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Trial registered on ANZCTR


Registration number
ACTRN12624000225516
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 (MI-DBT) for mothers with borderline personality disorder
Scientific title
Evaluation of Mother-Infant Dialectical Behaviour Therapy (MI-DBT) for mothers with borderline personality disorder: An open trial pilot study
Secondary ID [1] 311222 0
None
Universal Trial Number (UTN)
U1111-1301-7201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder (BPD) 332428 0
Condition category
Condition code
Mental Health 329116 329116 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In an open trial pilot study, the current study aims to test the feasibility and efficacy of Mother-Infant Dialectical Behaviour Therapy (MI-DBT) 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 the research officer to explain the research before they are offered to take part in the study.

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 MI-DBT.

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). The homework will often involve practicing the skills taught during the lessons (e.g., "checking the facts") to help cope with any intense or unwanted emotions or relationship difficulties as they arise during the week. The applied skills are then 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.

Following MI-DBT, a post-treatment assessment will occur (T2; 60 minutes) 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 (T3 and T4; 45 minutes each), participants will complete a semi-structured interview and questionnaires.
Of note, refusal to participate in the MI-DBT study do not preclude an individual from participating in the MI-DBT program.

The therapists involved in delivering the therapies are senior psychologists and mental-health social workers with years of experience in perinatal mental health.
Intervention code [1] 327680 0
Treatment: Other
Comparator / control treatment
No control group – open trial pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336945 0
Participants change in BPD symptom severity
Timepoint [1] 336945 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment; primary endpoint), 12-month follow-up, and 36-month follow-up.
Primary outcome [2] 336946 0
Participants change in mother-infant interaction
Timepoint [2] 336946 0
At baseline and post MI-DBT (week 24 of MI-DBT treatment).
Primary outcome [3] 336947 0
Participants qualitative evaluation of the therapies (including treatment feasibility)
Timepoint [3] 336947 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment; primary endpoint), 12-month follow-up, and 36-month follow-up.
Secondary outcome [1] 430229 0
Participants change in depression
Timepoint [1] 430229 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [2] 430230 0
Participants change in anxiety
Timepoint [2] 430230 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [3] 430231 0
Participants change in self-reported parental competence
Timepoint [3] 430231 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [4] 430232 0
Participants change in reflection of mental experience
Timepoint [4] 430232 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [5] 430233 0
Participants change in DBT skill use
Timepoint [5] 430233 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [6] 430234 0
Participants change in parental stress
Timepoint [6] 430234 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [7] 430235 0
Infants change in social-emotional functioning
Timepoint [7] 430235 0
At baseline, post MI-DBT (week 24 of MI-DBT treatment), 12-month follow-up, and 36-month follow-up
Secondary outcome [8] 431426 0
Participants change in BPD symptom severity. Please note that this measure will be assessed as an additional primary outcome.
Timepoint [8] 431426 0
At baseline, post MI-DBT (week 24 of MI-DBT 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
Single group
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
1/01/2014
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
200
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315481 0
Charities/Societies/Foundations
Name [1] 315481 0
Lane Bequest, Health Services Charitable Gift Boards
Country [1] 315481 0
Australia
Funding source category [2] 315664 0
Charities/Societies/Foundations
Name [2] 315664 0
Hopscotch Foundation
Country [2] 315664 0
Australia
Primary sponsor type
Government body
Name
Helen Mayo House, Women's and Children's Health Network
Address
226 Fullarton Rd, Glenside SA 5065
Country
Australia
Secondary sponsor category [1] 317769 0
None
Name [1] 317769 0
Address [1] 317769 0
Country [1] 317769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314390 0
Womens and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 314390 0
Ethics committee country [1] 314390 0
Australia
Date submitted for ethics approval [1] 314390 0
13/07/2013
Approval date [1] 314390 0
05/09/2013
Ethics approval number [1] 314390 0
HREC/13/WCHN/111

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

Contacts
Principal investigator
Name 131410 0
A/Prof Anne Sved Williams
Address 131410 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, South Australia 5063
Country 131410 0
Australia
Phone 131410 0
+61 8 7087 1047
Fax 131410 0
Email 131410 0
Anne.SvedWilliams@sa.gov.au
Contact person for public queries
Name 131411 0
Anne Sved Williams
Address 131411 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, South Australia 5063
Country 131411 0
Australia
Phone 131411 0
+61 8 7087 1047
Fax 131411 0
Email 131411 0
Anne.SvedWilliams@sa.gov.au
Contact person for scientific queries
Name 131412 0
Anne Sved Williams
Address 131412 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, South Australia 5063
Country 131412 0
Australia
Phone 131412 0
+61 8 7087 1047
Fax 131412 0
Email 131412 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.