Rates of mental health difficulties among girls and young women in the UK have risen sharply, and disproportionately so for those from marginalised groups. My Story and Me is a new digital public mental health intervention that uses storytelling to reduce stigma, increase awareness and support early help-seeking among girls and young women aged 14–18. The feasibility study aims to determine the acceptability of the intervention and future full trial, including assessing optimal settings and meaningful changes in the primary outcome measure (anxiety and depression).

This is an 18-month mixed-methods, uncontrolled feasibility study conducted in secondary schools, further education colleges and community organisations across the UK. We will recruit 120–180 participants. Quantitative data will be collected at baseline and 7-month follow-up. The primary outcomes are anxiety and depression, and secondary outcomes are social support, mentalising, stigma, quality of life, loneliness, empowerment, intervention acceptability, resource use and randomisation acceptability. Platform-level engagement data will assess adherence and fidelity. Qualitative interviews with young women and staff will explore acceptability, feasibility, mechanisms of change and views on trial procedures, including randomisation in a future full trial. Analysis will be descriptive and exploratory, including comparisons across settings and priority groups (LGBTQIA+, neurodivergent and those experiencing digital poverty). A framework and reflexive thematic analysis approach will be used for qualitative data. Prespecified progression criteria will inform decisions about advancing to a full cluster randomised trial.

The University College London Research Ethics Committee (0692) has approved the My Story and Me protocol. Interested participants will be required to complete an expression of interest and consent form to take part in the study, and young people under 16 years old will be required to obtain parent/carer informed consent. Results will be disseminated through peer-reviewed publications, lived experience summaries, a policy briefing and academic conference presentations.

ISRCTN12191423.

The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.

A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.

Secondary care NHS perinatal health services across multiple centres in England.

A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.

Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.

The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.

Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.

On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.

SRCTN18308962.