Technology-Assisted Systems Change for Suicide Prevention
Phase: NA
Conditions: Suicide, Suicide, Attempted
Sponsor: University of Massachusetts, Worcester

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 1 of 11 
Template Revised 8/8/2017 
1. TITLE 
Technology-Assisted Systems Change for Suicide Prevention (TASCS) 
[NCT04720911]  
March 31 2021 
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
3. PRIOR APPROVALS: 
Conflict of Interest (COI): The project has been discussed with representatives from this 
committee, who deemed a formal review unnecessary at this time: the app is as yet undeveloped 
and so is not likely to be ready for commercialization for a number of years, at which time 
UMass is likely to assert its rights to IP.  
 
Electronic Health Record Integration: The focus of this study is to develop and user-test the 
TASCS app, and to test its potential eventual compatibility with a real EHR by testing its 
performance in the Epic Sandbox, an open-source test space provided by Epic (not by 
UMMHC). The current grant does not propose integration of TASCS into the test or production 
versions of the UMMHC EHR. 
 
4. OBJECTIVES* 
See grant: “SPECIFIC AIMS” (p.1) for details. 
 
5. BACKGROUND* 
See grant: “RESEARCH PLAN” (p.2-4) for details. 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
Inclusion and Exclusion Criteria: See grant: “HUMAN PARTICIPANTS PROTECTION” 
(p.15) for details. No prisoners will be enrolled (including individuals with ankle monitors) 
without first obtaining IRB review and approval for this population and without first setting 
the required prisoner certification in place 
For Aim 1, individuals will be eligible to provide input into the development of 
TASCS if they are aged ≥18 years, and have direct, family or clinical experience of 
suicidality. They will be excluded if they are medically/cognitively unable to participate or 
are a prisoner.   
For Aims 2 and 3, participants will be invited to participate if they own a smartphone 
and if they meet the following eligibility criteria: 
 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 2 of 11 
Template Revised 8/8/2017 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A  
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A  
 
9. STUDY TIMELINES* 
The study is anticipated to start July 1, 2020. Aims 1 and 2 (development and user testing) of 
the project will be completed in the 1st year of the study period. Participation of those 
involved in Aim 1 and Cycle 1 of Aim 2 will be limited to a once-off encounter. Participants 
in Cycle 2 of Aim 2 will be asked to complete a one-week follow-up usability survey. 
Aim 3 (pilot randomized controlled trial) will be completed in the second year of the 
project. Participation of those involved in Aim 3 will include a three-month follow-up period 
after the initial enrollment encounter. The estimated completion date for primary analyses is 
September 2022. See grant: “TIMELINE” (p.15) for details. 
 
10. STUDY ENDPOINTS* 
See grant: “RESEARCH PLAN” (p. 13) for details. 
 
11. PROCEDURES INVOLVED* 
For Aim 1, the design thinking workshops are described in the grant application under 
“RESEARCH PLAN” (p.9-10).  
 
For Aim 2, participants will be recruited from UMMHC EDs. This will include patients 
(n~12) and their treating physicians or behavioral health clinicians (n~4). See grant: 
“RESEARCH PLAN” (p.10) for details on the procedure. We will collect the following: 
• 
Patient case report form, for demographics, psychiatric and suicide history, familiarity 
with mobile phone/computing technology, self-efficacy/capability 
• 
System Usability Scale (SUS)  
• 
User Engagement Scale (UES)  
The second half of these participants (Cycle 2) will also be invited to download the app to their 
smartphone and followed up to obtain these usability measures again one week after ED discharge 
(“Cycle 2”, RESEARCH PLAN, p.10). Participation will not affect their care, see grant: “HUMAN 
PARTICIPANTS PROTECTIONS” (p.19-20).  
Aim 3 is a pilot randomized controlled trial of 45 ED patients who screened positive 
during triage for recent active suicidal ideation or suicide attempt. They will be recruited from 
UMMHC EDs. They will be randomized to one of three TASCS App modalities in the ED (in-
person clinician, telehealth clinician, self-directed). All three groups will receive three 
Eligibility criteria 
Inclusion Criteria 
Exclusion Criteria 
Ø Age ≥18 years 
Ø Presenting to the UMMHC EDs 
Ø Screened positive for suicidal 
ideation in the past 2 weeks or 
attempt in the past 6 months 
Ø Medically/cognitively unable to participate in 
screening or assessment (e.g., sustained altered 
consciousness, psychosis, hostile behavior, intubation, 
severe pain) 
Ø Currently in state custody 
Ø Already enrolled during previous visit 
Ø No access to reliable telephone for follow-up 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 3 of 11 
Template Revised 8/8/2017 
counseling calls, access to the TASCS app, and one assessment call in the three months after 
discharge. See grant: “RESEARCH PLAN” (p.11-13) for details on the procedure. Participation 
will not affect their care see grant: “HUMAN PARTICIPANTS PROTECTIONS” (p.19-20). 
Measures to be included are: 
 
Suicide-related visits will be ascertained through medical record review. A HIPAA waiver of 
authorization will be obtained from the IRB in order to access medical records for to determine 
eligibility of potential subjects for the subject interviews. Additionally, patients will sign a 
HIPAA authorization during the consent process. 
 
The measures for Aim 2 are being uploaded with this submission. The remainder of the 
measures, data collection forms and surveys are still being developed and will be uploaded to the 
IRB for review and approval prior to implementation. 
 
12. DATA AND SPECIMEN BANKING* 
N/A 
 
13. Data Analysis and Management* 
See grant: “RESEARCH PLAN” (p.13) and “STATISTICAL DESIGN AND POWER” (p. 
26-27) for details. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
We will adhere to Investigator Guidance: Prompt Reporting Requirements (HRP-801). See 
grant: “HUMAN PARTICIPANTS PROTECTIONS” (p.14-23) and DATA SAFETY AND 
MONITORING PLAN (p.28-29) for details. The emergency number on the app will be for 
the National Suicide Prevention Lifeline (currently 1-800-273-8255, soon to be 988), a 24/7, 
toll-free hotline available to anyone in suicidal crisis or emotional distress. Calls to the 
national number are routed to local centers, which are supported with high-quality 
training and supervision.  
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
Measures at baseline and follow-up in feasibility trial (Aim 3) 
Construct 
Measure 
Initial implementation measures 
Usability  
System Usability Scale 
Acceptability  
Qualitative feedback 
Technology Acceptance Model Scale 
User Engagement Scale 
Patient-level outcomes 
 
Suicidal ideation and behavior  
Columbia Suicide Severity Rating Scale ;suicide-related ED visits 
Intervention targets 
 
Behavioral activation/effort  
Drive subscale of the Behavioral Activation Scale; BH engagement 
Perceived social support 
Interpersonal Needs Questionnaire; lethal means restriction  
Suicide-related impulse control 
Mccullumsmith et al. (2014) 
Implementation outcomes  
Engagement  
Session length, number of features used, screens with most user interaction, completeness 
of templates 
Costs 
Clinician time spent and associated costs; billability of services 
Reach and retention  
Refusals within each arm, number of calls answered, number of app sessions, session 
frequency patterns, family member registration 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 4 of 11 
Template Revised 8/8/2017 
Due to the sensitive nature of the topics being addressed (mental health, suicide), the 
investigator’s discretion will be used in deciding continued participation in the study. See 
grant: “HUMAN PARTICIPANTS PROTECTION” (p.22) for further “Withdrawal” details. 
 
16. RISKS TO SUBJECTS* 
See grant: “HUMAN PARTICIPANTS PROTECTION” (p.16-21) for details.  
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
See grant: “HUMAN PARTICIPANTS PROTECTION” (p.23) for details.  
 
