search
Back to results

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

Primary Purpose

Self-Harm, Deliberate, Suicidal Ideation, Masculinity

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Competency-based physical training (CbM)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self-Harm, Deliberate

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAU + six weekly sessions of competency-based module (CbM)

TAU

Arm Description

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.

This group of participants will be receiving online social work (OSW) treatment as usual (TAU) from NGO service provider.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2020
Last Updated
May 8, 2023
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04591223
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Harm, Deliberate, Suicidal Ideation, Masculinity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + six weekly sessions of competency-based module (CbM)
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
This group of participants will be receiving online social work (OSW) treatment as usual (TAU) from NGO service provider.
Intervention Type
Behavioral
Intervention Name(s)
Competency-based physical training (CbM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Adult Suicidal Ideation at 1-month, 3-month and 5-month
Description
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.
Time Frame
Baseline,1-month, 3-month, 5-month
Title
Change from baseline measurement of hopelessness at 1-month, 3-month and 5-month
Description
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.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change from baseline measurement of depression at 1-month, 3-month and 5-month
Description
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.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline sense of competency at 1-month, 3-month and 5-month
Description
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.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline perceived social support at 1-month, 3-month and 5-month
Description
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
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline measurements of weight (body composition) at 1-month, 3-month, 5-month
Description
Weight, as a one of the indicators of body composition, will be measured in kilograms at four different time points.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline measurements of skinfold (body composition) at 1-month, 3-month, 5-month
Description
A skinfold caliper will be used to assess the skinfold thickness, which is considered to be one of the indicators of body composition.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline measurements of hip and waist girth (body composition) at 1-month, 3-month, 5-month
Description
Both hip and waist girth will be measured in inches at four different time points as part of the measurement of body composition.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline measurement of self-reported compliance to service at baseline, 1-month, 3-month, 5-month
Description
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.
Time Frame
Baseline, 1-month, 3-month, 5-month
Title
Change of baseline measurement of suicidal behavior at 1-month, 3-month, 5-month
Description
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.
Time Frame
Baseline, 1-month, 3-month, 5-month

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male Internet user
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yik Wa Law
Phone
+852-3917-5940
Email
flawhk@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Sik-ying Ho
Phone
+852-3917-2091
Email
psyho@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yik Wa Law
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sik-ying Ho
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Ho, BPsych

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs