ANZCTR - Registration

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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

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]

Secondary outcome measure for family members and carers:
Depression as measured by the Depression Anxiety and Stress Scales

Timepoint [2]

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]

Secondary outcome measure for family members/carers:
subjective experience of burden as measured by the Burden Assessment Scale

Timepoint [3]

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]

Secondary outcome measure for family members/carers:
wellbeing as measured by the Warwick-Edinburgh Mental Well-being Scale

Timepoint [4]

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]

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]

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]

Secondary outcome measure for family members/carers:
family empowerment as measured by the Family Empowerment Scale

Timepoint [6]

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]

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]

One week post their family member/carer completing the MBT-FACT Program

Secondary outcome [8]

Secondary outcome measure for family members and carers:
Anxiety as measured by the Depression Anxiety and Stress Scales

Timepoint [8]

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]

Secondary outcome measure for family members and carers:
Stress as measured by the Depression Anxiety and Stress Scales

Timepoint [9]

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

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]

The Alfred - Prahran

Recruitment postcode(s) [1]

3189 - Moorabbin

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Health

Country [1]

Australia

Primary sponsor type

Individual

Name

Celeste Benetti

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Commitee

Ethics committee address [1]

Office of Ethics and Research Governance
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/02/2019

Approval date [1]

12/03/2019

Ethics approval number [1]

89/19

Summary

Brief summary

The Mentalization-Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) is a five session Mentalization Based Treatment (MBT) informed skills and education program for family members and carers of someone with Borderline Personality Disorder (BPD) (Bateman & Fonagy, 2019). MBT-FACTS focuses on providing family members and carers the knowledge and skills to interact more effectively with their family member with BPD. The sessions are structured and semi-manualised and include didactic psychoeducation, group discussions, in-session practice of skills and homework tasks to practice between sessions. The program was designed to be delivered by family members or carers with lived experience of caring for a person with a diagnosis of BPD. At Alfred CYMHS the program will be facilitated by both a carer support consultant with lived experience of caring for a family member with BPD, and a trained mental health clinician. The program is designed to provide families and carers the skills to understand and interact with their person with BPD differently.
The project will evaluate the impact of the program on the experience of adverse events by family members and carers in relation to the person with BPD, and the wellbeing, depression, anxiety, stress, family functioning, and experience of burden outcomes for the family members and carers participating. The project will also evaluate the impact of the program on the experience of family functioning as reported by the person with Borderline Personality Disorder via survey, and also their broader experience and perception of having their person complete the MBT-FACTS program which will be gathered via focus group. 
The project will utilise a delayed-treatment Randomised Control Trial (RCT) design, with half of the referred families and carers allocated randomly to commence in the first treatment group, and the other half allocated to commence the program approximately 3months after the commencement of the first group.  The young person with Borderline Personality Disorder will continue to receive treatment as usual regardless of the randomisation group of their family member or carer.  Any usual supports available to the carer of family member will also remain available.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Celeste Benetti

Address

Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189

Country

Australia

Phone

+61 38552055

Email

[email protected]

Contact person for public queries

Name

Celeste Benetti

Address

Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189

Country

Australia

Phone

+61 38552055

Email

[email protected]

Contact person for scientific queries

Name

Celeste Benetti

Address

Alfred CYMHS
Level 2, 999 Nepean Hwy
Moorabbin
Victoria 3189

Country

Australia

Phone

+61 38552055

Email

[email protected]

Trial Review

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