Suicide PreventionNCT06130943
Evaluation of the Quality of Telephone Calls to a Suicide Prevention Helpline
An observational study of Suicide Prevention and Suicidal Ideation, run by University Ghent at 1 site in Belgium.
Trial summary
This study adds to the existing evidence on suicide prevention helpline efficacy because it tackles some of the common limitations for helpline studies. High risk individuals were not excluded from the study, since there was no human interference in deciding if the study was offered to the lifeline callers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention, Suicidal Ideation
- How many people
- 608 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2020to 14 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All callers who contact the suicide prevention helpline are asked to participate in the study.
Who may be able to join
- being 18 years of age or older
- Dutch-speaking
- calling to the Flemish suicide prevention helpline because they felt suicidal
- Only callers for whom it is certain that they will be connected to the Flemish suicide prevention helpline will be asked to participate.
Who cannot join
- Third party callers were excluded
Trial locations and contacts
1 site in 1 country.
About this study
This study adds to the existing evidence on suicide prevention helpline efficacy because it tackles some of the common limitations for helpline studies. High risk individuals were not excluded from the study, since there was no human interference in deciding if the study was offered to the lifeline callers. Most of the existing studies exclude users in high risk and acute crisis situations. The study employed the callers' own ratings on a set of questions, automatically offered within the phone system immediately before and after the call to assess the immediate impact of the call and the intervention. The automatization of the self-report measures in the telephone system reduces the burden on the operators to offer the research questions without interrupting the crisis intervention and decreases the risk of bias in caller responses.
The goal of this observational study is to evaluatie the Flesmish suicide prevention helpline in people who call the helpline when feeling suicidal. The main questions it aims to answer are:
Read more
- Has the degree to which the caller feels in crisis subsided? (Crisis in this is seen as the subjective feeling of complete emotional upset)
- Does the caller report feeling less suicidal? (Score on selected indicators of suicidality, particularly hopelessness, entrapment, controllability, suicidal intent and social support)
- Is the caller satisfied with the conversation?
- Which elements in the conversation (i.e., responders' interventions) make it more or less effective, in terms of crisis level, suicidality (indicators) and caller satisfaction?
- Which elements of the conversation do callers name as (not) helpful during the follow-up conversation? Which elements promoted progress in this, besides merely lowering the crisis level?
- What possible (follow-up) actions do callers see as helping to sustain and/or improve the longer-term impact of the conversation with the suicide prevention helpline?
Participants are asked the fill in items before the call, immediately after the call and one to two weeks after the call.
Read the detailed description
All adult (18+) callers who contact the suicide prevention helpline are offered the opportunity to participate in the study, once per (coded) phone number. The study is presented to the caller before there is any interaction between the caller and the operator and only when an operator is immediately available to answer the call. Informed consent is acquired in two steps, in order to minimise the time between calling and being transferred to the operator for callers not wanting to participate in the study: callers are asked if they are interested in taking part in the research: if not, they are transferred immediately to the operator; if they indicated being interested they receive more information about the study. The information about the study, which is recorded, is given automatically by the telephone system. Callers can consent by using the telephone keypad. More detailed information about the study is available for them on the website of the helpline.
After consenting, participants are asked about their age and gender and to respond to six short statements on their state of crisis and suicidality. All questions are answered using the telephone keys. After completing the questionnaire, or whenever they want to discontinue the study, participants are immediately transferred to the operator.
At the end of the call, a post-test is offered to the participants using the automatic telephone system. The six statements on the state of crisis and suicidality are assessed again, in addition a question on the degree of satisfaction with the call. After completing the post-test participants are asked whether they want to participate in the follow-up study. In order to contact them a phone number on which they can be contacted after one to two weeks, is asked. This phone number is coded by the phone system in order to guarantee the anonymity of the participant.
One to two weeks after contacting the helpline, a follow-up interview is conducted. This interview is carried out by an interviewer with extensive training in crisis calls. After making an initial contact with the participant, the six statements on the state of crisis and suicidality and the satisfaction about the call are assessed again automatically.
- Conditions
- Suicide Prevention, Suicidal Ideation
- Medical subject headings
- Suicide Prevention, Suicidal Ideation
What is being measured
The primary outcome is the main question the study is designed to answer.
Indicatorts of crisis and suicidality
Since there is no common standardized set of measures for suicide prevention helplines (Mazzer et al., 2021; Trail et al., 2022) six indicators of suicidal ideation and behaviour (SIB) are used to evaluate the calls of the Flemish Suicide Prevention Helpline. The selection of the indicators is based on previous research on helpline efficacy (Gould et al., 2007; Hoffberg et al., 2020; Hvidt et al., 2016; Kalafat et al., 2007), and on a number of core elements identified in suicide prevention theories explaining the transition from suicidal ideation to suicidal behaviour. The six indicators are crisis, hopelessness, entrapment, controllability, suicidal intent, and social support. All indicators are scored by the callers on a 10-point Likert scale (using the telephone keypad), ranging from 0 (not at all) to 9 (totally).
