Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000679785
Ethics application status
Approved
Date submitted
26/04/2022
Date registered
11/05/2022
Date last updated
25/08/2022
Date data sharing statement initially provided
11/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The PROSPECT project (PROmoting Sexual health in young PEople with mental ill-health): Clinical feasibility Trial
Scientific title
The PROSPECT project (PROmoting Sexual health in young PEople with mental ill-health): Clinical feasibility Trial
Secondary ID [1] 305070 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROSPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
first episode of psychosis 323281 0
borderline personality disorder 323282 0
depression 323283 0
non-psychotic bipolar disorder 323284 0
anxiety 323285 0
sexual health 323286 0
sexually transmitted infections 323287 0
Condition category
Condition code
Public Health 320850 320850 0 0
Health promotion/education
Mental Health 320851 320851 0 0
Anxiety
Mental Health 320852 320852 0 0
Depression
Reproductive Health and Childbirth 320853 320853 0 0
Contraception
Reproductive Health and Childbirth 320854 320854 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be completed face-to-face in individual sessions with a sexual health clinician, who is a Registered Midwife with further professional development training in sexual/reproductive health. Sessions will be held at mental health services that the young people are familiar with.
Baseline assessment: 60-90 minutes in duration, completed within 2 weeks of commencing intervention, with $30 reimbursement.
PROSPECT Intervention (week 0 – week 8): The intervention begins with an initial check in session with clinician, lasting 20-30 minutes. The intervention continues with x4 further educational sessions held every 2 weeks, lasting 60-90 minutes in duration. Content of these sessions includes psychoeducation re. biology, contraception choices, consent, healthy relationships, STI testing and seeking support. The mode of training includes information sharing (via discussion, video content and poster content) and hands-on activities to encourage active learning. Youth friendly activities to prompt conversations such as card sorts, story completion and reflective journaling will be utilised. Demonstrations and with opportunities to practice behavioural skills e.g. condom application will also take place.

One-on-one ‘post-intervention’ assessment visit: 60-90 minutes in duration, completed within 1 week of finishing intervention, with $30 reimbursement. Outcome measures repeated on sexual health and mental wellbeing.

(+/-) One-on-one interview: lasting 30-45 minutes, with further $30 reimbursement, completed on same day as post intervention assessment. Purposive sampling methods will be used to recruit 12 of the participants to take part in an interview about their experience of the PROSPECT intervention.

An optional group session (week 10): lasting 60 minutes in duration, held within 2-4 weeks of completing intervention (TBC as dependent on if enough interest is expressed). An opportunity for young people to connect with others who have completed the intervention. This will be a self-guided group where participants will be invited to discuss what they have learned from taking part in the PROSPECT intervention and an opportunity to debunk some common sexual health myths in an interactive manner, now that they have finished the intervention.

One-on-one ‘follow up’ assessment visit: 60-90 minutes in duration, completed at 3 months after finishing intervention, with $30 reimbursement. Outcome measures repeated on sexual health and mental wellbeing.

Attendance to sessions will be recorded, with active follow up from the research team if required.
Intervention code [1] 321465 0
Behaviour
Intervention code [2] 321466 0
Prevention
Intervention code [3] 321467 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330903 0
Feasibility of a conducting a co-designed sexual health promotion intervention, established through recruitment rates (number of participants referred, number eligible, number agreeing to participate) by the end of the trial. These data will be extracted from recruitment and attendance records collected as part of participant recruitment tracking logs.
Timepoint [1] 330903 0
Post intervention
Secondary outcome [1] 408007 0
The acceptability of the intervention, as measured by 50% of the participants attending 50% or more of the intervention sessions. These data will be extracted from attendance records collected as part of participant recruitment tracking logs.
Timepoint [1] 408007 0
post intervention
Secondary outcome [2] 408008 0
Safety of the intervention, as measured by change in PHQ9 suicidality item from baseline to post intervention and 3 months post intervention.
Timepoint [2] 408008 0
baseline, post intervention and 3 months post intervention.
Secondary outcome [3] 409086 0
Investigate how young people experienced the sexual health intervention using thematic analysis of qualitative interviews
Timepoint [3] 409086 0
Within one week post intervention
Secondary outcome [4] 409391 0
Sexual Health knowledge and attitudes as measured on the Knowledge about HIV (HIV-KQ-18) measure.
Timepoint [4] 409391 0
Baseline, post-intervention, 3 months post intervention
Secondary outcome [5] 409392 0
Sexual health knowledge and attitudes as measured on the Sexual Health Capacity Scale (SHCS)
Timepoint [5] 409392 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [6] 409393 0
Sexual health knowledge and attitudes as measured on the 'Self Efficacy of protective sexual behavior' measure
Timepoint [6] 409393 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [7] 409394 0
Sexual health behaviours as measured by a questionnaire adapted previously from an instrument developed by the Australian Research Centre in Sex, Health & Society (ARCSHS) and includes questions about current sexual partners, drug use whilst having sex, condom and contraceptive use, history of sexually transmitted infections and pregnancy. The items in this questionnaire are treated as single items, with total scores not calculated here.
Timepoint [7] 409394 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [8] 409395 0
Changes in Sexual Functioning Questionnaire (CSFQ)
Timepoint [8] 409395 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [9] 409396 0
An individual’s perceived stigma as a result of their mental health problem, as measured on the 'Mental illness Stigma Scale (MSS-Q)'
Timepoint [9] 409396 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [10] 409397 0
Depression as measured on the PHQ-9
Timepoint [10] 409397 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [11] 409398 0
Anxiety, as measured on the GAD-7
Timepoint [11] 409398 0
Baseline, post intervention, 3 months post intervention
Secondary outcome [12] 409399 0
Level of functioning in social and occupational domains for the young person as measured on the SOFAS
Timepoint [12] 409399 0
Baseline, post intervention, 3 months post intervention

Eligibility
Key inclusion criteria
• Aged between 15 and 25
• Be a young person accessing Orygen’s clinical services. The following specific criteria apply for each of the Orygen clinical services:
- for EPPIC: experiencing a first episode of psychosis (defined as experiencing at least one positive psychotic symptom on a daily basis for at least one week)
- for PACE: might be at risk of developing psychosis i.e. attenuated positive psychotic symptoms at subthreshold symptom intensity or frequency, present within the last year for at least a week, or brief limited intermittent psychotic symptoms, which are full-threshold psychotic symptoms that have lasted no more than 1 week and remitted without intervention, or trait vulnerability, defined as either schizotypal personality disorder in that individual, or a first-degree relative with a psychotic disorder diagnosis.
- for HYPE : meeting 3 out of the 9 DSM-5 criteria of borderline personality disorder
- for the Mood clinic: experiencing depression, bipolar II disorder (non-psychotic bipolar disorder) and severe anxiety disorders such as anxiety and obsessive-compulsive disorder.
- for Headspace centres: experiencing mild-moderate common mental health disorders, predominantly anxiety and depression.
- For Parkville clinic: experiencing a range of mental health disorders but do not reach eligibility criteria for OSP, for example mood, anxiety, or eating disorders.

• Ability to provide informed consent, including ability to complete the ‘Evaluation to Sign an Informed Consent Document for Research’ if aged 15-17, or questions around capacity to provide consent

• Ability to communicate in English
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A young person who is likely to experience discomfort or distress, (due to cognitive impairment, intellectual disability, mental illness or their participation in the intervention), as determined by the study PI or CI.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
QUANTATIVE DATA
As this is a one-arm feasibility trial, standard descriptive statistical procedures will be undertaken to establish the feasibility and acceptability of the study intervention. For example, we will calculate the number of participants needed to invite to take part in order to recruit one participant to the trial, and the percentages of participants who complete all intervention sessions. The flow of participants will be detailed in a CONSORT flow diagram.
QUALITITAVE DATA
Data gathered from qualitative interviews will be transcribed verbatim and subsequently analysed using thematic analysis. Where possible, a young person with lived experience will collaborate with the research team to analyse the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2022
Actual
16/06/2022
Date of last participant enrolment
Anticipated
16/11/2022
Actual
Date of last data collection
Anticipated
16/02/2023
Actual
Sample size
Target
40
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22050 0
Orygen Youth Health - Parkville - Parkville
Recruitment hospital [2] 22051 0
Headspace Glenroy - Glenroy
Recruitment hospital [3] 22052 0
Headspace Sunshine - Sunshine
Recruitment hospital [4] 22246 0
Headspace Craigieburn - Craigieburn
Recruitment hospital [5] 22247 0
Headspace Werribee - Werribee
Recruitment postcode(s) [1] 37173 0
3052 - Parkville
Recruitment postcode(s) [2] 37174 0
3046 - Glenroy
Recruitment postcode(s) [3] 37175 0
3020 - Sunshine
Recruitment postcode(s) [4] 37409 0
3064 - Craigieburn
Recruitment postcode(s) [5] 37410 0
3030 - Werribee
Recruitment postcode(s) [6] 37411 0
3337 - Melton

Funding & Sponsors
Funding source category [1] 309469 0
Government body
Name [1] 309469 0
Department of Health
Country [1] 309469 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
35 Poplar Road, Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 312677 0
None
Name [1] 312677 0
Address [1] 312677 0
Country [1] 312677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309258 0
Melbourne Health HREC
Ethics committee address [1] 309258 0
Ethics committee country [1] 309258 0
Australia
Date submitted for ethics approval [1] 309258 0
24/11/2021
Approval date [1] 309258 0
08/03/2022
Ethics approval number [1] 309258 0

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

Contacts
Principal investigator
Name 113522 0
Prof Andrew Thompson
Address 113522 0
Orygen, 35 Poplar road, Parkville, Victoria, 3052
Country 113522 0
Australia
Phone 113522 0
+613 9966 9100
Fax 113522 0
Email 113522 0
[email protected]
Contact person for public queries
Name 113523 0
Ellie Brown
Address 113523 0
Orygen, 35 Poplar road, Parkville, Victoria, 3052
Country 113523 0
Australia
Phone 113523 0
+61 428 288 070
Fax 113523 0
Email 113523 0
[email protected]
Contact person for scientific queries
Name 113524 0
Ellie Brown
Address 113524 0
Orygen, 35 Poplar road, Parkville, Victoria, 3052
Country 113524 0
Australia
Phone 113524 0
+61 428 288 070
Fax 113524 0
Email 113524 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
Due to lack of funding to support a research assistant to manage these enquiries


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.