviour (DBT) which has been further adapted to provide relevant information about parenting to this parental population (hence mother-infant DBT or MI-DBT) combined with key elements of mentalisation based therapy (MDBT). Referred women will attend 10 weekly 2-hour groups each which will address topics of learning mindfulness, distress tolerance, emotional regulation, parenting and interpersonal relationships. The women will have homework which will be discussed in group each week. Infants are cared for in a nearby creche during these 2 hours, and at the end of that time are brought into the group for reunion with their mother, and an exercise based on either new skills the mother has learned or play activities which promote infant regulation and exploration. Two therapists who are either clinical psychologists, mental health social workers or mental health nurses with perinatal and infant mental health training and experience are present during all therapy time, and the infants have care from trained creche workers.

A list is kept of attendance and if women do not attend more than 2 consecutive groups, they will not be able to continue.

Women who are on waiting lists for MI-DBT will be progressively offered the option of attending Lifeboat, in the order in which they were placed on the waiting list until 12 places are filled for Lifeboat group. If they do not consent, they will remain on the MI-DBT waiting list but asked to voluntarily consent (ie it will not jeopardise their place on the waiting list) to undertake all research data collection until 12 women have accepted becoming wait-list controls. Women on waiting list who may not have been offered a place for Lifeboat as the group is full will also be contacted if still insufficient numbers for waitlist control ie 12, until numbers are completed. Again, if women do not consent, it will not jeopardise their place on the waitlist.

There will be 10 women and their infants enrolled for each group.

Homework in some weeks is expected to be a brief task each week such as:

- mindfully observe your infant
- use one of your DBT skills to calm yourself down when a difficult emotion arises.
It would be expected that these activities would take about 10 minutes each time to undertake and record.

Other weeks would involve completing homework on one occasion during the week following the group – completing a worksheet that involves identifying components of an emotion, or looking at whether an emotion fits the facts of a situation or not and then deciding whether to use ‘opposite action’ or ‘problem solving’. These activities would take about half an hour to 45 minutes to complete. So the expectation would be that clients would be spending between half and hour and an hour a week completing homework.
Intervention code [1] 326324 0
Treatment: Other
Intervention code [2] 326325 0
Prevention
Intervention code [3] 327066 0
Treatment: Other
Comparator / control treatment
Wait-list comparison group who will be asked to provide all the same information as the active participants at the same time points, which is pre-group, post-group completion ie 10 weeks on and then 6 months later if they have not yet started active treatment. Those who are on the waiting list will be offered either Lifeboat if available or mother-infant dialectical behavior therapy at the 6 month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 335083 0
Any change in the parenting attitudes and behavours as measured by the Tool to Measure Parenting Self-Efficacy (TOPSE)
Timepoint [1] 335083 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group: PRIMARY TIMEPOINT
T3 6 months after group completion
Primary outcome [2] 335859 0
Any change in the quality of parent infant interactions as measured by the Nursing Child Assessment Satellite Training parent-infant relationship (NCAST)
Timepoint [2] 335859 0
T1 Pregroup
T2 Post-group ie 10 weeks post-commencement of group: PRIMARY TIMEPOINT
T3 6 months after group completion
Primary outcome [3] 335860 0
Any change in depression in the women as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [3] 335860 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group: PRIMARY TIMEPOINT
T3 6 months after group completion
Secondary outcome [1] 422960 0

Any change in borderline symptom severity as measured by the borderline symptom list (BSL 23)
Timepoint [1] 422960 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group
T3 6 months after group completion
Secondary outcome [2] 425911 0
Severity of borderline personality disorder as measured by BSL-23
Timepoint [2] 425911 0
Pre-group assessment
Secondary outcome [3] 426309 0
Any change in emotional regulation as measured by Difficulties in Emotional Regulations Scale (DERS-18)
Timepoint [3] 426309 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group
T3 6 months after group completion
Secondary outcome [4] 426776 0
Changes in features of borderline personality disorder measured by the McLean Screening Instrument for BPD (MSI-BPD)
Timepoint [4] 426776 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group
T3 6 months after group completion
Secondary outcome [5] 426777 0
Any change in parenting reflective functioning as measured by PRFQ
Timepoint [5] 426777 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group
T3 6 months after group completion
Secondary outcome [6] 426778 0
Any changes in parent's parenting competence and confidence as measured by the Parenting Stress Index (PSI-4 SF)
Timepoint [6] 426778 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group
T3 6 months after group completion
Secondary outcome [7] 426779 0
Any changes in parents' mental health as described by participants in short (15-30 minute) semi-structured post-group face-to-face interview
Timepoint [7] 426779 0
10 weeks post-group commencement
Secondary outcome [8] 426780 0
Any change in frequency of borderline symptoms as measured by BSL-Supplementary
Timepoint [8] 426780 0
T1 Pre-group
T2 Post-group ie 10 weeks post-commencement of group
T3 6 months after group completion

