A Multi-Site, Non-Interventional Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
Conditions: Suicidal Ideation
Sponsor: Children's Hospital Medical Center, Cincinnati

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A Multi-Site, Non-Intervention Study to Compare the Outcomes of Psychiatric Treatment of 
Suicidal Adolescents in Different Treatment Settings  
 
NCT#: NCT04625686 
Jan 22 2021 
 
Sponsor Name and Legal Registered Address:  
Patient-Centered Outcomes Research Institute (PCORI)  
 
 
 

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Table of Contents 
1. 
Synopsis 
4 
2. 
Introduction 6 
2.1. Study Rationale 6 
2.2. Background 
7 
2.3. Benefit/Risk Assessment 
12 
3. 
Specific Aims and Hypothesis 
14 
4. 
Study Design 16 
4.1. Overall Design 16 
4.2. Number of Participants 17 
4.3. End of Study Definition 18 
5. 
Study Population 
18 
5.1. Workflow 
18 
5.2. Informed Consent 
19 
5.3. Payment for Participation 
19 
5.4. The CHRT-SR and Recruitment 19 
5.5. Inclusion Criteria 
20 
5.6. Exclusion Criteria 
21 
5.7. Screen Failures 21 
6. 
Treatments 
21 
6.1. Method of Treatment Assignment 
26 
6.2. Treatment Compliance 26 
6.3. Treatment After the End of the Study 
27 
7. 
Discontinuation Criteria 
28 
7.1. Discontinuation from the Study 28 
7.2. Lost to Follow Up 
28 
8. 
Study Assessments and Procedures 29 
8.1. Efficacy Assessments 
30 
8.2. Adverse Events 30 
8.2.1. 
Time Period and Frequency for Collecting AE and SAE Information 
30 
8.2.2. 
Method of Detecting AE and SAE 31 
8.2.3. 
Follow-up of AE and SAE 31 
8.2.4. 
Regulatory Reporting Requirements for SAE 
32 

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9. 
Statistical Considerations 
32 
9.1. Sample Size Determination 
32 
9.2. Statistical Analyses 
33 
9.2.1. 
Efficacy Analyses 
33 
9.2.2. 
Safety Analyses 34 
9.2.3. 
Other Analyses 34 
10. 
References 
37 
11. 
Appendices 
46 
11.1. Appendix 1: Schedule of Events (SoE) / Milestones 
46 
 

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1. 
Synopsis 
Protocol Title: A Multi-Site, Non-interventional Study to Compare the Outcomes of Psychiatric 
Treatment of Suicidal Adolescents in Different Treatment Settings   
Rationale: Evaluating alternatives to inpatient treatment for suicidal adolescents is urgently 
needed. An unprecedented use of telehealth crisis services are being utilized during the COVID-
19 pandemic.  Evaluation of outcomes for telehealth care is greatly needed. To address the unmet 
need of optimizing the treatment and management for adolescent suicidality, we propose to 
compare treatment outcomes of Telehealth Crisis Intervention Services (CIS) to in-person 
Outpatient Crisis Intervention Clinic (OCIC) and inpatient treatment.  
Objective and Endpoint 
Objective 
Endpoint 
Primary 
 Evaluate the safety of CIS-telehealth 
relative to inpatient and OCIC-in-person 
among children with similar CHRT 
scores. 
 Time to first recurrence of a suicidal 
event 
 Number of suicidal events 
 Severity of suicidal ideation 
Secondary 
 Examine the effectiveness of CIS-
telehealth relative to inpatient and in-
person OCIC among children with 
similar CHRT scores. 
 Score from PROMIS Short Form v 1.0-
General Life Satisfaction-Short Form 5a 
(to assess the parent’s well-being) 
 Score from PROMIS Parent-Proxy Life 
Satisfaction-Short Form 8a 
 Score from PROMIS Pediatric Life   
Satisfaction-Short Form 4a 
 Score from CHRT-SR at baseline and 
follow-up visits  
 Assess patient and parent treatment 
satisfaction with CIS-telehealth relative 
to inpatient and in-person OCIC among 
children with similar CHRT scores. 
  Score from Client Satisfaction 
Questionnaire (CSQ-8)  
 
Tertiary/Exploratory 
 Does Telehealth CIS lead to greater 
reduction of emotional arousal or 
perceived stress levels in response to 
COVID-19 the pandemic  
 Scores from the COVID-19 survey 

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Overall Design: Observational Design 
Number of Participants: CCHMC- 61; other 3 sites- 61 each; total- 244 from all 4 sites 
Treatment Groups: Inpatient Psychiatric Treatment vs. Outpatient Crisis Intervention Clinic 
(OCIC) vs. Telehealth Crisis Intervention Services (CIS) 
Duration: 12 Months (1 Years) 
 

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2. 
Introduction 
Suicide is a leading cause of death for adolescents in the United States.1-5 Inpatient psychiatry, 
a frequent treatment setting for adolescents with suicidality 6-9, is problematic because it can 
lead to a burden on families 10-13, disruption in school 14, financial cost to society 15, 16, a 
substantial increase in the risk of suicide attempts after short psychiatric hospitalizations 17-23, 
assault by other patients 24-26, and poor self-esteem from the stigma.27-29 Indeed, alternatives to 
inpatient psychiatric treatment need to be explored due to bed shortages 8, 30, access issues 31-35, 
and boarding of adolescent psychiatric patients in medical units and Emergency 
Departments.36-39 Taken together, evaluating alternatives to inpatient treatment for suicidal 
adolescents is urgently needed. Outpatient Crisis Intervention Clinic (OCIC) is an alternative 
treatment option that provides a more intensive level of short-term (two to six weeks) support 
with multiple therapeutic visits for patients and families each week promptly starting within 
three days of the crises (the Emergency Department (ED) visit). OCIC provides these services 
for the adolescents and their families who are waiting for outpatient services without exposing 
these adolescents to the above-mentioned disadvantages of inpatient psychiatry treatment. 40-43 
Due to the worldwide pandemic, the mental health community has shifted many of its services 
to telehealth, including crisis intervention.  More research is needed to assess the effectiveness 
of this treatment modality compared to inpatient and OCIC services.   
2.1. 
Study Rationale 
The COVID-19 pandemic has led to disruptions throughout medicine, including psychiatry. The 
vast majority of psychiatric services at institutions across the country have rapidly shifted to 
telehealth-based services. This includes services for adolescents with suicidal ideation. Although 
this shift was done to provide services in a time of crisis that all but eliminated face-to-face 
services, the mental health community is left with questions regarding safety and effectiveness of 
telehealth. This is especially true for adolescents with suicidal thoughts.  Previous research that 
explored the use of telehealth in mental health services has focused primarily on rural 
populations where services are limited (Roberts et al 2017, Saurman et al, 2014). Research has 
not specifically examined the effectiveness and safety of telehealth for adolescents with suicidal 
thoughts. This is partly attributable to restrictions on telehealth like state regulations, licensing, 
insurance, and equipment (Mace et al, 2018). However, the US response to COVID-19 has 
effectively eliminated these barriers.  Currently, there is an unprecedented use of telehealth 
across US health systems. Yet, there is a deficiency of research indicating that telehealth for 
adolescents with suicidal thoughts is safe and effective. Given the current changes and their 
potential for long-term or permanent implementation, knowledge is urgently needed establish 
whether telehealth is a safe and effective approach for adolescents with suicidal thoughts. The 
START study is in a unique position to evaluate telehealth services relative to the current 
standards of care.  By integrating an enhancement project into our current START study, we will 
be able to make a critical contribution to the learning of safe and effective treatment for 
adolescents experiencing suicidal thoughts now and in the future. The mental health community 
needs to determine the factors that can identify the safety of treating adolescents with suicidal 
thoughts in an outpatient and telehealth setting. 

