Navigating Mental Health Treatment for Black Youth With Suicidal Risk
Phase: NA
Conditions: Adolescent Behavior, Suicidal Ideation
Sponsor: Children's Hospital of Philadelphia

 
Template version: January 30, 2020 
  
Title: 
Navigating Mental Health Treatment for Black Youth With 
Suicidal Risk 
Short Title 
Navigating Mental Health Treatment 
 
 
Regulatory Sponsor: 
National Institutes of Health 
eIRB Number: 
IRB 21-019141 
Protocol Date: 
September 28, 2021 
Amendment 1 Date: 03/11/2022 
Amendment 3 Date: 07/10/2023 
Amendment 2 Date: 01/05/2023 
Amendment 4 Date:  
 
 
Rhonda Boyd 
The Children’s Hospital of Philadelphia 
Department of Child and Adolescent Psychiatry and Behavioral Sciences 
Philadelphia, PA, 19104 
Phone 215-590-3945 
email: boydr@chop.edu 

 
 
 
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms............................................................................. iv 
Abstract ................................................................................................................................. vi 
TABLE 1: SCHEDULE OF STUDY PROCEDURES FOR RANDOMIZED CONTROLLED TRIAL ................................. VII 
    FIGURE 1: FLOW DIAGRAM FOR RCT 
 
 
 
 
 
 
VII 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ..................................... 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 2 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 2 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 3 
3.1.1 
Screening Phase .............................................................................................................................. 4 
3.1.2 
Study Treatment Phase (start of the study intervention) ................................................................. 4 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING. ....................................................................... 6 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 6 
3.3.1 
Duration of Subject Study Participation ......................................................................................... 6 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 6 
3.4 
STUDY POPULATION ............................................................................................................................. 6 
3.4.1 
Inclusion Criteria ............................................................................................................................ 6 
3.4.2 
Exclusion Criteria ........................................................................................................................... 7 
4 
STUDY PROCEDURES ............................................................................................................................ 8 
4.1 
SCREENING VISIT ................................................................................................................................. 8 
4.2 
STUDY TREATMENT PHASE .................................................................................................................. 8 
4.2.1 
Visit 1 .............................................................................................................................................. 8 
4.2.2 
Visit 2 .............................................................................................................................................. 9 
4.2.3 
Visit 6: End of Study ........................................................................................................................ 9 
4.3 
UNSCHEDULED VISITS .......................................................................................................................... 9 
4.4 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 9 
4.4.1 
Early Termination Study Visit ......................................................................................................... 9 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 10 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................ 10 
5.1.1 
Medical Record Review ................................................................................................................. 10 
5.1.2 
Other Evaluations, Measures ........................................................................................................ 10 
5.2 
EFFICACY EVALUATIONS ................................................................................................................... 11 
5.2.1 
Diagnostic Tests, Scales, Measures, etc. ....................................................................................... 11 
5.3 
SAFETY EVALUATION ......................................................................................................................... 12 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 12 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 12 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 12 
6.3 
STATISTICAL METHODS...................................................................................................................... 12 
6.3.1 
Baseline Data ................................................................................................................................ 12 
6.3.2 
Efficacy Analysis ........................................................................................................................... 12 

 
 
 
 
 
 
 
 
 
 
iii 
6.3.3 
Safety Analysis .............................................................................................................................. 13 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 13 
7 
SAFETY MANAGEMENT ..................................................................................................................... 13 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 13 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 13 
8 
STUDY ADMINISTRATION ................................................................................................................. 13 
8.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 13 
8.1.1 
Randomization............................................................................................................................... 13 
8.1.2 
Blinding ......................................................................................................................................... 14 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 14 
8.3 
CONFIDENTIALITY .............................................................................................................................. 14 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 15 
8.4.1 
Data and Safety Monitoring Plan ................................................................................................. 15 
8.4.2 
Risk Assessment ............................................................................................................................. 15 
8.4.3 
Potential Benefits of Trial Participation ....................................................................................... 16 
8.4.4 
Risk-Benefit Assessment ................................................................................................................ 16 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 16 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 17 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ..................................................................................................... 18 
8.7.1 
Reimbursement for travel, parking and meals .............................................................................. 18 
8.7.2 
Payments to subject for time, effort and inconvenience (i.e. compensation) ................................. 18 
9 
PUBLICATION ........................................................................................................................................ 18 
10 
REFERENCES ......................................................................................................................................... 18 
Appendix ............................................................................................................................... 21 
 

 
 