18. VULNERABLE POPULATIONS* 
Pregnant women: Because pregnant women can have suicide risk, it is scientifically 
justifiable to include them. For this reason, these patients will be included. No inducements, 
monetary or otherwise, will be offered to terminate a pregnancy. Individuals engaged in the 
research will have no part in any decisions as to the timing, method, or procedures used to 
terminate a pregnancy. Individuals engaged in the research will have no part in determining 
the viability of a neonate 
 
Employees: We will be asking UMMHC clinicians for input on the TASCS apps during their 
development. Because the study team is comprised of research faculty and the participating 
clinicians will ED physicians, none of the study team teaches or supervises them or has the 
ability to influence their grades, academic success, or professional advancement.  
 
Adults unable to consent:  A consent mini-quiz will be administered to ensure that all potential 
subjects possess an understanding of the risks and benefits of study participation. The patient 
will take a quiz testing their understanding. If a patient obtains a score of less than 80% on the 
quiz, the research staff will repeat the explanation a second time in even more detail and the 
patient will re-take the quiz. If the patient obtains a score of less than 80% on the quiz upon re-
administration, they will not be invited to participate.  
 
19. MULTI-SITE RESEARCH* 
N/A 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
N/A 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
It will be several years before the results of the research are available. If the subjects would like 
us to try to reach them at that time, we will request that they let us know during the consent 
process. 
 
22. SETTING 
We will recruit participants from all UMMHC EDs (University, Memorial, Marlborough, 
Clinton and Health Alliance campuses). 
 
23. RESOURCES AVAILABLE 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 5 of 11 
Template Revised 8/8/2017 
 
Investigators and key personnel will have undergone mandatory education in human research 
participants’ protection. Educational systems are in place to ensure that all research staff have 
been through such training and are approved by the IRB Human Subjects department. The 
responsibilities of investigators and research personnel are as follows:  
 
Contact Principal Investigator. The Contact Principal Investigator will be responsible for 
overall project governance at UMass, leadership of the Project Team at UMass, protocol 
development, informing the data analytic plan, and dissemination efforts through 
professional presentations and peer reviewed journal publications. They will be responsible 
for overseeing and monitoring patient safety and reporting adverse events, as per IRB 
protocols.  
 
Multi Principal Investigator and Co-investigators. The Multi Principal Investigator and Co-
investigators will provide guidance and expertise on the iterative development of the TASCS, 
as well as advising on trial methodology as needed.  
 
Project Manager. The Project Manager will be responsible for managing daily operations of 
recruitment and enrollment including training and supervising the research assistants. They 
will manage all IRB-related submissions, amendments, and reporting. 
 
Research Clinician(s). Will serve as the study clinician and will perform the TASCS 
intervention, including the in-ED components and post-ED counseling calls. They will field 
referrals from the research assistant conducting follow-up assessment calls, if a participant is 
found to have emerging suicide risk during that assessment call (see HUMAN 
PARTICIPANTS PROTECTION” (p.17-19).   
 
Research Assistant(s). The research assistant(s) will be responsible for approaching and 
enrolling participants including carrying out the informed consent process, collecting 
baseline data, collecting healthcare utilization data, and conducting follow-up assessment 
calls.  
 
PhD student: The PhD student will be present for usability-focused data collection in Aims 1 
and 2 and will assist with transcription and qualitative analyses of anonymized data. She will 
not be involved in the informed consent process, will not be enrolling patients, and will not 
conduct trial-related patient data collection like chart reviews or follow-up phone-calls.  
 
Software Engineer. The software engineer(s) will be responsible for programming the 
TASCS mobile application and ensuring all data is flowing correctly between the mobile 
application and the secure server. They will have access to data that is entered into the app 
(such as safety plans and life plans) within the UMass secure environment. Although they 
may be contractors from WPI or Programination, they will operate within the UMass secure 
environment and will therefore adhere to the standard protocols and restrictions applied to all 
individuals working within the that environment. We will assess whether a reliance 
agreement is necessary for non-UMMS personnel and that any necessary IRB approvals will 
be in place for them before they interact with subjects or access private identifiable 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 6 of 11 
Template Revised 8/8/2017 
information about them. PHI will be directly entered by real users into the mobile application 
during the pilot trial in Aim 3, but not in the user testing phases (Aims 1 and 2). The TASCS 
mobile application will not store PII/PHI locally on the device.  
 
UMMHC Patient and Family Advisory Council (PFAC). The UMMHC Patient and Family 
Advisory Council is comprised of several advisory boards that provide input to clinicians and 
researchers to ensure that programs and interventions are designed to best fit the needs and 
preferences of patient stakeholders. The facilitators will support us in engaging those with 
lived experience to advise on the development of TASCS in the Aim 1 design thinking 
workshops and verification interviews.  
 
24. LOCAL RECRUITMENT METHODS 
For Aim 1, participants will be invited to participate through the PFAC. We will visit the PFAC 
to outline the purpose of the study, describe what participation in the design thinking workshop 
or verification interview would entail, and provide an email address for members to reach out if 
they have a direct or family lived experience of suicidality and are interested in participating. 
They will receive a $30 gift-card upon participating. 
For Aims 2 and 3, Research Assistants (RAs) will review the electronic health record 
dashboard for patients with positive suicide risk (answered “yes” to suicidal ideation in the past 
two weeks or a suicide attempt in the past 6 months on the Patient Safety Screener, which is 
routinely asked by nurses of all patients presenting to acute care). They will document all such 
patients who present during their shift on a Screening Log, recording demographic details but not 
patient names. They will use medical records and consultation with clinical staff to determine if 
an individual is appropriate to approach. All consecutive patients who screen positive for suicide 
risk will be considered for enrollment.  The RA will approach each potentially patient after the 
patient has been medically assessed and stabilized by medical staff. The RA will explain the 
nature, purpose, risks, and benefits of the study. If eligible and the patient is interested in 
participating, the consent mini-quiz will be conducted and written informed consent will be 
obtained (See CONSENT PROCESS, section #30 below). All patient participants will receive an 
initial $30 remuneration upon enrollment during their ED visit. Upon participating in the follow-
up assessment call, the patient will receive an additional $30 gift-card. There is no compensation 
for participating in the counseling calls with the study clinician.  
Compensation will be carried out through the Bank of America (BoA) reloadable gift card 
system, which is HIPAA compliant and in line with the University system for dispatching 
compensation to study participants. The participant’s contact details (name, address, phone 
number, and possibly social security number) must be shared by the research team with BoA in 
order for BoA to disburse the card. The BoA card will be delivered to the participant within 10 
days of enrollment and will be reloaded upon the completion of their follow up calls. Cash can 
then be withdrawn from these cards, without a fee at BoA ATMs or $1.50 at non-BoA ATMs. 
For any participants without a stable address, “anonymous” BoA cards will be given during the 
initial and follow-up encounters (these cards are not reloadable and have a 3-year expiration 
date). Participants will be made aware of the process when they enroll in the study. The research 
team will destroy the personal information that is needed for the BoA gift card no later than six 
years after study closure.  
 
 
25. LOCAL NUMBER OF SUBJECTS 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 7 of 11 
Template Revised 8/8/2017 
In Aim 1 (design thinking workshop and verification interviews), an estimated 16 
participants will be enrolled. In Aim 2 (usability assessment), an estimated 12 patients (and 
four clinicians) will be enrolled. In Aim 3, 45 participants will be enrolled, leading to a total 
of 73 participants.  
 
