Clinical trial NCT03081078: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Self Inflicted Injury
Suicide and Self Inflicted Injury
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: United Christian Hospital
name: North District Hospital
name: Pamela Youde Nethersole Eastern Hospital
First posted: 2017-03-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change from baseline Service Utilization at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change from baseline Suicidality at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
Secondary outcomes:
measure: Change from baseline Depressive state at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change from baseline Self-harming repetition at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change from baseline suicide deaths at 1-month, 2-month and 3-month
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Change of baseline index self-harm episode
timeFrame: Baseline, 1 month, 2 months, 3 months
measure: Demographic and socioeconomic information
timeFrame: Baseline
measure: Change of time spent on each programme activity of the app at 1-months, 2-months
timeFrame: From Baseline to 2 months
measure: Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months
timeFrame: 1-month, 2-months
measure: Final and Monthly Qualitative Description on participants' progress
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Chai Wan
country: Hong Kong
facility: Pamele Youde Nethersole Eastern Hospital
state: Eastern District
city: Sau Mau Ping
country: Hong Kong
facility: United Christian Hospital
state: Kwun Tong
city: Sheung Shui
country: Hong Kong
facility: North District Hospital
state: North District
city: Central
country: Hong Kong
facility: Queen Mary Hospital
state: Southern District
Study officials:
affiliation: The University of Hong Kong
name: Yik-wa Law, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.