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

Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03081078
Enrollment
108
Registered
2017-03-15
Start date
2017-06-01
Completion date
2021-06-30
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self Inflicted Injury, Suicide and Self Inflicted Injury

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.

Interventions

BEHAVIORALVolunteer support

Each participant will be matched with a pair of trained volunteers (under pre-determined safety measures), who will initiate caring contact via telephone or text messages at least twice a month for two months. Participants will be free to respond or not.

OTHERMobile app

Participants will receive programmed care messages and reminders of community resources and healthcare contacts on a regular basis. The app will also provide simple self-help mood checking and relaxation exercises.

Sponsors

Queen Mary Hospital, Hong Kong
CollaboratorOTHER
United Christian Hospital
CollaboratorOTHER
North District Hospital
CollaboratorOTHER
Pamela Youde Nethersole Eastern Hospital
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsChange 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 Measurement of Hopelessness at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsChange 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 Interpersonal Needs at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsChange 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 Service Utilization at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsSelf-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 Suicidality at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsSuicidality 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

MeasureTime frameDescription
Change of time spent on each programme activity of the app at 1-months, 2-monthsFrom Baseline to 2 monthsThe 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 Depressive state at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsDepressive state as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) (Lam et al., 2004).
Final and Monthly Qualitative Description on participants' progressup to 3 monthsReported by volunteers. items included case summary, services offered, volunteer-participant relationship, follow-up plan, self-reflection and areas of improvement, etc.
Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months1-month, 2-monthsVolunteer service records on time-stamp of each type of contact (i.e. in-person, phone contact, letters & email, and social media)
Change from baseline Self-harming repetition at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsSelf-reported frequency of self-harm repetition (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)
Change from baseline suicide deaths at 1-month, 2-month and 3-monthBaseline, 1 month, 2 months, 3 monthsNumber of suicide deaths (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)
Change of baseline index self-harm episodeBaseline, 1 month, 2 months, 3 monthsHospital 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)
Demographic and socioeconomic informationBaselineQuestionnaire 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.

Countries

Hong Kong

Contacts

Primary ContactFrances LAW, PhD
flawhk@hku.hk+852-3917-5940

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026