Self-Harm, DeliberateNCT04591223
Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity
A study testing Competency-based physical training (CbM) in people with Self-Harm, Deliberate and Suicidal Ideation, run by The University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Self-Harm, Deliberate, Suicidal Ideation, Masculinity
- What is being tested?
- Competency-based physical training (CbM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2020to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals with severe physical disabilities
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong, 0000
Ben Ho, BPsych
About this study
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.
Read the 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).
- Conditions
- Self-Harm, Deliberate, Suicidal Ideation, Masculinity
- Being tested
- Competency-based physical training (CbM)
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Masculinity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competency-based physical training (CbM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TAU + six weekly sessions of competency-based module (CbM) | Experimental | 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. Receives: Behavioral: Competency-based physical training (CbM) |
| TAU | No intervention | This group of participants will be receiving online social work (OSW) treatment as usual (TAU) from NGO service provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1-month, 3-month, 5-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2020
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Harm, DeliberateStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Yik-Wa Law, The University of Hong Kong
- Investigators
- Yik Wa Law, Principal investigator, The University of Hong KongSik-ying Ho, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591223
- Sponsor's protocol ID
- 17602620
- Status last verified
- May 2023
- First submitted
- 9 Oct 2020
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity
- ClinicalTrials.gov ID
- NCT04591223
- Acronym / sponsor ID
- 17602620
- Conditions
- Self-Harm, Deliberate, Suicidal Ideation, Masculinity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + six weekly sessions of competency-based module (CbM) | Experimental | Behavioral: Competency-based physical training (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. |
| TAU | No intervention | –This group of participants will be receiving online social work (OSW) treatment as usual (TAU) from NGO service provider. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals with severe physical disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TAU + six weekly sessions of competency-based module (CbM) |
Primary outcome
Change from baseline Adult Suicidal Ideation at 1-month, 3-month and 5-month
Time frame: Baseline,1-month, 3-month, 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.
Change from baseline measurement of hopelessness at 1-month, 3-month and 5-month
Time frame: Baseline, 1-month, 3-month, 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.
Change from baseline measurement of depression at 1-month, 3-month and 5-month
Time frame: Baseline, 1-month, 3-month, 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.
Change of baseline sense of competency at 1-month, 3-month and 5-month
Time frame: Baseline, 1-month, 3-month, 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.
Change of baseline perceived social support at 1-month, 3-month and 5-month
Time frame: Baseline, 1-month, 3-month, 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
Change of baseline measurements of weight (body composition) at 1-month, 3-month, 5-month
Time frame: Baseline, 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.
Change of baseline measurements of skinfold (body composition) at 1-month, 3-month, 5-month
Time frame: Baseline, 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.
Change of baseline measurements of hip and waist girth (body composition) at 1-month, 3-month, 5-month
Time frame: Baseline, 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.
Change of baseline measurement of self-reported compliance to service at baseline, 1-month, 3-month, 5-month
Time frame: 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.
Change of baseline measurement of suicidal behavior at 1-month, 3-month, 5-month
Time frame: Baseline, 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yik Wa Law principal investigator
The University of Hong Kong
Sik-ying Ho principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Competency-based physical training (CbM) in people with Self-Harm, Deliberate and Suicidal Ideation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yik Wa Law (+852-3917-5940, flawhk@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Adult Suicidal Ideation at 1-month, 3-month and 5-month (time frame: Baseline,1-month, 3-month, 5-month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.