Optimizing Suicide Prevention Strategies for Pediatric Primary Care
Phase: NA
Conditions: Suicidal Ideation, Suicidal and Self-injurious Behavior, Depression
Sponsor: University of Pittsburgh

Study Protocol 
Official Title: Optimizing Suicide Prevention Strategies for Pediatric Primary Care 
ClinicalTrials.gov ID (NCT number): 
Protocol Date: 6/8/2023

Scientific Background 
Suicide and suicidal behavior among adolescents have been on the rise. The majority of suicide 
decedents have their last clinical contact in primary care, and 7-15.6% of youth in pediatric 
primary care (PPC) screen positive for suicidal risk. Thus, PPC settings are critical for identifying 
and treating suicidal youth. Although annual universal depression screening is recommended 
for youth >12 years, once high-risk youth are identified, PPC providers lack a reliable service 
delivery strategy. Indeed, several national medical associations recently declared a national 
emergency in child and adolescent mental health and offered a Blueprint for Youth Suicide 
Prevention based on NIMH research and backed by the American Academy of Pediatrics (AAP). 
In our prior work, we developed and tested the effectiveness of the components of an 
integrated adolescent suicide prevention intervention, iCHART (integrated Care to Help At-Risk 
Teens), in an academic setting that relied on behavioral health (BH)providers and research 
support (P50 MH115838, PI: Brent). iCHART consists of: 1) Screening Wizard, a web-based 
enhanced screener to aid PPC providers in treatment decisions; 2) BRITE, an app-supported 
intervention that guides youth in developing a personalized, smartphone-based safety plan; 
and 3) Text2Connect, an automated texting intervention that motivates youth to follow 
providers’ recommendations. The original version of iCHART components showed feasibility, 
usability, and acceptability across youth, parents, and providers and preliminary effectiveness 
in enhancing BH referral and referral attendance and decreasing depression severity. The 
original version required support from embedded BH providers. A critical gap remains: these 
interventions are not feasible for use by frontline pediatricians who practice in less-resourced 
PPC settings, and who generally lack access to onsite BH providers.  
Feasibility and effectiveness of current iCHART components. The current version of iCHART 
consists of three components, each demonstrating preliminary effectiveness in PPC settings 
when provided with onsite BH support, and that have been developed and integrated into one 
electronic platform in collaboration with NuRelm, a small business and software company that 
designs mobile and web application tools for behavioral health interventions (see Letters of 
Support). To address barriers to implementation identified by PPC providers, we will continue 
our work with NuRelm to develop and test the proposed adaptation of iCHART (iCHART-cASAP) 
that can be delivered by PPC providers without onsite BH support.  
iCHART Component 1: Screening Wizard (SW). Researchers created SW as a web-based 
enhanced screener for adolescents and parents which produces a summary report to assist PPC 
clinicians with their management decisions when responding to a positive suicide risk screen 
during routine care. Initial development of SW involved iterative usability testing with 
providers, patients, and parents.57 These groups identified concerns with their current 
screening practices which SW could improve on by: (1) promoting accurate self-disclosure, (2) 
identifying comorbidities, (3) elucidating barriers and treatment preferences, and (4) 
highlighting differences in symptom ratings, treatment preferences, and barriers reported by 

