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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial

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 Summary:

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.


Sponsor: The University of Hong Kong

Current Primary Outcome:

  • 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)
  • 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).
  • 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).
  • 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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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).
    • 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)
    • 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)
    • 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)
    • 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.
    • 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.)
    • 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)
    • 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.


    Original Secondary Outcome: Same as current

    Information By: The University of Hong Kong

    Dates:
    Date Received: March 3, 2017
    Date Started: May 15, 2017
    Date Completion: June 2019
    Last Updated: May 2, 2017
    Last Verified: May 2017