ANZCTR - Registration

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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]

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)

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

No control group – open trial pilot study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Participants change in BPD symptom severity

Timepoint [1]

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]

Participants change in mother-infant interaction

Timepoint [2]

At baseline and post MI-DBT (week 24 of MI-DBT treatment).

Primary outcome [3]

Participants qualitative evaluation of the therapies (including treatment feasibility)

Timepoint [3]

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]

Participants change in depression

Timepoint [1]