Abstract
Background: In adolescent and young adults (AYA) with sickle cell disease (SCD) seen for routine clinical care, up to 11% may endorse suicidality (Tran et al, Blood 2023). Depression and/or chronic pain is a known risk factor for future suicide attempts. Behavioral randomized controlled trials involving AYA SCD populations may benefit from safety protocols regarding suicidality. PRESENCE is a multi-site NIH funded HEAL initiative RCT evaluating effectiveness of digital cognitive behavioral therapy with or without peer support for AYAs living with SCD and chronic pain. Participants are actively being recruited from 17 academic hospitals, 5 community-based organizations, and virtually. To qualify, participants must be 16-30 years old, have SCD, experience >4 days of chronic pain and/or take prescribed pain medication for past 3 months. Participants who report active and/or severe suicidality at screening are excluded. Primary study outcome will evaluate overall pain intensity and interference at 6 months. A Suicide Risk Management Protocol (SRMP) is employed by a safety team including an adolescent medicine physician, clinical psychologist, clinical research coordinator, and licensed clinical social workers to address suicidal risk and evaluate ongoing study eligibility.
Study Design and Methods: Potential participants complete an electronic pre-screen including PHQ-9M (Patient Health Questionnaire-Modified) prior to study consent and at each timepoint (3, 6, 12-month). The SRMP is triggered if severe depressive symptoms (score >20) and/or suicidality is endorsed [i.e. any answer but “none” on PHQ-9M question 9 - past 2 weeks “thoughts you would be better off dead, or of hurting yourself in some way”; yes to question 12 (serious thoughts about ending your life in the past month); yes to question 13 (lifetime suicide attempt)]. The SRMP can also be initiated by study or health coach staff if a participant indicates thoughts of suicide during study procedures.
When SRMP is triggered, national suicide crisis resources are provided and participants are electronically redirected to answer the Ask Suicide-Screening Questions (ASQ), a validated suicide screening tool recommended by National Institute of Mental Health. A positive response to any ASQ question prompts a safety team contact attempted <48 business hours. Immediate notification of positive ASQ response is provided to the safety and clinical site teams.
Participants answering positively to ASQ question 5, “thoughts of killing yourself right now?” are classified as “imminent risk.” The safety team de-escalates the participant, if a minor (age 16 or 17) immediately contacts the parent/guardian, and inquires about a current mental health clinician. If this clinician cannot be immediately reached or there is not one available, the participant is directed to emergency or crisis services. For all other participants (ASQ 5 is no), the safety team asks a series of clinical risk questions using the Brief Suicide Safety Assessment (BSSA), and determines risk level: low risk, further evaluation needed, or imminent risk. For those at imminent risk, procedures described above are followed. For those at low risk, follow up with a primary care or SCD provider is recommended for further mental health concerns. For those for whom further evaluation is needed, the safety team develops a safety plan together with the patient (and parent/guardian if minor) involving a series of steps (e.g. coping strategies, support people, contacting provider or crisis services, lethal means restriction) participants can take to de-escalate when feeling suicidal and inquires whether the participant feels they can employ this plan if needed. Participants not feeling safe using this plan are directed to emergency services. For those who feel they can de-escalate suicidality utilizing their safety plan, permission is asked to provide this safety plan to current SCD or mental health providers, after obtaining a release of information. If not in treatment, resources are provided about treatment seeking. The safety team completes a 1 week follow up call to provide further recommendations as needed. All participants are provided with national resources and site-specific crisis and mental health resources.
SRMP activation frequency, risk levels and characteristics for those assessed will be reported in future. SRMP protocols application may improve participant safety in behavioral health trials.
