The SHIFT Trial is an NIHR HTA-funded 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 intervention, Family therapy, is delivered by qualified Family Therapists using the Leeds Family Therapy & Research Centre Systemic Family Therapy Manual (LFTRC Manual), adapted for use in the self-harm population.
We worked with around 40 child and adolescent mental health teams in Yorkshire, Manchester and London. We invited over 800 young people aged between 11 and 17 years old who had self-harmed at least twice to take part in the re-search. As well as the young person, their main caregiver (for example, Mum or Dad) also took part. If they both agreed they were then randomly allocated to either family therapy or the usual treatment in their local CAMHS.
We followed the young person and their main caregiver for 18 months to collect the primary outcome, repetition of self-harm leading to hospital attendance, and secondary outcomes including cost-effectiveness and quality of life.
The trial reached its target of 832 participants recruited on 30th December 2013 and the results of the study have been published.
Additional funding was received to extend the study and see if any differences between the family therapy and treatment as usual groups can be seen at least 36 months after randomisation.
Cottrell D J, Wright-Hughes A, Collinson M, Boston P, Eisler I, Fortune S, Graham E H, Green J, House A O, Kerfoot M, Owens D W, Saloniki E, Simic M, Tubeuf S & Farrin A J. A pragmatic randomised controlled trial and economic evaluation of family therapy vs. treatment as usual for young people seen after second or subsequent episodes of self-harm: the Self-Harm Intervention – Family Therapy (SHIFT) trial. Health Technol Assess 2018;22(12)
Main results publication:
Cottrell DJ, Wright-Hughes A, Collinson M, Boston P, Eisler I, Fortune S, Graham EH, Green J, House AO, Kerfoot M, Owens DW, Saloniki EC, Simic M, Lambert F, Rothwell J, Tubeuf S, Farrin AJ. Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial. Lancet Psychiatry 2018; 5: 203–16.
Trial Intervention Manual:
To request access to the SHIFT manual please click here.
What were the main findings?
We found that those who had family therapy went to hospital after self-harm about the same number of times as those who had treatment as usual. This means that there was no real difference between the treatments; they were about as good as each other.
Did you find out anything else?
Yes, we found that:
We also looked at the cost effectiveness (value for money) of the two treatments. There was no evidence that family therapy was cost-effective when compared with treatment as usual when we focused on just the young people who took part. However, there was a suggestion that family therapy may be cost effective if the health benefits to caregivers are also taken into account.
What information was collected about participants?
We collected lots of information about the young person and their family at the beginning, before treatment started so that we can answer the research questions. Treatment lasted around 6-8 sessions although some people had more and some less. We collected more information over the next 18 months for each participant and again 36 months after the last participant had been recruited, including whether the young person had presented to hospital having self-harmed again. At the end of the study, data will be securely stored at the CTRU and CAMHS units for a minimum of 5 years.
The information collected on participants included personal data, such as name, address and date of birth, and information about their health and any hospital admissions. This information was collected from the participant, their medical notes and from a central place called the NHS Digital formally known as the Health and Social Care Information Centre (known as the HSCIC) which holds information from all the NHS hospitals in England. We sent NHS number, Gender, Date of Birth and Postcode to NHS Digital and in return they informed us of A&E attendances and admissions to hospital, and deaths.
Information obtained from NHS Digital was linked to the information we already hold from the study. Identifiers were removed from any medical data to avoid identification.
Who has organized this project?
The SHIFT study is coordinated by the Clinical Trials Research Unit (CTRU) at the University of Leeds. The Chief Investigator is Professor David Cottrell (email@example.com).
If you have any general trial-related questions, please contact the CTRU: firstname.lastname@example.org
Sharing data when the research has finished
Collecting data for research takes a lot of time and money to do. One way we can get the most benefit from this work is to make data available, when the research has finished, to other researchers who would like to use it for other research projects. These other researchers may be at the CTRU or University of Leeds, or in other organisations such as universities, NHS organisations or companies involved in health and care research. They may be in the UK or abroad.
If we get requests to use our research data, we will only agree to share it for valid and worthwhile research projects in healthcare or medicine. The data we share does not identify individuals and is not combined with other data in a way that means individuals could be identified. We only share data with qualified researchers who agree to store data securely.
Any data we share cannot be used to contact individuals and does not affect anyone’s care. It is not used to make decisions about future services available to individuals, such as insurance.
Information governance and individuals’ rights
By law, we are required to identify a ‘lawful basis’ for dealing with people’s personal data.
For our research data, like with the SHIFT study, this is ‘task in the public interest’, or in other words, we are collecting data that we need in order to complete our research, which aims to improve healthcare for the general public. All our projects are ethically approved, and receive funding from charities or public bodies. All our projects involve patients or patient groups in how they are designed and run.
For all of our projects we need to collect data about people’s health, which is by law a ‘special category’ of personal data. We need an additional lawful basis to justify collecting and using this. In our case, this lawful basis is that the use of the data is necessary for scientific research purposes.
Because we use personal data to support scientific research in the public interest, individuals participating in our research do not have the same rights regarding their personal data as they would in other situations. The laws mentioned above say that data being used for research needs to be protected to make sure the research results are reliable and useful to the public. This means that the following rights are limited for individuals who participate or have participated in our research:
Who is responsible for how data is used?
The University of Leeds is the ‘data controller’, which means the University has overall responsibility for what data are collected and how they are handled.
Any queries or concerns about the way personal data has been processed should be sent to the University of Leeds Data Protection Officer using any of the following details:
The University of Leeds data controller registration number provided by the Information Commissioner’s Office is Z553814X.
Individuals whose data are held at the University of Leeds or CTRU, who are not satisfied with the response to any queries or complaints, or believe their data is being used unlawfully, have the right to complain to the Information Commissioner’s Office.