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To address the unmet need of optimizing the treatment and management for adolescent 
suicidality, we propose to evaluate the effectiveness and safety of telehealth services compared 
to inpatient and OCIC  for suicidal adolescents in our target population. To achieve this goal, we 
propose a multi- site study to compare  telehealth, OCIC, and inpatient care,  and see which can 
lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction 
(TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and 
patients.11, 44, 45 Furthermore, we will assess which clinical and socioeconomic factors at baseline 
may affect the treatment outcomes. With the results from our proposed study, we will be able to 
reduce the family and clinician decisional uncertainty about the best treatment setting for suicidal 
adolescents in our target population. The results will significantly help patients, families, and 
clinicians with this decision-making process and improve outcomes for suicidal adolescents. 
2.2. 
Background 
Suicide is a leading cause of death for adolescents in the United States. 1-5 Adolescent suicidality 
includes suicidal thoughts, intent, plans, and attempts. 73 Suicidality does not include nonsuicidal 
self-injury (NSSI) because it does not include intent to die. 74 The primary outcome measure for 
this proposed research will be the time to first recurrence of a suicidal event. 75 A suicidal event 
is defined as: a suicide attempt, interrupted attempt, hospitalization because of suicidal risk, an 
emergency/urgent evaluation because of suicidal risk, and a death by suicide. NSSI is not our 
primary target and we will focus on adolescents who present with suicidal thoughts and suicide 
attempts which can also include NSSI. Therefore, to improve generalizability, we will collect 
data on NSSI even though it is not part of our primary outcome. 
Our stakeholder partner, Heather Turner, Executive Director, NAMI of Southwest Ohio, clarified 
that the most acceptable terminology is death by suicide or died by suicide rather than committed 
or completed suicide.76 For adolescents in the United States in 2015, suicide was the third 
leading cause of death between the ages of 10 and 14, and the second leading between the ages 
of 15 and 34. 2, 4, 5 For girls (ages 15 to 19), the suicide rate doubled from 2007 to 2015 and was 
at its highest peak in 40 years in 2015 with a rate of 5.1 per 100,000. For males (ages 15 to 19), 
the suicide rate increased by 31% between 2007 and 2015 when the rate was 14.2 per 100,000.3 
The Youth Risk Behavior Surveillance Survey estimated that of high school students, 16% 
reported seriously considering suicide, 13% reported creating a plan to kill themselves, and 8% 
reported trying to kill themselves in the previous 12 months. 77 Adolescent suicidal behavior is 
common, with more than 1 million attempts and 4,600 deaths by suicide each year. 52 There is a 
clear need for development of treatment programs both aimed at preventing adolescent suicide 
attempts, as well as addressing recurrent suicidal ideation and promotion of safety following an 
attempt. 78, 79  
The Problems with the Current Standard Treatment for Adolescent Suicidality: The 
standard and common treatment for adolescents with suicidality is inpatient psychiatry 6-9, which 
includes therapy (individual and group), improving coping skills, family meetings, close 
monitoring of safety, and medication management. 81 It is important to note that the Standard of 
Care at Cincinnati Children’s Hospital Medical Center has improved, as OCIC interventions 
have been introduced. CCHMC, Northwell Health, Nationwide Children’s and Children’s Health 
(in Dallas), along with at least 10 other locations across America have introduced OCIC 
interventions.1-2, 4-5 Inpatient psychiatry is a short term intensive treatment method that is 
commonly used in clinical practice for suicidal adolescents and is seen as an important 

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component in the treatment of adolescents with mental illness.6-9 However, there are no direct 
studies on the efficacy of inpatient hospitalization in reducing adolescent suicidal behavior. Not 
all adolescents brought to the ED for suicidality are acutely suicidal.  Suicidal ideation runs on a 
spectrum of increasing severity and intensity of the ideation and behavior.  The following scale 
displays the increasing severity nature of suicidal ideation: 1) Wish to be dead, 2) Non-Specific 
Active Suicidal thoughts, 3) Active Suicidal Ideation with Any Methods (Not Plan) without 
Intent to Act, 4) Active Suicidal Ideation with Some Intent to Act, without Specific Plan, 5) 
Active Suicidal Ideation with Specific Plan and Intent.  (Columbia-Suicide Severity Rating Scale 
2016).  While the demand for inpatient psychiatric treatment is high, the number of inpatient 
beds has been decreasing in the U.S. in the past decade. 8, 30 Studies have shown that inpatient 
hospitalization may not be effective in the linkage of patients to outpatient treatment. 82The time 
period after discharge from inpatient hospitalization can be a time for increased risk for suicidal 
behavior. The first month following discharge from an inpatient psychiatric hospitalization has 
been identified as the greatest period of risk for reattempt. 17 In addition, despite the importance 
of continued outpatient care, previous research shows that the majority of adolescents who 
attempt suicide receive limited follow up care with less than 40% receiving a follow-up visit 
within 30 days. 75, 83 A study from 2017 found that children’s hospital admissions for suicidality 
more than doubled from 2008 to 2015. 84 Inpatient psychiatry is problematic because it can cause 
worsened depression 85, be a burden to families 10-13, disrupt school 14, increase the risk of suicide 
attempts after short psychiatric hospitalizations 17-23, and lead to poor self-esteem from the 
stigma of inpatient treatment. 27-29 Moreover, adolescents whom have suicidal thoughts that 
return may not seek help if they had a negative experience with inpatient psychiatry. 86, 87 Indeed, 
alternatives to inpatient psychiatric treatment need to be explored due to bed shortages 8, 30, 
access issues 31-35, and boarding of adolescent psychiatric patients on medical units and 
Emergency Departments. 36-39  
 Alternative Treatment to Standard Treatment of Adolescent Suicidality:  Telehealth services 
encompass an emerging intervention due to the need for social distancing measures.  They 
encompass crisis interventions that include safety planning, therapeutic interventions and 
emergency medication consultations.  Telehealth services will not be the same at all sites, but 
involve similar services. 
At CCHMC, our study team developed the term Outpatient Crisis Intervention Clinic (OCIC) to 
encompass the programs from the 4 individual sites, CCHMC, Northwell Health, Nationwide 
Children’s and Children’s Health, that provide similar, but not the same, services.  The 4 
programs that encompass the term OCIC have some variation in treatment approaches and 
duration, however all 4 programs have crisis intervention work in common, including 
appointments that occur soon after emergency department visits for crisis intervention.  In 
comparison to inpatient psychiatry, Outpatient Crisis Intervention Clinic (OCIC) provides more 
intensive therapeutic services for adolescent suicidality with frequent family focused mental 
health appointments, specific therapeutic interventions for suicidality while outside of the 
hospital, and more thorough safety planning to prevent future suicidal events. OCIC has 
advantages because it provides a more intensive level of short-term (about two to six weeks) 
support with multiple therapeutic visits for adolescents with suicidality and their families each 
week starting within three days of the crises. OCIC provides these services for the adolescents 
and their families who are waiting for outpatient services without exposing these adolescents to 
the above-mentioned disadvantages 

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Gaps in Knowledge about Outcomes of Alternative Treatment of Adolescent Suicidality: Few 
programs have been developed that bridge the vulnerable period of time spanning between 
Emergency Room evaluation for adolescent suicidality to outpatient care,88-90 and even fewer 
that provide intensive treatment in an outpatient setting for teens.17 As such, there is tremendous 
need to develop and test optimal treatment strategies for adolescents during this high risk period, 
as highlighted in Objective 8.4 of the National Strategy for Suicide Prevention, to “promote 
continuity of care and the safety and well-being of all patients treated for suicide risk in 
emergency departments or hospital inpatient units.” 91 
This study aims to evaluate treatment outcomes for Telehealth CIS, In-Person OCIC and 
Inpatient treatment. The gap in knowledge is that it is unknown if telehealth services or OCIC 
will lead to better outcomes than inpatient psychiatry. Clinical trials have not examined the 
effectiveness of telehealth or OCIC in treating adolescent suicidality. The last publication on the 
American Academy of Child and Adolescent Psychiatry Practice Parameters (AACAP) for the 
treatment of children and adolescents with suicidal behaviors was from 2001. 54, 92 Our proposed 
research will provide the needed evidence to update these practice parameters for adolescents 
with suicidal behaviors. Although there are no randomized controlled trials to determine the 
effectiveness of admitting suicidal adolescents, the AACAP parameters recommended inpatient 
psychiatry for adolescent suicide attempters with persistent suicidal thoughts. Since the time of 
the last AACAP parameters publication, standard of care for the treatment of adolescent 
suicidality has improved to include OCIC interventions. This improvement has led to a decrease 
in unnecessary inpatient hospitalizations.1-2, 4-5  
Although the National Action Alliance for Suicide Prevention released evidence-based 
recommendations for standard care for adults with suicide risk on April 17, 2018, no 
recommendations for standard care were provided for adolescents with suicide risk.94The adult 
recommendations are as follows: 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Outpatient 
Mental He 
InpMental 
Health  
Emergency 
Depart-
ment  
Primary 
Care  
 Assess all patients for suicide risk and stratify patients according to risk level 
 
 If risk is Elevated 
 
 Complete a collaborative safety plan as part of the treatment plan during the visit.  
 Provide crisis hotline information (Preferably someone with training in assessment ad safety planning).  
 Reassess risk and review and/or update the safety plan at every visit until risk levels decrease to less threatening 
levels. 
 Assess all patients for suicide risk and stratify patients according to risk level 
 Completely safety plan on admission 
 Develop a collaborative safety plan for the environment the patient will return to. This should include 
individuals that can help support the patient after discharge.  
 Provide crisis hotline information (Preferably someone with training in assessment ad safety planning).  
 Engage the patient with a licensed mental health provider after discharge. 
 Make “caring contact” with the patient 24 hours after discharge and again 7 days after discharge.   
 Assess all patients for suicide risk and stratify patients according to risk level. Pay close attention to any injuries 
sustained and the nature of those injuries since this may affect risk level.  
 Determine risk level and treatment type (Discharge with support, Outpatient or Inpatient treatment). 
 Provide a safe, monitored space and remove items that could be used to do bodily harm. 
 For those with elevated risk who will be discharged with support 
 
 Provide information on crisis hotlines which include the National Suicide Prevention Lifeline number (1-800-
273TALK). 
 During the visit, complete a safety plan that focuses on reducing access to lethal methods and ask for assistance 
from loved ones.   
 Engage the patient with a licensed mental health provider after discharge. 
 Make “caring contact” with the patient 24 hours after discharge and again 7 days after discharge.   
 Identify and assess the risk for suicide among all patients who have mental illnesses, misuse substances, have 
been prescribed psychiatric medication or have a substance use disorder an stratify them according to risk level.  
 For those with elevated risk 
 Provide information on crisis hotlines which include the National Suicide Prevention Lifeline. Work with family 
and significant others to reduce patient’s access to lethal means. 
 Work with behavioral health professionals to engage with the patient.  
 Follow up with patient within 24 hours after discharge.  

