About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
AMPERE EMA app
Other interventionAMPERE EMA smartphone app using MyCap
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Client Satisfaction Questionnaire (CSQ)
This is a 3 item measure to assess consumer satisfaction with health and human services
Secondary outcomes
Suicide Related Coping Scale (SRCS)
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)
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).
Other outcomes
PhenX Social Determinants of Health Core
The PhenX Social Determinants of Health (SDOH) Collection is a toolset to help measure individual as well as structural factors that shape behaviors and health outcomes. The Core Collection is designed to create common data elements for measuring key variables across studies or clinical trials. It includes elements such as: Race and Ethnicity, Age, Gender Identity, Annual Family Income, English Proficiency, Occupational Prestige and Access to Health Services.
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) consists of 9 depression items and one disability item. Each item is associated with a DSM symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time, with a total sum score ranging from 0 - 27. Higher scores indicate higher depression symptom severity.
Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
The Generalized Anxiety Disorder Scale (GAD-7) is a 7- item screener for generalized anxiety. It consists of items related to generalized anxiety disorder. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks to crease a total sum score ranging from 0 - 21. The scale is a valid screener for generalized anxiety symptoms. Higher scores indicate higher anxiety symptom severity.
WHO ASSIST V3.0
World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is a questionnaire that screens for all levels of problem or risky substance use in adults. The ASSIST consists of eight questions covering tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants (including ecstasy) inhalants, sedatives, hallucinogens, opioids and 'other drugs'. A risk score is provided for each substance, and scores are grouped into 'low risk', 'moderate risk' or 'high risk'. The risk score determines the level of intervention recommended (brief intervention or brief intervention plus referral to specialist treatment).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator