A pragmatic adaptive trial of hope-focused mentoring to improve mental health and social outcomes for young women who are not in education, employment or training in deprived coastal areas (The Looking Forward Project): Feasibility trial stage protocol

Background: A large number of young women are not in education, employment, or training (NEET) in England. This group experiences poorer mental health and social outcomes than young women who work and/or study, and NEET young men. Gender disparities are compounded in deprived coastal areas, where young women especially lack self-agency and aspirations. Research suggests that greater hope lowers risks of staying NEET and developing mental health problems. We developed a hope-focused intervention (HOPEFUL) for this group. HOPEFUL is a flexible modular programme, delivered over 4-12 weeks, with the aim to develop a more hopeful mindset that facilitates setting and pursuing personally meaningful goals. It is designed to be supported by a mentor, if possible selected by the participant from their existing social network. We aim to understand the feasibility of involving NEET young women and mentors in a trial of HOPEFUL conducted in coastal and adjacent local authority areas in Sussex, Kent and Medway, and East Anglia.

Methods: This protocol describes the feasibility stage of an adaptive assessor-blind pragmatic randomised controlled trial (RCT) with 1:1 allocation (stratified by age group and local authority area) to 1) mentor-supported HOPEFUL plus usual support versus 2) usual support with waitlist access to HOPEFUL materials. NEET young women (aged 16-25 years) are recruited from local authority, charity and voluntary, and primary care services, as well as directly from the community using outreach, local advertising, social media, and peer networks. Our adaptive trial design incorporates a preliminary feasibility trial (N=70) with progression to a definitive RCT (N=248), as warranted. Feasibility outcomes (corresponding to the recruitment and retention of young women and mentors) will be assessed post-intervention (16 weeks) against pre-specified progression criteria.

Discussion: Feasibility trial results will inform decisions about progression to a definitive RCT of the HOPEFUL intervention. If warranted, the latter will test whether HOPEFUL improves hope (primary outcome) and secondary outcomes (including mental health symptoms and social outcomes) compared to usual support services at 16 weeks (primary endpoint) and 12-month follow-up. We will disseminate feasibility results using tailored outputs. In the longer term, we anticipate practice impacts through scaled-up access to HOPEFUL.