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

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ClinicalTrials.gov Identifier: NCT03081078
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
United Christian Hospital
North District Hospital
Pamela Youde Nethersole Eastern Hospital
Information provided by (Responsible Party):
Dr.Yik-Wa Law, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Self Inflicted Injury Suicide and Self Inflicted Injury Behavioral: Volunteer support Other: Mobile app Not Applicable

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 18-39 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, during the 6-month observation (3 and 6 months) and at post-intervention (9 months from baseline). The primary outcomes include Suicidal ideation, hopelessness, thwarted belongingness & perceived burdensomeness, treatment (TAU) compliance, and suicidality.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

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 six 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 Name: 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 Name: 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.



Primary Outcome Measures :
  1. Change from baseline Adult Suicidal Ideation at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 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)

  2. Change from baseline Measurement of Hopelessness at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 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).

  3. Change from baseline Interpersonal Needs at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 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).

  4. Change from baseline Service Utilization at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 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.

  5. Change from baseline Suicidality at 3-month, 6-month and 9-month [ Time Frame: Time Frame: Baseline, 3 months, 6 months, 9 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)


Secondary Outcome Measures :
  1. Change from baseline Depressive state at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 months ]
    Depressive state as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) (Lam et al., 2004).

  2. Change from baseline Self-harming repetition at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 months ]
    Self-reported frequency of self-harm repetition (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)

  3. Change from baseline suicide deaths at 3-month, 6-month and 9-month [ Time Frame: Baseline, 3 months, 6 months, 9 months ]
    Number of suicide deaths (retrieved from the Hong Kong Special Administrative Region (HKSAR) Coroner's Court)

  4. Change of baseline index self-harm episode [ Time Frame: Baseline, 3 months, 6 months, 9 months ]
    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)

  5. Demographic and socioeconomic information [ Time Frame: Baseline ]
    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.

  6. Change of time spent on each programme activity of the app at 3-months, 6-months [ Time Frame: From Baseline to 6 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.)

  7. Change of time spent and type of contact made by volunteers with participants at 3-months, 6-months [ Time Frame: 3-months, 6-months ]
    Volunteer service records on time-stamp of each type of contact (i.e. in-person, phone contact, letters & email, and social media)

  8. Final and Monthly Qualitative Description on participants' progress [ Time Frame: up to 9 months ]
    Reported by volunteers. items included case summary, services offered, volunteer-participant relationship, follow-up plan, self-reflection and areas of improvement, etc.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081078


Contacts
Contact: Carmen Lai, MSocSc +852 28315234 carmenlai@hku.hk

Locations
Hong Kong
Pamele Youde Nethersole Eastern Hospital Recruiting
Chai Wan, Eastern District, Hong Kong, 852
United Christian Hospital Recruiting
Sau Mau Ping, Kwun Tong, Hong Kong, 852
North District Hospital Recruiting
Sheung Shui, North District, Hong Kong, 852
Queen Mary Hospital Recruiting
Central, Southern District, Hong Kong, 852
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
United Christian Hospital
North District Hospital
Pamela Youde Nethersole Eastern Hospital
Investigators
Principal Investigator: Yik-wa Law, PhD The University of Hong Kong

Publications:
Responsible Party: Dr.Yik-Wa Law, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03081078     History of Changes
Other Study ID Numbers: HKU-ECS-27612816
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Suicide
Self Mutilation
Self-Injurious Behavior
Behavioral Symptoms