 
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
ED 
 
Emergency Department 
AE 
SAE 
STAT-ED 
RCT 
CBC 
EHR 
BHS 
ADAPT-ITT 
 
MYTS 
SIQ-Jr 
PANAS 
ICD 
NDA 
NIH 
DSMB 
AIM 
ED STARS   
FIM               
 
Adverse event 
Serious adverse event 
Suicidal Teens Accessing Treatment 
Randomized Controlled Trial 
Congressional Black Caucus 
Electronic Health Record 
Behavioral Health Screen 
Assessment, Decision, Administration, Production, Topical Experts and 
Integration, Training, and Testing 
Motivation for Youth’s Treatment Scale 
Suicide Ideation Questionnaire-Junior 
Positive and Negative Affect Scale 
International Classification of Diseases, Functioning and Disability 
NIMH Data Archive 
National Institutes of Health 
Data Safety and Monitoring Board 
Acceptability of Intervention Measure 
Emergency Department Screen for Teens at Risk for Suicide  
Feasibility of Intervention Measure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v
 
 
 

 
 
 
 
 
 
 
 
 
 
vi
ABSTRACT 
Context:   
Recent research has shown significant increases in suicides among Black youth and suicide 
attempts among Black high school students.  
Objectives: 
Primary 
• To conduct a systematic adaptation of STAT-ED for Black youth presenting in the 
ED who have suicidal risk. 
• To examine preliminary efficacy of the intervention on primary (mental health 
treatment initiation and number of visits) and secondary (suicidal ideation) outcomes 
using a prospective RCT design. 
Secondary 
• To examine implementation outcomes of the adapted STAT-ED for Black youth and 
caregivers compared to the control condition (enhanced Treatment as Usual). 
Study Design:  
The study utilizes a mixed methods design which involves a qualitative phase (interviews 
and field testing) and RCT phase.  
Setting/Participants: 
The study will recruit from CHOP pediatric hospital ED with a total of 151 participants (75 
youth, 75 caregivers, and 1 patient navigator). Eligible youth will identify as Black, be 
between the ages of 10-18, have recent or past suicidal ideation or behaviors and are not 
currently receiving mental health treatment. Caregivers are parents or legal guardians of 
eligible youth. Patient navigator will be hired patient navigator who consents to being a 
secondary research participant. Study procedures may be conducted in-person, over the 
phone, or online. 
 
Study Interventions and Measures:  
Participants will be randomized to the adapted STAT-ED or enhanced Treatment as Usual  
which will consist of follow up telephone contacts following discharge from the ED.  Main 
RCT study outcomes are mental health treatment initiation and suicidal ideation.   
 

 
vii  
 
 
 
 
 
 
 
 
Table 1: Schedule of Study Procedures for Randomized Controlled Trial 
 
Study Phase 
Screening 
Observation Study Visits 
Visit Number 
 
Baseline 
2 month follow up 
6 month follow up 
Informed Consent/Assent 
X 
 
 
 
Review Inclusion/Exclusion Criteria 
X 
X 
 
 
MYST 
 
X 
X 
X 
SIQ-Jr 
 
X 
X 
X 
Demographics 
 
X 
 
 
PANAS 
 
X 
 
 
AIM 
 
 
X 
X 
 ED STARS 
 
 
X 
X 
Adverse Event / Unanticipated Problems 
Assessment 
 
X 
X 
X 
 
 
 
 

 
viii  
 
 
 
 
 
Figure 1: Flow Diagram for RCT 
 
 
 
 
Screening 
Screen Failures 
Visit 1 
Randomize 
Baseline Measures 
Adapted STAT-ED 
Enhanced Treatment as Usual 
Visit 2 
Parent & Youth Measures 
Intervention Group 
Visit 2 
Parent & Youth Measures 
Control Group 
Visit 3 
Parent & Youth Measures 
Intervention Group 
Visit 3 
Parent & Youth Measures 
Control Group 

 
 
 
 
 
 
