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Trial registered on ANZCTR


Registration number
ACTRN12624000224527
Ethics application status
Approved
Date submitted
20/12/2023
Date registered
7/03/2024
Date last updated
7/03/2024
Date data sharing statement initially provided
7/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mother-Infant Dialectical Behaviour Therapy Plus (MI-DBT +) program for mothers with borderline personality disorder
Scientific title
Combined treatment of Mother-Infant Dialectical Behaviour Therapy (MI-DBT) and Attachment and Biobehavioral Catch-up (ABC) for mothers with borderline personality disorder: A feasibility and initial proof of efficacy study
Secondary ID [1] 311169 0
None
Universal Trial Number (UTN)
U1111-1300-6916
Trial acronym
MI-DBT +
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder (BPD) 332345 0
Condition category
Condition code
Mental Health 329055 329055 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a non-randomised trial with a crossover design, the MI-DBT+ study aims to test the feasibility and efficacy of combining Mother-Infant Dialectical Behaviour Therapy (MI-DBT) with Attachment and Biobehavioral Catch-up (ABC) for mothers with borderline personality disorder (BPD).

MI-DBT groups, organised by Helen Mayo House of the Women’s and Childrens Health Network, are run annually across Greater Adelaide. MI-DBT group members are typically referred by their GP or mental-health clinician. Facilitators of the clinical MI-DBT group will meet with potential MI-DBT group members for a 90-minute pre-commitment session before the group begins. This session is typically booked one-month before the pre-treatment assessment and MI-DBT starts. This session is used to provide clinical information about the MI-DBT group program (e.g., program content & specific group dates) and, additionally, to outline behavioural expectations, such as contacting the group facilitators if unable to attend a session, and the requirement for completing homework involving the practice of DBT skills in the home environment. During this pre-commitment session, the research will be explained and clients will be assessed for eligibility. Eligible participants will then receive a phone call from a research officer to explain the research before they are offered to take part in the study. Participants on the waitlist for MI-DBT who would like to take part in the research will be offered to start ABC prior to MI-DBT to offer earlier intervention for these participants. Dependant on the start dates of the MI-DBT group and the availability of the ABC therapist, there may be a gap of up to 3 months between participants receiving the different treatment types, however, when possible it is anticipated participants will start the treatment A one month after treatment B (and vice versa).

Following a comprehensive pre-treatment assessment (T1; 60 minutes) including a semi-structured interview, the NCAST Parent Child Interaction (PCI) Teaching Scales and questionnaires, eligible participants begin either MI-DBT or ABC dependent on their position on the waitlist for the MI-DBT group.

Treatment A: Mother-Infant Dialectical Behaviour Therapy (MI-DBT)
MI-DBT is a group therapy program for women living with Borderline Personality Disorder (BPD) in the Perinatal period. MI-DBT is an adaptation of Dialectical Behaviour Therapy (DBT) that aims to improve a woman’s emotional regulation, interpersonal effectiveness, and parenting skills at a critical time in an infant’s development. MI-DBT involves a weekly 3-hour group therapy session, for 24 weeks, at either Helen Mayo House or a Department for Education community children’s centre. There is a maximum of 12 participants per group. Local community MI-DBT groups are typically run at Lake Windemere Children’s Centre in Salisbury North, at Woodcroft Heights Children’s Centre in Woodcroft, at Tinyeri Children’s Centre at Murray Bridge and Avenues College Children's Centre at Windsor Gardens. There are four blocks of content during MI-DBT, including mindfulness, emotion regulation, distress tolerance, and interpersonal effectiveness. Within each block, participants are taught skills that are practiced during the week as homework exercises (approximately 1 hour of homework per week) and then the applied skills are reviewed within the group at the next session. While the mother undertakes the formal DBT skills group learning session, their infants are cared for by a mix of paid professionals and volunteers, using consistent primary-caregiver principles. At the conclusion of each session, mothers are reunited with their infants using structured activities that use the skills the mothers have just learnt in the formal group session.

Treatment B: Attachment and Biobehavioral Catch-up (ABC)
ABC therapy is a home-visiting parenting program that is designed to help mothers identify and respond to their infants’ signals, while helping their infant learn to regulate their behaviours and emotions. ABC involves 10 weekly or fortnightly (dependant on the infants age) 1-hour sessions that occur in the mother’s home with play time and discussion around parenting. Sessions focus on ‘in the moment’ commenting from the therapist to highlight moments that the mother is engaging in behaviours that are known to enhance child attachment and regulation. A part of the therapy process involves video recording mother-infant play and reviewing the footage with the therapist who provides positive feedback to the mother or helps problem-solve any difficulties.

At the conclusion of each therapy, a post-treatment assessment will occur (T2 and T3; 60 minutes each) that will include a semi-structured interview, the NCAST Parent Child Interaction (PCI) Teaching Scales and questionnaires.

Finally, at 12- and 36-month follow-up time points (T4 and T5; 45 minutes each), participants will complete a semi-structured interview and questionnaires.

Of note, declining to participate in the MI-DBT+ study does not preclude an individual from participating in the MI-DBT therapy. However, those who decline to participate in the study will not be able to receive ABC therapy.

The therapists involved in delivering MI-DBT and ABC are senior psychologists and mental-health social workers with years of experience in perinatal mental health.
Intervention code [1] 327614 0
Treatment: Other
Comparator / control treatment
The study involves an AB/BA crossover design with participants allocated to the AB study arm receiving treatment A (MI-DBT) first, followed by treatment B (ABC), and vice versa in the BA arm.
Control group
Active

Outcomes
Primary outcome [1] 336858 0
Participants change in BPD symptom severity
Timepoint [1] 336858 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up. The primary endpoint is the assessment that occurs after both MI-DBT and ABC have been completed (i.e., for participants in the MI-DBT then ABC group, the primary endpoint is the post-ABC assessment, and for those in the ABC then DBT group, the primary endpoint is the post-MI-DBT assessment).
Primary outcome [2] 336859 0
Participants change in mother-infant interaction
Timepoint [2] 336859 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment). The primary endpoint is the assessment that occurs after both MI-DBT and ABC have been completed (i.e., for participants in the MI-DBT then ABC group, the primary endpoint is the post-ABC assessment, and for those in the ABC then DBT group, the primary endpoint is the post-MI-DBT assessment).
Primary outcome [3] 336860 0
Participants qualitative evaluation of the therapies (including treatment feasibility)
Timepoint [3] 336860 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up. The primary endpoint is the assessment that occurs after both MI-DBT and ABC have been completed (i.e., for participants in the MI-DBT then ABC group, the primary endpoint is the post-ABC assessment, and for those in the ABC then DBT group, the primary endpoint is the post-MI-DBT assessment).
Secondary outcome [1] 429896 0
Participants change in depression
Timepoint [1] 429896 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [2] 429897 0
Participants change in anxiety
Timepoint [2] 429897 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [3] 429898 0
Participants change in self-reported parental competence
Timepoint [3] 429898 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [4] 429899 0
Participants change in reflection of mental experience
Timepoint [4] 429899 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [5] 429900 0
Participants change in DBT skill use
Timepoint [5] 429900 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [6] 429901 0
Participants change in parental stress
Timepoint [6] 429901 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [7] 429902 0
Infants change in child social-emotional functioning
Timepoint [7] 429902 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [8] 431429 0
Participants change in BPD symptom severity
Timepoint [8] 431429 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), post-ABC (week 10 of ABC treatment), 12-month follow-up, and 36-month follow-up

Eligibility
Key inclusion criteria
Inclusion criteria are women who have an infant under three years of age who are referred for MI-DBT therapy and have been assessed by mental health clinicians and either diagnosed with BPD or have traits of BPD as defined by the DSM-5. The referral pathway for entry into the MI-DBT group therapy program is either via recommendation from a consulting psychiatrist following a mother’s inpatient stay at Helen Mayo House or referral from a community mental health provider.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include illiteracy, current uncontrolled psychosis, substance dependence that requires detox, and/or significant cognitive impairment. These criteria are on the basis that individuals need to have a sufficient level of functioning to be able to participate in therapy.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed modelling (LMM) will be used for continuous data to determine treatment effects (i.e., pre-post and pre- to follow-up reductions) for both intent-to-treat and completer samples. For dichotomous outcomes (e.g., diagnostic outcomes), chi-square/Fishers Exact Test analyses will be used.

Qualitative data will be analysed following interpretive phenomenological analysis (IPA) guidelines. Transcripts of semi-structured interviews will be imported into NVivo to group data into themes and subthemes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/06/2021
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
28
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315424 0
Charities/Societies/Foundations
Name [1] 315424 0
Womens and Children's Hospital Foundation
Country [1] 315424 0
Australia
Funding source category [2] 315431 0
Charities/Societies/Foundations
Name [2] 315431 0
Channel 7 Children's Research Foundation
Country [2] 315431 0
Australia
Primary sponsor type
Government body
Name
Women's and Children's Health Network
Address
72 King William Road, North Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 317497 0
None
Name [1] 317497 0
Address [1] 317497 0
Country [1] 317497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314338 0
Womens and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 314338 0
72 King William Road, North Adelaide, South Australia 5006
Ethics committee country [1] 314338 0
Australia
Date submitted for ethics approval [1] 314338 0
13/07/2013
Approval date [1] 314338 0
05/09/2013
Ethics approval number [1] 314338 0
HREC/13/WCHN/111

Summary
Brief summary
The current study aims to test the feasibility and efficacy of combining Mother-Infant Dialectical Behaviour Therapy (MI-DBT) with Attachment and Biobehavioral Catch-up (ABC) for mothers with borderline personality disorder (BPD). The study uses a non-randomised crossover design, where participants start with either MI-DBT or ABC dependent on their position on the waitlist for the MI-DBT group. MI-DBT involves weekly 3-hour group therapy sessions across 24 weeks within community mental health settings, whereas ABC involves weekly 1-hour therapy sessions that occur over 10 weeks within the mother’s homes. Outcome measures will be assessed at pre- and post-treatment and at a 12- and 36-month follow-up. Primary outcomes are BPD symptom severity and mother-infant interaction. Important secondary outcomes include depression, anxiety, parental competence, reflection of mental experience, DBT skill use, parental stress, and child social-emotional functioning. It is hypothesised that this approach will be feasible (measured via mother’s reports in a semi-structured interview), and we predict that most clients will achieve significant improvement from pre- to post-treatment in terms of BPD symptom severity and mother-child interaction scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131234 0
A/Prof Anne Sved Williams
Address 131234 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, South Australia 5063
Country 131234 0
Australia
Phone 131234 0
+61 8 7087 1047
Fax 131234 0
Email 131234 0
Anne.SvedWilliams@sa.gov.au
Contact person for public queries
Name 131235 0
A/Prof Anne Sved Williams
Address 131235 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, South Australia 5063
Country 131235 0
Australia
Phone 131235 0
+61 8 7087 1047
Fax 131235 0
Email 131235 0
Anne.SvedWilliams@sa.gov.au
Contact person for scientific queries
Name 131236 0
A/Prof Anne Sved Williams
Address 131236 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, South Australia 5063
Country 131236 0
Australia
Phone 131236 0
+61 8 7087 1047
Fax 131236 0
Email 131236 0
Anne.SvedWilliams@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.