Measured: Baseline, post (immediately after the call), follow-up (one to two weeks after the call)
Secondary outcomes (1)
Satisfaction with the service
The satisfaction of the caller is assessed by the question 'I am satisfied about the call I just had with the suicide prevention helpline'.
Measured: Post (immediately after the call), follow-up (one to two weeks after the call)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start12 Oct 2020
- Primary completion4 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130943
- Sponsor's protocol ID
- B6702020000210
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Telephone Calls to a Suicide Prevention Helpline
- ClinicalTrials.gov ID
- NCT06130943
- Acronym / sponsor ID
- B6702020000210
- Conditions
- Suicide Prevention, Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study adds to the existing evidence on suicide prevention helpline efficacy because it tackles some of the common limitations for helpline studies. High risk individuals were not excluded from the study, since there was no human interference in deciding if the study was offered to the lifeline callers. Most of the existing studies exclude users in high risk and acute crisis situations. The study employed the callers' own ratings on a set of questions, automatically offered within the phone system immediately before and after the call to assess the immediate impact of the call and the intervention. The automatization of the self-report measures in the telephone system reduces the burden on the operators to offer the research questions without interrupting the crisis intervention and decreases the risk of bias in caller responses.
The goal of this observational study is to evaluatie the Flesmish suicide prevention helpline in people who call the helpline when feeling suicidal. The main questions it aims to answer are:
- Has the degree to which the caller feels in crisis subsided? (Crisis in this is seen as the subjective feeling of complete emotional upset)
- Does the caller report feeling less suicidal? (Score on selected indicators of suicidality, particularly hopelessness, entrapment, controllability, suicidal intent and social support)
- Is the caller satisfied with the conversation?
- Which elements in the conversation (i.e., responders' interventions) make it more or less effective, in terms of crisis level, suicidality (indicators) and caller satisfaction?
- Which elements of the conversation do callers name as (not) helpful during the follow-up conversation? Which elements promoted progress in this, besides merely lowering the crisis level?
- What possible (follow-up) actions do callers see as helping to sustain and/or improve the longer-term impact of the conversation with the suicide prevention helpline?
Participants are asked the fill in items before the call, immediately after the call and one to two weeks after the call.
Detailed description
All adult (18+) callers who contact the suicide prevention helpline are offered the opportunity to participate in the study, once per (coded) phone number. The study is presented to the caller before there is any interaction between the caller and the operator and only when an operator is immediately available to answer the call. Informed consent is acquired in two steps, in order to minimise the time between calling and being transferred to the operator for callers not wanting to participate in the study: callers are asked if they are interested in taking part in the research: if not, they are transferred immediately to the operator; if they indicated being interested they receive more information about the study. The information about the study, which is recorded, is given automatically by the telephone system. Callers can consent by using the telephone keypad. More detailed information about the study is available for them on the website of the helpline.
After consenting, participants are asked about their age and gender and to respond to six short statements on their state of crisis and suicidality. All questions are answered using the telephone keys. After completing the questionnaire, or whenever they want to discontinue the study, participants are immediately transferred to the operator.
At the end of the call, a post-test is offered to the participants using the automatic telephone system. The six statements on the state of crisis and suicidality are assessed again, in addition a question on the degree of satisfaction with the call. After completing the post-test participants are asked whether they want to participate in the follow-up study. In order to contact them a phone number on which they can be contacted after one to two weeks, is asked. This phone number is coded by the phone system in order to guarantee the anonymity of the participant.
One to two weeks after contacting the helpline, a follow-up interview is conducted. This interview is carried out by an interviewer with extensive training in crisis calls. After making an initial contact with the participant, the six statements on the state of crisis and suicidality and the satisfaction about the call are assessed again automatically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All callers who contact the suicide prevention helpline are asked to participate in the study.
Key inclusion criteria (4 listed)
- being 18 years of age or older
- Dutch-speaking
- calling to the Flemish suicide prevention helpline because they felt suicidal
- Only callers for whom it is certain that they will be connected to the Flemish suicide prevention helpline will be asked to participate.
Key exclusion criteria (1 listed)
- Third party callers were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Indicatorts of crisis and suicidality
Time frame: Baseline, post (immediately after the call), follow-up (one to two weeks after the call)
Since there is no common standardized set of measures for suicide prevention helplines (Mazzer et al., 2021; Trail et al., 2022) six indicators of suicidal ideation and behaviour (SIB) are used to evaluate the calls of the Flemish Suicide Prevention Helpline. The selection of the indicators is based on previous research on helpline efficacy (Gould et al., 2007; Hoffberg et al., 2020; Hvidt et al., 2016; Kalafat et al., 2007), and on a number of core elements identified in suicide prevention theories explaining the transition from suicidal ideation to suicidal behaviour. The six indicators are crisis, hopelessness, entrapment, controllability, suicidal intent, and social support. All indicators are scored by the callers on a 10-point Likert scale (using the telephone keypad), ranging from 0 (not at all) to 9 (totally).
1 secondary outcome
Satisfaction with the service
Time frame: Post (immediately after the call), follow-up (one to two weeks after the call)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide Prevention and Suicidal Ideation, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indicatorts of crisis and suicidality (time frame: Baseline, post (immediately after the call), follow-up (one to two weeks after the call)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.