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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04591223
Collaborator
(none)
60
1
2
23
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Competency-based physical training (CbM)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline Adult Suicidal Ideation at 1-month, 3-month and 5-month [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.

  2. Change from baseline measurement of hopelessness at 1-month, 3-month and 5-month [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.

  3. Change from baseline measurement of depression at 1-month, 3-month and 5-month [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.

  4. Change of baseline sense of competency at 1-month, 3-month and 5-month [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.

  5. Change of baseline perceived social support at 1-month, 3-month and 5-month [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

  6. Change of baseline measurements of weight (body composition) at 1-month, 3-month, 5-month [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.

  7. Change of baseline measurements of skinfold (body composition) at 1-month, 3-month, 5-month [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.

  8. Change of baseline measurements of hip and waist girth (body composition) at 1-month, 3-month, 5-month [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.

  9. Change of baseline measurement of self-reported compliance to service at baseline, 1-month, 3-month, 5-month [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.

  10. Change of baseline measurement of suicidal behavior at 1-month, 3-month, 5-month [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong 0000

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr.Yik-Wa Law, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04591223
Other Study ID Numbers:
  • 17602620
First Posted:
Oct 19, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2020