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The PROSPECT project (PROmoting Sexual health in young PEople with mental ill-health): Clinical feasibility Trial

The PROSPECT project (PROmoting Sexual health in young PEople with mental ill-health): Clinical feasibility Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000679785
Acronym
PROSPECT
Enrollment
7
Registered
2022-05-11
Start date
2022-06-16
Completion date
2022-11-16
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Young people with mental ill-health continue to be at a higher risk for poorer sexual health compared to their peers in the general population. However, there is yet to be an intervention introduced that promotes sexual health and wellbeing within this at-risk group. Ensuring that young people have good sexual/reproductive health is a public health concern, yet is commonly overlooked by healthcare professionals. Learnings from a large systematic review have shown that future interventions should address sexual health as more than the absence of negative outcomes in at risk populations. The PROSPEct project has developed a sexual health promotion intervention, which was co-designed with key stakeholders, in order to address this issue. The purpose of this feasibility trial will be to determine if it is feasible and acceptable to run a trial of this co-designed sexual health promotion intervention with young people with mental ill-health. With the knowledge gained from this feasibility trial, we hope to be able to answer this research question and establish the parameters for a fully powered trial. We hope that findings from the PROSPECT project can inform clinical practice, and that this intervention can eventually translate to routine clinical practice whereby a multidisciplinary approach is taken to ensure positive sexual health for young people with mental illness.

Interventions

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 init

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.

Sponsors

Orygen
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026