ANZCTR - Registration

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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]

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)

Condition category

Condition code

Mental Health

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]

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]

Participants change in BPD symptom severity

Timepoint [1]

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]

Participants change in mother-infant interaction

Timepoint [2]

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]

Participants qualitative evaluation of the therapies (including treatment feasibility)

Timepoint [3]

Secondary outcome [1]

Participants change in depression

Timepoint [1]