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Trial registered on ANZCTR


Registration number
ACTRN12620001257954
Ethics application status
Approved
Date submitted
22/10/2020
Date registered
24/11/2020
Date last updated
24/11/2020
Date data sharing statement initially provided
24/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the outcomes of a group parenting program for parents experiencing difficulties with affect, identity and relationships
Scientific title
A randomised control trial assessing the efficacy of a group parenting intervention versus treatment as usual for parents with Borderline Personality Disorder or difficulties with affect, identity or relationships
Secondary ID [1] 296616 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Nil known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 310422 0
Condition category
Condition code
Mental Health 309139 309139 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the 'Parenting with Borderline Personality Disorder and Difficulties with Affect, Identity and Relationships' brief parenting intervention. This brief group parenting intervention is a three module program that covers six target areas, including safety planning, reflecting on the parent-child attachment relationship, keeping the child's mind in mind, connecting with children of different ages and stages, talking to children about complex mental health issues and emphasising self care. The brief group parenting intervention provides tailored strategies for health professionals working with parents with a personality disorder, including accompanying resources comprising of a manual, fact sheets, help sheets and an audio-visual case study.

Following clinical assessment confirming trial eligibility, all participants will be randomised either to the brief parenting intervention (in addition to treatment as usual) or a waitlist condition (treatment as usual only). Both the parenting intervention and treatment as usual will presented by mental health clinicians (e.g., psychologist, psychiatrist, social worker) in the service in which participants were recruited.

The parenting intervention takes place over four weekly two-hour group sessions, which cover the three modules and six target areas outlined above. The intervention is intended to be delivered face to face. However, some adjusts may need to take place. Adherence to the intervention will be monitored by facilitating clinicians completing a questionnaire on treatment fidelity after each group.
Intervention code [1] 312919 0
Treatment: Other
Comparator / control treatment
The comparison group will be placed on a waitlist condition where they will receive "treatment as usual". As there is no one gold standard of treatment for personality disorder or difficulties with affect, identity of relationships, participants in the control and intervention groups both received treatment as usual at the direction of their health practitioner. Treatment as usual will be a tailored treatment that incorporates the current treatment options provided by the community mental health service (e.g. referral to individual psychology, psychiatric consultation and medication review and case coordination). The control group will be offered a place in the next available intervention group.
Control group
Active

Outcomes
Primary outcome [1] 308123 0
Change in level of parenting stress, as measured by Parenting Stress Index 4th Edition – Short Form (PSI-4-SF).
Timepoint [1] 308123 0
Measured at baseline during intake assessment and post-intervention. Post-intervention will be within 2 weeks of completing the intervention.
Secondary outcome [1] 354745 0
Change in severity of parent's mental health symptomology, as measured by Mental Health Inventory (MHI-5).
Timepoint [1] 354745 0
Measured at baseline during intake assessment and post-intervention. Post-intervention will be within 2 weeks of completing the intervention.

Eligibility
Key inclusion criteria
Eligible participants were all adults aged 18 or over who were currently parenting at least one child (aged zero to 19 years) and either showed symptoms of, or met caseness for Borderline Personality Disorder (BPD) and/or were experiencing BPD traits such as difficulties with affect, identity or relationships.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be acute suicidal risk, in current episode of psychosis, has a moderate to severe intellectual impairment, not fluent in spoken or written English, is currently in acute alcohol or drug withdrawal, or participation in another supplementary parenting programme.

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)
Allocation involved contacting the holder of the allocation schedule who was "off site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence will randomly allocate participants to the parenting intervention or treatment as usual. Randomisation will be blocked to ensure number of children, parent age, parent gender and relationship status are balanced between the groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using G*Power calculations (http://www.gpower.hhu.de/en.html), we would need a minimum of 66 participants to conduct a linear multiple regression model, with a power of 95% at a significance level of .05, and minimum effect size of d = .52. Given an estimated dropout rate of 25%, we would initially need to recruit 83 participants. Based on clinical output, this number of participants can be recruits in an 18-24 month period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/11/2020
Actual
Date of last participant enrolment
Anticipated
26/11/2021
Actual
Date of last data collection
Anticipated
26/07/2022
Actual
Sample size
Target
83
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 30373 0
5061 - Unley

Funding & Sponsors
Funding source category [1] 301193 0
University
Name [1] 301193 0
University of Wollongong
Country [1] 301193 0
Australia
Primary sponsor type
University
Name
Project Air Strategy, University of Wollongong
Address
School of Psychology
Building 22
School of Psychology
Northfields Ave,
Wollongong,
NSW 2522
Country
Australia
Secondary sponsor category [1] 300818 0
Other Collaborative groups
Name [1] 300818 0
BPD Collaborative
Address [1] 300818 0
Barossa Hills Fleurieu LHN
Mental Health Services
100 Greenhill Road
Unley
SA 5061
Country [1] 300818 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301934 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 301934 0
Ethics committee country [1] 301934 0
Australia
Date submitted for ethics approval [1] 301934 0
16/03/2020
Approval date [1] 301934 0
15/10/2020
Ethics approval number [1] 301934 0

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

Contacts
Principal investigator
Name 88610 0
Prof Brin Grenyer
Address 88610 0
Project Air Strategy
School of Psychology
Building 22
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 88610 0
Australia
Phone 88610 0
+61 242213474
Fax 88610 0
Email 88610 0
grenyer@uow.edu.au
Contact person for public queries
Name 88611 0
Brin Grenyer
Address 88611 0
Project Air Strategy
School of Psychology
Building 22
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 88611 0
Australia
Phone 88611 0
+61 242213474
Fax 88611 0
Email 88611 0
grenyer@uow.edu.au
Contact person for scientific queries
Name 88612 0
Brin Grenyer
Address 88612 0
Project Air Strategy
School of Psychology
Building 22
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 88612 0
Australia
Phone 88612 0
+61 242213474
Fax 88612 0
Email 88612 0
grenyer@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants give permission for their data to be used for this study only.


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.