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Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide

Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06164106
Enrollment
57
Registered
2023-12-11
Start date
2023-11-01
Completion date
2025-01-22
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide Prevention

Keywords

Suicide, Crisis Response Planning, Ecological Momentary Assessments

Brief 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. 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.

Interventions

BEHAVIORALVirtual Crisis Response Planning

Individuals complete a chat-based experimental collaborative suicide intervention virtually.

BEHAVIORALIn-Person Crisis Response Planning

Individuals complete a collaborative suicide intervention in-person.

Individuals complete a standard crisis risk management intervention.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment ArmsTwo weeks after the intervention sessionSelf-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.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-InterventionApproximately 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.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).

Countries

United States

Participant flow

Pre-assignment details

Of the 57 enrolled participants, 55 were randomized to treatment.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
55 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
19 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 190 / 18
other
Total, other adverse events
0 / 180 / 190 / 18
serious
Total, serious adverse events
0 / 180 / 190 / 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026