Clinical trial NCT06164106: Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
Official title: Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide Prevention
Keywords: Suicide
Crisis Response Planning
Ecological Momentary Assessments
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 52
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Feasibility and acceptability of the experimental treatment as measured by ecological momentary assessments.
timeFrame: EMA surveys will be sent 5 times daily for 14 days post-intervention.
measure: Feasibility and acceptability of the experimental treatment as measured by qualitative interview.
timeFrame: Approximately 14 days post-intervention.
measure: Changes in suicidal ideation, intent, behaviors, and urges as measured by ecological momentary assessments.
timeFrame: EMA surveys will be sent 5 times daily for 14 days pre-intervention and 5 times daily for 14 days post-intervention.
measure: Changes in thoughts of death and suicide as measured by the Ask Suicide-Screening Questions (ASQ) questionnaire.
timeFrame: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
measure: Changes in suicidal ideation, intent, behaviors, and urges as measured by the Beck Scale for Suicidal Ideation (BSSI) questionnaire.
timeFrame: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
measure: Changes in suicidal ideation, intensity, behaviors, and intent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
timeFrame: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References: