Augmented Momentary Personal Ecological Risk Evaluation

Early Phase 1

Not yet recruiting

• Conditions: Suicidal Ideation; Self Harm

• Registration Number: NCT06704958
• Lead Sponsor: University of Washington

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2025-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
System Usability Scale (SUS)	2 month post-initiation of AMPERE EMA use	This is a 10 item measure of system usability with 5 response options. SUS score can range from 0 to 100 with a higher score indicating high usability.
Acceptability of Intervention Scale (AIM)	2 month post-initiation of AMPERE EMA use	This is a four-item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.
Client Satisfaction Questionnaire (CSQ)	2 month post-initiation of AMPERE EMA use	This is a 3 item measure to assess consumer satisfaction with health and human services

Secondary Outcome Measures

Name	Time	Method
Suicide Related Coping Scale (SRCS)	0, 1, 2 month post-initiation of AMPERE EMA use	Suicide-Related Coping Scale (SRCS) measures how well a person manages suicidal thoughts through the use of internal and external coping strategies. A 17-item tool with two score factors, internal and external coping strategies.
Helping Alliance Questionnaire (Haq-II)	1, 2 month post-initiation of AMPERE EMA use	The Helping Alliance Questionnaire is a 11-item patient self-report measure which assesses the extent to which the patient experiences the therapist and the therapy as helpful. It contains two types of helping alliance: Type I -- Perceived Helpfulness -- defined as the patient's experience of the therapist as providing or being capable of providing the help that is needed; and Type II -- Collaboration or Bonding -- defined as the patient's experience of treatment as a process of working together with the therapist toward the goals of treatment. The HAQ contains 11 items rated on a 4-point scale (completely disagree, disagree, agree, and completely agree).