Title: SHIFT. Self-Harm Intervention, Family Therapy: a randomised controlled trial of family therapy vs. treatment as usual for young people seen after second or subsequent episodes of self-harm
Funder: Department of Health and Social Care

Abstract: The SHIFT Trial has been designed as a pragmatic, individually-randomised, controlled trial comparing Family Therapy (FT) with Treatment as Usual (TAU) for adolescents aged 11 - 17 years who have engaged in at least one previous episode of self-harm. The trial aims to recruit 832 participants from centres in Yorkshire, Greater Manchester and London. Family therapy will be delivered by qualified family therapists using a modified version of the Leeds Family Therapy & Research Centre Systemic Family Therapy Manual (LFTRC Manual), the development of which was funded by the MRC to support trials of FT. The primary outcome is rate of repetition of self-harm leading to hospital attendance 18 months after randomisation. Secondary outcomes include rate of repetition at 12 months, cost-effectiveness, quality of life, and predictive / process measures.

Lay abstract: Adolescents who self-harm are at increased risk of poor emotional and health development, and death by suicide. Many adolescents who self-harm experience difficulties in their family relationships. Therefore family therapy may be an effective treatment for this group of young people, but there is no conclusive research evidence for or against this idea. This study will be a randomised, controlled, trial comparing family therapy with the treatment usually offered to adolescents aged 11 - 17 years who self-harm by the NHS child and adolescent mental health services. The main outcomes will be repetition of self-harm needing hospital treatment 18 months after entering the study. Other important outcomes are repetition at 12 months, the nature of further self-harm, suicidal thoughts, cost effectiveness and quality of life. Adolescents aged 11-17 years who have self-harmed on at least 2 occasions will be recruited at their first follow up contact with child & adolescent mental health services in Yorkshire, Manchester and London. Adolescents will receive either family therapy or treatment as usual. Family therapy will be delivered by specially trained therapists using a research-based and clinically tested manualised approach. Both groups will be treated in the service local to where they live and will receive approximately 8 sessions of treatment. Adolescents with severe depression, sucidality or other serious mental illness will not be asked to take part in the study. Service user groups (adolescents and parents) are involved in the study and ethical approval will be sought prior to commencement. The study team have extensive experience in both research and clinical treatment of adolescents who self-harm and their families. The team includes experts in adolescent self-harm, family therapy, conducting trials, the epidemiology of self-harm and health economics. In order to find enough adolescents who will meet the study criteria a large number of collaborating centres are required and it will take three years to recruit and a further 18 months to complete collection of follow-up data. Costs include funding for a trial manager, statistician, research assistants at each collaborating site, travel and consumables. The training and checks to ensure the family therapy is delivered with good fidelity are also included. The costs outlined will allow a robust trial.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH