Structured InterviewNCT04888845
Refinement of Suicide Risk Management Intervention
A study testing Safety Plan, Crisis Response Plan and Structured interview in people with Structured Interview and Narrative Assessment, run by University of Utah at 2 sites in United States.
Trial summary
Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Structured Interview, Narrative Assessment, Safety Plan
- What is being tested?
- Safety Plan, Crisis Response Plan and Structured interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2021to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of suicide Ideation
- History of suicide attempts
Who cannot join
- Geographic location outside the U.S.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State
Columbus, Ohio, 43214
University of Utah
Salt Lake City, Utah, 84112
About this study
Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.
- Being tested
- Safety Plan, Crisis Response Plan, Structured interview, Narrative Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety PlanBehavioural
The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.
Crisis Response PlanBehavioural
Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.
Structured interviewBehavioural
In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.
Narrative AssessmentBehavioural
In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.
| Study group | Role | What they receive |
|---|---|---|
| Structured interview and Safety Plan | Active comparator | In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. Receives: Behavioral: Safety Plan; Behavioral: Structured interview |
| Structured interview and Crisis Response Plan | Active comparator | In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. Receives: Behavioral: Crisis Response Plan; Behavioral: Structured interview |
| Narrative assessment and Safety Plan | Active comparator | In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. Receives: Behavioral: Safety Plan; Behavioral: Narrative Assessment |
| Narrative assessment and Crisis Response Plan | Active comparator | In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. Receives: Behavioral: Crisis Response Plan; Behavioral: Narrative Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicide relevant thoughts and behaviors after the intervention (Self Injurious Thoughts and Behaviors questionnaire)
Items from the Self Injurious Thoughts and Behaviors questionnaire (Fox et al., 2020) will be used to assess suicide relevant thoughts and behaviors
Measured: During an average of 2-weeks pre-intervention, 2-weeks post-intervention, 1 month follow-up after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start22 Apr 2021
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Structured InterviewStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Monika Lohani, University of Utah
- Investigators
- Monika Lohani, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888845
- Sponsor's protocol ID
- IRB_00135355
- Status last verified
- May 2026
- First submitted
- 29 Apr 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lohani M, Baker JC, Elsey JS, Dutton S, Findley SP, Langenecker SA, Do AS, Bryan CJ. Suicide prevention via telemental health services: insights from a randomized control trial of crisis response plan and self-guided safety planning approaches. BMC Health Serv Res. 2024 Nov 12;24(1):1389. doi: 10.1186/s12913-024-11739-w.
PubMed 39533271
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement of Suicide Risk Management Intervention
- ClinicalTrials.gov ID
- NCT04888845
- Acronym / sponsor ID
- IRB_00135355
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 17 May 2021 (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.
Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Structured interview and Safety Plan | Active comparator | Behavioral: Safety Plan, Behavioral: Structured interviewIn the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. |
| Structured interview and Crisis Response Plan | Active comparator | Behavioral: Crisis Response Plan, Behavioral: Structured interviewIn the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. |
| Narrative assessment and Safety Plan | Active comparator | Behavioral: Safety Plan, Behavioral: Narrative AssessmentIn the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. |
| Narrative assessment and Crisis Response Plan | Active comparator | Behavioral: Crisis Response Plan, Behavioral: Narrative AssessmentIn the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of suicide Ideation
- History of suicide attempts
Key exclusion criteria (1 listed)
- Geographic location outside the U.S.
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 |
|---|---|---|
| Safety PlanThe safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. | Behavioural | Narrative assessment and Safety Plan, Structured interview and Safety Plan |
| Crisis Response PlanCrisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. | Behavioural | Narrative assessment and Crisis Response Plan, Structured interview and Crisis Response Plan |
| Structured interviewIn the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. | Behavioural | Structured interview and Crisis Response Plan, Structured interview and Safety Plan |
| Narrative AssessmentIn the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. | Behavioural | Narrative assessment and Crisis Response Plan, Narrative assessment and Safety Plan |
Primary outcome
Change in suicide relevant thoughts and behaviors after the intervention (Self Injurious Thoughts and Behaviors questionnaire)
Time frame: During an average of 2-weeks pre-intervention, 2-weeks post-intervention, 1 month follow-up after intervention
Items from the Self Injurious Thoughts and Behaviors questionnaire (Fox et al., 2020) will be used to assess suicide relevant thoughts and behaviors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 39533271Lohani M, Baker JC, Elsey JS, Dutton S, Findley SP, Langenecker SA, Do AS, Bryan CJ. Suicide prevention via telemental health services: insights from a randomized control trial of crisis response plan and self-guided safety planning approaches. BMC Health Serv Res. 2024 Nov 12;24(1):1389. doi: 10.1186/s12913-024-11739-w.
- Individual participant dataSharing planned: No
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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.
Monika Lohani, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Plan, Crisis Response Plan and Structured interview in people with Structured Interview and Narrative Assessment, run by University of Utah at 2 sites 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 2 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in suicide relevant thoughts and behaviors after the intervention (Self Injurious Thoughts and Behaviors questionnaire) (time frame: During an average of 2-weeks pre-intervention, 2-weeks post-intervention, 1 month follow-up after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888845, which also lists 1 linked publication.
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 12 May 2026.