Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000552583p
Ethics application status
Submitted, not yet approved
Date submitted
4/03/2024
Date registered
1/05/2024
Date last updated
1/05/2024
Date data sharing statement initially provided
1/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Mother-Infant Dialectical Behavioural Therapy (MI-DBT) Evaluation
Scientific title
Evaluation of Mother-Infant Dialectical Behavioural Therapy (MI-DBT) Targeting Parenting and Emotional Dysregulation in Mothers with an Infant Under the Age of Two Years
Secondary ID [1] 311614 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 333035 0
Condition category
Condition code
Mental Health 329718 329718 0 0
Psychosis and personality disorders
Reproductive Health and Childbirth 329719 329719 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20-week mother-infant dialectical behavioural therapy (MI-DBT) group, delivered to 8-12 women annually, with skills group, individual therapy, and phone coaching components.

Women with a diagnosis of borderline personality disorder and an infant under two years of age are offered enrolment into an adaptation of an evidence-based therapy for perinatal BPD, Mother-infant dialectical behaviour therapy. Mothers attend groups whilst their infants receive care close by, and at the conclusion of the mother-only groups, infants join the group and mother-infant work concludes the group.

In addition to a 20 session group program for the mothers, adapted from the South Australian model,
1. Introduction of weekly individual therapy sessions
2. Introduction of phone skills coaching during business hours

Group skills content is organised in the four usual DBT categories of emotional regulation, mindfulness, distress tolerance, and interpersonal effectiveness. The Circle of Security (COS) parenting program (Powell 2016) is an evidence-based attachment focused parenting intervention, which helps parents to make sense of their own emotional reactions to the needs of their child, and improve reflective parenting function. COS content is interwoven with DBT content.

Group skills sessions last for 2 to 2 ½ hours weekly for 20-24 weeks except in school holidays. They are administered by a team of psychologists, social workers, psychiatrists and mental health occupational therapists. Skills groups consist of mindfulness, homework review, teaching of new skills and in-vivo practice of skills, setting of homework, and a mother-infant component, for example mindfulness activities involving the infant, or coaching on reunion with the infant. Attendance is recorded on the electronic medical record.

Weekly therapy sessions last for 1 to 1 ½ hours and are conducted either in person or by videoconference. There is a precommitment phase of between 3-5 weeks of weekly sessions, followed by 20-24 weeks of weekly therapy sessions except during school holidays. Individual sessions consist of mindfulness, diary card and homework review, and review of the use of DBT skills through the week where possible incorporating content involving the infant. Attendance is recorded on the electronic medical record.

Phone coaching is available during working hours, clients can phone the MI-DBT team and one of the clinicians involved in the intervention, although not necessarily their allocated clinician, will coach them to use skills to manage distressing situations for 5-10 minutes. After hours clients can access the crisis mental health team who can provide some limited DBT informed phone support. Use of phone coaching is recorded on the electronic medical record.
Intervention code [1] 328067 0
Behaviour
Intervention code [2] 328068 0
Treatment: Other
Comparator / control treatment
No control group - pilot
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337516 0
EPDS – Edinburgh Postnatal Depression Scale, a 10 item self-report scale for postnatal depression
Timepoint [1] 337516 0
Baseline, at commencement of the intervention (week 0), week 10 of the intervention, week 20 of the intervention, 6 months post-completion of the intervention
Secondary outcome [1] 432163 0
CCQ – Composite Caregiving Questionnaire, a 42 item self-report questionnaire for parents of children between the ages of 0 and 6 exploring parenting self-efficacy in empathy, parenting self-efficacy in expressing affection and managing child emotion, caregiving helplessness, hostile perceptions of the child, and parent mentalisation.
Timepoint [1] 432163 0
Baseline, at commencement of the intervention (week 0), week 10 of the intervention, week 20 of the intervention, 6 months post-completion of the intervention
Secondary outcome [2] 432164 0
Zan-BPD – Zanarini Rating Scale for Borderline Personality Disorder, a 10 item self-report scale for borderline personality disorder
Timepoint [2] 432164 0
Baseline, at commencement of the intervention (week 0), week 10 of the intervention, week 20 of the intervention, 6 months post-completion of the intervention
Secondary outcome [3] 432165 0
MSI-BPD – The McLean Screening Instrument for Borderline Personality Disorder, a 9 item self-report criterion based scale for borderline personality disorder
Timepoint [3] 432165 0
Baseline, at commencement of the intervention (week 0), week 10 of the intervention, week 20 of the intervention, 6 months post-completion of the intervention
Secondary outcome [4] 432166 0
DERS-16 – Difficulties in Emotion Regulation Scale, 16 item version, assessing difficulties in nonacceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, limited access to emotion regulation strategies and lack of emotional clarity
Timepoint [4] 432166 0
Baseline, at commencement of the intervention (week 0), week 10 of the intervention, week 20 of the intervention, 6 months post-completion of the intervention
Secondary outcome [5] 432167 0
BSL-23 – Borderline Symptom List, 23 item self-rating instrument assessing affective instability, recurrent suicidal behaviour, gestures, or threats, or self-mutilating behaviour, and transient dissociative symptoms
Timepoint [5] 432167 0
Baseline, at commencement of the intervention (week 0), week 10 of the intervention, week 20 of the intervention, 6 months post-completion of the intervention
Secondary outcome [6] 432168 0
Qualitative feedback. Semi-structured interview exploring the experience of group participation, helpful features of the intervention, unhelpful features of the intervention, the impact of the intervention on mental health, the impact of the intervention on parenting confidence, and any other areas they would like to raise.
Timepoint [6] 432168 0
Immediately post-completion of the intervention, 6 months post-completion of the intervention.

Eligibility
Key inclusion criteria
Diagnosis of borderline personality disorder or three or more features of borderline personality disorder as defined by DSM 5
Infant between the ages of 3 months and 24 months at the commencement of group
Lives in the Australian Capital Territory
Moderate to severe mental illness (impact on functioning)
Minimum age
3 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to participate in the group due to such factors as severe untreated comorbid mental illness, cognitive deficits, language barrier, violence or aggression
Substance use that interferes with participation and engagement in therapy
Infant not in the care of the parent
Unable to commit to the entirety of the program

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 315922 0
Government body
Name [1] 315922 0
ACT Government
Country [1] 315922 0
Australia
Primary sponsor type
Government body
Name
Canberra Health Service
Address
Country
Australia
Secondary sponsor category [1] 318137 0
None
Name [1] 318137 0
Address [1] 318137 0
Country [1] 318137 0
Other collaborator category [1] 282970 0
University
Name [1] 282970 0
University of Canberra
Address [1] 282970 0
Country [1] 282970 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314767 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 314767 0
Ethics committee country [1] 314767 0
Australia
Date submitted for ethics approval [1] 314767 0
19/02/2024
Approval date [1] 314767 0
Ethics approval number [1] 314767 0

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

Contacts
Principal investigator
Name 132666 0
Dr Clare Watsford
Address 132666 0
University of Canberra, 11 Kirinari St, Bruce ACT 2617
Country 132666 0
Australia
Phone 132666 0
+61 232063802
Fax 132666 0
Email 132666 0
[email protected]
Contact person for public queries
Name 132667 0
Clare Watsford
Address 132667 0
University of Canberra, 11 Kirinari St, Bruce ACT 2617
Country 132667 0
Australia
Phone 132667 0
+61 232063802
Fax 132667 0
Email 132667 0
[email protected]
Contact person for scientific queries
Name 132668 0
Clare Watsford
Address 132668 0
University of Canberra, 11 Kirinari St, Bruce ACT 2617
Country 132668 0
Australia
Phone 132668 0
+61 232063802
Fax 132668 0
Email 132668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small numbers of participants and highly sensitive mental health/parenting data, individuals may be identifiable if data is released.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22279Ethical approval  [email protected]


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22279Ethical approval  [email protected] 387402-(Uploaded-18-08-2024-13-18-54)-18.14 - 2024.ETH.00082 - Keightley.pdf

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.