Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity

To propose a competency-based theory of change for reducing suicide risks among male Internet users with salient traits of societal masculinity; To test whether the theory of change using the competency-based model has additional effects on reducing self-harm and/or suicidal ideation in addition to the online social work treatment-as-usual model; To provide online social work service providers with evidence-based measures for reducing the risks of self-harm and/or suicide among young male Internet users.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Self-Harm, Deliberate; Masculinity
• Intervention / Treatment: Behavioral: Competency-based physical training (CbM)

Detailed Description

This is a randomized waitlist-controlled trial of 60 participants examining the effects of a proposed competency-based model on self-harm relative to those of OSW alone. In the online survey (T0), subjects with self-harm or suicidal ideation will be invited to give informed consent, and then be randomly assigned to one of two groups: 1) OSW (control), or 2) OSW + six weekly sessions of competency-based physical training (intervention). They will be assessed at three measurement time points (T1 = one-month; T2 = three-month; and T3 = five-month from T0 at post-intervention). The intervention group is hypothesized to display a greater reduction in the primary outcomes of self-harm and suicidal ideation than the OSW group. Chi-square tests giving p <=0.05 will indicate a goodness of fit of the linear mixed model, which address random effects in the data and handles intention-to-treat (ITT).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sik-ying Ho; Phone Number: +852-3917-2091; Email: psyho@hku.hk
• Study Contact Backup: Name: Yik Wa Law; Phone Number: +852-3917-5940; Email: flawhk@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Recruiting
    • University of Hong Kong
    • Contact: Ben Ho, BPsych

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals who meet the cut-off of 1.0 on the Chinese Adult Suicidal Ideation Questionnaire (ASIQ4); Self-injury incidents in the past 12 months

Exclusion Criteria:

• Individuals with severe physical disabilities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAU + six weekly sessions of competency-based module (CbM); This group of participants will be receiving online social work (OSW) treatment as usual (TAU) from NGO service provider as well as a well-designed, one on one structural physical workout module to be offered by a licensed senior physical trainer in public sports ground or gymnasium.	Behavioral: Competency-based physical training (CbM); The intervention to be added to online social work treatment as usual (OSW) is a well-designed, one-on-one structural physical workout module which will be offered by a licensed senior physical trainer in public sports ground or gymnasium. The aim is to strengthen participants' sense of competence, improve their physical fitness, self-confidence and self-image through an outcome-driven Circuit training. One of the chief advantages of Circuit training is its adaptability. Circuit training can be performed with gym equipment and/or bodyweight exercises which is deemed to be suitable for beginner and easy to practice at home on oneself. Participants can continue to replicate the exercise with or without any equipment. The program will be delivered in six one-hour sessions, including face-to-face and online mode, over one month.
No Intervention: TAU; This group of participants will be receiving online social work (OSW) treatment as usual (TAU) from NGO service provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Adult Suicidal Ideation at 1-month, 3-month and 5-month	Change in scores on Suicidal ideation as measured by the self-report the Adult Suicidal Ideation Questionnaire (ASIQ-4) - the four-item short form in Chinese, scoring on a 7-point scale ranging from 0 to 24. A higher score on the scale suggests a higher risk of suicide.	Baseline,1-month, 3-month, 5-month
Change from baseline measurement of hopelessness at 1-month, 3-month and 5-month	Hopelessness will be assessed by four questions measuring hopelessness extracted from the Beck Hopelessness Scale (BHS4), scoring on a 6-point scale ranging from 0 to 20. A higher score on the scale suggests a higher levels of depression, suicidal intent, and/or ideation.	Baseline, 1-month, 3-month, 5-month
Change from baseline measurement of depression at 1-month, 3-month and 5-month	Depression will be assessed via 12 questions from the short-form General Health Questionnaire (GHQ-12), scoring on a 4-point scale ranging from 0 to 36. A higher score on the scale suggests a higher level of emotional distress and depression.	Baseline, 1-month, 3-month, 5-month
Change of baseline sense of competency at 1-month, 3-month and 5-month	Sense of competency will be assessed via 40 questions from the Chinese Physical Self-Description Questionnaire-Short Form (CPSDQ-S), scoring on a 6-point scale ranging from 0 to 200. A higher score suggest a higher level of self-perceived physical competency and self-esteem.	Baseline, 1-month, 3-month, 5-month
Change of baseline perceived social support at 1-month, 3-month and 5-month	Social support will be assessed using the Chinese version of the Multidimensional Scale of Perceived Social Support (MSPSS-C). The MSPSS measures the degree of social support received from family, friends, and significant others, and has been proven to have good internal and test-retest reliability and moderate construct validity	Baseline, 1-month, 3-month, 5-month
Change of baseline measurements of weight (body composition) at 1-month, 3-month, 5-month	Weight, as a one of the indicators of body composition, will be measured in kilograms at four different time points.	Baseline, 1-month, 3-month, 5-month
Change of baseline measurements of skinfold (body composition) at 1-month, 3-month, 5-month	A skinfold caliper will be used to assess the skinfold thickness, which is considered to be one of the indicators of body composition.	Baseline, 1-month, 3-month, 5-month
Change of baseline measurements of hip and waist girth (body composition) at 1-month, 3-month, 5-month	Both hip and waist girth will be measured in inches at four different time points as part of the measurement of body composition.	Baseline, 1-month, 3-month, 5-month
Change of baseline measurement of self-reported compliance to service at baseline, 1-month, 3-month, 5-month	Questionnaire will be distributed to subjects to assess their compliance to service: frequency of service use, including medical and psychosocial services at four different time points.	Baseline, 1-month, 3-month, 5-month
Change of baseline measurement of suicidal behavior at 1-month, 3-month, 5-month	Subjects were expected to answer three separate questions with dichotomous yes/no responses: in the past few weeks, (1) have you thought about committing suicide? 2) have you been actively planning to commit suicide? 3) did you make any suicide attempts.	Baseline, 1-month, 3-month, 5-month

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Sik-ying Ho, The University of Hong Kong; Principal Investigator: Yik Wa Law, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Suicidal Ideation; Self-Injurious Behavior
• Other Study ID Numbers: 17602620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No