Suicide PreventionNCT06164106
Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
A study testing Virtual Crisis Response Planning, In-Person Crisis Response Planning and Crisis Risk Counseling in people with Suicide Prevention, run by Ohio State University at 1 site in United States.
Trial summary
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- Virtual Crisis Response Planning, In-Person Crisis Response Planning and Crisis Risk Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant is 14-18 years old at the time of assent/consent
- Participant's legal guardian is willing and able to give parental permission (if 14-17 years old)
- Participant is able to give informed assent or consent (as applicable by age)
- Participant endorses current desires to make a suicide attempt as defined as answering "yes" to item #3 on the Ask Suicide Screening Question (ASQ) tool
Who cannot join
- Factors that would interfere with data interpretation including serious medical or neurologic conditions
- Presence of current moderate to severe substance use disorder
- Lack of access to a personal smartphone
- Lack of fluency in English
Trial locations and contacts
1 site in 1 country.
About this study
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adolescents with current suicidal intent will be randomly assigned to receive either a 1-hour session of virtual crisis response planning (CRP), a 1-hour session of in-person CRP, or a 1-hour session of standard crisis risk management (treatment as usual). The feasibility and acceptability of the virtual CRP, compared to in-person CRP, will be assessed 14 days post-treatment. Additional assessments of changes in mood, behavior, and suicidality will be collected daily for 14 days post-treatment via ecological momentary assessments. The investigators hypothesize the following: 1) Virtual CRP will be rated as more feasible and acceptable compared to traditional CRP and treatment as usual interventions; 2) Both versions of CRP will be associated with changes in frequency and severity of suicidal ideation and behavior compared to treatment as usual; 3) Virtual CRP will be equally as effective as traditional CRP at reducing suicide risk, suggesting that virtual CRP is a promising scalable intervention adaptation.
- Conditions
- Suicide Prevention
- Being tested
- Virtual Crisis Response Planning, In-Person Crisis Response Planning, Crisis Risk Counseling
- Keywords
- Suicide, Crisis Response Planning, Ecological Momentary Assessments
- Medical subject headings
- Suicide Prevention, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Crisis Response PlanningBehavioural
Individuals complete a chat-based experimental collaborative suicide intervention virtually.
In-Person Crisis Response PlanningBehavioural
Individuals complete a collaborative suicide intervention in-person.
Crisis Risk CounselingBehavioural
Individuals complete a standard crisis risk management intervention.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Crisis Response Planning | Experimental | The virtual crisis response planning (CRP) session will last between 30 minutes to 1-hour and be conducted via doxy.me with a trained study therapist. The virtual CRP is primarily text-based, instead of verbal, and utilizes the chat feature on doxy.me. CRP involves the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The CRP active component involves a collaborative process in which the therapist invites the participant to share the events, symptoms, and contextual factors leading up to and surrounding their suicidal crisis. Next, the participant identifies their personal warning signs, self-management coping skills, reasons for living, and sources of social support. The participant types the components on a template via the white board feature on doxy.me. The CRP will be saved and serve as a concrete reference for participants in the real-world. Receives: Behavioral: Virtual Crisis Response Planning |
| In-Person Crisis Response Planning | Active comparator | The in-person crisis response planning (CRP) session will last between 30 minutes to 1-hour. The in-person CRP will follow the same protocol and include the same treatment components as the virtual CRP. However, it will occur face-to-face, instead of on doxy.me, with a trained study therapist. The treatment components, outlined under the virtual CRP arm description, are written by the participant on an index card. The index card serves as a concrete reference for participants in the real-world. Receives: Behavioral: In-Person Crisis Response Planning |
| Virtual Crisis Risk Counseling | Active comparator | The crisis risk counseling session will last between 30 minutes to 1-hour. It will occur virtually on doxy.me with a trained study therapist. It will include the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The therapist will conduct a semi-structured suicide risk assessment interview, after which participants will complete a self-guided safety plan worksheet via the white board feature. The worksheet will take approximately 10-minutes to complete and will be done independently. Receives: Behavioral: Crisis Risk Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment Arms
Self-reported utilization of the crisis response planning (CRP) treatment was assessed at the end of the trial. Participants randomized to one of the CRP treatment arms were asked to complete a form assessing whether participants used their CRP plan in the two weeks following the intervention (yes or no). Individuals in the virtual crisis risk counseling control group did not complete the CRP use form.
Measured: Two weeks after the intervention session
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by Ecological Momentary Assessments.
Self-reported suicidal ideation, intent, behaviors, and urges will be repeatedly assessed 5 times per day for 14 days before the intervention and 14 days after the intervention using ecological momentary assessments (EMA). A composite suicide risk score was calculated for each day by averaging five suicide risk items (range per item 0 - 10). Higher composite scores indicate greater suicide risk.
Measured: Average suicide risk score across the 14 days before the intervention and across the 14 days post-intervention.
Number of Participants Who Reported Thoughts of Death and Suicide at 2 Weeks Post-Intervention
Thoughts of death and suicide will be assessed utilizing the Ask Suicide-Screening Questions (ASQ) questionnaire. The ASQ utilizes "yes" or "no" questions to assess thoughts of death and suicide "during the past few weeks". Post-treatment endorsement of ASQ item 3 (i.e., "yes" response) will be compared across the three treatment arms.
Measured: Approximately 2 weeks after treatment.
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by the Beck Scale for Suicidal Ideation (BSSI) Questionnaire Total Score.
Self-reported suicidal ideation, intent, behaviors, and urges will be assessed utilizing the Beck Scale for Suicidal Ideation (BSSI) questionnaire. Each question on the BSSI utilizes a rating scale of 0, 1, and 2 and a total score is calculated by summing the score for each question (range 0-38; higher scores indicate greater severity of suicidal ideation).
Measured: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Nov 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie M Gorka, PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164106
- Sponsor's protocol ID
- 2023B0257
- Status last verified
- Feb 2026
- First submitted
- 9 Nov 2023
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
- ClinicalTrials.gov ID
- NCT06164106
- Acronym / sponsor ID
- 2023B0257
- Conditions
- Suicide Prevention
- Keywords
- Suicide, Crisis Response Planning, Ecological Momentary Assessments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adolescents with current suicidal intent will be randomly assigned to receive either a 1-hour session of virtual crisis response planning (CRP), a 1-hour session of in-person CRP, or a 1-hour session of standard crisis risk management (treatment as usual). The feasibility and acceptability of the virtual CRP, compared to in-person CRP, will be assessed 14 days post-treatment. Additional assessments of changes in mood, behavior, and suicidality will be collected daily for 14 days post-treatment via ecological momentary assessments. The investigators hypothesize the following: 1) Virtual CRP will be rated as more feasible and acceptable compared to traditional CRP and treatment as usual interventions; 2) Both versions of CRP will be associated with changes in frequency and severity of suicidal ideation and behavior compared to treatment as usual; 3) Virtual CRP will be equally as effective as traditional CRP at reducing suicide risk, suggesting that virtual CRP is a promising scalable intervention adaptation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Crisis Response Planning | Experimental | Behavioral: Virtual Crisis Response PlanningThe virtual crisis response planning (CRP) session will last between 30 minutes to 1-hour and be conducted via doxy.me with a trained study therapist. The virtual CRP is primarily text-based, instead of verbal, and utilizes the chat feature on doxy.me. CRP involves the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The CRP active component involves a collaborative process in which the therapist invites the participant to share the events, symptoms, and contextual factors leading up to and surrounding their suicidal crisis. Next, the participant identifies their personal warning signs, self-management coping skills, reasons for living, and sources of social support. The participant types the components on a template via the white board feature on doxy.me. The CRP will be saved and serve as a concrete reference for participants in the real-world. |
| In-Person Crisis Response Planning | Active comparator | Behavioral: In-Person Crisis Response PlanningThe in-person crisis response planning (CRP) session will last between 30 minutes to 1-hour. The in-person CRP will follow the same protocol and include the same treatment components as the virtual CRP. However, it will occur face-to-face, instead of on doxy.me, with a trained study therapist. The treatment components, outlined under the virtual CRP arm description, are written by the participant on an index card. The index card serves as a concrete reference for participants in the real-world. |
| Virtual Crisis Risk Counseling | Active comparator | Behavioral: Crisis Risk CounselingThe crisis risk counseling session will last between 30 minutes to 1-hour. It will occur virtually on doxy.me with a trained study therapist. It will include the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The therapist will conduct a semi-structured suicide risk assessment interview, after which participants will complete a self-guided safety plan worksheet via the white board feature. The worksheet will take approximately 10-minutes to complete and will be done independently. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participant is 14-18 years old at the time of assent/consent
- Participant's legal guardian is willing and able to give parental permission (if 14-17 years old)
- Participant is able to give informed assent or consent (as applicable by age)
- Participant endorses current desires to make a suicide attempt as defined as answering "yes" to item #3 on the Ask Suicide Screening Question (ASQ) tool
Key exclusion criteria (4 listed)
- Factors that would interfere with data interpretation including serious medical or neurologic conditions
- Presence of current moderate to severe substance use disorder
- Lack of access to a personal smartphone
- Lack of fluency in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Crisis Response PlanningIndividuals complete a chat-based experimental collaborative suicide intervention virtually. | Behavioural | Virtual Crisis Response Planning |
| In-Person Crisis Response PlanningIndividuals complete a collaborative suicide intervention in-person. | Behavioural | In-Person Crisis Response Planning |
| Crisis Risk CounselingIndividuals complete a standard crisis risk management intervention. | Behavioural | Virtual Crisis Risk Counseling |
Primary outcome
Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment Arms
Time frame: Two weeks after the intervention session
Self-reported utilization of the crisis response planning (CRP) treatment was assessed at the end of the trial. Participants randomized to one of the CRP treatment arms were asked to complete a form assessing whether participants used their CRP plan in the two weeks following the intervention (yes or no). Individuals in the virtual crisis risk counseling control group did not complete the CRP use form.
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by Ecological Momentary Assessments.
Time frame: Average suicide risk score across the 14 days before the intervention and across the 14 days post-intervention.
Self-reported suicidal ideation, intent, behaviors, and urges will be repeatedly assessed 5 times per day for 14 days before the intervention and 14 days after the intervention using ecological momentary assessments (EMA). A composite suicide risk score was calculated for each day by averaging five suicide risk items (range per item 0 - 10). Higher composite scores indicate greater suicide risk.
Number of Participants Who Reported Thoughts of Death and Suicide at 2 Weeks Post-Intervention
Time frame: Approximately 2 weeks after treatment.
Thoughts of death and suicide will be assessed utilizing the Ask Suicide-Screening Questions (ASQ) questionnaire. The ASQ utilizes "yes" or "no" questions to assess thoughts of death and suicide "during the past few weeks". Post-treatment endorsement of ASQ item 3 (i.e., "yes" response) will be compared across the three treatment arms.
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by the Beck Scale for Suicidal Ideation (BSSI) Questionnaire Total Score.
Time frame: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
Self-reported suicidal ideation, intent, behaviors, and urges will be assessed utilizing the Beck Scale for Suicidal Ideation (BSSI) questionnaire. Each question on the BSSI utilizes a rating scale of 0, 1, and 2 and a total score is calculated by summing the score for each question (range 0-38; higher scores indicate greater severity of suicidal ideation).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing Virtual Crisis Response Planning, In-Person Crisis Response Planning and Crisis Risk Counseling in people with Suicide Prevention, run by Ohio State University at 1 site in United States.
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 4 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 Mar 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment Arms (time frame: Two weeks after the intervention session). The study lists 4 primary outcomes in all. 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 Mar 2026.