adolescents vs. their parent/guardian. A youth stakeholder advisory board provided feedback 
to develop within-screen engaging messaging to reassure youth of confidentiality, which we 
have implemented. SW is administered via a secure web-based platform on the iCHART 
dashboard, where unique links and username/passwords are generated and provided to 
adolescent sand parents separately. These links are generated from the iCHART dashboard, 
which allows scheduling of links and direct text message of the link to the survey via Twilio 
automated text message. The SW screen includes standardized screening questions for 
depression and suicide risk (PHQ-9-M; Y-CAT Static Suicidality screen), anxiety (GAD-7), mania 
(CMRS brief), substance use (CRAFFT), and 1-item assessing overall functioning (~2 minutes). 
For those who screen positive for depression and/or suicide risk or another mental health 
problem, they are additionally asked about treatment history and treatment satisfaction (if 
applicable),treatment readiness, perceived barriers to treatment (cost, transportation, time, 
confidentiality, stigma, medication side effects, items adapted from the BASH and 
Antidepressant Meanings Scales), and treatment preferences (medication, talk therapy, both, 
not interested) (~5 minutes). After SW is completed, providers can immediately view a SW 
summary report on the iCHART dashboard or can export it as a pdf. This report highlights 
summary scores of mental health symptoms, discrepancies between adolescents’ and parents’ 
treatment preferences and agreement with barriers to treatment, as well as an item-level list of 
responses to each screening question. Included in this report are patient handouts providing 
psychoeducation, and a clinician document with guidance on reference tools for mental health 
management in adolescents as well as talking points around counseling about psychotropic 
medications. In a pilot RCT of 100 youth receiving SW as compared to enhanced screening as 
usual (item level responses to symptoms, but not treatment preferences, barriers, and 
readiness) during all well visits for youth ages 12 and older, adolescents receiving SW were 
more likely to receive a referral for psychotherapy (25.7 % vs. 18.2%), odds ratio = 1.56, and 
satisfaction with SW was high, with mean scores of 6.5 on a 1-7 scale. Thus, SW is feasible, 
usable, acceptable, and effective in supporting PPC provider’s decisions to refer for BH 
treatment and incorporating adolescents and parents’ readiness, barriers, and preferences.  
iCHART Component 2: BRITE. BRITE is a smart phone application designed to support clinical 
management of adolescent suicidality. In 2013, researchers began developing BRITE as an app 
to support the ASAP intervention, which was first delivered on psychiatric inpatient units to 
adolescents transitioning to outpatient care and promoted collaboration between inpatient and 
outpatient mental health providers. Among 66 adolescents hospitalized for suicide ideation 
(n=26) or suicide attempt (n=40), there was a reduction in onset (16% vs. 31%) and time to 
onset of suicide attempt (HR=0.49, 95% CI: 0.16, 1.47) in those receiving BRITE+ASAP compared 
to usual care 24 weeks post-hospital discharge.42 We also found an inverse relationship 
between the number of times BRITE was used and suicidal ideation among 79 adolescent 
psychiatric inpatients (r=-0.20, p=0.07), supporting app utilization as a potential treatment 
mechanism. In 2018, researchers further developed BRITE as a stand-alone safety planning and 
skills building app and as one of the components of the iCHART intervention. Our initial 

iteration for iCHART included an electronic guide to support BH providers in PPC settings in 
developing a safety plan with youth. However, during usability testing providers found safety 
planning created workflow burden and would require additional support from research 
personnel; thus, providers preferred more automation. Based on this feedback, we developed 
an electronic guide to assist youth in developing their own safety plan in a series of onboarding 
modules:(1) identify likely triggers of suicidal and self-harm urges (or triggers of high distress if 
youth is depressed but not suicidal); assess lethality and restricting access to means with parent 
input; (2) teach skills to cope with distress, and (3) identify supportive social contacts and 
professional resources to access in a crisis should others means of coping fail. After BRITE is 
completed, providers can immediately view the safety plan on the iCHART dashboard and 
export it as a pdf, view the safety plan with patient and parent, and make modifications if 
needed. When reviewing the safety plan with the patient and parent, the provider reinforces 
skills and BRITE content and identifies possible barriers to youth implementing the safety plan 
and develops potential solutions to these barriers with patient and parent. BRITE sends daily 
reminders to youth to monitor distress (1-5 scale) and then suggests skills to practice based on 
distress rating. After skill use, youth re-rate their distress and can continue practicing suggested 
skills until distress is significantly decreased. Failure to use the BRITE app consecutively for 3 
days OR ratings of high distress for 5 consecutive days results in automatic deployment of T2C 
to encourage youth and parent participation and encourage follow-up with PPC provider or BH 
referral. Our qualitative assessments with youth, parents, pediatricians, and BH providers 
support the acceptability of BRITE.67 We examined the effectiveness of BRITE when 
administered in academic-affiliated PPC settings with onsite BH providers in reducing 
depression and suicidal risk in 48 adolescents. We found significant reduction in suicidal 
ideation as measured on the PHQ-9 item 9and a computer adaptive suicide risk screen. There 
were also significant decreases in depression and anxiety symptoms. Thus, BRITE is feasible, 
usable, acceptable, and effective across inpatient settings (when administered with ASAP) and 
PPC settings (when administered as a component of iCHART) and in open trials and RCTs with a 
combined total of 246 adolescents.  
iCHART Component 3: Text2Connect (T2C). Researchers developed T2C, a theory-based 
automated text messaging component of iCHART for adolescents with suicide risk and their 
parent to (1)facilitate follow-through with BH initiation when referred by PPC provider; (2) 
engage youth who are not interacting with BRITE; and (3) provide “just-in-time” self-
management strategies and prompts to reach out to PPC provider for youth with high distress. 
During the development phase, researchers conducted focus groups with adolescents with 
suicide risk (n=9) and their parents(n=9) separately. Texting was perceived as an ideal modality. 
Parents thought it could be useful to convince reluctant parents that their adolescent needed 
treatment, provide parents with the same information as their adolescent so that they could be 
“on the same page,” and for parents to discuss the information with the adolescent. These 
factors were implemented in T2C through personalized text messages providing 
psychoeducation (for child and parent) about BH treatment and prompts and tips for parents to 

