NCT06100575

Brief Summary

This study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. Moreover, it aims to examine how participants evaluate the website.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 16, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

October 20, 2023

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020)

    The Gatekeeper Self-Efficacy Scale is a 9-item self-report scale to be scored on a 7-point Likert scale (1= not at all to 5 = Extremely) to measure participants' self efficacy in dealing with suicidal individuals. Higher scores indicate higher self-efficacy.

    Change from Baseline (before intervention) to post-test (after 3 days of access to website)

Secondary Outcomes (5)

  • Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)

    Change from Baseline (before intervention) to post-test (after 3 days of access to website)

  • Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)

    Change from Baseline (before intervention) to post-test (after 3 days of access to website)

  • Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire

    Change from Baseline (before intervention) to post-test (after 3 days of access to website)

  • Changes in self-care and awareness

    Change from Baseline (before intervention) to post-test (after 3 days of access to website)

  • Evaluation of the website

    post-test (after 3 days of access to website)

Other Outcomes (2)

  • Socio-demographic characteristics

    Baseline

  • Characteristics of the suicidal family member

    Baseline

Study Arms (1)

Website (www.mee-leven.be)

EXPERIMENTAL

Participants in this group (all participants) are asked to complete a questionnaire and then receive access to the website during three days, after which they were asked to complete another questionnaire.

Behavioral: Website (www.mee-leven.be)

Interventions

The tool is a website aimed siblings and children of someone who has suicidal thoughts and/or behaviors. The intended objectives of the tool are 1) to contribute to knowledge about suicide and health care options, 2) to increase perceived competences in dealing with suicidality of a family member, 3) to reduce perceived pressure and negative feelings such as hopelessness and 4) to be accessible and user-friendly. These objectives are achieved by providing the following content: 1) concerning the sibling/child themselves (primary objective) : information about the potential impact of having a suicidal family member, own needs, informal and formal (self) care, dealing with the suicidal family member, dealing with other family members 2) concerning the suicidal family member (Secondary objective): information about the suicidal process, signal recognition, how to provide support/create a safe environment for suicidal loved ones , help available for suicidal relatives

Website (www.mee-leven.be)

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Siblings and children of someone who has suicidal thoughts and/or behavior
  • years old
  • Have access to internet
  • Speak Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flemish Centre of Expertise in Suicide Prevention, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gwendolyn Portzky, Phd

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

October 16, 2023

Primary Completion

January 24, 2024

Study Completion

January 29, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations