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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591223
• Other study ID #: 17602620
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Yik Wa Law
• Phone: +852-3917-5940
• Email: flawhk[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Masculinity
• Self-Harm, Deliberate
• Self-Injurious Behavior
• Suicidal Ideation
• Suicide

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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