communicate about BH treatment with their adolescent. These text messages are designed to 
facilitate engagement with PPC recommendations and follow-through with referral 
appointments. To initiate T2C, providers or staff enter patient and parent phone numbers in the 
T2C platform on the iCHART dashboard. In pilot work, our group found that T2C was feasible, 
acceptable, and effective to reduce barriers to BH treatment initiation among adolescents and 
parent.43,44 We found that just-in-time support when youth were experiencing emotional 
distress reduced depressive symptoms compared withcontrols.43,44 In a feasibility study of 43 
adolescents, 84.5% responded to SMS messages within the first 6 days. At 4-weeks, among the 
42 adolescents who completed follow-up, 22 (52%) reported having initiated BH treatment and 
an additional 3 (7%) were planning on initiating BH treatment. Thus, T2C is feasible, usable, 
acceptable, and effective to reduce barriers to BH treatment initiation among adolescents and 
parents.  
Since April 2021, researchers, as well as pediatricians affiliated with practices in the PROS 
network (members of the Executive and Steering Committees, Chapter Coordinators, and 
Advisors; pediatricians from 22 PROS-affiliated practices were in attendance > 1 meetings) to 
develop the research design and methods for this proposal. These providers unanimously 
expressed interest in participating in research to develop and test effectiveness of a suicide 
prevention intervention for adolescents (see Letter of Support). Most practices lack onsite BH 
providers and wait times for BH referrals are long. Providers noted that a suicide prevention 
intervention optimized for the PPC provider and setting might be especially beneficial to youth 
in rural settings. Interventions delivered in-office settings with predictable workflows were seen 
as ideal. Overall, this feedback from PROS stakeholders also supports provider preference for 
an intervention requiring minimal staff support. Additionally, pediatricians from PROS 
unanimously supported this project, which support the feasibility of this project. 
ASAP Content and Functionality. ASAP was originally developed as an app-supported (BRITE) 
intervention for youth transitioning from inpatient to outpatient care (see Preliminary Data 
above for information about its effectiveness when paired with BRITE). There are 3 overarching 
content areas: 1) Motivating patients to commit to not engaging in suicide behavior by using 
skills and safety plan. 2)Teaching distress tolerance and emotion regulation skills that can be 
utilized to cope with distress and triggers identified for suicidal crises. 3) Review of safety plan 
and skills with patient and parent to facilitate parent involvement in the safety plan and the 
youth’s mental health treatment. ASAP was originally delivered in 3-5 individual psychotherapy 
sessions, 30-45 minutes each. BH providers teach skills and assess comprehension with the use 
of handouts, worksheets, and visual aids.  
Innovation: 
1) Seeks to design the first effective intervention for the primary care setting to treat and 
manage suicidal youth. Although primary care practices following USPTF recommendations to 
integrate depression screening into routine care will also inevitability increase detection of 

