Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000893303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/07/2026
Date registered
Help: Date registered
20/07/2026
Date last updated
Help: Date last updated
20/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/07/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Evaluating telehealth Mother–Infant Dialectical Behaviour Therapy for mothers with borderline personality disorder
Scientific title
Clinical and implementation effectiveness of telehealth Mother–Infant Dialectical Behaviour Therapy for mothers with borderline personality disorder: a non-randomised controlled trial
Additional trial identifiers [1] 317776 0
Nil
Universal Trial Number (UTN)
Trial acronym
tMIDBT
Related trial records

Health condition
Health condition(s) studied:
Borderline personality disorder 342680 0
Condition category
Condition code
Mental Health 338818 338818 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study aims to evaluate the effectiveness of the telehealth Mother–Infant Dialectical Behaviour Therapy (tMIDBT) group programme for mothers with borderline personality disorder (BPD) and their infants under 2 years of age.

The tMIDBT is an adaptation of the established Mother–Infant Dialectical Behaviour Therapy (MIDBT) programme developed at Helen Mayo House, Women’s and Children’s Health Network, Adelaide, South Australia (SA). The tMIDBT has been developed to increase access to specialised treatment for mothers who are unable to attend in-person groups because of geographical location, limited transport options or discomfort with in-person group participation. The tMIDBT retains the core therapeutic components of the in-person programme while adapting its delivery for telehealth.

The study will include three study arms: tMIDBT, in-person MIDBT and a wait-list control. Participants will be allocated to one of these study arms according to service availability. Mothers who cannot attend in-person groups because of geographical location, transport difficulties or other practical barriers will be allocated to the tMIDBT group. Mothers offered a place in the in-person MIDBT programme will be allocated to the in-person MIDBT group. Mothers awaiting the next available telehealth or in-person MIDBT programme will be allocated to the wait-list group. In-person MIDBT programmes typically run once per year, while there will be two tMIDBT groups scheduled each year.

The MIDBT is a structured, manualised intervention that teaches mothers with BPD DBT skills to manage the challenges of parenting while supporting their infant’s emotional regulation and socio-emotional development. The programme comprises four modules: mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness. These modules address managing difficult parenting thoughts and emotions, responding effectively to infant distress, supporting emotional regulation in both mothers and infants, and promoting healthy mother–infant relationships and social development.

The tMIDBT programme will run for 24 weeks. During the programme, participants will have access to a secure online portal for MIDBT group-specific content that will include module handouts, skill-specific teaching videos and homework exercises. In addition, printed handouts, homework worksheets and items required to complete activities will be posted to participants before the commencement of each module.

Each week, participants will be expected to watch pre-recorded skill-specific teaching videos (~60 minutes) and complete homework exercises (~60 minutes) before attending the online group session (~90 minutes). Each group will include a maximum of 12 mothers. Infants may be present during group sessions; however, their attendance is not required, and participants may choose to arrange alternative childcare. The group sessions will be delivered via Coviu, a secure telehealth platform approved by SA Health, and will include a review of homework, discussion and application of the weekly skills and a structured mother–infant activity. Participants will join group sessions from home or another agreed private setting using an internet-enabled device with video and audio capability. If needed, participants will be provided with a suitable device and/or mobile data to support participation.

Homework will consist of reflections and activities that are primarily centred on the participant’s child. These activities encourage participants to practice and integrate DBT skills within their parenting role and in interactions with their child, supporting the application of skills and the parent–child relationship. Participants are asked to complete specific worksheets each week and practice daily Mindfulness techniques. At the next group session, participants share examples of their homework, enabling facilitators to assess participants’ understanding of the concepts, provide additional support where needed and reinforce learning. This process also allows participants to learn from one another through shared experiences and practical examples.

Participants will also attend fortnightly 50-minute individual telehealth sessions (via Coviu) with a therapist to support engagement and implementation of the skills. Access to the online programme materials, including pre-recorded skill-specific teaching videos, will be monitored throughout the intervention. Attendance at group and individual sessions, programme completion and reasons for non-attendance or non-completion, where available, will be recorded. Participants will receive SMS and email reminders before each group and individual session. Participants who do not attend a scheduled session or who show reduced engagement with the online programme materials will be followed up by facilitators to identify and address barriers to participation.

The tMIDBT programme will be facilitated by two therapists (a mental health social worker and a mental health nurse) based at Helen Mayo House who are trained and experienced in delivering the MIDBT programme. Facilitators will receive ongoing monthly 50-minute clinical supervision sessions throughout the study. In addition, they will have access to ad hoc supervision, as required, to support the management of clinical risk, adverse events and other issues arising during treatment.
Intervention code [1] 334619 0
Treatment: Other
Intervention code [2] 334710 0
Behaviour
Description of the comparator or control
Comparator 1: Mother–Infant Dialectical Behaviour Therapy (MIDBT)

Participants will receive the established in-person MIDBT programme which involves a weekly 3-hour group session for 24 weeks. In-person MIDBT groups will take place at Helen Mayo House, selected Department for Education Children’s Centres in Adelaide area (SA) and one site at Canberra Health Services in the Australian Capital Territory (ACT). Each group will include a maximum of 12 mothers and their infants.

Required printed handouts and homework activities will be provided to participants before commencement of each module. Each week, participants will be taught DBT skills in group sessions and will be expected to practise these skills during the week as homework exercises (~60 minutes), with the applied skills reviewed within the group at the next session. While mothers undertake the formal DBT skills group learning session, their infants will be cared for by paid childcare staff using consistent primary-caregiver principles. In the last 20 minutes of each session, mothers will be reunited with their infants through structured activities that provide opportunities to practise the skills introduced during the group session. Participants will also be offered fortnightly 50-minute individual sessions with a therapist to support engagement and implementation of DBT skills.

Attendance at group and individual sessions, programme completion and reasons for non-attendance or non-completion, where available, will be recorded throughout the intervention. Participants who do not attend a scheduled session will be followed up by facilitators to identify and address barriers to participation and support ongoing engagement with the programme.

The MIDBT groups will be facilitated by two therapists who are trained and experienced in delivering the MIDBT programme. Facilitators will include mental health professionals (psychiatrists, clinical psychologists, mental health social workers, mental health nurses). They will receive ongoing monthly 50-minute clinical supervision sessions and will also be able to have ad hoc supervisions, if required, to support the management of clinical risk, adverse events and other issues emerging during the study period.

Comparator 2: Wait-list control (reference comparator)

Participants in the wait-list control group will be recruited from existing MIDBT and tMIDBT waiting lists in both SA and ACT with referrals coming from community mental health staff or inpatient mother-infant unit at Helen Mayo House. Recruitment will be aligned with the timing of scheduled groups to ensure participants complete the 24-week study assessment period before the next available programme. During this period, participants will continue to receive usual care from their healthcare team and complete outcome measures on the same time frame as the Intervention and Comparator 1 group. Following the 24-week study period, participants will be offered a place in the next available MIDBT programme. Their participation in the programme will be outside this research study.
Control group
Active

