Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm
Primary Purpose
Self Inflicted Injury, Suicide and Self Inflicted Injury
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Volunteer support
Mobile app
Sponsored by
About this trial
This is an interventional supportive care trial for Self Inflicted Injury
Eligibility Criteria
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
Sites / Locations
- Pamele Youde Nethersole Eastern HospitalRecruiting
- United Christian HospitalRecruiting
- North District HospitalRecruiting
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
TAU w/ mobile app + volunteer support
TAU w/ mobile app engagement
Treatment as Usual (TAU)
Arm Description
Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers.
Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement 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.
Outcomes
Primary Outcome Measures
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)
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).
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).
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.
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)
Secondary Outcome Measures
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).
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)
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)
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)
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.
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.)
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)
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.
Full Information
NCT ID
NCT03081078
First Posted
March 3, 2017
Last Updated
October 15, 2020
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, United Christian Hospital, North District Hospital, Pamela Youde Nethersole Eastern Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03081078
Brief Title
Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm
Official Title
Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, United Christian Hospital, North District Hospital, Pamela Youde Nethersole Eastern Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Inflicted Injury, Suicide and Self Inflicted Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU w/ mobile app + volunteer support
Arm Type
Experimental
Arm Description
Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention, plus support from volunteers.
Arm Title
TAU w/ mobile app engagement
Arm Type
Experimental
Arm Description
Participants will be receiving usual medical treatment from the hospitals with a mobile app engagement intervention.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Volunteer support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mobile app
Other Intervention Name(s)
Mobile app engagement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month
Description
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)
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month
Description
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).
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month
Description
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).
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change from baseline Service Utilization at 1-month, 2-month and 3-month
Description
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.
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change from baseline Suicidality at 1-month, 2-month and 3-month
Description
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)
Time Frame
Baseline, 1 month, 2 months, 3 months
Secondary Outcome Measure Information:
Title
Change from baseline Depressive state at 1-month, 2-month and 3-month
Description
Depressive state as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) (Lam et al., 2004).
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change from baseline Self-harming repetition at 1-month, 2-month and 3-month
Description
Self-reported frequency of self-harm repetition (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change from baseline suicide deaths at 1-month, 2-month and 3-month
Description
Number of suicide deaths (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Change of baseline index self-harm episode
Description
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)
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Demographic and socioeconomic information
Description
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.
Time Frame
Baseline
Title
Change of time spent on each programme activity of the app at 1-months, 2-months
Description
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.)
Time Frame
From Baseline to 2 months
Title
Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months
Description
Volunteer service records on time-stamp of each type of contact (i.e. in-person, phone contact, letters & email, and social media)
Time Frame
1-month, 2-months
Title
Final and Monthly Qualitative Description on participants' progress
Description
Reported by volunteers. items included case summary, services offered, volunteer-participant relationship, follow-up plan, self-reflection and areas of improvement, etc.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frances LAW, PhD
Phone
+852-3917-5940
Email
flawhk@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yik-wa Law, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamele Youde Nethersole Eastern Hospital
City
Chai Wan
State/Province
Eastern District
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
United Christian Hospital
City
Sau Mau Ping
State/Province
Kwun Tong
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
North District Hospital
City
Sheung Shui
State/Province
North District
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital
City
Central
State/Province
Southern District
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27278570
Citation
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.
Results Reference
background
PubMed Identifier
22846445
Citation
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.
Results Reference
background
PubMed Identifier
21928908
Citation
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.
Results Reference
background
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
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Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm
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