depressed and suicidal youth, there is no current effective intervention for the primary care 
setting. 
2) Partnership with AAP to test in real-world PPC settings. Our collaboration with PROS affords 
the opportunity to develop and initially test iCHART-cASAP in PPC settings from around the US, 
which will provide more input on pragmatic, effective strategies for future implementation in 
this setting and may allow for faster deployment. 
3) Use of digitized suicide prevention brief intervention allows provider input but also 
scalability. The automated components of iCHART-cASAP, such as development of a safety plan, 
will make it feasible to use in PPC setting while retaining the ability for PPC provider to have 
input (e.g., modify the safety plan with patient and parent input; review the outcome of the 
intervention and discuss with the patient and parent). 
4) Our focus on implementation science principles will help maximize the fit between our 
iCHART- cASAP intervention and primary care settings to consistently reach youth most in need. 
The use of the post-pilot study phase to understand implementation will allow us to better 
prepare for the next phase by providing crucial pilot data for an R01 Type 2 Hybrid Clinical 
Effectiveness-Implementation trial.  
 
 

Study Objectives 
 
The proposed study will help Pediatric Primary Care (PPC) providers to identify and manage 
adolescents at risk for suicidal behavior, which will ultimately reduce suicidal behavior in youth. 
During the development phase of this project, PPC providers will guide us in developing the 
workflow when utilizing integrated Care to Help At Risk Teens-computerized As Safe As Possible 
(iCHART-cASAP) intervention, which would include when and how they review the safety plan 
and outcome of the brief intervention afterwards with the patient to reinforce what they have 
learned and make a management decision going forward (send home with follow-up scheduled 
or send to emergency department). The overall racial and ethnic breakdown of children 
participating in recent PROS studies is similar to or more diverse than child population 
estimates in the 2020 US Census. Thus, partnering with PROS ensures our ability to recruit a 
racially and ethnically diverse sample of youth and will increase the generalizability of our 
findings.  
 
Our overarching goal is to optimize iCHART feasibility, acceptability, and scalability for PPC 
settings without onsite behavioral health (BH) providers to offer as a temporization method for 
youth at risk for suicide until BH services can be initiated. In the proposed study, we will partner 
with the AAP national PPC practice-based research network, Pediatric Research in Office 
Settings (PROS) to develop and test a version of iCHART that can be provided in the PPC setting 
without onsite BH personnel, termed iCHART-cASAP. We aim to develop a computerized 
version of As Safe As Possible (cASAP) to deliver those aspects of the iCHART intervention that 
required BH support: psychoeducation about safety planning, cognitive-behavioral skills to cope 
with distress, and facilitate collaboration with parents. We will draw upon our extensive 
expertise in human-computer interaction (HCI) methods and user studies with youth, parents, 
and PPC providers, to inform the technology design of cASAP, designed to be provided within 
PPC without onsite BH support. We will then conduct a stepped wedge pilot randomized trial 
with 60 youth aged 12-17 at risk for suicide (past month suicide ideation/attempt) identified in 
PPC. We will compare iCHART-cASAP vs usual care and the impact on suicide risk and 
depression assessed at 1-, 3-, and 6-months follow-up. Finally, guided by the Consolidated 
Framework for Intervention Research (CFIR), we will gather mixed method survey data and 
post-trial interviews with PPC providers and staff to understand factors which may optimize 
iCHART-cASAP implementation.  
 
Aim 1 (Usability): Use HCI methods to iteratively develop a stand-alone computerized version of 
ASAP, termed “cASAP.” We will recruit youth, parents, and providers from varied settings 
(urban, suburban, and rural) and conduct 6 initial end-user specific focus groups (8-10 
individuals/group) to review cases presenting mock-ups of cASAP prototypes to solicit feedback 
on preferences for modality (e.g., animated vs. human character, quizzes, customizability), level 
of parental involvement, content comprehension, provider preferences for session summaries 
and workflow integration. Based on this feedback, we will develop an initial cASAP prototype 
and conduct usability interviews with 5 youth, 5 parents, and 5 PPC providers to iteratively 
inform its finalized design.  

 
Aim 2 (Stepped Wedge Cluster Randomized Pilot): Conduct a stepped wedge cluster 
randomized pilot trial of iCHART-cASAP vs. usual care for 60 suicidal youth across 4 PROS 
practices, in which we will (a) observe high iCHART-cASAP feasibility (providers administer to 
youth at well visits >80%; youth complete >80%)and acceptability among all end users (ratings 
>80%); and (b) preliminarily assess effects of iCHART-cASAP on targeted mechanisms 
(increased: use of safety plan, use of distress tolerance and emotion regulation skills to cope 
with distress, BH referral and follow-up; decreased: distress, emergency department referrals) 
and clinical outcomes (depression symptom severity and suicidal ideation, behavior, and 
attempts). 
 
Aim 3 (Pre-Implementation Mixed Methods Study): To inform design of a future 
implementation strategy, we will apply CFIR to identify attitudes, beliefs, and behaviors (e.g., 
adaptability, relative priority, compatibility) critical for implementing iCHART-cASAP in PPC to 
manage depressed and suicidal youth without support of onsite behavioral and research staff. 
We will conduct surveys and qualitative interviews with 30 PPC providers, youth, and parents 
who participate in the trial to inform the design of a future iCHART-cASAP large-scale pragmatic 
Type 2effectiveness-implementation trial in the PROS network and in partnership with the AAP. 
 
 
 

Study Design & Method 
Total number of subjects to be enrolled: 
165. 
Study Design: 
 
Aims 1 & 3 will use a qualitative, descriptive design. 
 
Aim 2 will be a stepped wedge randomized clinical trial.  
 
Primary and secondary study endpoints: 
Primary Outcomes: 
1) Suicidal ideation and attempt will be measured by the PHQ-9-M and the Columbia 
Suicide risk scale (C-SSRS).2) 
2) Depression severity will be assessed by the PHQ-9-M. 
3) Application utilization will be assessed by the iCHART-cASAP utilization. 
4) Parent and youth knowledge of the treatment plan. 
5) Service utilization as assessed by mental health services utilization. 
6) Intervention acceptability and usability as determined by the cASAP and theiCHART-
cASAP. 
7) Feasibility as determined by provider use of interventions and other measures. 
 
Secondary: 
1) Distress as measured by the Pediatric PROMIS Psychological Stress Experiences 4-item 
Short Form and from BRITE app logs of youth distress ratings.  
 
Duration of an individual subject’s active participation: 
6 months. 
Duration anticipated to enroll all subjects: 
5 years. 
Estimated date of study completion (complete primary analyses): 
3/31/2026. 
 
 

Informed Consent Protocol 
How and when consent will take place: 
Aim 1 and 3: Parental consent and youth-participant assent will occur verbally (with parents 
either in person or over the phone). Consent will take place prior to the start of any related 
research activities with Pitt research staff. Individuals involved in conducting the consent 
discussion will take note of the date and time that verbal informed consent was obtained in the 
study record.  
Aim 2: Electronic consent will occur via Pitt Redcap and/or Pitt Licensed Qualtrics from parents 
and youth (assent) interested in participating in the trial phase of the study. Consent will be 
obtained prior to research activities taking place with Pitt research staff. Participants are able to 
sign with their finger and will also be prompted to answer questions to verify identity/security.  
 
Steps of Informed Consent: 
Potential participants will be informed that their study involvement is voluntary, that their 
decision to participate will not affect their relationship or care they may receive with 
Pitt/UPMC, or their current provider, or current employer (for providers) and that consent and 
authorization can be withdrawn at any time.  
 
Consent for youth: 
If a family or patient is approached in person at an appointment in which they are receiving 
healthcare, and they cannot decide to participate in enough time during their visit, the research 
staff can offer the possibility to make an appointment to complete the necessary screening and 
informed consent process, and onboarding to the intervention, during a later time and follow 
up with primary care provider on the results of the intervention visit. 
 
