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Tool for Sibling and Children of Someone With Suicidal Thoughts

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Website (www.mee-leven.be)
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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: /

Sites / Locations

  • Flemish Centre of Expertise in Suicide Prevention, Ghent UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.
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

Full Information

First Posted
October 20, 2023
Last Updated
October 20, 2023
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT06100575
Brief Title
Tool for Sibling and Children of Someone With Suicidal Thoughts
Official Title
A Tool for Siblings and Children of Someone With Suicidal Thoughts and/or Behaviors: Evaluation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Website (www.mee-leven.be)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020)
Description
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.
Time Frame
Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary Outcome Measure Information:
Title
Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)
Description
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.
Time Frame
Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Title
Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)
Description
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
Time Frame
Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Title
Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire
Description
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.
Time Frame
Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Title
Changes in self-care and awareness
Description
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.
Time Frame
Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Title
Evaluation of the website
Description
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
Time Frame
post-test (after 3 days of access to website)
Other Pre-specified Outcome Measures:
Title
Socio-demographic characteristics
Description
age (continuous), gender (man, woman, other), previous health care (yes/no; categories 'professional healthcare provider', 'suicide prevention helpline', 'other'), needed health care (yes/no)
Time Frame
Baseline
Title
Characteristics of the suicidal family member
Description
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)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: /
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva De Jaegere
Phone
+32 (0)9 332.07.75
Email
eva.dejaegere@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Stas
Phone
+32 (0)9 332.07.75
Email
pauline.stas@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Portzky, Phd
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flemish Centre of Expertise in Suicide Prevention, Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva De Jaegere, MSc
Phone
+3293320775
Email
eva.dejaegere@ugent.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Tool for Sibling and Children of Someone With Suicidal Thoughts

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