The prevalence of depression and mood disorders has been steadily rising in Australian youth, with a concomitant increase in antidepressant pharmacotherapy prescription rates. Yet, the tolerability and efficacy of antidepressant drugs in youth remain poor. Pharmacogenetic (PGx) testing, or the personalised and guided treatment of medication based on genetic data, has been suggested to improve the effectiveness and tolerability of antidepressants. However, limited studies have evaluated the utility of antidepressant PGx-guided treatment in adolescent and young adult populations. Thus, this pilot randomised controlled trial (RCT), the GENE-YD Study, will evaluate the feasibility for a large-scale RCT assessing the effect of PGx-guided antidepressant prescription vs treatment as usual in youth with major depressive disorder (MDD).

Eighty young people between 16 and 24 years of age and in the early stages of pharmacotherapy treatment for MDD will be recruited. Following initial screening, participants will be randomised on a 1:1 ratio to either the intervention or control study group. Participants in the intervention condition will have their treatment tailored based on their PGx profile. Participants randomised into the control group will have their prescription based on current best practice recommendations, or treatment as usual. Individuals will be assessed at drug prescription baseline and again 6 and 12 weeks following drug prescription. The primary outcome of the study will be to evaluate the feasibility and acceptability of the GENE-YD protocol. Specifically, this study will explore participation recruitment strategies and attrition to the study protocols to guide the recruitment processes of a large-scale RCT, along with participating satisfaction in overall study protocols. Secondary outcomes will inform the utility and variability of specific measures (eg, depression rating scales, quality of life measures and medication adherence scales) that may be scaled up for use in a future full-scale trial.

Ethics approval was granted by the Department of Health, Western Australia’s Human Research Ethics Committee (RGS0000006822) and recognised by the University of Western Australia’s Human Research Ethics Committee (2024/ET000685). All participants will be required to provide written informed consent. Results will be published in international peer-reviewed journals.

ACTRN12624000760572.

Practice guidelines recommend addressing patient non-medical drivers of health such as access to nutritious food and transportation as part of whole-person care. Emergent electronic health record (EHR)-based tools can enable non-medical needs care coordination, but adoption commonly faces workflow and infrastructure barriers. Targeted implementation support strategies (eg, training, practice facilitation) can enhance technology adoption in healthcare settings, but no prior research has assessed if implementation strategies can improve how care managers use enabling technologies for non-medical needs care coordination. This study will test whether providing implementation support to primary care health centre care management teams improves the adoption of EHR-based enabling technologies to address patients’ non-medical needs.

This hybrid implementation-effectiveness type 2 pragmatic trial has a mixed methods design. The primary outcomes include: (1) Whether patients enrolled in care management programmes have been screened for unmet non-medical health-related needs and (2) Whether patients with identified unmet non-medical health-related needs received a referral to a community organisation to address their need. The secondary outcomes include: (1) Whether referrals for financial-related non-medical needs had a documented outcome in the EHR, such as successful connection to services, service unavailability or other disposition statuses, (2) Whether the referral outcomes indicated ‘successful connection to services’ and (3) Clinical markers including hypertension and diabetes control. Formative evaluation of barriers and facilitators to using EHR tools to conduct non-medical needs screening, referrals and tracking of receipt of services will include semi-structured interviews and a ‘guided tour’ of enabling technology used by care managers. A modified Delphi process will then inform the development of a set of implementation strategies for inclusion in the intervention. The intervention will be piloted in three health centres, refined, then tested in a stepped-wedge cluster-randomised trial in 20 health centres.

We obtained ethics approval for all study activities from Advarra Institutional Review Board (registration number #00000971). Results will be disseminated to Health Centres and Health Centre network nationally at meetings and we will disseminate to researchers via manuscripts in peer-reviewed journals and scientific meetings.

NCT06489002.

Self-harm is the strongest predictor of suicide in young people. Self-harm presentations to the emergency department (ED) are associated with repeat self-harm and suicide. Rapid follow-up contact after ED offers an opportunity to intervene before self-harm becomes an established coping strategy. Despite recent progress in self-harm treatment, currently, there are no evidence-based interventions to prevent future self-harm and suicide offered to young people after visits to the ED. Preliminary evidence suggests therapeutic assessment and rapid follow-up contacts may reduce self-harm and improve engagement in follow-up care. In this study, we assess the clinical and cost-effectiveness of a brief psychological intervention, supporting adolescents with self-harm (SASH), in addition to standard care in a randomised controlled trial, compared with standard care only. As per National Institute for Health and Care Excellence guidelines, standard care involves at least one follow-up by a mental health professional within 7 days of ED discharge.

The SASH intervention comprises up to six follow-up contacts with a mental health professional delivered over approximately 2 months for young people and their carers using a solution-focused approach, shortly after presenting to the ED. Participants are aged 12–18, presenting to the ED with self-harm or suicidal ideation (with self-harm in the past month), with capacity to consent. We aim to recruit 144 young people into the trial who will be randomised on a 1:1 basis to the SASH intervention or treatment as usual. Participants are assessed postintervention/standard care and at 6-month follow-up after randomisation. Self-reported self-harm is assessed via text message survey every 2 weeks during the 6-month follow-up period. The primary outcome is self-reported episodes of self-harm in the past month assessed at 6 months by summing three behavioural domains of the self-injurious thoughts and behaviours interview. We hypothesise that the therapeutic relationship with the mental health practitioner will mediate this relationship. Secondary outcomes include symptoms of depression and anxiety, frequency of reattendance at ED, death by suicide, school attendance, well-being and additional domains of self-harm-related behaviour and thoughts in the past month. The trial will also consider service use, costs to carer and carer health-related quality of life to evaluate the costs and cost-effectiveness of the intervention.

London-Riverside Nation Health Service REC (22/LO/0400) provided a favourable ethical opinion. Findings will be disseminated through social media, a website, scientific papers, conferences and reports, in collaboration with our Young Person’s Lived Experience Advisory Group.

ISRCTN81846131.

13.0, 30.06.2025.