Eligibility
Key inclusion criteria
- Parents with borderline symptomatology and at least one child aged up to 3 years old
- The parent must have at least partial custody of the child.
- Ages =>16 years
- Residents of South Australia
- English speaking
Minimum age
16 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Aged less than 16 years
- Acute concerns regarding the child’s safety and/or the child having been removed from their care
- Cognitive impairment that impacts on an individual’s capacity to safely engage in group or consent to research
- Not fluent in spoken or written English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Mixed Linear Mixed Modelling (MLMM) will be utilised to test whether there was significant difference in the ‘change scores’ (e.g. Waitlist T0 – T1 vs intervention T1 - T2 scores) on the aforementioned variables. Several models will be tested
a. effect of condition (waitlist/intervention) as a fixed factor on outcome
b. baseline score (group centered mean) as a covariate
c. Group as a random intercept.
MLMM will be utilised to explore the clinical variables in the same manner. Furthermore, we will assess whether change in symptoms is clinically significant utilizing the method outlined by Jacobson and Truax (1991). Clinically significant change (CSC) will be calculated for the BSL-23 utilizing the Jacobson and Traux (1991) method in which treatment efficacy can be indexed by the degree individuals return to normal functioning after treatment. Outcomes were categorized as recovered, improved, unchanged or deteriorated. The calculation considers both the reliability (RCI cut-off 1.96) and clinical significance of the change which in the current study was the midpoint between the clinical and general population means (Method C).

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
17/10/2023
Actual
5/02/2024
Date of last participant enrolment
Anticipated
6/12/2024
Actual
29/04/2024
Date of last data collection
Anticipated
28/06/2025
Actual
12/07/2024
Sample size
Target
132
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24909 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 40561 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 314084 0
Other Collaborative groups
Name [1] 314084 0
Hopscotch Foundation
Country [1] 314084 0
Australia
Primary sponsor type
Other Collaborative groups
Name
BPD Collaborative, Barossa Hills Fleurieu LHN
Address
1/100 Greenhill Rd, Unley SA 5061
Country
Australia
Secondary sponsor category [1] 315999 0
Charities/Societies/Foundations
Name [1] 315999 0
Hopscotch Foundation
Address [1] 315999 0
c/- Campbell LawSuite 7 Level 1118 Halifax StreetAdelaide SA 5000
Country [1] 315999 0
Australia
Secondary sponsor category [2] 316627 0
Charities/Societies/Foundations
Name [2] 316627 0
Womens and Children's Health Network
Address [2] 316627 0
King William Road, North Adelaide, 5006South Australia
Country [2] 316627 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313222 0
Womens and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 313222 0
Ethics committee country [1] 313222 0
Australia
Date submitted for ethics approval [1] 313222 0
07/12/2022
Approval date [1] 313222 0
06/06/2023
Ethics approval number [1] 313222 0
2022/GEM00539

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

Contacts
Principal investigator
Name 127398 0
A/Prof Anne Sved Williams
Address 127398 0
Helen Mayo House, Glenside Campus226 Fullarton RoadEastwoodSouth Australia 5063
Country 127398 0
Australia
Phone 127398 0
+61 8 7087 1047
Fax 127398 0
Email 127398 0
[email protected]
Contact person for public queries
Name 127399 0
Anne Sved Williams
Address 127399 0
Helen Mayo House, Glenside Campus226 Fullarton RoadEastwoodSouth Australia 5063
Country 127399 0
Australia
Phone 127399 0
+61 8 7087 1047
Fax 127399 0
Email 127399 0
[email protected]
Contact person for scientific queries
Name 127400 0
Anne Sved Williams
Address 127400 0
Helen Mayo House, Glenside Campus226 Fullarton RoadEastwoodSouth Australia 5063
Country 127400 0
Australia
Phone 127400 0
+61 8 7087 1047
Fax 127400 0
Email 127400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics consent has not been provided for this step


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.