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The standard care for adolescents with suicidality is expected to be different because adolescents 
often have a built-in safety net with their families who can provide supervision. Hence, OCIC is 
more feasible for adolescents with suicidality than adults. Additionally, with the COVID-19 
safety measures in place around the country, telehealth services are more widely used service in 
treating mental health crises. With the results from our proposed study, we will be able to 
eliminate the family and clinician decisional uncertainty about standard care and the best 
treatment setting for suicidal adolescents and improve treatment outcomes. We will address the 
comparative clinical effectiveness research (CER) question regarding the evidence gap about 
which treatment setting is most effective. We will compare the effectiveness of: telehealth CIS, 
OCIC and inpatient treatment at reducing adolescent suicidality by assessing the time to first 
recurrence of a suicidal event, the number of suicidal events, treatment satisfaction (TS), and 
satisfaction with life (SL). 
Most Relevant Preliminary Data: In 2017, out of 401 adolescent patients with suicidality who 
were in the Cincinnati Children’s Hospital’s OCIC, only 25 (6%) returned to the ED for 
psychiatric reasons within 90 days of their first OCIC appointment. Also, the treatment 
satisfaction ratings by parents were higher for OCIC than inpatient in 2017. For example, 
significantly more parents (88%) rated that they felt that they participated as much as they should 
have in OCIC in comparison to inpatient psychiatry (74%). Upon completion of the Dallas 
OCIC, one of our four sites, teens and parents completed the Client Satisfaction Questionnaire 
(CSQ-8) CSQ to assess satisfaction. Both patient and parent satisfaction were very high. In 
response to the question, “In an overall, general sense, how satisfied are you with the service you 
have received?”, 99% of parents and 96% of teens responded that they were mostly satisfied or 
very satisfied. When asked if they would refer a friend, 89% of parents and 67% of teens 
responded “definitely yes” while only 1% of parents and 2.3% of teens responded “don’t think 
so”. The average score across items on the CSQ for those who were enrolled in the program was 
3.78 (SD=.33) for parent (n=290), and 3.54 (SD=.49) for teen (n=302) on a 4 point scale (with 4 
indicating the highest level of satisfaction). The findings suggest that OCIC for adolescents with 
suicidality is both acceptable and feasible as well as efficacious as an alternative to inpatient 
psychiatry treatment. However, a randomized trial is needed in order to determine the efficacy of 
OCIC compared to inpatient psychiatry. At our site in Dallas, Drs. Kennard and Emslie saw 364 
eligible adolescents (aged 12 to 17 years; mean age 14.9 ±1.4 years) from January 1, 2014 and 
December 31, 2015 who had a worsening of suicidal ideation or a recent suicide attempt were 
enrolled in a newly-developed OCIC and attended at least 1 appointment. Suicidality (CHRT-
SR) was assessed at baseline and discharge from the program. The majority of patients 
completed the OCIC program (81.04% over a 4 week period). Patients were improved at the time 
of discharge on depressive symptoms and suicidal ideation and behavior. Both parents and 
patients reported significant improvement in depression severity based on the QIDS-A at exit 
(7.67±4.87 and 8.65±5.58, respectively) compared to baseline (13.22±4.81 and 13.65±5.98, 
respectively), p<.0001. 
Scores on the CHRT were also significantly reduced by discharge with propensity scores 
(26.01±10.43 vs. 16.72±10.03; p<.0001) as well as active suicidal ideation scores (4.85±3.63 vs. 
1.91±2.40; p<.0001) showing a marked improvement compared to baseline. Preliminary clinical 
outcomes at discharge from Drs. Kennard and Emslie’s OCIC and at six month follow-up were 
positive. Patients were improved at the time of discharge on self-report of depressive symptoms 

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and suicidal ideation and behavior. 286 of the 364 adolescents (or 78.57%) responded to the 6 
month follow up questions. In total, 8.7% and 27.3% of the 286 respondents reported a suicide 
attempt and event, respectively, within 6 months of discharge from OCIC. Reattempt rates at 6 
months were at 8.7%, with almost half these occurring within one month after discharge. 
Suicidal events (includes attempts, emergency room visits or hospitalization) at 6 months were at 
27.3%. It is possible that the suicidal events were higher than attempts because the adolescents 
were following their safety plan and reaching out for professional support when suicidal ideation 
increases. Patients who made an attempt within the 6 month follow up period had a history of 
more previous attempts, higher self-report of depressive symptoms at discharge, and higher 
levels of active suicidal ideation (CHRT) at entry and exit. 
Those patients who had a suicide event at follow-up were more likely to be female, had more 
previous attempts, and had higher self-reported and parent reported depression at entry in the 
program. Those with a suicidal event also had higher self-reported active suicidal ideation at 
entry into the program. 
Due to the fact that telehealth CIS is only currently being widely used for mental health services 
in this population group, CHRT-SR and other follow up data is not currently known.  This 
research will seek to fill in this gap of knowledge. 
2.3. 
Benefit/Risk Assessment 
 
Potential Benefits to Participants: The benefits of participation include having an 
increased level of safety monitoring which involves gathering data from parents and participants 
every two weeks for up to180 days. Participants and their parents will receive monitoring that is 
likely to be more intensive than what would be available in the community. Overall, safety may 
improve for participants in all treatment groups when compared to adolescents with suicidality 
who are not in this study. All of this monitoring will be provided at no cost to the participants 
and their families. Research project staff will be on call during business hours for participants in 
all treatment groups. We will check in with patients in person or with phone calls as needed. 
Phone calls or in person visits will occur depending on whether research staff feel that it is 
needed based on participant responses to scales and questionnaires. If safety concerns are 
identified during follow survey completion, including suicidal behavior or an increase in suicidal 
ideation based on questions 13-14 on the CHRT-SR, an automated text message or email will be 
sent to guardians identifying the safety concern and providing emergency numbers if needed.  
Research staff will then attempt to contact legal guardian to encourage follow up with patient’s 
clinical team and provide referrals if needed. If serious safety concerns are identified, including 
significantly worsening suicidal thoughts or suicidal behaviors, family will be referred to the ED. 
Text messaging may also be used as a reminder of study participation and/or to notify that 
further communication by phone or in person is needed. Study related questions or safety 
concerns may be addressed via text messaging, email, phone calls or in person communication. 
Participants may derive a sense of accomplishment from participation in research and 
contributing to the knowledge of treatment of adolescents with suicidality. 
 
Potential Benefits to Others: Potential benefits to society may be considerable. 
Information will be provided about the outcomes and treatment satisfaction of telehealth CIS, 
OCIC, and inpatient for adolescents with suicidality. If telehealth CIS and/or OCIC is found to 
have the same or better outcome to inpatient within our study population group of patients with 

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low to moderate suicidal ideation, this could help inform patients, parents, and clinicians about 
the best treatment. We will also learn about which factors influence outcomes within each 
treatment group. Finally, we will learn about barriers to treatment by assessing the “no show” 
group. Our research is expected to reduce decisional uncertainty about the best treatment setting 
for adolescents with suicidality. Given the careful assessment and monitoring for safety, and the 
potential benefits to adolescents with suicidality, we believe that this study has a favorable risk to 
benefit ratio. With the above significant benefits to participants and others, the minimal risks to 
the participants are reasonable. 
 
By comparing outcomes from telehealth CIS versus OCIC versus inpatient treatment, we 
will significantly help patients, families, and clinicians with the decision-making process and 
improve outcomes. Important knowledge gained about HTE’s (clinical and sociodemographic 
factors) will help with future decision making about treatment options. Furthermore, important 
knowledge will also be gained concerning barriers to treatment for the “no show” group. The 
minimal risks to the participants are reasonable in relation to the importance of the knowledge to 
be gained since telehealth CIS, OCIC and inpatient provide a higher level of care. Our proposed 
research (with minimal risks) will provide important evidence to fill in the knowledge gap 
regarding standard care for adolescents with suicidality. 
Risks and Discomforts 
A potential risk is the possible disclosure of PHI during the gathering and assessment of the data. 
The risk of PHI being disclosed to unintended recipients is minimal and secured systems have 
been in place at each location that will ensure the protection of any information from any 
unauthorized releases. In order to further enhance our data security measures, we are limiting 
access to the data to our Data management team located at CCHMC. 
 Also, surveys and assessments can cause burden and potentially trigger feelings of sadness in 
the participants. Since this research is working with a vulnerable population (adolescents with 
suicidal thoughts), there is a risk of a possible increase in suicidal thoughts if a participant 
becomes more sad. Follow up surveys will be reviewed by study staff to assess if intervention 
and/or referral is needed due to triggered emotions. 
Breach of confidentiality: There is a potential risk of loss of confidentiality. Consistent with the 
Federal guidelines, all patients and guardians will be informed of the federally mandated 
reporting laws for child abuse and neglect, verbally and in the written consent form. Therefore, if 
abuse or neglect is suspected, per institutional and legal standards and requirements, the 
Department of Human Services may be called if appropriate and indicated. Risks associated with 
this reporting include embarrassment, legal consequences, and removal of the child from home. 

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3. 
Specific Aims and Hypothesis 
Specific Aims 
Hypothesis 
 
SA1: Evaluate the safety of CIS-
telehealth relative to inpatient and 
OCIC-in-person among children with 
similar CHRT-SR scores.  
  
