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Trial registered on ANZCTR


Registration number
ACTRN12619000592145
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
17/04/2019
Date last updated
28/06/2023
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the Mentalization- Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) in a Child and Youth Mental Health Service
Scientific title
An evaluation of the Mentalization- Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) in a Child and Youth Mental Health Service
Secondary ID [1] 297917 0
nil known
Universal Trial Number (UTN)
U1111-1231-4211
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 312309 0
Condition category
Condition code
Mental Health 310871 310871 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MBT-FACTS Program is a five-session psychoeducation and support program group, with the first session lasting two hours and the subsequent four sessions to be one and a half hours duration. Sessions occur weekly over a total of 5 weeks. All sessions are delivered face to face and in group format at an Alfred Health community psychiatry clinic site. The program was designed to be delivered by carers with relevant lived experience, to be brief, and specifically to be both educational and skills based in it’s content. The Program will be delivered at Alfred CYMHS by a carer with lived experience and a mental health experienced social worker. There will be an attendance log taken at each session.
Materials given to participants include handouts and presentation of slides and small group discussions. These can be found here: https://www.annafreud.org/training/mentalization-based-treatment-training/families-and-carers-training-and-support-programme-facts/
Each of the five sessions covers a different topic:
Session 1. Introduction: What is BPD? Discussion of the characteristics of BPD, and identifying the main areas of difficulty that families and carers face in their relationship and interactions with the person with BPD.
Session 2. Mindfulness and Mentalizing. Discussion of both mindfulness and Mentalizing, and practice of mindfulness to manage the emotional reactivity of family member’s and increase Mentalizing language in interpersonal processes.
Session 3. Mentalizing. Role plays based on the difficulties that families have been experiencing.
Session 4: Mentalizing and empathic validation. Working with the participants to develop the capacity to understand things from the other person’s experience.
Session 5. Problem-solving and review. Using Mentalizing techniques to enhance problem solving. The previous modules are also reviewed.

Due to the Covid-19 Pandemic and related lockdown measures and restrictions in Melbourne, Victoria, the 2021 Group intervention was delivered online via MS Teams.
Intervention code [1] 314142 0
Treatment: Other
Intervention code [2] 314143 0
Behaviour
Comparator / control treatment
The control group will be a delayed-treatment condition. Participants will be randomly allocated at the time of enrolment to either an immediate start group that will commence within 4 weeks, or a delayed treatment group that will commence within 3 months.
Control group
Active

Outcomes
Primary outcome [1] 319699 0
The primary outcome for family and carer participants is occurrence of adverse events experienced by family members and carers in relation to the person who meets criteria for BPD. These will be measured by weekly incident logs that record problematic interactions with the person with BPD which are relational manifestations of the symptoms of BPD. These will be developed individually with family members/carers in a weekly incident log. Examples may include incidents such as: psychiatric admissions; self-harming, becoming withdrawn and refusing contact, behaving impulsively (e.g. eating too much, drinking excessively, taking illicit substances, spending too much, gambling).
Timepoint [1] 319699 0
Time points for immediate start condition:
-At the time of referral
- Weekly for the 5 week duration of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Weekly for the 5 week duration of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [1] 369212 0
The outcome measure for young people aged 14 to 25 years who meet criteria for Borderline Personality Disorder is perception of family function as measures by the SCORE_15 Index of Family Functioning and Change (Stratton, Bland, Janes, & Lask, 2010).
Timepoint [1] 369212 0
Young people whose family member/carer is in the immediate start group:
-At the time of referral
-Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program

Young people whose family member/carer is in the delayed start group:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
Secondary outcome [2] 369213 0
Secondary outcome measure for family members and carers:
Depression as measured by the Depression Anxiety and Stress Scales
Timepoint [2] 369213 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [3] 369214 0
Secondary outcome measure for family members/carers:
subjective experience of burden as measured by the Burden Assessment Scale
Timepoint [3] 369214 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [4] 369215 0
Secondary outcome measure for family members/carers:
wellbeing as measured by the Warwick-Edinburgh Mental Well-being Scale
Timepoint [4] 369215 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [5] 369216 0
Secondary outcome measure for family members/carers:
perception of family functioning as measured by the SCORE-15 Index of Family Functioning and Change
Timepoint [5] 369216 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [6] 369217 0
Secondary outcome measure for family members/carers:
family empowerment as measured by the Family Empowerment Scale
Timepoint [6] 369217 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [7] 369218 0
Secondary outcome measure for young people aged 14 to 25 years who meet criteria for BPD to assess the young person's experience of their family member or carer having participated in the MBT-FACTS program including their perception of what was helpful and unhelpful as measured by a Qualitative focus group one hour duration.
Timepoint [7] 369218 0
One week post their family member/carer completing the MBT-FACT Program
Secondary outcome [8] 369437 0
Secondary outcome measure for family members and carers:
Anxiety as measured by the Depression Anxiety and Stress Scales
Timepoint [8] 369437 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program
Secondary outcome [9] 369438 0
Secondary outcome measure for family members and carers:
Stress as measured by the Depression Anxiety and Stress Scales
Timepoint [9] 369438 0
Time points for immediate start condition:
-At the time of referral
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Delayed treatment condition:
-At the time of referral
-Monthly pre-MBT-FACTS Program
- Commencement of the MBT-FACTS Program
-One week post completion of MBT-FACTS Program
-One month post completion of MBT-FACTS Program
-Two months post completion of MBT-FACTS Program
-Three months post completion of MBT-FACTS Program

Eligibility
Key inclusion criteria
Participants will be only be included if they are able to understand and speak English.

