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

NCT ID: NCT06164106

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-01-22

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.

Conditions

Suicide Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Crisis Response Planning

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

In-Person Crisis Response Planning

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Crisis Risk Counseling

Intervention Type: BEHAVIORAL

Individuals complete a standard crisis risk management intervention.

Interventions

Virtual Crisis Response Planning

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

Intervention Type: BEHAVIORAL

In-Person Crisis Response Planning

Individuals complete a collaborative suicide intervention in-person.

Intervention Type: BEHAVIORAL

Crisis Risk Counseling

Individuals complete a standard crisis risk management intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie M Gorka, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2023B0257

Identifier Type: -

Identifier Source: org_study_id