Consent for Providers & Caregivers/parents: 
At the time that a provider and/or caregiver is approached to participate in the research study, 
they will have sufficient time to decide to participate in the study. If needed, a telephone call 
can be scheduled later to check in if the healthcare provider or patient's caregiver is interested, 
if they cannot decide at first approach by a research staff member. 
 
Research staff will explain to providers that study involvement is voluntary, and that their 
participation will not impact their current relationship with their employer. 
 
Research staff will clearly communicate with caregivers to inform them that the study 
participation is voluntary and will not impact their relationship with the treatment provider of 
the child, or with the own care they may receive from any institution.  
 
Ensuring Ongoing Consent: 

During each and every follow up phone call or assessment, the assessor will ask the family 
and/or patient if they interested in continuing their participation in the data collection 
questions.  
 
Ensuring understanding of consent: 
The research staff is trained to ascertain if the participant understands the consent and 
research activities. The research staff will answer any questions and explain informed consent 
concepts. Research assessors are trained to ascertain if a participant is adequately 
understanding what is being said during the informed consent discussion and the research 
questions. Assessors will describe the study in wording to reflect appropriate literacy level of a 
teen and parent. Assessors will ask if the family has questions throughout the process and 
provide responses to questions as they arise.  
 
Who will obtain consent: 
The research involves minimal risk thus research staff and co-investigators trained in the 
process of informed consent will obtain informed consent for study participation and document 
that they certify they gave informed consent. Due to the nature of research activities an 
investigator will not practicably be available to participate in the consenting process of each 
subject. The study aims to enroll from geographically diverse practices in the PROS national 
network. An investigator will be made available to those subjects who wish to speak to them. 
 
Consent process for child participants: 
For children under 18, the research staff will inquire if a parent is biological or adoptive and it 
will be documented. Adults without this status must present paperwork to the research staff 
who will filter it to the IRB and legal counsel for review and verify if an adult is legally able to 
consent for the child. Participants will not be enrolled if unable to confirm legal guardianship. 
 
The youth must assent, and the parent provides their consent. The research staff will ask the 
youth if they understand what is involved in the research and if they are willing to participate. 
The research staff will document the response of each the parent and child during this process 
and any questions that came up in the study record. 
 
If a child participant turns 18 while enrolled in the research: 
If a child turns 18 years old, the research staff will use the addendum consent language to 
obtain consent of the individual as an adult for continued participation. This will only apply to 
Aim 2 trial as the qualitative interviews are onetime visits when adolescents must be 12-17 
years old. 
 
 

Eligibility Criteria 
Inclusion Criteria: 
Aim 1: 
-12-17 years old 
-English fluency and literacy 
-self-reported prior diagnosis of depression or suicidal thoughts or behaviors (Aim 1only) 
Caregiver/Parent inclusion: 
-English fluency and literacy 
Aim 2: 
-12-17 years old 
-Parent/legal guardian consents for youth to be in study 
-English fluency and literacy-own a smart phone or device (Aim 2 only) 
-PHQ-9M score indicating moderate or severe depression or suicidal ideation in past month, 
past 2 weeks, or an attempt in their lifetime (Aim 2 only) 
Aim 3: 
Provider criteria: 
-Pediatricians and other practice-based providers from one of participating PROS network 
practices 
Youth and Caregiver/parent inclusion: 
-Participated in AIM 2 study procedures 
 
Exclusion Criteria: 
Aim 1: 
Youth Exclusion: 
-evidence of intellectual delay 
-pervasive developmental disorder 
-other condition from medical history that would prohibit comprehension of questions or 
modules 

 
Aim 2:  
Youth Exclusion: 
-evidence of intellectual delay 
-pervasive developmental disorder 
-other condition from medical history that would prohibit comprehension of questions or 
modules 
Aim 3: 
Youth Exclusion: 
-evidence of intellectual delay 
-pervasive developmental disorder 
-other condition from medical history that would prohibit comprehension of questions or 
modules