- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06100575
Tool for Sibling and Children of Someone With Suicidal Thoughts
A Tool for Siblings and Children of Someone With Suicidal Thoughts and/or Behaviors: Evaluation.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- Flemish Centre of Expertise in Suicide Prevention, Ghent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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:
- /
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Website (www.mee-leven.be)
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020)
Time Frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)
Time Frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
|
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)
|
|
Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)
Time Frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
|
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)
|
|
Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire
Time Frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
|
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)
|
|
Changes in self-care and awareness
Time Frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
|
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)
|
|
Evaluation of the website
Time Frame: post-test (after 3 days of access to 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Socio-demographic characteristics
Time Frame: Baseline
|
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
|
|
Characteristics of the suicidal family member
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gwendolyn Portzky, PhD, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B6702023000493 - ONZ-2023-0335
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
VA Office of Research and DevelopmentRecruitingSuicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation | Suicide | Suicide AttemptUnited States
Clinical Trials on Website (www.mee-leven.be)
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
NYU Langone HealthCompleted
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR); CIHR Canadian HIV Trials NetworkCompleted
-
University of Illinois at ChicagoTerminatedHead and Neck CancerUnited States
-
University of Texas at AustinCompletedAlzheimer DiseaseUnited States
-
Odense University HospitalCompletedHealth Knowledge, Attitudes, Practice | Downs SyndromeDenmark
-
Northwestern UniversityNational Cancer Institute (NCI); Georgetown University; Hackensack Meridian HealthRecruitingLymphoma | Myelodysplastic Syndromes | Leukemia | Multiple Myeloma | Stem Cell Transplant | Hematologic Malignancy | Bone Marrow TransplantUnited States
-
Northwestern UniversityPatient-Centered Outcomes Research InstituteCompletedAlzheimers, Falls, Aging in PlaceUnited States
-
University of MichiganEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedEndometriosis | Chronic Pelvic PainUnited States
-
Universitätsklinikum Hamburg-EppendorfSanofiCompletedMultiple Sclerosis | Clinically Isolated Syndrome | Multiple Sclerosis, Relapsing-RemittingGermany