NCT04591223

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

October 9, 2020

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Interventions

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.

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

Eligibility Criteria

Age18 Years - 39 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale Internet user
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with severe physical disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Self-Injurious BehaviorSuicidal IdeationMasculinity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSocial Behavior

Study Officials

  • Yik Wa Law

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Sik-ying Ho

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

September 1, 2020

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations