Augmented Momentary Personal Ecological Risk Evaluation

NCT06704958 | Recruiting DMC

• 2 other identifiers: STUDY00017404P50MH129708-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Self Harm

Keywords

suicidal ideation; self harm

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Scale (AIM)

  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.

  2 month post-initiation of AMPERE EMA use

• System Usability Scale (SUS)

  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.

  2 month post-initiation of AMPERE EMA use

• Client Satisfaction Questionnaire (CSQ)

  This is a 3 item measure to assess consumer satisfaction with health and human services

  2 month post-initiation of AMPERE EMA use

Secondary Outcomes (2)

• Suicide Related Coping Scale (SRCS)

  0, 1, 2 month post-initiation of AMPERE EMA use

• Helping Alliance Questionnaire (Haq-II)

  1, 2 month post-initiation of AMPERE EMA use

Other Outcomes (7)

• PhenX Social Determinants of Health Core

  0 month post-initiation of AMPERE EMA use

• Patient Health Questionnaire (PHQ-9)

  0 month post-initiation of AMPERE EMA use

• Generalized Anxiety Disorder (7-Item) Scale (GAD-7)

  0 month post-initiation of AMPERE EMA use

Study Arms (1)

Use of AMPERE EMA prototype

OTHER

An EMA risk monitoring system using a smartphone EMA app to collect self-reported data from participating patients experiencing suicidal ideation.

Other: AMPERE EMA app

Interventions

AMPERE EMA app OTHER

AMPERE EMA smartphone app using MyCap

Use of AMPERE EMA prototype

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Study Officials

• Ian M Bennett, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mindy Vredevoogd, MS

CONTACT

206-465-0099; mindyv@uw.edu

Tess Grover, BA

CONTACT

206-830-1950; grovet@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Psychiatry & Behavioral Sciences

Model Details: Iterative intervention Development

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: September 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)