SHIFT Trial - Family therapy vs treatment as usual for young people seen after second or subsequent episodes of self-harm

Not Applicable

Completed

• Conditions: Self-harm in adolescents; Mental and Behavioural Disorders

• Registration Number: ISRCTN59793150
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26537599 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29532784 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29449180 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30294758 (added 28/04/2020) 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31956857 (added 21/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-26
• Study Completion: 2016-03-31
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 832

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 caregiver
7. Both child/adolescent and primary caregiver have sufficient proficiency in English to participate in therapy without an interpreter
8. Both child/adolescent and primary caregiver have given written informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Repetition of self-harm leading to hospital attendance within 12 months of randomisation<br> 2. The cost per self-harm event avoided due to FT, measured using a structured questionnaire designed for use in the trial<br> 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<br> 4. Suicidal ideation as measured by the Beck Scale for Suicide Ideation<br> 5. Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction measure, PQ-LES<br><br> Mediator and moderator variables which influence engagement with and benefit from treatment will also be measured.<br><br> Timepoints of assessment and other details are being finalised as of 28/01/2009.<br>