Outcomes
Primary outcome [1] 346024 0
Change in borderline personality disorder symptom severity
Timepoint [1] 346024 0
Baseline and at 24 weeks after intervention commencement (primary timepoint)
Secondary outcome [1] 464290 0
Change in depression symptom severity
Timepoint [1] 464290 0
Baseline and at 24 weeks after intervention commencement
Secondary outcome [2] 464291 0
Change in anxiety symptom severity
Timepoint [2] 464291 0
Baseline and at 24 weeks after intervention commencement
Secondary outcome [3] 464292 0
Change in parental stress severity
Timepoint [3] 464292 0
Baseline and at 24 weeks after intervention commencement
Secondary outcome [4] 464293 0
Change in child social-emotional functioning
Timepoint [4] 464293 0
Baseline and at 24 weeks after intervention commencement
Secondary outcome [5] 464294 0
Change in borderline personality disorder symptoms
Timepoint [5] 464294 0
Baseline and at 24 weeks after intervention commencement
Secondary outcome [6] 464295 0
Change in post-traumatic stress symptom severity (PTSD/complex PTSD)
Timepoint [6] 464295 0
Baseline and at 24 weeks after intervention commencement
Secondary outcome [7] 464296 0
Change in health-related quality of life
Timepoint [7] 464296 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [8] 464298 0
Participants’ experiences of tMIDBT, including perceived acceptability, barriers and facilitators to participation, and recommendations for programme improvement
Timepoint [8] 464298 0
Following completion of tMIDBT, 24–28 weeks after intervention commencement
Secondary outcome [9] 464822 0
Implementation effectiveness of tMIDBT
Timepoint [9] 464822 0
At 24 weeks after intervention commencement
Secondary outcome [10] 464823 0
Implementation effectiveness of tMIDBT
Timepoint [10] 464823 0
At 24 weeks after intervention commencement
Secondary outcome [11] 464824 0
Implementation effectiveness of tMIDBT
Timepoint [11] 464824 0
At 24 weeks after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria are women who:
(1) have an infant under 2 years of age;
(2) have been assessed by a mental health clinician and diagnosed with BPD or identified as having clinically significant BPD traits according to the DSM-5;
(3) have been referred to either the in-person or telehealth MIDBT programme; and
(4) have a satisfactory understanding of English.
The referral pathway for entry into the programme 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
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria are:
(1) current uncontrolled psychosis;
(2) substance dependence requiring detoxification; and/or
(3) significant cognitive impairment that would limit participation in the intervention.
These criteria are intended to ensure that participants have a sufficient level of functioning and are able to engage meaningfully with the therapeutic programme and study procedures.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on the primary clinical outcome, BSL-23, for the comparison between tMIDBT and wait-list control at 24 weeks. Previous MIDBT evaluation data showed a change in BSL-23 scores from baseline to post-intervention with a moderate effect size (mean 43.0 [SD = 18.0] to 32.2 [SD = 18.7]; r = 0.36). This effect size was used as a guide for the sample size calculation and corresponds to Cohen’s f = 0.39. Using ANCOVA, with alpha = 0.05 and power = 0.80, a sample of approximately 26 participants per group is required. To allow for expected attrition of ~30–35%, the study will aim to recruit 40 participants per arm, with a total target sample size of 120 participants across the three study arms.

Quantitative outcomes will be analysed using linear mixed-effects models to estimate changes over time and differences between study groups. Analyses will follow the intention-to-treat principle using all available data. Sensitivity analyses will be conducted using the completer/per-protocol sample. Implementation outcome measures (AIM, IAM and FIM) will be summarised using descriptive statistics and compared between groups (in-person vs telehealth) using appropriate parametric or non-parametric tests. Semi-structured interviews will be analysed using thematic analysis, with de-identified transcripts managed using NVivo.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2026
Actual
Date of last participant enrolment
Anticipated
6/09/2028
Actual
Date of last data collection
Anticipated
25/04/2029
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA

Funding & Sponsors
Funding source category [1] 322319 0
Charities/Societies/Foundations
Name [1] 322319 0
Women’s and Children’s Hospital Foundation, Bloom Grant
Country [1] 322319 0
Australia
Funding source category [2] 322321 0
Charities/Societies/Foundations
Name [2] 322321 0
Hopscotch Foundation
Country [2] 322321 0
Australia
Funding source category [3] 322322 0
Government body
Name [3] 322322 0
ACT Health, Perinatal and Infant Mental Health Consultation Service
Country [3] 322322 0
Australia
Primary sponsor type
Government body
Name
Women's and Children's Health Network
Address
Country
Australia
Secondary sponsor category [1] 325242 0
None
Name [1] 325242 0
Address [1] 325242 0
Country [1] 325242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320824 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 320824 0
Ethics committee country [1] 320824 0
Australia
Date submitted for ethics approval [1] 320824 0
24/01/2026
Approval date [1] 320824 0
02/03/2026
Ethics approval number [1] 320824 0
2020/HRE01120

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

Contacts
Principal investigator
Name 151758 0
A/Prof Anne Sved Williams
Address 151758 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, 5063 South Australia
Country 151758 0
Australia
Phone 151758 0
+61 8 7087 1047
Fax 151758 0
Email 151758 0
[email protected]
Contact person for public queries
Name 151759 0
Anne Sved Williams
Address 151759 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, 5063 South Australia
Country 151759 0
Australia
Phone 151759 0
+61 8 7087 1047
Fax 151759 0
Email 151759 0
[email protected]
Contact person for scientific queries
Name 151760 0
Agne Raneberg
Address 151760 0
Helen Mayo House, Glenside Campus, 226 Fullarton Road, Eastwood, 5063 South Australia
Country 151760 0
Australia
Phone 151760 0
+61 8 7087 1047
Fax 151760 0
Email 151760 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.