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Trial registered on ANZCTR


Registration number
ACTRN12616000304437
Ethics application status
Approved
Date submitted
1/03/2016
Date registered
8/03/2016
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a group intervention for family and friends of youth with borderline personality disorder.
Scientific title
A randomised controlled trial of a group intervention for family and friends of youth with borderline personality disorder.
Secondary ID [1] 288253 0
None.
Universal Trial Number (UTN)
Trial acronym
Making Sense of Borderline Personality Disorder (MS-BPD)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 297188 0
Condition category
Condition code
Mental Health 297406 297406 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MS-BPD group is a manualised psychoeducation group program for family members or friends of young people (ages 15 to 25) with borderline personality disorder features. The group consists of three 2-hour sessions facilitated by two specialist youth mental health clinicians from Orygen Youth Health, and is run in the evening over three consecutive weeks (ie. a 15-day intervention). The family intervention aims to provide psychoeducation regarding the diagnosis of BPD within a youth developmental context, an explanatory model of the causes of BPD, rationale for and nature of the treatment of BPD, and information about the difficult relationship processes that often occur for youth with BPD. Information is delivered as a power point presentation and participants are afforded the opportunity to ask questions and share their experiences, if they wish to. An attendance record will be kept by the group facilitators.

Participants who are assigned to the MS-BPD group study arm will also have access to the online BPD psychoeducation program for the same 15-day period that they are participating in the MS-BPD group. This program comprises two modules: ‘Introduction to Early Intervention for Borderline Personality Disorder?’ and ‘Caring For A Young Person with Borderline Personality Disorder - Information for Families and Friends’. The modules take approximately 30 minutes and 20 minutes to complete respectively. The modules have been designed to be used by family and friends of youth (15-25 year olds) with borderline personality disorder features. The information is delivered via a combination of written material and through video interviews with experienced clinicians, patients and parents. It is a self-directed program that can be accessed 24 hours a day, at the convenience of the family member or friend, and as often as the family or friend would find useful. The program is designed to record the date, time and duration of each visit. Access to the online BPD psychoeducation program will be provided on the day of the first MS-BPD group session.
Intervention code [1] 293543 0
Treatment: Other
Intervention code [2] 294104 0
Behaviour
Comparator / control treatment
The comparison group will only have access to the online BPD psychoeducation program. This program has been designed for family and friends of youth (15-25 year olds) with borderline personality disorder features. The program comprises two modules: ‘Introduction to Early Intervention for Borderline Personality Disorder?’ and ‘Caring For A Young Person with Borderline Personality Disorder - Information for Families and Friends’. The modules take approximately 30 minutes and 20 minutes to complete respectively. The information is delivered via a combination of written material and through video interviews with experienced clinicians, patients and parents. It is a self-directed program that can be accessed 24 hours a day, at the convenience of the family member or friend, and as often as the family or friend would find useful. The program is designed to record the date, time and duration of each visit. Access to the online BPD psychoeducation program will be provided for a 15-day period.
Control group
Active

Outcomes
Primary outcome [1] 296962 0
Burden of care as measured by the total of the negative subscales of Experiences of Caregiving Inventory (ECI).
Timepoint [1] 296962 0
Week 7 follow-up assessment
Secondary outcome [1] 319771 0
Positive experience of caregiving as measured by the total positive subscales of the Experiences of Caregiving Inventory (ECI).
Timepoint [1] 319771 0
Week 7 follow-up assessment
Secondary outcome [2] 319772 0
Coping as measured by the Coping Inventory for Stressful Situations (CISS).
Timepoint [2] 319772 0
Week 7 follow-up assessment
Secondary outcome [3] 319773 0
Personality disorder knowledge as measured by selected items from the Personality Disorder Knowledge Attitudes and Skills Questionnaire (PDKASQ).
Timepoint [3] 319773 0
Week 7 follow-up assessment
Secondary outcome [4] 319774 0
Distress (mood and anxiety symptoms) as measured by the Kessler Psychological Distress Scale (K-10).
Timepoint [4] 319774 0
Week 7 follow-up assessment
Secondary outcome [5] 321437 0
Expressed emotion as measured by the Family Questionnaire.
Timepoint [5] 321437 0
Week 7 follow-up assessment
Secondary outcome [6] 321438 0
Quality of life as measured by the Assessment of Quality of Life - 8D and the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form.
Timepoint [6] 321438 0
Week 7 follow-up assessment

Eligibility
Key inclusion criteria
Client:
* Client of the HYPE clinic, Orygen Youth Health;
* Aged 15-25 years inclusive;
* Able to give informed consent;
* Able to comply with study procedures; and
* Sufficient fluency in English to complete study procedures.

Family/friends:
* A family member, partner, or friend of a young person (aged 15-25 years inclusive) attending HYPE;
* Able to give informed consent;
* Able to comply with study procedures; and
* Sufficient fluency in English to complete study procedures.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clients:
* Currently or previously meeting the Orygen Youth Health’s Early Psychosis Prevention and Intervention Clinic (EPPIC) criteria for first episode psychosis.

Family/friends/carers:
* Family member, partner, or friend of a HYPE client that meets the Orygen Youth Health client exclusion criteria.
* Previous participation in the MS-BPD group program or online BPD psychoeducation program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation concealment will be achieved by using a password-protected computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be computer-generated by an independent statistician. Intervention participants (families, friends, etc.) will be assigned randomly and consecutively as a unit in a ratio of 1:1 to one of the two interventions. Treatment allocation will use randomised permuted blocking and will be stratified by the client's age (<18 years old vs 18 years old & older) and client's sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
No.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis:
Analyses will be based within a repeated measures design with planned contrasts depicting group differences between the measures taken on the baseline and 7-week follow-up assessments. There are two sources of potential non-independence (clustering) of observations. The first is participation in an intervention group (e.g., BPD online program or MS-BPD group + BPD online program) by more than one family member/friend. The second source of clustering only applies to the MS-BPD group + BPD online module treatment arm, and that is the MS-BPD group attended. So the family unit is considered a cluster and with the treatment arm, the MS-BPD group attended is the intervention cluster (IC). Such a design is referred to as a partially nested clustered randomised controlled trial (Lohr, Schochet, & Sanders, 2014).

To accommodate this design, mixed models will be used with group, family membership and MS-BPD group fitted as random factors (Lohr et al., 2014). Mixed models also have the advantage that they retain the observations of participants who have missing observations. In contrast, conventional repeated measures ANOVA excludes those with any missing observations. Although low levels of missing data are expected, mixed modelling represents a preferable approach to analysis (see Hamer & Simpson, 2009).

The models will be extended to include baseline and time varying covariates and categorical variables that may confound outcomes and require adjustment. A two step approach will first identify individually significant and near-significant associations with outcome measures and then simultaneous fit these variables in a multiple predictor model. This approach will be applied to each of the outcomes specified in the hypotheses. Adaptations of this approach will be used to explore predictors of outcome.

The most frequent attendees of the MS-BPD groups to date have been the mothers of clients. As family members might play different caring roles and that of the mother is highly significant, exploratory analyses of this subgroup alone is proposed. It is recognized that these analyses will have reduced power to detect change and the study has not been powered for subgroup analyses.

Descriptive statistics that characterise the clients, that is, youth with borderline personality disorder features, will also be reported.

Sample size and power:
Power analyses must take into account the clustering effects due to family cluster as well as intervention cluster (IC) within the treatment group (Lohr et al., 2014). Power calculations were based on the formula provided by Lohr et al. (2014). The average number of individuals per family unit is 1.5 (mH). The responses of members from within the same family unit may be more alike than responses between different families, because the participants are carers of the same client. It is difficult to estimate the magnitude of likely intraclass correlations but substantial effects must be considered. For this purpose, the intraclass correlation coefficient was conservatively estimated to be at 0.2.

