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

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.

Study Overview

• Status: Unknown
• Conditions: Self Inflicted Injury; Suicide and Self Inflicted Injury
• Intervention / Treatment: Behavioral: Volunteer support; Other: Mobile app

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.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frances LAW, PhD; Phone Number: +852-3917-5940; Email: flawhk@hku.hk

Study Locations

• Hong Kong
  • Eastern District
    • Chai Wan, Eastern District, Hong Kong, 852
      • Recruiting
      • Pamele Youde Nethersole Eastern Hospital
  • Kwun Tong
    • Sau Mau Ping, Kwun Tong, Hong Kong, 852
      • Recruiting
      • United Christian Hospital
  • North District
    • Sheung Shui, North District, Hong Kong, 852
      • Recruiting
      • North District Hospital
  • Southern District
    • Central, Southern District, Hong Kong, 852
      • Recruiting
      • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAU w/ mobile app + volunteer support; Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers.	Behavioral: Volunteer 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.; Other: Mobile 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.; Other Names: Mobile app engagement
Experimental: TAU w/ mobile app engagement; Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention.	Other: Mobile 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.; Other Names: Mobile app engagement
No Intervention: Treatment as Usual (TAU); Participants will be receiving usual medical treatment from the hospitals, and without the interventions (i.e., mobile app and/or volunteer support) introduced through this randomized control trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: North District Hospital; Queen Mary Hospital, Hong Kong; Pamela Youde Nethersole Eastern Hospital; United Christian Hospital
• Investigators: Principal Investigator: Yik-wa Law, PhD, The University of Hong Kong

Publications and helpful links

General Publications

• 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.
• 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.
• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Suicide; Self-Injurious Behavior; Self Mutilation
• Other Study ID Numbers: HKU-ECS-27612816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No