 Our working hypothesis is that CIS-telehealth is 
associated with a greater risk of suicidal event 
relative to inpatient and in-person OCIC. 
 Response is defined by a delay in first 
recurrence of a suicidal event and a lower 
number of suicidal events over 90 days and 180 
days.  
 Clinical Features: 
1. Severity of suicidal ideation at baseline 
and over 180 days 
2. number of suicidal events at baseline 
only 
3. Substance use at baseline and over 180 
days.  
 Sociodemographic features: 
Age, Gender, Gender Identity, Type of insurance 
(Public, Private or none), Ethnicity, Race, or living 
with one biological parent, two biological parents, a 
stepparent, a relative, or other.  
SA2: Examine the effectiveness of 
CIS-telehealth relative to inpatient and 
in-person OCIC among children with 
similar CHRT scores.  
 
 Our working hypothesis is that CIS-telehealth 
will be associated with poorer reduction in 
emotional arousal and perceived stress levels 
in response to COVID-19 the pandemic 
relative to CIS-inpatient and CIS-in-person. 
 
SA3: Assess patient and parent 
treatment satisfaction with CIS-
telehealth relative to inpatient and in-
person OCIC among children with 
similar CHRT scores.  
 
 Our working hypothesis is that CIS-telehealth 
is associated with less patient satisfaction than 
inpatient and in-person OCIC among children 
with similar CHRT scores. 
Exploratory Aim 

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Specific Aims 
Hypothesis 
SA4: As an exploratory aim, assess the 
demographics and potential barriers to 
treatment for a third comparator of the 
“no show” group who were placed in 
Telehealth, OCIC or inpatient 
treatment but never showed up or left 
the inpatient unit against medical 
advice (AMA).  Please see section 6.2 
Treatment Compliance to view plan 
regarding follow up for this “no show” 
group. 
 
SA5: As an exploratory aim, assess the 
impact of the COVID-19 pandemic on 
social and emotional functioning. 
 
 
 The no show group (the third comparator) 
who did not arrive for any OCIC 
appointments or left AMA from inpatient 
treatment will differ from the other 
comparators with respect to the following 
barriers to treatment: 1) Age 2) Gender 53-
56 3) Type of Insurance (public 
insurance/no insurance/private) 61-63 4) 
Ethnicity (Hispanic/Non) 64; 5) Race 
(African-American (AA) versus non-
African American) 65-67; 6) Living with 
one biological parent, two biological 
parents, a stepparent, a relative, or other 
68, 69   
 The no show group will have significantly 
shorter time to first recurrence of a 
suicidal event and a larger number of 
suicidal events over 90 days and 180 days 
in comparison to the other patients. 
 We hypothesize that the levels of perceived 
stress and depressed mood have been 
increased amidst the COVID-19 pandemic. 
 
 
 

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16 
4. 
Study Design  
4.1. 
Overall Design  
The study conceptual framework is illustrated in Figure 1. Briefly, we have proposed an 
observational design.  Eligible individuals will be identified during a crisis assessment, either in 
the emergency department or during an emergency phone or telehealth assessment.  Once the 
individual has been assessed and assigned to the clinician for treatment, study staff will assess if 
the patient is appropriate for the study using the study eligibility criteria.  Individuals who 
receive treatment in one of the following treatment arms will be eligible for this observation 
study: inpatient, in-person OCIC or telehealth crisis intervention service.  Eligible individuals 
will be contacted by study staff to introduce and offer the study.  If patient and guardian agree, 
they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes. 
Figure 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical features will be measured with the CHRT-SR, Suicidal Event Form for START, and our 
short START-Clinical Features (CF) form at baseline and every two weeks (see Schedule of 
Events) to evaluate HTE’s. A one time survey will be completed at week 2 that collects 
information related to the impact of COVID-19 on the family.  To decrease clinician, patient, and 
family burden, the scales are self- report short forms.  All START follow up forms will be sent to 
participants and guardians every 2 weeks via email prompts in REDCap and data will be 
collected upon return from participants.  Study CRCs will make best efforts to contact families 
for reminder to complete data within the study milestone window, however completion at each 
milestone marker is not ensured due to nature of population group.  Data will be collected when 
available.  The research coordinators, a research team member, or clinicians will ensure the 
Placed in treatment arm depending on clinician 
decision 
Inpatient 
Telehealth 
CIS 
In-person 
OCIC 
Monitor suicidal events and survey data within 90 
days and 180 days 
Perform comparative effective research (CER) and 
evaluate the impacts of HTE-related covariates 
Recruiting eligible cases from the ED or crisis 
assessments via telehealth or phone 

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17 
completion of the Suicidal Event Form for START and the brief START-CF form based on EHR 
review and/or other sources of information (family and patients) within 72 hours of admission 
(baseline) to inpatient, telehealth CIS, or OCIC and every two weeks. The research coordinators 
will search the EHR for all hospitals (with permission and consent) on weekly basis for suicidal 
events which may have ICD-10-CM code. 100 We developed this plan based on feedback from 
patients, families, and clinicians. 
 
The following sociodemographic data will be gathered by our research coordinators or a research 
team member at baseline (within 72 hours of admission to inpatient, telehealth CIS, or OCIC) 
with our Demographic Form from our prior and current research on school safety: 1) Age 2) 
Gender 53-56 3) Gender Identity 57-60 4) Type of Insurance (public Insurance/no insurance/private) 
61-63 5) Ethnicity (Hispanic/Non64; 6) Race (African-American (AA) versus non-African 
American) 65-67; 7) Living with one biological parent, two biological parents, a stepparent, a 
relative, or other. 68, 69 
4.2. 
Number of Participants 
We proposed to recruit approximately 244 eligible cases that will be placed in 3 treatment arms: 
inpatient, in-person OCIC and telehealth CIS. We expect to recruit a small proportion of the 
suicidal adolescent group in the ED or who receive crisis assessment from telehealth or via 
phone.  To test Aim 1, we will use Cox proportional regression model (CPR) to test whether the 
telehealth only CIS; outpatient, in-person CIS; and in-patient CIS groups have different 
incidence rates for recurrent episodes within 3 months. We expect that the sample sizes for the 
three arms will be at least 75, 75, and 70 respectively. To test Aims 2 and 3, we will use the 
generalized linear model (GLM) to evaluate whether telehealth only CIS; outpatient, in-person 
CIS; and in-patient CIS groups have different levels of changes in emotional arousal (Aim 2) and 
treatment satisfaction (Aim 3) at 3 months, after adjusting for several covariates (e.g., age, 
gender, triage “location”). For CPR, we will have power for our pilot study greater than 0.70 
assuming a hazard ratio of 2.8 and greater than 0.8 for our GLM analyses assuming f2 = 0.1 and 
correcting for multiple comparisons.  
Recruitment Plan for Prospective Studies 
. 
Estimated number of potentially eligible study participants  
 500 
. 
Total number of study participants expected to be screened: 
 300 
. 
Total number of study participants expected to be eligible of those screened: 
 270 
. 
Target sample size (use same number stated in milestones): 
 244 
. 
Total number of practices or centers that will enroll participants: 
      4 
. 
Projected month first participant enrolled (month after project initiation): 
   2nd 
Month 

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18 
. 
Projected month last participant enrolled (month after project initiation): 
 10st 
Month 
. 
Projected rate of enrollment (anticipated number enrolled per month of 
enrollment period): 
    2-
10/mon
th 
. 
Estimated percentage of participant dropout: 
 10% 
 
4.3. 
End of Study Definition 
The end of the study is defined as the date, October 1, 2021, or when the last participant 
completes the last study visit. 
5. 
Study Population 
The study population and the study settings are appropriate for the proposed research question as 
we will include adolescents (ages 12 to 18) who present in the ED or for crisis assessment with 
suicidal ideation and  who have been recommended from treatment in one of the following 
treatment arms: inpatient, in-person OCIC, and telehealth CIS. After discussion with our 
patient/parent partners and site clinicians, we determined that the appropriate study population is 
patients presenting to the ED in a mental health crisis with a history of suicidal-related symptoms 
and behaviors who are clinically judged to require a mental intervention following the ER visit 
or crisis assessment that could be safely treated in inpatient care or intensive  outpatient 
management, in-person or telehealth.  
5.1. 
 Workflow 
The START Non-intervention study workflow is as follows: 
 Patient presents in the ED or crisis assessment with chief complaint of suicidal ideation. 
 Patients will be assessed by a mental health clinician and treatment will be determined. 
The CHRT-SR will be clinically obtained or during baseline data gathering at crisis 
assessment. 
 If a patient is determined to need inpatient, in-person OCIC or telehealth CIS, they are 
eligible for the study and will be contacted by research staff to introduce the study. 
 If patient and guardian agree to be in the study, they will be remotely consented and 
complete baseline surveys. 
 Patient will be contacted every 2 weeks for up to 6 months to complete surveys. 
Consistent with Informed Consent standard operating procedures a guardian can withdraw 
consent at any time in the study.  

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19 
 
5.2. 
Informed Consent 
To avoid causing undue stress and burden to patients and their families, research coordinators 
will use a script when gaining consent that is specifically designed to minimize burden and 
stress.  Research coordinators will be provided with extensive formal training regarding the 
proper administration of the informed consent process. This will be documented in the Study 
Staff Checklist.  
We will be obtaining documented consent for this study.  Consent will be obtained either in 
person or through REDCap. Study personnel will initiate the e-consent process and explain the 
study and the e-consent/assent forms.  Participants will have the opportunity to ask questions 
prior to deciding whether to continue with enrollment or to decline.  All participants will have 
the capacity to provide e-consent.  
For this study, the IRB approved consent/assent document has been uploaded into the REDCap 
database. The IRB approved document has been modified to an electronic format, but will 
include all of the same elements as the IRB approved document (i.e. IRB number, approval 
dates, and CCHMC logo, etc.).  The electronic informed consent form includes fields for full 
name, signature, and date and time of the signature for the consenter and witness, along with text 
that states that all signatures are associated with the Subject ID# registered in the database. When 
completed, REDCap will generate a footer that contains the long date and time the document was 
submitted and “Confidential” listed in the header as an added precaution to preserve the research 
participants’ confidentiality.   
 
