Self Inflicted Injury Clinical Trial
Official title:
Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial
The study will determine whether community-based caring contact via a mobile app connection with or without volunteer support in addition to treatment as usual (psychiatric and psychosocial treatments) has an effect on suicidal ideation and treatment compliance among post-discharge self-harm young adults.
| Status | Recruiting |
| Enrollment | 108 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | March 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - Individuals with an index episode of self-poisoning or self-injury with or without suicide intent, based on the ICD-10 codes for self-harm with and without suicide intent (i.e., X60 to X84 and R45.8) - Admission to the AEDs at the 4 collaborating public hospitals in Hong Kong (United Christian Hospital, North District Hospital, Queen Mary Hospital, and Pamela Youde Nethersole Eastern Hospital) - Mentally well assessed by a psychiatrist or Consultation Liaison Nurses (CLNs) - Capable of providing written Informed Consent Form Exclusion Criteria: - Individuals with DSM-IV-TR Axis II disorder; or - Individuals with severe psychotic mental illness or bipolar disorder |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Queen Mary Hospital | Central | Southern District |
| Hong Kong | Pamele Youde Nethersole Eastern Hospital | Chai Wan | Eastern District |
| Hong Kong | United Christian Hospital | Sau Mau Ping | Kwun Tong |
| Hong Kong | North District Hospital | Sheung Shui | North District |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong | North District Hospital, Pamela Youde Nethersole Eastern Hospital, Queen Mary Hospital, Hong Kong, United Christian Hospital |
Hong Kong,
Law YW, Yip PS, Lai CC, Kwok CL, Wong PW, Liu KS, Ng PW, Liao CW, Wong TW. A Pilot Study on the Efficacy of Volunteer Mentorship for Young Adults With Self-Harm Behaviors Using a Quasi-Experimental Design. Crisis. 2016 Nov;37(6):415-426. doi: 10.1027/0227-5910/a000393. Epub 2016 Jun 9. — View Citation
Luxton DD, June JD, Comtois KA. Can postdischarge follow-up contacts prevent suicide and suicidal behavior? A review of the evidence. Crisis. 2013 Jan 1;34(1):32-41. doi: 10.1027/0227-5910/a000158. Review. — View Citation
Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month | Change in scores on Suicidal ideation as measured by the self-report the Adult Suicidal Ideation Questionnaire - the four-item short form in Chinese (ASIQ-4) (Fu, Liu, & Yip, 2007) | Baseline, 1 month, 2 months, 3 months | |
| Primary | Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month | Change in scores on Hopelessness as measured by a self-report 4-item short-form of Beck Hopelessness Scale Chinese version (BHS-4) (Beck, Weissman, Lester, & Trexler, 1974; Yip & Cheung, 2006; Shek, 1993). | Baseline, 1 month, 2 months, 3 months | |
| Primary | Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month | Change in scores on Thwarted Belongingness (TB) and Perceived Burdensomeness (PB) as measured by the Interpersonal Needs Questionnaire (INQ-15), a 15-item measure of beliefs about whether one's need to belong is met or unmet and self-perceptions of being a burden to others (Van Orden, 2012). | Baseline, 1 month, 2 months, 3 months | |
| Primary | Change from baseline Service Utilization at 1-month, 2-month and 3-month | Self-reported compliance with prescribed treatment (frequency) in relation to the index self-harm episode, including psychiatric follow-up care (e.g., medication, out-patient follow-up treatment, and community psychiatric nursing service) and psycho-social services (e.g., clinical psychology service, medical social work service, etc.) as measured by a self-developed service utilization checklist. | Baseline, 1 month, 2 months, 3 months | |
| Primary | Change from baseline Suicidality at 1-month, 2-month and 3-month | Suicidality as measured by a four-item scale for levels of suicidality in the past 12 months (Centre for Suicide Research and Prevention, The University of Hong Kong, 2005) | Baseline, 1 month, 2 months, 3 months | |
| Secondary | Change from baseline Depressive state at 1-month, 2-month and 3-month | Depressive state as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) (Lam et al., 2004). | Baseline, 1 month, 2 months, 3 months | |
| Secondary | Change from baseline Self-harming repetition at 1-month, 2-month and 3-month | Self-reported frequency of self-harm repetition (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court) | Baseline, 1 month, 2 months, 3 months | |
| Secondary | Change from baseline suicide deaths at 1-month, 2-month and 3-month | Number of suicide deaths (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court) | Baseline, 1 month, 2 months, 3 months | |
| Secondary | Change of baseline index self-harm episode | Hospital records on the details of index self-harm episode including clinical diagnosis, treatment received, discharged information and number of Accident & Emergency Department (AED) re-admissions, etc. in Clinical Management System (CMS), Outpatient Appointment System (OPAS), and Accident & Emergency Department Clinical Information System (AEIS) | Baseline, 1 month, 2 months, 3 months | |
| Secondary | Demographic and socioeconomic information | Questionnaire on participants' demographic and socioeconomic information (e.g. Sex, Date of birth, birth place, years living in Hong Kong, Marital status, religion, residential district, education, living status, employment, occupation, social security, etc. | Baseline | |
| Secondary | Change of time spent on each programme activity of the app at 1-months, 2-months | The log-in time-stamp of each activity (including but not limited to reviewing the information or messages provided on the app, pattern of using the app, etc.) | From Baseline to 2 months | |
| Secondary | Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months | Volunteer service records on time-stamp of each type of contact (i.e. in-person, phone contact, letters & email, and social media) | 1-month, 2-months | |
| Secondary | Final and Monthly Qualitative Description on participants' progress | Reported by volunteers. items included case summary, services offered, volunteer-participant relationship, follow-up plan, self-reflection and areas of improvement, etc. | up to 3 months |