Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm

Not Applicable

• Conditions: Suicide and Self Inflicted Injury; Self Inflicted Injury
• Interventions: Behavioral: Volunteer support; Other: Mobile app

• Registration Number: NCT03081078
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

The proposed study will determine whether community-based caring contact via a mobile app connection with or without volunteer support in addition to treatment as usual (TAU; psychiatric and psychosocial treatments) is effective in reducing suicidal ideation, enhancing treatment compliance, reducing thwarted belongingness and perceived burdensomeness and hopelessness among post-discharge self-harm young adults, and if personalized contact by volunteers has additional effects reducing suicidal ideation among post-discharge self-harm individuals.

108 participants aged 18-45 with an index self-harm episode will be recruited from the Accident \& Emergency Department (AED) of 4 local public hospitals, and randomized into the TAU, mobile app group with, and without volunteer support. Each participant will complete a questionnaire at the 4 measurement time points at baseline (T0), one-month (T1) and the end of the 2-month intervention period (T2), and post-intervention at the three-month point (T3) from the baseline. The primary outcomes include Suicidal ideation, hopelessness, thwarted belongingness \& perceived burdensomeness, treatment (TAU) compliance, and suicidality.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-15
• Study Start: 2017-06-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

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Exclusion Criteria

• Individuals with DSM-IV-TR Axis II disorder; or
• Individuals with severe psychotic mental illness or bipolar disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU w/ mobile app + volunteer support	Volunteer support	Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers.
TAU w/ mobile app + volunteer support	Mobile app	Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers.
TAU w/ mobile app engagement	Mobile app	Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention.

Primary Outcome Measures

Name	Time	Method
Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	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).
Change from baseline Service Utilization at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	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.
Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	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)
Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	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).
Change from baseline Suicidality at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	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)

Secondary Outcome Measures

Name	Time	Method
Change from baseline suicide deaths at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	Number of suicide deaths (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)
Final and Monthly Qualitative Description on participants' progress	up to 3 months	Reported by volunteers. items included case summary, services offered, volunteer-participant relationship, follow-up plan, self-reflection and areas of improvement, etc.
Demographic and socioeconomic information	Baseline	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.
Change from baseline Depressive state at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	Depressive state as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) (Lam et al., 2004).
Change of time spent on each programme activity of the app at 1-months, 2-months	From Baseline to 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.)
Change from baseline Self-harming repetition at 1-month, 2-month and 3-month	Baseline, 1 month, 2 months, 3 months	Self-reported frequency of self-harm repetition (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)
Change of baseline index self-harm episode	Baseline, 1 month, 2 months, 3 months	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)
Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months	1-month, 2-months	Volunteer service records on time-stamp of each type of contact (i.e. in-person, phone contact, letters \& email, and social media)

Trial Locations

Locations (4)

Queen Mary Hospital; 🇭🇰 Central, Southern District, Hong Kong

Pamele Youde Nethersole Eastern Hospital; 🇭🇰 Chai Wan, Eastern District, Hong Kong

North District Hospital; 🇭🇰 Sheung Shui, North District, Hong Kong

United Christian Hospital; 🇭🇰 Sau Mau Ping, Kwun Tong, Hong Kong