Plain English Summary
Background and study aims
The main aim of this study is to assess the effectiveness of Family Therapy (FT) compared to Treatment as Usual (TAU) for adolescents aged 11-17 years who have engaged in at least one previous episode of self-harm, as measured by rates of repetition of self-harm leading to hospital attendance over an 18-month period.
Who can participate?
The study aimed to recruit 832 families (adolescents aged 11-17 years who have engaged in at least one previous episode of self-harm, and their parent/guardian) over a 3-year period from Child and Adolescent Mental Health Services (CAMHS) in Yorkshire, Greater Manchester and London.
What does the study involve?
Families who consented to participate in the trial were randomly allocated to either TAU (standard care offered by local CAHMS team) or FT (delivered by trial-specific Family Therapists). If allocated to FT, families were requested to attend about eight FT sessions over a 6-month period depending on individual requirements. All families were then followed-up at 3, 6, 12 and 18 months to complete questionnaires and assessments.
What are the possible benefits and risks of participating?
The trial team do not anticipate any addition risks in taking part in this trial. Although the trial team hope that families completing family therapy will find the treatment useful we can't say that this treatment will definitely help. The same would be true for families not taking part in the trial. The main benefit is that the research project will help us learn more about how to help people who have self-harmed in the future.
Where is the study run from?
The study is being led by a team of researchers at the University of Leeds, in collaboration with researchers at the University of Manchester and Kings College London.
When is the study starting and how long is it expected to run for?
The first family was recruited to the trial in April 2010. The trial closed to recruitment in December 2013 (44 months), having recruited the full sample required for statistical analysis. The trial is now in the follow-up phase ahead of final analysis with trial results anticipated by early 2016.
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).
Who is the main contact?
Chief Investigator - Professor David Cottrell, University of Leeds (d.j.cottrell@leeds.ac.uk)
Senior Trial Manager - Ms Liz Graham, University of Leeds (e.h.graham@leeds.ac.uk)
Trial website
Contact information
Type
Scientific
Primary contact
Prof David Cottrell
ORCID ID
Contact details
Level 8
Worsley Building
University of Leeds
Clarendon Way
Leeds
LS2 9NL
United Kingdom
-
d.j.cottrell@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/33/01
Study information
Scientific title
SHIFT Trial. 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
Acronym
SHIFT
Study hypothesis
The primary objective is to assess the effectiveness of Family Therapy (FT) compared to Treatment as Usual (TAU) as measured by rates of repetition of self-harm leading to hospital attendance 18 months after randomisation.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/073301
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0007/51775/PRO-07-33-01.pdf
Updated 20/08/2013: the overall trial end date was changed from 28/02/2014 to 31/03/2016.
Updated 07/01/2014: the SHIFT trial has now closed to recruitment, achieving its target sample size of 832 participants on 30/12/2013.
Ethics approval
Leeds (West) Research Ethics Committee, 23/04/2009, REC ref: 09/H1307/20
Study design
Randomised controlled multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Self-harm in adolescents
Intervention
Participants will be individually randomised to either FT or TAU arm.
FT: This will be delivered by qualified family therapists using a modified version of the Leeds Family Therapy & Research Centre Systemic Family Therapy Manual (LFTRC Manual). Adolescents and their families randomised to receive FT will receive up to 8 sessions of FT of approximately 1 h 15 min hours duration, delivered over 6 months at approximately monthly intervals but with more frequent initial appointments.
TAU: This treatment is likely to be diverse and may involve individual and/or family-orientated work, delivered by a range of practitioners with various theoretical orientations. The average duration of treatment in CAMHS is approximately 6 sessions.
Patients in both arms of the trial will be followed up for 18 months post-randomisation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Repetition of self-harm leading to hospital attendance within 18 months of randomisation. Admissions data will be collected from CAMHS notes and hospital records.
Secondary outcome measures
1. Repetition of self-harm leading to hospital attendance within 12 months of randomisation
2. The cost per self-harm event avoided due to FT, measured using a structured questionnaire designed for use in the trial
3. Characteristics of further episodes of self-harm (number of subsequent self-harm events, time to next event, severity of event [fatal, near fatal or not] and dangerousness of method used, as measured by the Suicide Attempt Self-Injury Interview
4. Suicidal ideation as measured by the Beck Scale for Suicide Ideation
5. Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction measure, PQ-LES
Mediator and moderator variables which influence engagement with and benefit from treatment will also be measured.
Timepoints of assessment and other details are being finalised as of 28/01/2009.
Overall trial start date
01/09/2009
Overall trial end date
31/03/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, aged 11-17 years (from date of 11th birthday to the day prior to 18th birthday)
2. Self-harmed prior to assessment by the Child and Adolescent Mental Health (CAMHS) team
3. Engaged in at least one previous episode of self-harm prior to current presentation by self-injury or self-poisoning (or both)
4. Assessed in hospital following current episode, or referred directly to CAMHS from primary care within a week of current episode (i.e. 7 days maximum from event to referral)
5. Assessed as requiring treatment
6. Lives with primary care-giver
7. Both child/ adolescent and primary care-giver have sufficient proficiency in English to participate in therapy without an interpreter
8. Both child/ adolescent and primary care-giver have given written informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
832
Participant exclusion criteria
1. At serious risk of suicide
2. Severe major depressive disorder requiring psychiatric inpatient care
3. Undergoing a current child protection investigation
4. Would not ordinarily be treated in generic CAMHS but rather by a specific service (e.g., for teenage pregnancy, schizophrenia and other psychotic disorders, bipolar disorders, eating disorders [anorexia and bulimia nervosa], significant substance misuse where this is the primary diagnosis)
5. Has not been seen in CAMHS more than once in the last three months
6. In Local Authority or foster accommodation (often too transitory to allow FT)
7. Moderate to severe mental retardation or lacks capacity to comply with protocol
8. Involved in another research project - currently or within the last six months
Recruitment start date
01/04/2010
Recruitment end date
30/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9NL
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/10/2016
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26537599