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

Suicide Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164106
• Other study ID #: 2023B0257
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Virtual Crisis Response Planning
Individuals complete a chat-based experimental collaborative suicide intervention virtually.
• In-Person Crisis Response Planning
Individuals complete a collaborative suicide intervention in-person.
• Crisis Risk Counseling
Individuals complete a standard crisis risk management intervention.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of the experimental treatment as measured by ecological momentary assessments.	Self-reported utilization of the crisis response planning (CRP) treatment components will be assessed and measured by ecological momentary assessments (EMA) between the treatment groups. EMA questions utilize a discrete rating scale to measure utilization of the treatment components.	EMA surveys will be sent 5 times daily for 14 days post-intervention.
Primary	Feasibility and acceptability of the experimental treatment as measured by qualitative interview.	The feasibility and acceptability of the experimental treatment will be measured by open-ended questions during a qualitative interview.	Approximately 14 days post-intervention.
Primary	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 throughout the protocol using ecological momentary assessments (EMA). EMA questions utilize a discrete rating scale to measure changes from pre-treatment and post-treatment.	EMA surveys will be sent 5 times daily for 14 days pre-intervention and 5 times daily for 14 days post-intervention.
Primary	Changes in thoughts of death and suicide as measured by the Ask Suicide-Screening Questions (ASQ) questionnaire.	Self-reported 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".	Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
Primary	Changes in suicidal ideation, intent, behaviors, and urges as measured by the Beck Scale for Suicidal Ideation (BSSI) questionnaire.	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.	Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
Primary	Changes in suicidal ideation, intensity, behaviors, and intent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).	Suicidal ideation, intensity, behaviors, and intent will be assessed utilizing the Columbia-Suicide Severity Rating Scale (C-SSRS) interview. The C-SSRS interview utilizes "yes" or "no" questions. The C-SSRS also utilizes open-ended questions about how recently the thought or behavior occurred and the interviewer scores the severity based on a standard rating scale.	Approximately 2 weeks before treatment and approximately 2 weeks after treatment.