NCT03081078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3.8 years

First QC Date

March 3, 2017

Last Update Submit

October 15, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (8)

  • Change from baseline Depressive state at 1-month, 2-month and 3-month

    Baseline, 1 month, 2 months, 3 months

  • Change from baseline Self-harming repetition at 1-month, 2-month and 3-month

    Baseline, 1 month, 2 months, 3 months

  • Change from baseline suicide deaths at 1-month, 2-month and 3-month

    Baseline, 1 month, 2 months, 3 months

  • Change of baseline index self-harm episode

    Baseline, 1 month, 2 months, 3 months

  • Demographic and socioeconomic information

    Baseline

  • +3 more secondary outcomes

Study Arms (3)

TAU w/ mobile app + volunteer support

EXPERIMENTAL

Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers.

Behavioral: Volunteer supportOther: Mobile app

TAU w/ mobile app engagement

EXPERIMENTAL

Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention.

Other: Mobile app

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

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.

TAU w/ mobile app + volunteer support

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.

Also known as: Mobile app engagement
TAU w/ mobile app + volunteer supportTAU w/ mobile app engagement

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pamele Youde Nethersole Eastern Hospital

Chai Wan, Eastern District, 852, Hong Kong

RECRUITING

United Christian Hospital

Sau Mau Ping, Kwun Tong District, 852, Hong Kong

RECRUITING

North District Hospital

Sheung Shui, North District, 852, Hong Kong

RECRUITING

Queen Mary Hospital

Central, Southern District, 852, Hong Kong

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27278570BACKGROUND
  • 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.

    PMID: 22846445BACKGROUND
  • 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.

    PMID: 21928908BACKGROUND
  • Law YW, Lok RHT, Chiang B, Lai CCS, Tsui SHM, Chung PYJ, Leung SC. Effects of Community-Based Caring Contact in Reducing Thwarted Belongingness Among Postdischarge Young Adults With Self-Harm: Randomized Controlled Trial. JMIR Form Res. 2023 Aug 16;7:e43526. doi: 10.2196/43526.

  • 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.

MeSH Terms

Conditions

Self-Injurious BehaviorSuicide

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yik-wa Law, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances LAW, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 15, 2017

Study Start

June 1, 2017

Primary Completion

March 30, 2021

Study Completion

June 30, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations