Self Inflicted InjuryNCT03081078
Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm
A study testing Volunteer support and Mobile app in people with Self Inflicted Injury and Suicide and Self Inflicted Injury, run by The University of Hong Kong at 4 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Self Inflicted Injury, Suicide and Self Inflicted Injury
- What is being tested?
- Volunteer support and Mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 4 sitesHong Kong
- Study dates
- 1 Jun 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals with DSM-IV-TR Axis II disorder; or
- Individuals with severe psychotic mental illness or bipolar disorder
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites, 4 recruiting
- Recruiting
Queen Mary Hospital
Central, Southern District, 852
- Recruiting
Pamele Youde Nethersole Eastern Hospital
Chai Wan, Eastern District, 852
- Recruiting
United Christian Hospital
Sau Mau Ping, Kwun Tong District, 852
- Recruiting
North District Hospital
Sheung Shui, North District, 852
About this study
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.
Read the 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.
- Being tested
- Volunteer support, Mobile app
- Medical subject headings
- Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer supportBehavioural
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.
Mobile appOther
Also called Mobile app engagement
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Volunteer support; Other: Mobile app |
| TAU w/ mobile app engagement | Experimental | Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Baseline, 1 month, 2 months, 3 months
Secondary outcomes (8)
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.)
Measured: 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)
Measured: 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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Jun 2017
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Self Inflicted InjuryStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, United Christian Hospital, North District Hospital, Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Principal investigator, Dr.Yik-Wa Law, The University of Hong Kong
- Investigators
- Yik-wa Law, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081078
- Sponsor's protocol ID
- HKU-ECS-27612816
- Status last verified
- Oct 2020
- First submitted
- 3 Mar 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27278570Luxton 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.
PubMed 22846445Van 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.
PubMed 21928908Law 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.
PubMed 37585260Witt 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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03081078
- Acronym / sponsor ID
- HKU-ECS-27612816
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, United Christian Hospital, North District Hospital, Pamela Youde Nethersole Eastern Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAU w/ mobile app + volunteer support | Experimental | Behavioral: Volunteer support, Other: Mobile appParticipants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers. |
| TAU w/ mobile app engagement | Experimental | Other: Mobile appParticipants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals with DSM-IV-TR Axis II disorder; or
- Individuals with severe psychotic mental illness or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer supportEach 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. | Behavioural | TAU w/ mobile app + volunteer support |
| Mobile appAlso: Mobile app engagementParticipants 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 | TAU w/ mobile app + volunteer support, TAU w/ mobile app engagement |
Primary outcome
Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month
Time frame: 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 Measurement of Hopelessness at 1-month, 2-month and 3-month
Time frame: 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 Interpersonal Needs at 1-month, 2-month and 3-month
Time frame: 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 Service Utilization at 1-month, 2-month and 3-month
Time frame: 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 Suicidality at 1-month, 2-month and 3-month
Time frame: 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)
8 secondary outcomes
Change from baseline Depressive state at 1-month, 2-month and 3-month
Time frame: Baseline, 1 month, 2 months, 3 months
Change from baseline Self-harming repetition at 1-month, 2-month and 3-month
Time frame: Baseline, 1 month, 2 months, 3 months
Change from baseline suicide deaths at 1-month, 2-month and 3-month
Time frame: Baseline, 1 month, 2 months, 3 months
Change of baseline index self-harm episode
Time frame: Baseline, 1 month, 2 months, 3 months
Demographic and socioeconomic information
Time frame: Baseline
Change of time spent on each programme activity of the app at 1-months, 2-months
Time frame: From Baseline to 2 months
Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months
Time frame: 1-month, 2-months
Final and Monthly Qualitative Description on participants' progress
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 27278570Law 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.
- Background: PubMed 22846445Luxton 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.
- Background: PubMed 21928908Van 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.
- Derived from this study: PubMed 37585260Law 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.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yik-wa Law, PhD principal investigator
The University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer support and Mobile app in people with Self Inflicted Injury and Suicide and Self Inflicted Injury, run by The University of Hong Kong at 4 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frances LAW, PhD (+852-3917-5940, flawhk@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (time frame: Baseline, 1 month, 2 months, 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081078, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.