Tool for Sibling and Children of Someone With Suicidal Thoughts

Suicide Clinical Trial

Official title:

A Tool for Siblings and Children of Someone With Suicidal Thoughts and/or Behaviors: Evaluation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06100575
• Other study ID #: B6702023000493 - ONZ-2023-0335
• Status: Completed
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: February 2024
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 29, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

Inclusion Criteria:

• Siblings and children of someone who has suicidal thoughts and/or behavior
• 16-25 years old
• Have access to internet
• Speak Dutch

Exclusion Criteria:

• /

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

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

Locations

Country	Name	City	State
Belgium	Flemish Centre of Expertise in Suicide Prevention, Ghent University	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-demographic characteristics	age (continuous), gender (man, woman, other), previous health care (yes/no; categories 'professional healthcare provider', 'suicide prevention helpline', 'other'), needed health care (yes/no)	Baseline
Other	Characteristics of the suicidal family member	relationship to participant (parent, sibling), previous thoughts and/or attempts (never, sometimes, regularly, n/a; as estimated by the participant), age (continuous), gender (man, woman, other)	Baseline
Primary	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	Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)	The Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995) scale is a 9-item self-report scale. Participants rate items to be applicable to them with the options: 'No!', 'No', 'More or less', 'Yes', 'Yes!', where 'No' and 'No!' are scored as 0 and the other options as 1. Total scores of 0-3 indicate little pressure, 4-6 moderate and 7-9 a lot.	Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary	Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)	The ATTS is a 37-item to be scored on a 5-point Likert scale (1= disagree completely to 5 = agree completely) to measure participants' attitudes towards suicide. The included subscales in this study are: incomprehensibility, non-communication, preventability, tabooing, preparedness to prevent	Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary	Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire	The BHS A 4-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness.; Self-developed questionnaire: 4-item self-report questionnaire to measure hopelessness in relation to the loved one, based on the BHS 4-item version. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness in relation to the loved one.	Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary	Changes in self-care and awareness	Self-developed questionnaire consisting of 5 statements to be rated on a 5-point Likert scale, with 1=strongly disagree and 5=strongly agree. Higher scores indicate higher levels of self-care and awareness.	Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary	Evaluation of the website	18 statements about the content, structure and effect of the website to be rated on a 5-point Likert scale (1= strongly disagree, 5= strongly agree) 4 open questions: "Which part of the website benefited you the most and why?"; "Which part of the website benefited you the least and why?"; "What can be improved on the website?" "Would you like to say anything else about the website?" Participants were asked to rate the website on a scale of 1-10	post-test (after 3 days of access to website)