The HIPAA Consent is queued to automatically open once the consent has been signed and all 
logic is satisfied. 
For the HIPAA and Notice of Privacy Practices the IRB approved consent document will be 
uploaded into the database instrument.  The instrument includes fields to capture full name, 
signature, and date and time of the signature for the consenter, and witness and conditional text 
that states that all signatures are associated with the Subject ID# registered in the database. 
Signature process: 
Participants and Witnesses will type their first and last name into a text box, sign their name in 
the signature field with a stylus or finger and then click “Now” by the date field to automatically 
enter the date and time. A copy will be printed or sent electronically to the subject per their 
preference. 
5.3. 
Payment for Participation 
Study participants (i.e. the adolescent patient) will be paid $20 for each survey completion for up 
to 6 months for their time and effort. Payments will be given upon completion of each milestone 
survey. Participants will receive payment for this study in the form of a reloadable debit card 
(Clincard). 
5.4. 
The CHRT-SR and Recruitment  
The CHRT-SR will be obtained at baseline and at all follow up milestones.  The baseline CHRT-
SR will be used to help identify a consistent population group for analysis across all treatment 

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20 
arms.  The baseline CHRT-SR will be clinically obtained and can be accessed through the 
medical record or will be obtained during baseline data gathering.  The distributions of CHRT-
SR scores from the beginning months, November 2019 to March 2020, of the START study are 
shown in Figure 2. One-way ANOVA was used to evaluate whether the three disposition groups 
differ by CHRT-SR scores. The results suggest that CHRT-SR scores did not vary by the 
disposition outcome (F = 0.23, p-value = 0.7921, Barlett’s test for equal variance χ2 = 4.55, p-
value = 0.103). We further used multinomial logistic regression model to examine whether 
CHRT-SR scores could predict the disposition outcome, and results also indicate that the 
outcome was independent of the score (p > 0.05 for two comparisons: Bridge vs. Outpatient and 
Inpatient vs. Outpatient, separately).  
 
 
Figure 2. CHRT-SR scores stratified by disposition status. 
 
  Participant’s ability to understand and read English may be determined through screening 
questions during initial recruitment before the consenting process. If participants are able to 
understand English but have difficulty with reading, then questionnaires and surveys may be read 
to them.  
 
5.5. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Adolescents that are 12 through 18 years old. 

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START Enhancement Protocol Version 22Jan2021 
21 
2. Are brought to the Emergency Department (ED) or for crisis evaluation due to suicidal 
thoughts or behaviors 
3. Require a higher level of care (In-person OCIC, Inpatient, or Telehealth CIS) 
4. The presence of a legal guardian for consent 
5. Capable of giving signed informed consent/assent, which includes compliance with the 
requirements and restrictions listed in the informed consent form (ICF) and in this 
protocol. 
5.6. 
Exclusion Criteria  
Participants are excluded from the study if any of the following criteria apply: 
1. Adolescents with suicidal thoughts who had prior OCIC treatment in the past 12 months  
2. Adolescents without the ability to answer survey questions  
3.  Adolescents that are non-English speaking due to the scales and surveys that are used for 
this study only being available in English. 
5.7. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently included in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility criteria, 
and any serious adverse events (SAE). 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened. Rescreened participants will be assigned the same participant number as for the 
initial screening.  
6. 
Treatments 
Study treatment is defined as psychiatric treatment within either Outpatient Crisis Intervention 
Clinic (OCIC), on an Inpatient unit, or telehealth crisis intervention services.  Participants will be 
placed in the treatment setting by the assessing clinician.  These therapeutic interventions are 
available whether or not the subject agrees to participate in the study. 
Telehealth crisis intervention services (telehealth CIS) is defined as psychiatric services provided 
via telehealth services that is expected to be scheduled within 7 business days of the crisis 
assessment.  Interventions can be with a social worker, therapist or psychiatrist.  Services are not 
in person and occur over a computer video/phone system. 
Inpatient treatment includes supportive individual therapy, improving patient’s coping skills, 
family meetings about safety planning, and medication management. 6-9, 81 
OCIC services include crisis psychotherapy/intervention, evidence-based screening/risk 
assessments, coordination of care/referral to an ongoing provider, short-term therapy/crisis 
treatment, safety planning, and/or referral and linkage to follow-up care. Treatment in OCIC may 
include group therapy, individual therapy, and/or family therapy, depending on the site.  Please 

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START Enhancement Protocol Version 22Jan2021 
22 
see below for full description of services by site. Adolescents in OCIC will be referred to a 
psychiatrist for medication management as needed. OCIC provides crisis intervention therapy 
and/or components of Cognitive Behavior (CBT), Dialectical Behavior Therapy (DBT), 
mindfulness CBT, Relapse Prevention CBT, and/or Supportive Psychotherapy. The length of 
time in OCIC and telehealth CIS can range from around one to six weeks depending on the needs 
of the patients and families.  Due to the pragmatic approach to the research design, interventions 
provided will be site specific but all sites will include the crisis intervention component, 
including crisis stabilization (therapeutic intervention) and safety planning and assessment.  
Additionally, patients will have the expectation of being scheduled to be seen within 7 business 
days of the ED visit for follow up care. The charts below outline a description of the OCIC 
program, Inpatient services, and Telehealth CIS services provided at each of the four sites.  4043 
The following is an explanation of services provided in the treatment arms. All treatment is 
clinically based and data will be collected. No decisions on treatment will be part of this study 
and the data from this study will not be shared with clinicians to alter care. 
Site 
Describe 
intervention with 
patient 
Describe 
intervention 
with family 
Length 
of visit 
Length of 
treatment 
Staff 
performing 
treatment 
Plan if subject has 
increased risk of 
suicide 
Cincinnati 
A crisis 
intervention 
appointment will 
entail:  
1.Identification of 
current crisis and 
precipitants 
2.Exploration of 
feelings/emotions 
using components 
of CBT, DBT and 
other therapies 
3.Identification 
and exploration of 
coping skills and 
resources 
4.Safety planning 
and assessment 
  
1.Family 
support 
2.Safety 
assessment 
and planning 
3.Referral to 
psychiatric 
provider for 
evaluation 
for need of 
medication 
4. Referral 
and 
connection 
to 
outpatient 
provider for 
continued 
care. 
60 min 
or 
longer 
as 
needed 
Average 
1-3 
sessions, 
longer as 
needed 
Licensed 
Independent 
Social 
workers, 
Clinical 
Counselors, 
APRNs and 
child and 
adolescent 
psychiatrist 
for medication 
management 
Pt would be 
referred to the ED 
for evaluation or 
admitted to 
inpatient by 
clinical staff. 
 
 
 
 

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23 
 
Site 
Describe 
intervention 
with patient 
Describe intervention 
with family 
Length 
of visit 
Length of 
treatment 
Staff 
performing 
treatment 
Plan if subject 
has increased 
risk of suicide 
 New 
York 
A crisis 
intervention 
appointment 
will entail:  
1.Identification 
of current crisis 
and precipitants 
2.Exploration of 
feelings/emotio
ns using 
components of 
CBT and other 
therapies 
3.Identification 
and exploration 
of coping skills 
and resources 
4.Safety 
planning and 
assessment 
  
1.Family support and 
psychoeducation 
2.Safety assessment 
and planning 
3.Psychopharmacology 
4. Referral and 
connection to 
outpatient provider 
for continued care. 
60 min 
or 
longer 
as 
needed 
Average 
1-3 
sessions, 
longer as 
needed 
Licensed 
Independent 
Social 
workers, 
Clinical 
Counselors, 
APRNs and 
child and 
adolescent 
psychiatrist 
and fellows 
under 
supervision 
for 
medication 
management 
Pt would be 
referred to the 
ED for evaluation 
or admitted to 
inpatient by 
clinical staff. 
 
 
Site 
Describe 
intervention with 
patient 
Describe 
intervention 
with family 
Length 
of visit 
Length of 
treatment 
Staff 
performing 
treatment 
Plan if subject has 
increased risk of 
suicide 
Columbus 
A crisis 
intervention 
appointment will 
entail:  
1.Identification of 
current crisis and 
precipitants 
1.Family 
support 
2.Safety 
assessment 
and planning 
3.Referral to 
psychiatric 
provider for 
evaluation 
60 min 
or 
longer 
as 
needed 
Average 
1-3 
sessions, 
longer as 
needed 
Licensed 
Independent 
Social 
workers, 
Clinical 
Counselors, 
APRNs and 
child and 
adolescent 
Pt would be 
referred to the ED 
for evaluation or 
admitted to 
inpatient by 
clinical staff. 

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24 
2.Exploration of 
feelings/emotions 
using components 
of CBT, DBT and 
other therapies 
3.Identification 
and exploration of 
coping skills and 
resources 
4.Safety planning 
and assessment 
  
for need of 
medication 
4. Referral 
and 
connection 
to 
outpatient 
provider for 
continued 
care. 
psychiatrist 
for medication 
management 
 
 
 
 
Site 
Describe 
intervention 
with patient 
Describe 
intervention 
with family 
Length of 
visit 
Length of 
treatment 
Staff 
performing 
treatment 
Plan if subject 
has increased 
risk of suicide  
Dallas 
A crisis 
intervention 
appointmen
t will entail:  
1.Identificati
on of 
current 
crisis and 
precipitants 
2.Exploratio
n of 
feelings/em
otions using 
components 
of CBT, DBT 
and other 
therapies 
3.Identificati
on and 
exploration 
of coping 
1.Family 
support (on an 
individual level) 
2.Safety 
assessment and 
planning 
3. Multi-family 
group, which 
includes family 
wellness, 
communication, 
strength 
building 
4. Referral and 
connection to 
outpatient 
provider for 
continued care. 
Group (9 
hrs/week, 
which 
includes 
two teen 
groups 
and one 
multi-
family 
group), 
Once 
weekly 
individual 
therapy 
(60 
minutes) 
Treatment 
duration is 
4-6 weeks, 
Follow-up 
assessment 
phone calls 
at 1 month 
and 6 
months 
post-
discharge 
 
Licensed 
Clinical Social 
workers, 
Licensed 
Professional 
Counselors, 
and child and 
adolescent 
psychiatrists 
for 
medication 
management; 
All of the 
above include 
trainees 
performing  
treatments 
under the 
supervision 
of licensed 
providers 
First preference 
is direct 
admission to 
Inpatient Unit 
(either at our 
site or in the 
community); if 
after hours, 
refer patient to 
ED 

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25 
skills and 
resources 
4.Safety 
planning 
and 
assessment 
5. 
Psychiatric 
evaluation 
and 
medication 
managemen
t, as needed 
*Note: #2 
and #3 
above are 
done in both 
individual 
and group 
format 
throughout 
the course 
of treatment 
 
 
 
Treatment Components 
Inpatient  
 
Medication 
evaluation and 
management 
Safety planning Individual and 
family therapy 
Skills 
groups 
DBT program 
with skills group Length of stay 
Dallas 
X 
X 
X 
X 
 
7 days 
New York 
X 
X 
X 
 
X 
8 days 
Nationwide 
Children’s 
X 
X 
X 
X 
 
8 days 
Cincinnati 
X 
X 
X 
X 
 
6 or 7days 
  
Outpatient (OCIC) 

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26 
 
Group 
therapy 
Individual 
and family 
therapy 
Referral to 
psychiatrist for 
med 
management 
Crisis 
stabilization/ 
safety 
reassessment 
Safety 
Planning 
Parents 
attend 
skills class 
Length of 
treatment 
Dallas 
X 
X 
X 
X 
X 
X 
4-6 weeks 
New York 
 
X 
X 
X 
X 
 
3 visits 
Nationwide 
Children’s 
 
X 
X 
X 
X 
 
1-6 weeks 
Cincinnati 
 
X 
X 
X 
X 
 
1-6 weeks 
 
Telehealth Crisis Intervention Services CIS 
 
Individual 
and family 
therapy 
Referral to 
psychiatrist for 
med 
management 
Crisis 
stabilization/ 
safety 
reassessment 
Safety 
Planning 
Length of 
treatment 
Dallas 
X 
X 
X 
X 
4-6 weeks 
New York 
X 
X 
X 
X 
1-3 visits 
Nationwide 
Children’s 
X 
X 
X 
X 
1-6 weeks 
Cincinnati 
X 
X 
X 
X 
1-6 weeks 
 
Once a patient has agreed to participate in the study, meets eligibility, and has given 
consent/assent, they will be followed in their treatment group. The patient’s treatment will be 
done by social workers, doctors (MD), and/or other mental health professionals. 
 
6.1. 
Method of Treatment Assignment  
All eligible individuals will be followed in three treatment arms: OCIC versus inpatient 
treatment versus telehealth groups. Potential participants will be identified once they have been 
assigned to a treatment setting by a licensed clinician at each institution (Cincinnati, Dallas, 
Columbus, and New York).  Research coordinators will be in contact with clinicians who 
complete the assessments to identify appropriate participants.  The CHRT-SR will be reviewed 
to identify participants who meet study criteria (i.e. need higher level of treatment due to suicidal 
thoughts).  Once a potential participant is identified, research coordinators will contact guardians 
via phone to introduce the study and complete remote enrollment and consenting procedures. 
 
6.2. 
Treatment Compliance   
For this study, treatment compliance is defined as adhering to appointments assigned by 
assessing clinician to telehealth or OCIC and not leaving against medical advice (AMA) if 
assigned to inpatient treatment. For patients who are not treatment compliant, attempts will be 

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27 
made by the study staff to follow up and encourage recommended treatment.  Study staff will 
work with PIRC or equivalent to complete up to two phone calls or text messages to attempt to 
contact patients who do not show for scheduled telehealth appointments, OCIC appointments, or 
inpatient recommendation.  If we are unable to contact these patients or they refuse any or all 
follow up treatment (including telehealth, OCIC, inpatient or outpatient recommendations), we 
will continue to follow them until they withdraw from the study.  If patients refuse telehealth, 
OCIC or inpatient treatment from the emergency department or crisis assessment, we will 
continue to follow these patients until they withdraw from the study.  For patients who are AMA 
from the inpatient unit, this process of following up regarding services will be addressed by the 
inpatient treatment team. It is standard of care for inpatient treatment teams to not provide 
prescriptions and follow up services for AMA’s but this practice varies based on the inpatient 
treatment team. If the AMA (from inpatient treatment) patient remains in our study, we will 
encourage the AMA patient to return to treatment (inpatient, OCIC, and/or telehealth outpatient).  
 
 
6.3. 
Treatment After the End of the Study  
Follow up care after the end of this study will be decided by the participants’ parents’/guardians’, 
therapist, mental health professional, and/or physician. 

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7. 
Discontinuation Criteria 
It is unlikely that a patient will be discontinued from the study during the inpatient, telehealth, or 
OCIC phase of the study. If patient experiences worsening symptoms while inpatient, this 
treatment will be extended to meet their needs as identified by inpatient clinicians. Patient in the 
OCIC or telehealth treatment arms with worsening symptoms may be recommended for 
evaluation in the ED, referral for inpatient, and/or connected to outpatient services as identified 
by a qualified mental health clinician. If a patient is involved in an adverse event that is 
associated with study procedures, leading to harm, the DSMB and external medical monitor may 
identify the need for removal from the study for safety concerns.  This is unlikely but will be 
monitored by the DSMB, EMM and IRB 
 
7.1. 
Discontinuation from the Study 
 
 A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, or 
administrative reasons. 
 If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
 Refer to the Schedule of Events (SoE) in the Appendix for data to be collected at the time 
of study discontinuation and follow-up and for any further evaluations that need to be 
completed. 
7.2. 
Lost to Follow Up 
 
A participant will be considered lost to follow-up if he or she repeatedly fails to complete 
surveys and/or fails to return for scheduled visits and is unable to be contacted by the study site.  
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit or fails to complete the surveys/questions that occur about every 2 weeks: 
 The site must attempt to contact the participant and reschedule the missed survey or visit 
as soon as possible and counsel the participant on the importance of maintaining the 
assigned survey or visit schedule and ascertain whether or not the participant wishes to 
and/or should continue in the study. Text messaging may be used as a method of 
communication with the participant to encourage survey completion and/or to notify that 
further communication by phone or in person is needed. 
 In cases in which the participant is deemed lost to follow up, the investigator or designee 
must make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing address or 
local equivalent methods). These contact attempts should be documented in the 
participant’s research record. 

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 Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.  
8. 
Study Assessments and Procedures 
 
 Study procedures and their timing are summarized in the SoE (Appendix). Surveys are 
administered and requested for completion every 2 weeks.  Data will be collected upon return 
of surveys.  If surveys are not completed within 10 days of milestone window, that window 
will be skipped and study team will request data at the next milestone window. 
 Baseline data and follow surveys/forms will be completed through REDCap and/or paper 
forms. CCHMC REDCap can collect almost any type of data, and is particularly designed to 
support online and offline data capture for research studies and operations. 
 Adherence to the study design requirements, including those specified in the SoE, is essential 
and required for study conduct. 
 All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.  
 Time to first recurrence of a suicidal event and number of suicidal events will be measured 
with the Suicidal Event Form for START (appendix), a short supplemental form (developed 
by our team), at baseline and every two weeks (see Schedule of Events; appendix) 
 Severity of suicidal ideation will be measured with the self-report scale: CHRT-SR 
(appendix) at baseline and every two weeks (see Schedule of Events; appendix). 
 The Suicidal Treatment AlteRnatives for Teens (START)-Clinical Features (CF) form 
(appendix), a short supplemental form with 13 questions (developed by our team), will be 
completed at baseline (within 72 hours of admission to inpatient or OCIC) and every two 
weeks to monitor substance use based on information from patient, parent, and/or EHR. 
 The C-SSRS Self-Report form, included in the CF survey, will be completed at baseline and 
every 2 weeks by the participant to assess for suicidal thoughts and behaviors. 
 Satisfaction with Life (SL) will be measured with self-report scales including the PROMIS 
Short Form v 1.0-General Life Satisfaction-Short Form 5a (to assess the parent’s well-being), 
PROMIS Parent-Proxy Life Satisfaction-Short Form 8a, and PROMIS Pediatric Life 
Satisfaction-Short Form 4a every 2 weeks. 
 Treatment satisfaction (TS) data about, telehealth CIS, OCIC and inpatient psychiatry will be 
collected only after two weeks and/or subsequent to completion of inpatient psychiatry or 
OCIC. TS will be measured once with the Client Satisfaction Questionnaire (CSQ-8) 95 after 
completion of telehealth, OCIC or inpatient treatment which is typically completed by week 
3 (but could be completed by week 2 to week 6). 
 COVID-19 Impact survey will be completed at week 2 and will gather information regarding 
the impact of the pandemic on the participant and families social, emotional, and economic 
functioning. 