It is recognized that receiving counselling or psychoeducation in a group setting may result in participants’ responses being more alike within groups than responses by participants in other groups. This may arise due to effects associated with the group’s facilitator, events or experiences in the group and group dynamics. In the case of psychoeducation interventions, clustering effects are typically very low. This is due to the absence of any pre-existing clustering (in contrast to cluster randomized trials), the programmatic nature of the intervention and the limited amount of interaction participants have within the groups. We conservatively estimated that the intervention cluster to be 0.03. The average number of participants per MS-BPD group has been about 10 (J). So using these parameters the maximum design effect would be 1.24.

Taking the above factors into account and assuming a correlation of 0.5 between baseline and outcome measures, a sample of 80 intervention participants comprising approximately 54 families (27 families in MS-BPD group + online BPD program group and the online BPD program alone group) would have power of 80% to detect a difference in 0.5 standard deviations between the MS-BPD group + online BPD program and online BPD program alone group. This effect size is regarding as a medium size difference. Based on previous groups, this would require four waves of the MS-BPD group program. Based on the consent rate in our pilot study, we estimate that 54 clients will consent to providing access to their information for our analyses. The total sample will thus comprise 54 clients (youth with borderline personality disorder features) and 80 intervention participants (family and friends).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2016
Actual
31/03/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
8/11/2017
Date of last data collection
Anticipated
30/09/2017
Actual
8/11/2017
Sample size
Target
134
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12494 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 292635 0
Hospital
Name [1] 292635 0
Melbourne Health
Country [1] 292635 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre of Excellence in Youth Mental Health
Address
Sponsor Operations
Orygen, The National Centre of Excellence in Youth Mental Health
Locked Bag 10
Parkville 3052
Country
Australia
Secondary sponsor category [1] 291353 0
None
Name [1] 291353 0
None.
Address [1] 291353 0
None.
Country [1] 291353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294115 0
Melbourne Health Human Research and Ethics Committee
Ethics committee address [1] 294115 0
Office for Research
Level 6 East
300 Grattan Street
The Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [1] 294115 0
Australia
Date submitted for ethics approval [1] 294115 0
27/05/2014
Approval date [1] 294115 0
17/07/2014
Ethics approval number [1] 294115 0
2014.105

Summary
Brief summary
Borderline Personality Disorder (BPD) is a severe mental disorder that arises during adolescence and young adulthood. This study investigates the most effective form of psychoeducation for families and friends of young people (15-25 years old) presenting for treatment of BPD for the first time. It is a randomised controlled trial comparing two interventions: the MS-BPD group with online BPD program compared with the individual, self-directed online BPD program alone. The primary outcome is reduction in burden of care. It is expected that post-intervention, participants who receive the MS-BPD group in addition to the online BPD program will have better outcomes than those who receive the online BPD program without the MS-BPD group. The measures to be used assess level of coping, burden, and personality disorders knowledge of participants, along with mood and anxiety symptoms, expressed emotion, and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62526 0
Prof Andrew Chanen
Address 62526 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, (Locked Bag 10), Parkville, VIC, 3052
Country 62526 0
Australia
Phone 62526 0
+61393422800
Fax 62526 0
+61393873003
Email 62526 0
andrew.chanen@orygen.org.au
Contact person for public queries
Name 62527 0
Prof Andrew Chanen
Address 62527 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, (Locked Bag 10), Parkville, VIC, 3052
Country 62527 0
Australia
Phone 62527 0
+61393422800
Fax 62527 0
+61393873003
Email 62527 0
andrew.chanen@orygen.org.au
Contact person for scientific queries
Name 62528 0
Prof Andrew Chanen
Address 62528 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, (Locked Bag 10), Parkville, VIC, 3052
Country 62528 0
Australia
Phone 62528 0
+61393422800
Fax 62528 0
+61393873003
Email 62528 0
andrew.chanen@orygen.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA comparison of experiences of care and expressed emotion among caregivers of young people with first-episode psychosis or borderline personality disorder features.2022https://dx.doi.org/10.1177/00048674211050299
N.B. These documents automatically identified may not have been verified by the study sponsor.