Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000962730
Ethics application status
Approved
Date submitted
3/06/2022
Date registered
7/07/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Personality disorder in young people: Evaluation of Screening measures And relational Peer Work (EScAPe)
Scientific title
Personality disorder in young people: Evaluation of Screening measures And the safety and acceptability of relational Peer Work (EScAPe)
Secondary ID [1] 306736 0
Nil known
Universal Trial Number (UTN)
U1111-1276-7811
Trial acronym
EScAPe: Evaluation of Screening measures And relational Peer Work
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Personality disorder 325731 0
Condition category
Condition code
Mental Health 323072 323072 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Relational peer work

Relational peer work is a manualised intervention that aims to provide support and information from the perspective of a peer with lived experience of mental ill-health.

Over 13 weeks, participants will be offered up to 10 individual 50-minute relational peer work sessions. These sessions will be delivered weekly, face-to-face (either in person and/or via videoconferencing), and at a location based on participant preference (e.g. at a clinical site and/or in the community). A 13-week period was chosen to allow for missed sessions.

Sessions will be semi-structured, with core parts covered including: (i) improving psychosocial functioning, (ii) reducing distress, (iii) increasing self-care, and (iv) increasing appropriate help seeking. The sessions will be under pinned by the values of peer work but supported but a manual which has been co-developed alongside peer workers, specifically for this study.

Peer workers will be aged between 18 and 30 years (inclusive), with lived experience of mental ill-health. They will bring knowledge of ‘transdiagnostic’ experiences, such as seeking treatment, receiving a diagnosis, and experiencing distress.

Each peer worker will have undergone Orygen’s comprehensive peer worker training. This includes an online, self-paced, module, 'Youth Mental Health Peer Support 101', which typically takes four hours to complete. This module is available publicly at: https://www.orygen.org.au/Training/Resources/Peer-work/Modules. The peer workers will also attend two interactive, half-day workshops on relational peer work, designed specifically for this study. The first will cover a brief overview of the relational model underpinned by cognitive analytic therapy (CAT), and provide a reflective model for assisting peer workers to better understand young peoples’ sometimes challenging relational patterns and self-defeating coping strategies. The second will provide an overview and discussion of what constitutes a personality disorder, how this might emerge and why it is important to intervene early. This session will cover myths and stigma, and will outline the principles of relational clinical care (Chanen et al, 2008) and how these fit with the principles of peer work. Each session will aim to provide some didactic material and links to resources in a conversation style designed to facilitate participants to engage in reflection and discussion. A senior clinical psychologist and a senior peer worker will deliver these workshops.

The peer workers will receive regular supervision from a senior clinical psychologist and a senior peer worker.

Treatment attendance will be recorded by the peer workers, using a measure developed for this study.

Treatment fidelity will be managed via regular supervision sessions and use of standardised training resources. Fidelity will be assessed with the Peer Specialist Fidelity Measure (Chinman et al, 2016).
Intervention code [1] 323186 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330842 0
Acceptability, assessed as the proportion of young people who consent to participate in the study, determined by data collected by the study team as part of routine study implementation procedures.
Timepoint [1] 330842 0
This will be evaluated at the end of the study.
Primary outcome [2] 331157 0
Acceptability, assessed by the proportion of young people who complete the relational peer work intervention, determined by data from the treatment adherence measure.
Timepoint [2] 331157 0
This will be evaluated at the end of the study.
Primary outcome [3] 331739 0
Safety, assessed by the proportion of young people withdrawn from the relational peer work, determined by data collected by the study team as part of routine study implementation procedures.
Timepoint [3] 331739 0
This will be evaluated at the end of the study.
Secondary outcome [1] 407793 0
Quality of life assessed using the Recovering Quality of Life - 10 items (ReQoL-10).
Timepoint [1] 407793 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [2] 409029 0
Social isolation, assessed with the PROMIS Short Form 2.0 Social Isolation 4a.
Timepoint [2] 409029 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [3] 409031 0
Hope, as measured with the Hope Scale.
Timepoint [3] 409031 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [4] 409032 0
Functioning, measured with the Sheehan Disability Scale (SDS).
Timepoint [4] 409032 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [5] 409033 0
Severity of personality pathology, assessed with the Personality Disorder Severity - ICD-11 scale (PDS-ICD-11).
Timepoint [5] 409033 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [6] 409034 0
Severity of depressive symptoms, assessed with Patient Health Questionnaire - 9 items (PHQ-9).
Timepoint [6] 409034 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [7] 409035 0
Severity of anxiety symptoms, measured with Generalised Anxiety Disorder - 7 items (GAD-7).
Timepoint [7] 409035 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [8] 409036 0
Substance use, measured with the Monitoring Future Drug Use (MFDU).
Timepoint [8] 409036 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [9] 410931 0
Acceptability, assessed as the self-reported level of service satisfaction, determined by data from the headspace Youth (mental health) Service Satisfaction Scale (YSSS).
Timepoint [9] 410931 0
13 weeks after the intervention commences.
Secondary outcome [10] 410932 0
Safety, determined by self-reported level of support during treatment, assessed by a single item ("I was adequately supported during treatment.") with a five-point Likert response scale, developed for this study.
Timepoint [10] 410932 0
13 weeks after the intervention commences.
Secondary outcome [11] 410933 0
Quality of life assessed using the Assessment of Quality of Life – 6 Dimensions (AQoL-6D).
Timepoint [11] 410933 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.
Secondary outcome [12] 410934 0
Severity of personality pathology, assessed with the Levels of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0).
Timepoint [12] 410934 0
Baseline (pre-intervention), 6 weeks and 13 weeks after intervention commences.

Eligibility
Key inclusion criteria
(i) Aged 12 to 25 years (inclusive);
(ii) Score of 9 or more on the 15-item Structured Clinical Interview for DSM-IV Axis II Disorders Personality Questionnaire (SCID-II PQ BPD);
(iii) Be a current headspace client; and
(iv) Be seeking mental health support.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Currently receiving psychosocial treatment;
(ii) Currently receiving peer work;
(iii) An acute psychiatric disorder requiring specialist care;
(iv) Unable to provide informed consent or comply with study protocol; or
(v) Inadequate English fluency to complete study measures.

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
With regard to sample size, there is no universal recommendation for participant numbers in a pilot study. Based on the authors’ previous experience publishing multiple pilot studies in peer review journals, ~30 participants would allow sufficient numbers to determine safety and acceptability. For the exploratory paired sample t tests, with alpha set at .05, a sample of 34 participants would be sufficient to detect a medium effect (.5) (sample-size.net/sample-size-study-paired-t-test). Based on a mean research retention rate of 82% at 12-13 weeks from our previous trials with young people with personality disorder (e.g. 83.5% (116/139), 86.8% (66/76), 76.2% (16/21), we intend to recruit 40 participants.

Descriptive statistics (e.g. mean, standard deviation, median, interquartile range, frequency and proportion) will be generated to characterise participants. Descriptive statistics will also be produced to characterise the relational peer work delivered, the therapeutic alliance, and use of concomitant treatment (Concomitant Psychosocial Treatment questionnaire, MOST usage).

With regard to the safety and acceptability of relational peer work, descriptive statistics will be generated to determine whether a priori thresholds have been met with regard to the intervention being:
Acceptable:
1. >30% of young people invited to participate provide consent;
2. >50% of young people complete treatment; and
3. Mean total score of <3 on the headspace Youth (mental health) Service Satisfaction Scale (YSSS) with lower scores indicating greater satisfaction.
Safe:
4. <10% of young people are withdrawn because their involvement with the intervention interferes with appropriate management of risk to self or others;
5. A mean score of >3 in response to the item ‘I was adequately supported during treatment’ (Likert scale from 1=strongly disagree to 5=strongly agree).

To determine whether there is preliminary evidence for the effectiveness of relational peer work in improving quality of life, paired sample t tests will be conducted and Cohen’s d for repeated measures will be determined for each quality of life measure (ReQoL-10, AQoL-6D). The reliable change index (RCI), the standardised change score for each participant, will also be calculated, and the critical RCI will be set at 1.96. These analyses will be repeated for additional exploratory outcomes (PROMIS social isolation, Hope Scale, SDS, LPFS-BF 2.0, PDS-ICD-11, PHQ-9, GAD-7, and MFDU).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
13/07/2022
Actual
31/08/2022
Date of last participant enrolment
Anticipated
13/04/2023
Actual
16/11/2023
Date of last data collection
Anticipated
11/04/2024
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22232 0
Headspace Sunshine - Sunshine
Recruitment hospital [2] 22233 0
Headspace Werribee - Werribee
Recruitment hospital [3] 22234 0
Headspace Craigieburn - Craigieburn
Recruitment hospital [4] 22235 0
Headspace Glenroy - Glenroy
Recruitment hospital [5] 22273 0
Headspace Melton - Melton
Recruitment postcode(s) [1] 37108 0
3020 - Sunshine
Recruitment postcode(s) [2] 37111 0
3030 - Werribee
Recruitment postcode(s) [3] 37112 0
3064 - Craigieburn
Recruitment postcode(s) [4] 37396 0
3046 - Glenroy
Recruitment postcode(s) [5] 37435 0
3338 - Melton

Funding & Sponsors
Funding source category [1] 311068 0
Charities/Societies/Foundations
Name [1] 311068 0
Perpetual IMPACT Philanthropy Program
Country [1] 311068 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 312400 0
None
Name [1] 312400 0
Nil
Address [1] 312400 0
Nil
Country [1] 312400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310612 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 310612 0
Ethics committee country [1] 310612 0
Australia
Date submitted for ethics approval [1] 310612 0
22/12/2021
Approval date [1] 310612 0
25/03/2022
Ethics approval number [1] 310612 0
22831

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

Contacts
Principal investigator
Name 118262 0
Prof Andrew Chanen
Address 118262 0
Orygen, 35 Poplar Road, Parkville, VIC, 3052
Country 118262 0
Australia
Phone 118262 0
+61 3 9966 3258
Fax 118262 0
Email 118262 0
[email protected]
Contact person for public queries
Name 118263 0
Andrew Chanen
Address 118263 0
Orygen, 35 Poplar Road, Parkville, VIC, 3052
Country 118263 0
Australia
Phone 118263 0
+61 3 9966 3258
Fax 118263 0
Email 118263 0
[email protected]
Contact person for scientific queries
Name 118264 0
Andrew Chanen
Address 118264 0
Orygen, 35 Poplar Road, Parkville, VIC, 3052
Country 118264 0
Australia
Phone 118264 0
+61 3 9966 3258
Fax 118264 0
Email 118264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual study-related participant data collected during the study, after de-identification.
When will data be available (start and end dates)?
Data will be available immediately following publication and for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15498Study protocol  [email protected]
16022Statistical analysis plan  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.