Clinical trial NCT04591223: Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity
Official title: Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self-Harm, Deliberate
Suicidal Ideation
Masculinity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Adult Suicidal Ideation at 1-month, 3-month and 5-month
timeFrame: Baseline,1-month, 3-month, 5-month
measure: Change from baseline measurement of hopelessness at 1-month, 3-month and 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change from baseline measurement of depression at 1-month, 3-month and 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline sense of competency at 1-month, 3-month and 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline perceived social support at 1-month, 3-month and 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline measurements of weight (body composition) at 1-month, 3-month, 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline measurements of skinfold (body composition) at 1-month, 3-month, 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline measurements of hip and waist girth (body composition) at 1-month, 3-month, 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline measurement of self-reported compliance to service at baseline, 1-month, 3-month, 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
measure: Change of baseline measurement of suicidal behavior at 1-month, 3-month, 5-month
timeFrame: Baseline, 1-month, 3-month, 5-month
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Yik Wa Law
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong
name: Sik-ying Ho
role: PRINCIPAL_INVESTIGATOR
References: