Trial Outcomes & Findings for Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide (NCT NCT06164106)
NCT ID: NCT06164106
Last Updated: 2026-03-18
Results Overview
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.
COMPLETED
NA
57 participants
Two weeks after the intervention session
2026-03-18
Participant Flow
Of the 57 enrolled participants, 55 were randomized to treatment.
Participant milestones
| Measure |
Virtual Crisis Response Planning
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.
Virtual Crisis Response Planning: Individuals complete a chat-based experimental collaborative suicide intervention virtually.
|
In-Person Crisis Response Planning
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.
In-Person Crisis Response Planning: Individuals complete a collaborative suicide intervention in-person.
|
Virtual Crisis Risk Counseling
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.
Crisis Risk Counseling: Individuals complete a standard crisis risk management intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
Baseline characteristics by cohort
| Measure |
Virtual Crisis Response Planning
n=18 Participants
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.
Virtual Crisis Response Planning: Individuals complete a chat-based experimental collaborative suicide intervention virtually.
|
In-Person Crisis Response Planning
n=19 Participants
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.
In-Person Crisis Response Planning: Individuals complete a collaborative suicide intervention in-person.
|
Virtual Crisis Risk Counseling
n=18 Participants
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.
Crisis Risk Counseling: Individuals complete a standard crisis risk management intervention.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=110 Participants
|
19 Participants
n=114 Participants
|
18 Participants
n=224 Participants
|
55 Participants
n=104 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=110 Participants
|
15 Participants
n=114 Participants
|
14 Participants
n=224 Participants
|
43 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
12 Participants
n=104 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
4 Participants
n=104 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=110 Participants
|
17 Participants
n=114 Participants
|
17 Participants
n=224 Participants
|
51 Participants
n=104 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
7 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
8 Participants
n=104 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=110 Participants
|
11 Participants
n=114 Participants
|
12 Participants
n=224 Participants
|
35 Participants
n=104 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
4 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
1 Participants
n=104 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=110 Participants
|
19 participants
n=114 Participants
|
18 participants
n=224 Participants
|
55 participants
n=104 Participants
|
PRIMARY outcome
Timeframe: Two weeks after the intervention sessionPopulation: Participants who were randomized to one of the CRP arms and completed the post-treatment use form were included in the analyses.
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.
Outcome measures
| Measure |
Virtual Crisis Response Planning
n=16 Participants
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.
Virtual Crisis Response Planning: Individuals complete a chat-based experimental collaborative suicide intervention virtually.
|
In-Person Crisis Response Planning
n=17 Participants
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.
In-Person Crisis Response Planning: Individuals complete a collaborative suicide intervention in-person.
|
Virtual Crisis Risk Counseling
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.
Crisis Risk Counseling: Individuals complete a standard crisis risk management intervention.
|
|---|---|---|---|
|
Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment Arms
|
14 Participants
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Average suicide risk score across the 14 days before the intervention and across the 14 days post-intervention.Population: Participants who completed their intervention and the follow-up forms.
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.
Outcome measures
| Measure |
Virtual Crisis Response Planning
n=16 Participants
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.
Virtual Crisis Response Planning: Individuals complete a chat-based experimental collaborative suicide intervention virtually.
|
In-Person Crisis Response Planning
n=17 Participants
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.
In-Person Crisis Response Planning: Individuals complete a collaborative suicide intervention in-person.
|
Virtual Crisis Risk Counseling
n=18 Participants
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.
Crisis Risk Counseling: Individuals complete a standard crisis risk management intervention.
|
|---|---|---|---|
|
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by Ecological Momentary Assessments.
Pre-Treatment Mean SI Risk
|
1.3 Units on a scale
Standard Error 0.3
|
0.9 Units on a scale
Standard Error 0.3
|
0.8 Units on a scale
Standard Error 0.2
|
|
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by Ecological Momentary Assessments.
Post-Treatment Mean SI Risk
|
0.90 Units on a scale
Standard Error 0.3
|
1.0 Units on a scale
Standard Error 0.3
|
0.8 Units on a scale
Standard Error 0.3
|
PRIMARY outcome
Timeframe: Approximately 2 weeks after treatment.Population: All participants who completed the single session intervention protocol and completed the post-treatment forms was included.
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.
Outcome measures
| Measure |
Virtual Crisis Response Planning
n=16 Participants
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.
Virtual Crisis Response Planning: Individuals complete a chat-based experimental collaborative suicide intervention virtually.
|
In-Person Crisis Response Planning
n=17 Participants
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.
In-Person Crisis Response Planning: Individuals complete a collaborative suicide intervention in-person.
|
Virtual Crisis Risk Counseling
n=18 Participants
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.
Crisis Risk Counseling: Individuals complete a standard crisis risk management intervention.
|
|---|---|---|---|
|
Number of Participants Who Reported Thoughts of Death and Suicide at 2 Weeks Post-Intervention
|
9 Participants
|
12 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.Population: Participants who completed the intervention and post-treatment follow-up questionnaires.
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).
Outcome measures
| Measure |
Virtual Crisis Response Planning
n=16 Participants
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.
Virtual Crisis Response Planning: Individuals complete a chat-based experimental collaborative suicide intervention virtually.
|
In-Person Crisis Response Planning
n=17 Participants
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.
In-Person Crisis Response Planning: Individuals complete a collaborative suicide intervention in-person.
|
Virtual Crisis Risk Counseling
n=18 Participants
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.
Crisis Risk Counseling: Individuals complete a standard crisis risk management intervention.
|
|---|---|---|---|
|
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by the Beck Scale for Suicidal Ideation (BSSI) Questionnaire Total Score.
Pre-Treatment BSSI Total
|
9.6 units on a scale
Standard Error 1.5
|
9.0 units on a scale
Standard Error 1.6
|
7.4 units on a scale
Standard Error 1.5
|
|
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by the Beck Scale for Suicidal Ideation (BSSI) Questionnaire Total Score.
Post-Treatment BSSI Total
|
5.4 units on a scale
Standard Error 1.6
|
9.5 units on a scale
Standard Error 1.6
|
4.1 units on a scale
Standard Error 1.5
|
Adverse Events
Virtual Crisis Response Planning
In-Person Crisis Response Planning
Virtual Crisis Risk Counseling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place