Inclusion criteria are as follows:
Family member/carer inclusion criteria
1. The family member or carer is aged 18 years or over
2. The family member or carer is related to, or cares for, a young person aged between 14 to 25 years who meets criteria for Borderline Personality Disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual for Mental Disorders (5th Edition) (American Psychiatric Association, 2013).
3. The family member or carer is willing to attend all 5 sessions of the FACTS program
4. The family member or carer is able to speak English
Young person inclusion criteria
1. The young person is aged over 14 years of age
2. The young person meets criteria for Borderline Personality Disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual for Mental Disorders (5th Edition) (American Psychiatric Association, 2013).
3. The young person is able to speak English
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded where the young person with a diagnosis of BPD also has a current diagnosis of Schizophrenia, Schizoaffective disorder, other primary psychotic disorder, or where there is a severe substance abuse disorder that is the primary focus of treatment.

Family member/carer exclusion criteria
1. If the family member or carer is below 18 years of age
2. If the young person they are caring for is under 14 years of age
3. If the family member/carer is unable to attend all sessions
4. The family member or carer is unable to speak English

Young person exclusion criteria
1. If the young person is less than 14 years of age
2. If the young person does not meet criteria for BPD
3. The young person is unable to speak English

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with allowance for pragmatic allocation of family members/carers of the same individual to attend together.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Delayed-treatment. All family member/carers will have the opportunity to complete the intervention. they will be allocated to either an immediate or delayed treatment group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There will be up to 30 family member/carer participants and up to 30 young people with BPD participants. This number is considered to be acceptable for internal pilot and feasibility projects (Lancaster, Dodd, and Williamson, 2002).

Randomization of the family member/carer participants will be carried out independently and will be down with block randomization using Excel with a pragmatic change schedule which will allow family members/carers who are in close relationship (e.g. parenting couple) to attend the course together as this is likely to be most beneficial from a clinical perspective. The allocation ratio will be 1:1.

A mixed-effects model using random intercepts and slope will be used to compare the immediate treatment and delayed treatment groups including all family member/carer participants for whom data has been collected with intention to treat for the primary outcome measure of adverse events reported.

Secondary analysis to compare pre and post intervention for all participants will be tested using Cohen’s d to calculate effect size. For the family member/carer participants this will be variables of depression, anxiety, stress, well-being, family functioning, experience of burden. For young people with BPD this will family functioning.
The qualitative data collected from focus groups will be analysed using both theoretically informed coding and grounded theory so that new, project-specific data codes are developed. Data will be coded using the Nvivo software package and coded data will be examined to draw out themes pertinent to the objectives of the evaluation. It is anticipated that there will be up to 30 young people with BPD across 4 focus groups, which is considered to be an acceptable number to attain theoretical saturation of the data, whereby no new information will emerge from the data (Krueger & Casey, 2009).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/04/2019
Actual
30/04/2019
Date of last participant enrolment
Anticipated
2/10/2023
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
60
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13580 0
The Alfred - Prahran
Recruitment postcode(s) [1] 26239 0
3189 - Moorabbin

Funding & Sponsors
Funding source category [1] 302434 0
Hospital
Name [1] 302434 0
Alfred Health
Country [1] 302434 0
Australia
Primary sponsor type
Individual
Name
Celeste Benetti
Address
Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189
Country
Australia
Secondary sponsor category [1] 302336 0
None
Name [1] 302336 0
Address [1] 302336 0
Country [1] 302336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303103 0
Alfred Hospital Ethics Commitee
Ethics committee address [1] 303103 0
Ethics committee country [1] 303103 0
Australia
Date submitted for ethics approval [1] 303103 0
20/02/2019
Approval date [1] 303103 0
12/03/2019
Ethics approval number [1] 303103 0
89/19

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

Contacts
Principal investigator
Name 92482 0
Dr Celeste Benetti
Address 92482 0
Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189
Country 92482 0
Australia
Phone 92482 0
+61 38552055
Fax 92482 0
Email 92482 0
c.benetti@alfred.org.au
Contact person for public queries
Name 92483 0
Celeste Benetti
Address 92483 0
Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189
Country 92483 0
Australia
Phone 92483 0
+61 38552055
Fax 92483 0
Email 92483 0
c.benetti@alfred.org.au
Contact person for scientific queries
Name 92484 0
Celeste Benetti
Address 92484 0
Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189
Country 92484 0
Australia
Phone 92484 0
+61 38552055
Fax 92484 0
Email 92484 0
c.benetti@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Information is personally sensitive and will be aggregated for reporting


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1828Ethical approval    377356-(Uploaded-09-04-2019-16-23-06)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.