26. CONFIDENTIALITY  
Potential risks due to loss of confidentiality will be minimized by having all information 
collected and handled by research staff trained to deal appropriately with sensitive clinical issues. 
All research personnel will receive training in research ethics. All information will be treated as 
confidential material and will be available only to research and clinical staff. Audio recordings of 
all interviews will be obtained, unless the participant declines. The sound files will be recorded 
on digital voice recorders then downloaded to a password-protected folder on a secure drive 
hosted by UMass. After downloading to the secure drive, the recordings will be erased from the 
voice recorders. This will be described in the consent form, and patients can opt out of the 
recordings. All surveys will be digital and entered directly into REDCap. Any paper-based 
materials, like consent forms, will be kept in locked filing cabinets in a locked office. Data 
entered into the TASCS application will live within the UMass secure environment and will be 
de-identified before being exported outside that environment for analysis. All datasets will be 
handled in a HIPAA compliant manner, will be password-protected, and the analytic dataset will 
be de-identified. For additional information on processes to mitigate loss of confidentiality, 
please see grant “HUMAN PARTICIPANTS PROTECTION” (p.16-23). 
As of October 1, 2017, all NIH funded research collecting or using identifiable, sensitive 
information will automatically be issued a certificate of confidentiality (aka applications are no 
longer needed). The NIH is no longer using physical certificates, but rather the Notice of Award 
and Grants Policy Statement will suffice as documentation of CoC protection. See link below for 
the full policy details. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
The following security protocols will be applied to all data: physical protections - all databases 
and systems will be hosted behind the firewall by UMass Medical School and employ user 
authentication and role-based security for access. Standard security access procedures designed 
by UMass Medical School will be used to ensure that only authorized research staff has access to 
the study data. All paper-based materials, like consent forms, will be kept in locked files; logical 
protections. All datasets will be handled in a HIPAA compliant manner, will be password 
protected, and the analytic dataset will be de-identified. 
A HIPAA waiver of authorization will be obtained from the IRB in order to access 
medical records for to determine eligibility of potential subjects for the subject interviews. 
Additionally, patients will sign a HIPAA authorization during the consent process.  If the patient 
is excluded or refuses, this information, along with the reason for exclusion, will be documented 
on the Screening Log to allow comparisons of those enrolled vs. not enrolled, which will allow 
the team to assess representativeness of the sample. See Screening Log SOP (attached) for 
further details.  
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
This research involves no more than minimal risk or harm to subjects. However, the subjects 
will be informed during the consent process of the following: “The University of 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 8 of 11 
Template Revised 8/8/2017 
Massachusetts Medical School does not provide funds for the treatment of research-related 
injury. If you are injured as a result of your participation in this study, treatment will be 
provided. You or your insurance carrier will be expected to pay the costs of this treatment. 
No additional financial compensation for injury or lost wages is available.” 
 
29. ECONOMIC BURDEN TO SUBJECTS 
There will be no costs for which subjects may be responsible for due of participation in the 
research. 
 
30. CONSENT PROCESS 
For Aim 1, we propose a waiver of written documentation of consent for advisors participating in 
the design workshops and verification interviews. The research involves no more than minimal 
risk of harm to subjects and involves no procedures for which written documentation of consent 
is normally required outside of research context. Study procedures will be described verbally. An 
information sheet will be provided to the clinicians informing them about the study and that their 
participation is voluntary. The participants will be asked for permission to record the meetings 
for the purposes of notetaking. The recordings will be stored on a secure UMMS server and 
destroyed at the end of the study period, as described in Section 26. Confidentiality. In the event 
it becomes appropriate to provide participants with additional pertinent information after 
participation, we will seek the guidance of the IRB. 
 
Patients:  
For Aims 2 and 3, the RA will approach each patient after the patient has been medically 
assessed and stabilized by medical staff. They will explain the nature, purpose, risks, and 
benefits of the study. A five-item, multiple-choice consent mini-quiz will be administered to 
ensure that all potential subjects possess an understanding of the risks and benefits of study 
participation. Content will differ for patients depending on what participation entails, for Cycles 
1 and 2 of Aim 2 and for Aim 3. If a patient obtains a score of less than 80% on the quiz, the 
research staff will repeat the explanation a second time in even more detail and the patient will 
re-take the quiz. If the patient obtains a score of less than 80% on the quiz upon re-
administration, they will not be invited to participate. If the patient agrees to participate, 
electronic written informed consent will be obtained.  
 
Clinicians: Waiver of written documentation of consent will be obtained for the clinicians in Aim 
2. Being limited to user feedback, the research involves no more than minimal risk of harm to 
subjects and involves no procedures for which written documentation of consent is normally 
required outside of research context. Study procedures will be described verbally. An  
information sheet will be provided informing clinicians about the study and that their 
participation is voluntary. In the event it becomes appropriate to provide participants with 
additional pertinent information after participation, we will seek the guidance of the IRB.  
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
Patients: The consent process will be conducted in-person; the research staff will review the 
consent form with the participant in REDCap. The participant and the research staff will both 
electronically sign through REDCap’s “Wet Signature” feature, as required by UMMS.  The 
participant will then choose whether they would like to receive an emailed PDF copy of the 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 9 of 11 
Template Revised 8/8/2017 
consent or a paper copy of the consent. . Documentation of consent will be done in 
accordance with HRP-803 INVESTIGATOR GUIDANCE: Documentation of Informed 
Consent.  
 
Waiver of written documentation of consent will be obtained for Aim 1 advisors and Aim 2 
clinicians. The research involves no more than minimal risk of harm to subjects and involves no 
procedures for which written documentation of consent is normally required outside of research 
context. 
 
32. DRUGS OR DEVICES 
Based on the FDA’s Policy for Device Software Functions and Mobile Medical Applications 
(2019), TASCS is unlikely to be subject to regulatory requirements because (1) it resembles 
examples given under Appendix B for which the FDA intends to exercise enforcement discretion 
because they pose lower risk to the public and (2) will neither transform a mobile platform into a 
regulated medical device nor connect to an existing device type for purposes of controlling its 
operation, function, or energy source (Appendix C). Towards the end of the study period, we will 
revisit this issue based on the eventual functionality of the TASCS and initiate the 513(g) process 
as appropriate. 
 
 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 10 of 11 
Template Revised 8/8/2017 
Statistical Analysis Plan 
 
STATISTICAL DESIGN AND POWER 
 
In this two-year R34, data will be used primarily to iteratively improve the TASCS and assess 
feasibility and acceptability of pilot implementation in the emergency department. In Aim 1, we 
will build the TASCS using input and feedback from empaneled stakeholders. In Aim 2, we will 
obtain introduce the TASCS to emergency department patients with suicide risk to examine 
usability and acceptability in vivo. Finally, in Aim 3, we will conduct a pilot feasibility trial with 
three arms:  
(1) In-person clinician-administered TASCS ED App in the ED followed by 
telephone coaching calls, facilitated by the Post-ED Clinician App, and access to 
the Post-ED Patient and Family App 
(2) Telehealth-based TASCS in the ED followed by telephone coaching calls, 
facilitated by the Post-ED Clinician App, and access to the Post-ED Patient and 
Family App 
(3) Self-administered TASCS in the ED followed by telephone coaching calls, 
facilitated by the Post-ED Clinician App, and access to the Post-ED Patient and 
Family App 
 
Data analyses will proceed with an intent-to-treat approach. Statistical significance will be at p 
< .05 and analyses will occur via IBM® SPSS® Statistics V21 and SAS 9.4 statistical software 
package (SAS Institute Inc, Cary, NC). 
 
A. Aim 2: Usability Testing. Analyses will center around assessing usability, acceptability, and 
needs for program updates based on users’ experiences. We will apply descriptive statistics to 
assess participants’ comments and questions related to specific program/equipment features 
and global assessments. Usability outcomes will be: 1) ability to use the program and 
equipment without staff assistance after training (yes/no), 2) time (in minutes) to complete the 
TASCS process once trained, and 3) total number of deviations from the direct path of 
completing TASCS procedures after training. The stopping point for testing will be having three 
patients rate the platform as having a SUS score of ³ 80. We will track and store usage 
statistics, including time on each page and time in app. Google Analytics will constitute a 
secondary source of statistics.  
 
B. Aim 3: Feasibility Trial. It is important to note that, being an initial feasibility trial, the study 
is not powered to find a difference between arms and we are not seeking to compare TASCS to 
treatment-as-usual to examine effectiveness. Rather we are seeking to describe the usability 
and acceptability of different modes of delivering TASCS in the ED, of the Post-ED Clinician 
App, and the Post-ED Patient and Family App, to examine potential intervention targets, and to 
examine the utility of our chosen measures at baseline and follow-up.  
Initial analyses will compare the three treatment groups on baseline demographic and 
clinical variables using a chi-square test (for categorical variables) and analysis of variance (for 
continuous variables). Variables that significantly differ between groups or are theoretically 
important will be used as covariates in multivariate analysis, when appropriate. We will proceed 
with intent-to-treat analyses. Baseline and three-month usability and acceptability analyses will 
compare the three treatment groups using analysis of variance. The behavioral outcome in the 
feasibility trial will be occurrence of any suicidal behavior (attempt, preparatory, aborted or 
interrupted attempt, death by suicide) and categorical level of ideation during three-month 
follow-up. Analyses will compare the three arms via chi-square for suicidal behavior and 
Kruskal-Wallis test for ordinal level of suicidal ideation. Changes in suicidal behavior and 
suicidal ideation over time will be examined using McNemar (overall) and Friedman tests (by 

INVESTIGATOR STUDY PLAN - TASCS 
 
 
Page 11 of 11 
Template Revised 8/8/2017 
arm) respectively. To elucidate the impact of intervention components on intervention targets, 
we will use t tests to compare our three main intervention targets at follow-up (social support, 
behavioral activation, and impulse control) between those who did and did not receive the 
intervention component specific to that target, and will use t tests to examine the association 
between intervention targets and patient outcome (occurrence of any suicidal behavior and 
presence of active suicidal ideation at follow-up). For all analyses, effect sizes will be estimated, 
with parametric and non-parametric statistics as appropriate.  
 
Sample size justification. For our development and usability testing, we will engage 12 
individuals with lived experience for persona testing in Aim 1 and 12 ED patients for in vivo 
usability testing in Aim 2. This number was chosen because a sample of 10 users can identify 
95% of usability problems1 including in persons with serious mental illness.2 The sample size for 
the feasibility trial (n=45) is based on the same principle, allocating 15 patients in each of the 
three arms and allowing for moderate attrition over the three-month follow-up period. Because 
of the funding mechanism and our focus on platform development, the feasibility trial is not 
powered to test hypotheses but rather to inform the feasibility of the intervention and data 
collection measure for a future large-scale implementation trial. With significance set at 0.05 and 
assuming a power of 0.80, a sample size of 45 participants across three arms will allow us to 
detect a large effect size of f=0.48 in usability and acceptability scores and w= 0.46 in 
dichotomous suicidal behavior outcome.  
 
REFERENCES 
1. Faulkner L. Beyond the five-user assumption: Benefits of increased sample sizes in usability 
testing. Behav Res Methods, Instruments, Comput. 2003;35(3):379-383. 
doi:10.3758/BF03195514. 
2. Ben-Zeev D, Kaiser SM, Brenner CJ, Begale M, Duffecy J, Mohr DC. Development and 
usability testing of FOCUS: a smartphone system for self-management of schizophrenia. 
Psychiatr Rehabil J Rehabil. 2013;36(4):289-296. doi:10.1037/prj0000019.