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 The Self-Assessment Manikin (SAM) questionnaire will be completed at baseline and week 
12 follow up survey. 
8.1. 
Efficacy Assessments  
 
 Time to first recurrence of a suicidal event and number of suicidal events will be measured 
with the Suicidal Event Form for START (appendix), a short supplemental form (developed 
by our team), at baseline and every two weeks (see Schedule of Events; appendix) 
 Severity of suicidal ideation will be measured with the self-report scale: CHRT-SR and C-
SSRS (appendix) at baseline and every two weeks (see Schedule of Events; appendix). 
 The Suicidal Treatment AlteRnatives for Teens (START)-Clinical Features (CF) form 
(appendix), a short supplemental form with 13 questions (developed by our team), will be 
completed at baseline (within 72 hours of admission to inpatient, telehealth CIS, or OCIC) 
and every two weeks to monitor substance use based on information from patient, parent, 
and/or EHR. 
 Satisfaction with Life (SL) will be measured with self-report scales including the PROMIS 
Short Form v 1.0-General Life Satisfaction-Short Form 5a (to assess the parent’s well-being), 
PROMIS Parent-Proxy Life Satisfaction-Short Form 8a, and PROMIS Pediatric Life 
Satisfaction-Short Form 4a every 2 weeks. 
 
8.2. 
Adverse Events 
The primary outcomes in this study, suicidal ideation or a recent suicide attempt, are AEs that 
will be reported to the DSMB. In addition, youth at risk for suicide often engage in multiple 
health risk behaviors (e.g., alcohol/drug use, interpersonal violence) and consequently, are at 
increased risk for accidental injury and death, all of which constitute AEs or SAEs.  We expect 
AEs and SAEs in this population, but not related to study procedures. 
Prior to recruitment, the DSMB will meet in the first month to review the protocol, outcomes, 
AE and SAE definitions, and treatment components to ensure there are no concerns. 
AE will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally authorized representative).  
If the AEs and SAEs are related to study procedures, then we will review with the DSMB. We 
will also review the proportion of observed suicidal-related AEs in our study compared to the 
rate of suicidal ideation and suicide attempts we would expect in this population, based on the 
extant literature. 
8.2.1. 
 Time Period and Frequency for Collecting AE and SAE Information  
All AE and SAE will be collected from the start of treatment until 180 day follow-up or when the 
participant completes milestones. 
For serious adverse events that result in injury, disability, death or significant functional 
impairment, each site is required to notify the DSMB and the IRB within 24-48 hours of the 
knowledge of the occurrence one of these SAE’s, how the site personnel became aware of it, and 

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the response. The DSMB will make a determination as to whether the risks and benefits of the 
study are altered by the event. 
8.2.2. 
Method of Detecting AE and SAE 
Clinical worsening of suicidal ideation/behavior is assessed similarly at each site. On the 
inpatient units at each site, clinical worsening of suicidal ideation/behavior is assessed daily with 
observation and by interviewing the patient. For patients in the OCICs and telehealth outpatient 
clinics at every site, clinical worsening of suicidal ideation/behavior is assessed by the treating 
clinician during each visit or if the parent/legal guardian calls to discuss the patient. The Dallas 
OCIC uses a clinical approach and assessment tools to evaluate worsening of suicidal 
ideation/behavior while the other sites use a clinical approach (with collateral information and 
interviews of the patient). Furthermore, clinical worsening of suicidal ideation/behavior will be 
assessed through the use of surveys and questionnaires that patients and/or guardians will fill out 
about every 2 weeks. 
The risk of lack of improvement or worsening of psychiatric illness will be addressed by 
monitoring subjects closely during assessments. 
For this proposed research, we will plan to have the research coordinator at each site contact the 
legal guardians and patients by phone (or in person) within 24-48 business hours of the baseline 
assessment to review the referral to either inpatient psychiatric treatment, telehealth, or OCIC 
treatment and to review safety planning and identify any concerns or needs for referral. At 
Nationwide Children’s Hospital (NCH), they also plan to have text message outreach to patients 
within the 48 hours after discharge. Text messaging may also be considered as a potential 
method within 48 hours of discharge at other sites if phone calls are not successful in reaching 
the legal guardians and patients. 
During the baseline ED visit or assessment, all patients and families who receive telehealth or 
OCIC will receive safety planning, lethal means restriction education, emergency contact 
numbers, and will be advised that if a situation of potential harm should arise that they should go 
to the nearest ED by their assessing clinician. During the period between ED discharge and their 
first appointment in telehealth or OCIC, based on clinical judgment of the research team, patients 
and their families may be contacted by a research team member to further discuss safety 
planning, provide lethal means restriction education, provide emergency contact numbers, and/or 
advise that if a situation should arise that they should go to the nearest ED. Families will also be 
directed that they can contact research staff (during business hours) if they have any of the above 
stated needs and research staff can provide referrals. If patients in the inpatient arm of the study 
show signs they are clinically worsening, the patient will remain on the inpatient unit and 
hospital protocol will be used to determine the most appropriate safety measures. If the patient 
showed signs of worsening in the telehealth or OCIC arm of the study or while in the outpatient 
setting, the patient will be admitted into inpatient psychiatry, will attend partial hospitalization 
and/or will be evaluated in the ED.  All decision on treatment and care will be decided by the 
patient’s treating clinician.  Study staff will follow and document outcomes. 
8.2.3. 
Follow-up of AE and SAE 
The main adverse events (AEs) discerned during the 180 day follow--up interviews will be 
suicidal ideation with intent, or a recent suicide attempt. All AEs and SAEs will be documented 

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by the site manager and will be reported to the DSMB and IRB as needed.  Dr. Barzman will be 
notified because part of his role as overall PI of all AEs and SAEs.   
8.2.4. 
Regulatory Reporting Requirements for SAE 
 Prompt notification by the investigator to the sponsor of SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of 
a study treatment under clinical investigation are met.  
 The sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a study treatment under clinical 
investigation. The sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, Institutional Review Boards 
(IRB)/Independent Ethics Committees (IEC), and investigators. 
 The Institutional Review Boards of each site will be responsible for monitoring risks to 
human subjects and assessment of ethical issues related to this study, and will have 
approved the consent form and protocol prior to initiation of the study. The consent form 
will be scripted to minimize burden and stress. All unexpected AEs and SAEs will be 
reported to the IRB’s per institutional and regulatory requirements as well as the DSMB. 
If the AEs and SAEs are related to study procedures, then we will review with the 
DSMB. This will be part of our safety monitoring and DSMB charter. 
 Overall data monitoring will be the responsibility of the PIs. During the course of the 
study, the PIs will follow the progress of the clinical study and data entry to ensure 
utmost accuracy of the data and to detect any possible errors at an early time point. The 
research coordinators will generate weekly reports, which will include suicidality, and 
adverse events for each subject for review during weekly project meetings as well as an 
ongoing CONSORT diagram. DSMB reports will include recruitment data, demographic 
information, serious adverse events, early termination, and protocol deviations, as well as 
any other information requested by the DSMB. 
9. 
Statistical Considerations  
9.1. 
Sample Size Determination  
We proposed to recruit approximately 244 eligible cases that will be followed in three treatment 
arms: telehealth CIS, in-person OCIC, and inpatient.  We expect that the sample sizes for the 
three arms will be at least 75, 75, and 70 respectively.  These numbers account for an expected 
10 % dropout rate; 220 participants are expected to complete study procedures. Prior evidence 
suggests that the 6-month inpatient readmission rate for adolescents with a prior history of 
suicidality is approximately 19%. 108 Preliminary data suggest that almost 10% of adolescents 
who received OCIC treatment following a suicidal event could have recurrent suicidal attempts 
during the following 6 months after OCIC treatment (preliminary unpublished data from the sites 
from Dallas and Cincinnati). Therefore, if we assume the hazard ratio (inpatient group vs. OCIC 
group) will be approximately 2.8 and the readmission rates over 6 months for the two groups will 
be 19% (for the inpatient group) vs. 10% (for the OCIC group), we will be able to achieve the 
statistical power at 0.70 given the two-side alpha value = 0.05.  We expect numbers for the 

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Telehealth CIS to be larger than the inpatient group. We will achieve similar power when we 
compare the Telehealth CIS group with the inpatient group. The power is likely lower than 0.6 
when we compare Telehealth CIS with the OCIC group since the effect size (i.e., hazard ratio < 
2). The power calculation, based on the assumption that 19% (inpatient group) vs. 10% 
(Telehealth CIS or OCIC group) will be the averaged recurrence rates for the two arms across the 
four sites, was performed using the powerSurvEpi package in the software R. For continuous 
outcomes, we expect that the two-group comparison can achieve the power at 0.84 when the 
effect size Cohen’s d is 0.5 and sample sizes for the first and second group are 75 and 70, 
respectively. Alternatively, we will achieve the power at 0.76 if we use ANOVA to evaluate 
whether the continuous outcome differs among the three groups given the effect size f2 = 0.2 
For purposes of analysis, the following populations are defined: 
Population 
Description 
Enrolled  
All participants who sign the ICF 
Observational 
All patients will be followed in three treatment arms (telehealth 
CIS, in-person OCIC, and inpatient) 
Evaluable 
Inclusion: 1) Adolescents (12 to 18 years old) who were brought 
to the ED due to suicidal thoughts or behaviors and require a 
higher level of care (Telehealth, OCIC or inpatient); 2) The 
presence of a legal guardian. Exclusion:  1) Adolescents with 
suicidal thoughts who had prior OCIC treatment in the past 12 
months will be excluded; 2) Adolescents without the ability to 
answer survey questions will be excluded. 
Safety 
Participants will be analyzed according to the treatment they 
actually received. 
9.2. 
Statistical Analyses 
The statistical analysis plan will be developed and finalized before database lock and will 
describe the selection of participants to be included in the analyses, and procedures for 
accounting for missing, unused, and spurious data. Below is a summary of planned statistical 
analyses of the primary and secondary endpoints. 
9.2.1. 
Efficacy Analyses 
 
Endpoint 
Statistical Analysis Methods 
Primary 
The primary outcome measure for this proposed research will be the 
time to first recurrence of a suicidal event. We will examine if the 
treatment option can predict the “time to the first suicidal event” 
using the Cox-proportional hazard model. 
Secondary 
The secondary outcome is Satisfaction with Life (SL), which will be 
measured every two weeks. The treatment effect on such time-series 

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data will then be analyzed using mixed-effect ordinate logistic 
regression model. 
Exploratory 
Will be described in the statistical analysis plan finalized before 
database lock 
  
9.2.2. 
Safety Analyses 
All safety analyses will be performed on the Safety Sample.  
Endpoint 
Statistical Analysis Methods 
Primary 
Our primary outcomes are direct measures related to safety. Our 
treatments will not be associated with any safety concerns other than 
the primary outcome that will be analyzed in the treatment efficacy 
research. 
Exploratory 
Will be described in the statistical analysis plan finalized before 
database lock 
 
  
9.2.3. 
Other Analyses  
We will also evaluate heterogeneous treatment effects (HTE) to better understand whether the 
treatment effect depends on clinical or socioeconomic features. The overarching goal of the HTE 
analysis is to identify the factors that can predict if telehealth CIS and OCIC leads to different 
treatment outcomes compared to the inpatient treatment, which could shed some light on how 
individual characteristics might influence the treatment response, and pave the way for 
personalized medicine. The core hypothesis for our HTE analysis is that individual features 
correlated with poorer adherence with outpatient appointments (e.g., lower socioeconomic 
status) or psychiatric disturbances associated with poorer prognosis (e.g., severe suicidal 
thoughts) may at least partially determine who may have better treatment outcomes. The HTE’s 
include three clinical features: 1) Severity of suicidal ideation at baseline and over 180 days; 2) 
number of suicidal events at baseline only; 3) Substance use at baseline and over 180 days. 46-52 
The HTE’s also include seven sociodemographic features at baseline: 1) Age 2) Gender 53-56 3) 
Gender identity 57-60 4) Type of Insurance (public insurance/no insurance/private) 61-63 5) 
Ethnicity (Hispanic/Non) 64; 6) Race (African-American (AA) versus non-African American) 65-
67; 7) Living with one biological parent, two biological parents, a stepparent, a relative, or other. 
68, 69 A past suicide attempt (suicidal event) is one of the strongest risk factors for future suicide 
attempts and death by suicide in adolescence. 65, 101- 104 Adolescents who attempted suicide are 18 
times more likely to attempt suicide compared to adolescents with no prior suicide attempts. 101 
About 11% of adolescents who attempt suicide will eventually die by suicide. Although female 
adolescents have a higher rate of suicidal thoughts and attempts, the deaths by suicide are higher 
for male adolescents. 53-56 In addition, substance use 46-52 and gender dysphoria in adolescence 
substantially increase the risk for suicide. 57-60 Type of insurance will allow us to obtain an 
approximation of income level. Adolescents from lower socioeconomic backgrounds have an 

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increased risk of serious suicide attempts and suicide. 61-63 The cultural context of adolescent 
suicidal behavior and help-seeking is important and differs among races and ethnic groups. 105 
For example, in the Hispanic community, families are much less likely to seek mental health 
professionals in help seeking and prefer to rely on family first. 64 Ethnic groups and races differ 
in rates of adolescent suicidal behaviors. 105, 106 However, the gap has been decreasing between 
white adolescent suicides and African American suicides due to an increase in male African 
American deaths by suicide. 65-67 Living situation (living with one biological parent, two 
biological parents, a stepparent, a relative, or other) is an important HTE for adolescents because 
living with one parent or the presence of a stepparent was correlated with an increased risk of 
suicidal thoughts and suicide attempts by adolescents. 68, 69 
The analysis plan:  
To test Aim 1, we will use Cox proportional regression model (CPR) to test whether the 
telehealth only CIS; outpatient, in-person CIS; and in-patient CIS groups have different 
incidence rates for recurrent episodes within 3 months. We expect that the sample sizes for the 
three arms will be at least 75, 75, and 70 respectively. To evaluate Aims 2 and 3, we will use the 
generalized linear model (GLM) to evaluate whether telehealth only CIS; outpatient, in-person 
CIS; and in-patient CIS groups have different levels of changes in emotional arousal (Aim 2) and 
treatment satisfaction (Aim 3) at 3 months, after adjusting for several covariates (e.g., age, 
gender, triage “location”). For CPR, we will have power for our pilot study greater than 0.70 
assuming a hazard ratio of 2.8 and greater than 0.8 for our GLM analyses assuming f2 = 0.1 and 
correcting for multiple comparisons.  
The main objective of the analysis plan for the COVID-19 survey is to evaluate whether the 
changes of levels of emotional dysregulation, anxiety, depressed mood, perceived stress levels, 
and other indicators of well-being, during the pandemic, are associated with the treatment 
outcome. Furthermore, we will evaluate whether the changes of these indicators are associated 
with the perceived level of social support, disruptions in life events, and electronic media habits. 
First, the changes of levels of emotional dysregulation, anxiety, depressed mood, perceived stress 
levels, and other indicators of well-being, will be treated as covariates in the analysis under Aims 
1-3 (comparative treatment effect analysis). Second, we will then use generalized linear model to 
evaluate the relationship between continuous outcomes and predictors and ordinal logistic 
regression model to evaluate the relationship between ordinal outcomes and predictors. The 
outcomes include the changes of levels of emotional dysregulation, anxiety, depressed mood, 
perceived stress levels, and other indicators of well-being, and the predictors include perceived 
levels of social support, disruptions in life events, and electronic media habits. 
 
Interim analysis: 
We propose to evaluate the progress of the project at the end of the 6th month. The goal of the 
interim analysis is to examine the following outcomes: 1) scores from PROMIS Short Form v 
1.0-General Life Satisfaction-Short Form 5a (to assess the parent’s well-being), 2) scores from 
PROMIS Parent-Proxy Life Satisfaction-Short Form 8a, 3) Score from PROMIS Pediatric Life   
Satisfaction-Short Form 4a, 4) Score from CHRT-SR at baseline and follow-up visits. 
Specifically, the change in CHRT-SR scores will be used to facilitate the decisions for revising 
the protocol. If any of the three treatment groups is found to have statistically significant lower 

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levels of changes in CHRT-SR scores within the first six months with an effect size Cohen’s d > 
1.2 (which is considered as a “very large” effect size according to Sawiloski (2009)109 in 
comparison with another treatment group, we will discuss the results with all steering committee 
members and the DSMB to decide whether we should recommend to psychiatry leadership that 
the treatment group with overtly inferior treatment outcomes should be discontinued at the four 
sites.  

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11. 
Appendices 
 
1. Schedule of Events (SoE) / Milestones 
 
11.1. 
 Appendix 1: Schedule of Events (SoE) / Milestones 
 
Schedule of Events 
 
 
 
 
 
Table X. Schedule of Events
Baseline
2
4
6
8
10
12
14
16
18
20
22
24
Demographics Form
x
CHRT-SR (self-report)-14 item
x
x
x
x
x
x
x
x
x
x
x
x
x
Suicidal Event Form for START
x
x
x
x
x
x
x
x
x
x
x
x
x
Clinical Features (CF)
x
x
x
x
x
x
x
x
x
x
x
x
x
Client Satisfaction Questionnaite (CSQ-8)
x
PROMIS Short Form-Life Satisfaction (SL)
x
x
x
x
x
x
x
x
x
x
x
x
x
PROMS Parent-Proxy SL-Short Form 8a
x
x
x
x
x
x
x
x
x
x
x
x
x
PROMIS Pediatric SL-Short Form 4a
x
x
x
x
x
x
x
x
x
x
x
x
x
COVID-19 Survey 
x
Self Assesment Manikin (SAM)
x
x
Satisfaction with Life
Other
Measures
Visit (Weeks)
Age/Gender/Gender Identity/Insurance Type(Public, Private, No Insurance)/Ethinicity (Hispanic, Non Hispanic)/ Race (African American, Non African American)/ Living Situation (One Parent, Both Parents, Other)
Severity of Suicidal Ideation
Suicidal Events
Substance Use
Treatment Satisfaction