Clinical trial NCT06704958: Augmented Momentary Personal Ecological Risk Evaluation
Official title: Augmented Momentary Personal Ecological Risk Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Suicidal Ideation
Self Harm
Keywords: suicidal ideation
self harm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Iterative intervention Development
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this intervention study is to co-design and test an Ecological Momentary Assessment (EMA) prototype tool with young adults aged 16-30 experiencing suicidality to see if it is an acceptable and usable clinical tool for risk management.

The main study aims are:

* To co-design a prototype EMA suicide risk monitoring system with patients and health care provider input using Human Centered Design (HCD) methods.
* To test the developed EMA protype with providers and their young adult patients aged 16-30 experiencing suicidality to determine if the EMA prototype is an acceptable and usable clinical tool.

Young adult participants receiving care for active suicidal ideation will

* Download and use the EMA prototype for a total of two months.
* Complete 3 online surveys at 0, 1 and 2 months after enrolled in the study.

Detailed description: Death by suicide is a leading cause of preventable mortality for young adults in the United States, yet the health care delivery system is poorly equipped to address this preventable issue. Ecological momentary assessment (EMA) allows patients to easily self-monitor and track symptoms using devices young adults already use (e.g., smartphones) in their natural environments, and can combine self-reported assessment with digital indicators of wellbeing via native smartphone sensors (e.g., daily step counts; number of device unlocks during the night, which may indicate sleep problems). EMA suicide risk detection systems show promise, but acceptability among patients at risk for suicide is unknown, and an actionable system for response to these signals by outpatient health care providers has not been developed.

The current project aims to design (Aim 1) and to examine the acceptability and feasibility of an EMA tool with young adults at risk of suicide in typical outpatient medical settings (Aim 2). Specifically, the goal of this intervention study is to see how EMA based signals of suicide risk can be used in primary health care to support management and care of young adults aged 16-30 experiencing suicidality. We will use human centered design (HCD) to co-develop and test an EMA protype with young adult patients and their health care providers to determine if acceptable and usable clinical tool. The goal of the project is to develop an EMA based prototype that improves management and care for young adults experiencing suicidality and has the potential to be used in other effective risk monitoring strategies to follow.

The specific aims of this proposed study are:

Aim 1: Co-design a prototype EMA suicide risk monitoring system with patients and health care providers through human centered design (HCD).

Aim 1.1 Iteratively co-design an EMA prototype with patient and providers; Aim 1.2 Develop training, and support materials for EMA clinical use. Aim 2: Conduct a feasibility and acceptability pilot of the EMA prototype to inform its revision and further development.

The pilot will consist of approximately 50 University of Washington Primary Care (UWPC) patients receiving care for active suicidal ideation in a UWPC clinical site. Following consent, the pilot participants will download the EMA prototype to their smart phone and use it for two months. During the two months, participants will use the EMA prototype to complete a weekly depression screener and brief daily surveys on mood, activity level, sleep, diet, substance use and social support. Patient participants will be asked to complete three online surveys, one right after they enroll, one at 1 month and one at 2 months following enrollment. The surveys will ask about demographic information (age, race, ethnicity, etc.), suicidal ideation, self-injury, substance use, social support and their experience using the EMA prototype.

Eligibility criteria: Inclusion Criteria:

* Young adults (age 16-30 years)
* Receiving care at University of Washington Primary Care for suicidal ideation as determined by Electronic Health Record problem list or PHQ-9 suicide risk item \>0 in previous year and/or recent (past year) history of suicide attempt and/or active suicidal ideation.
* Ability to consent to participate

Exclusion Criteria:

* Age \<16 or \>30,
* Non-English speaking
* No smart phone access
* Any clinical medical/psychiatric condition, severity of that condition, or life situation that would compromise safe and voluntary study participation.

Primary outcomes:
measure: Acceptability of Intervention Scale (AIM)
timeFrame: 2 month post-initiation of AMPERE EMA use
measure: System Usability Scale (SUS)
timeFrame: 2 month post-initiation of AMPERE EMA use
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 2 month post-initiation of AMPERE EMA use
Secondary outcomes:
measure: Suicide Related Coping Scale (SRCS)
timeFrame: 0, 1, 2 month post-initiation of AMPERE EMA use
measure: Helping Alliance Questionnaire (Haq-II)
timeFrame: 1, 2 month post-initiation of AMPERE EMA use
Other outcomes:
measure: PhenX Social Determinants of Health Core
timeFrame: 0 month post-initiation of AMPERE EMA use
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 0 month post-initiation of AMPERE EMA use
measure: Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
timeFrame: 0 month post-initiation of AMPERE EMA use
measure: WHO ASSIST V3.0
timeFrame: 0 month post-initiation of AMPERE EMA use
measure: EuroQol 5 Dimension Youth (EQ-5D-Y)
timeFrame: 0 month post-initiation of AMPERE EMA use
measure: Columbia Suicide Severity Rating Scale Screener (C-SSRS)
timeFrame: 0, 1, 2 month post-initiation of AMPERE EMA use
measure: Harkavy Anais (HASS) Ideation
timeFrame: 0, 1, 2 month post-initiation of AMPERE EMA use
Locations:
Study officials:
affiliation: University of Washington
name: Ian M Bennett, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: