Self-harm Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/07/2024: General practices who are research active will be invited into the study and those who agree will become a study site. Participant inclusion criteria: 1. Young people aged 16-25 years 2. History of self-harm (defined by NICE) in the last 12 months 3. Able to give informed consent _____ Previous inclusion criteria: General practices who are research active within the NIHR Local CRN West Midlands primary care will be invited into the study and those who agree will become a study site. Participant inclusion criteria: 1. Young people aged 16-25 years 2. History of self-harm (defined by NICE) in the last 12 months 3. Able to give informed consent
Exclusion criteria
Exclusion criteria: Participant exclusion criteria: 1. Acute risk of suicide or harm to others needing urgent referral or admission 2. Moderate to severe learning disabilities 3. Current psychotic episode or organic mental illness 4. Receiving current psychological therapy including NHS talking therapies 5. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participant consent and willingness of enrolled participants and GPs to be randomised in a future RCT, estimated using rates of consent, participant, and GP self-report from the start of recruitment to the end, including at the 2-month participant follow-up timepoint 2. GP fidelity to COPING delivery and participant adherence to COPING, assessed retrospectively using case report forms and examining the proportion of participants who attend for a second COPING appointment 3. Participant follow-up data collection examined by total completions of the suicidal behaviours questionnaire-revised questionnaire at 2, 4, and 6 months 4. Acceptability of COPING for both participants and GPs, and deliverability of COPING for GPs, assessed using semi-structured interviews and a GP online survey post COPING delivery to end recruitment date | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured from the recruitment start date to the study end date (unless otherwise specified): 1. The response rate of invited general practices to participate, measured throughout the recruitment window 2. Whether GPs can be recruited, trained, and retained to deliver COPING 3. Identification of patients at GP site 4. Proportion of identified patients deemed eligible for inclusion 5. Participant recruitment uptake and baseline characteristics through each recruitment strategy 6. Participant attrition, follow-up, and withdrawal rates 7. Data collection procedures 8. Exploratory effectiveness data via participant-reported patient health questionnaire and suicidal behaviours questionnaire-revised at baseline, 2, 4, and 6 months | — |
Countries
England, United Kingdom