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

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 Overview

• Status: Recruiting
• Conditions: Suicide Prevention
• Intervention / Treatment: Behavioral: Crisis Risk Counseling; Behavioral: Virtual Crisis Response Planning; Behavioral: In-Person Crisis Response Planning

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Stephanie Gorka, PhD; Phone Number: 614-366-1027; Email: stephanie.gorka@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Virtual Crisis Response Planning; Individuals complete a chat-based experimental collaborative suicide intervention virtually.
Active Comparator: 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.	Behavioral: In-Person Crisis Response Planning; Individuals complete a collaborative suicide intervention in-person.
Active Comparator: 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.	Behavioral: Crisis Risk Counseling; Individuals complete a standard crisis risk management intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Suicide; Ecological Momentary Assessments; Crisis Response Planning
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide Prevention
• Other Study ID Numbers: 2023B0257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No