1 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Suicide is the second leading cause of death among 10-24 year olds, and suicide rates are 
increasing (Curtin & Heron, 2020). Historically, Black youth have had lower suicide risk; 
however, recent research has shown disturbing and significant increases over the last 3 
decades in suicides among Black youth and in self-reported suicide attempts among Black 
high school students (Sheftall et al, 2016; Bridge et al., 2015; Bridge et al., 2018; Ivey-
Stephenson, 2020;  Lindsey et al., 2018). Black youth are less likely than White youth to be 
treated for suicidal ideation or behaviors, and less likely to receive inpatient or outpatient 
care after a suicide attempt (Freedenthal, 2007; Marrast et al., 2016). Barriers to Black youth 
starting mental health treatment are myriad and include lack of perceived need, stigma, 
mistrust of providers and treatment, difficulties in physically accessing available services, 
and providers’ lack of cultural competence (Fante-Coleman & Jackson-Best; Planey et al., 
2019). Patient navigation offers a flexible model that can address many of these barriers and 
can be tailored to specific populations and needs. Although patient navigation models have 
been shown to improve outcomes such as screening and diagnostic appointment and referral 
completions in different patient populations (Ali-Faisal et al., 2017), there is paucity of such 
interventions and associated research to improve care and outcomes for suicidal youth. One 
of these patient navigation interventions, Suicidal Teens Accessing Treatment (STAT-ED) 
resulted in greater mental health care initiation and appointment at 6 months, however, 
adolescents of color were less likely to initiate mental health care than White adolescents 
(Grupp-Phelan et al., 2019). An intervention for Black youth requires adaptation, as many 
interventions do not address culturally relevant issues for Black patients. This proposed 
study will adapt and pilot test STAT-ED for Black youth presenting to emergency 
departments (EDs) with suicidal ideation or behaviors. 
 
1.2 Name and Description of Investigational Product or Intervention 
Patient navigation will generally be modeled after STAT-ED and can involve motivational 
interviewing, brief case management, and telephone contacts. While the complete 
intervention is contingent on our adaptations, we anticipate that the following strategies will 
be included: psychoeducation, problem-solving logistical barriers, and assistance with 
making and following up with mental health appointments (Godoy et al., 2019). As part of 
the cultural adaptation, we will directly address youth’s and caregivers’ negative perceptions 
and cultural stigma concerning mental health treatment. Psychoeducation will be provided 
on suicide risk, its negative effects, and treatment options.  The intervention will assist the 
family in following up with mental health referral recommendations provided by ED staff 
and eliciting families’ preferences in regards to race and gender of providers, convenience of 
provider, and type of treatment. This assistance could involve help with the initial telephone 
contact, getting to appointments, and preparing for the appointments. The patient navigator 
will communicate with the family in person, by telephone, and/or by text messaging as per 
family’s preference. This once to twice a week communication will promote mental health 
care initiation and identify barriers and problem-solving solutions.  The intervention group is 
expected to be administered the adapted STAT-ED until the first mental health appointment 

 
 
 
 
 
 
2 
date.  A comparison intervention (enhanced Treatment as Usual) will consist of follow up 
contacts following discharge from the ED to confirm referral recommendations. 
 
1.3 Relevant Literature and Data 
A systematic review of interventions that attempted to increase initiation of mental health 
care for people of color found that most were culturally adapted. Adaptations included 
incorporating racially diverse perspectives in intervention design, training staff on cultural 
sensitivity issues, referencing racial/ethnic diversity in educational materials, and 
incorporating cultural conceptualizations of mental health (Lee-Tauler et al., 2018). A 
similar systematic review of psychosocial mental health interventions for youth of color 
found that all interventions shown to be efficacious were culturally adapted (Pina et al., 
2019),  and a third review supported cultural adaptations of interventions for mental health 
care engagement among adolescent and young adults of color (Moore, 2018). Although 
there are not substantial data indicating that culturally adapted interventions are more 
effective, in the mental health intervention field, the clear disparity in engaging Black 
individuals strongly suggests that current approaches may not be sufficient. The CBC 
Taskforce report on Black youth suicide and mental health (2019) further emphasizes this 
point, recommending that researchers develop and test interventions to mitigate suicide risk 
that are developmentally, culturally, and linguistically relevant for Black youth  We will 
adapt a patient navigation intervention, the STAT-ED for Black youth with suicide risk, 
following the ADAPT-ITT framework steps of Assessment, Decision, Administration, 
Production, Topical Experts and Integration, Training, and Testing (Wingood et al., 2008).  
This will involve data from qualitative phases of study, as well as input for advisory group 
and consultants.   
 
1.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46. All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
 
2 
STUDY OBJECTIVES 
The purpose of the study is to determine the efficacy of the adapted STAT-ED patient 
navigation intervention for Black youth initiation of mental health treatment.   

 
 
 
 
 
 
3 
2.1 Primary Objective (or Aim)  
• To conduct a systematic adaptation of STAT-ED for Black youth presenting in the 
ED, who have suicidal risk. 
• To examine preliminary efficacy of the adapted STAT-ED on primary (mental health 
treatment initiation and number of visits) and secondary (suicidal ideation) outcomes 
using a prospective RCT design. 
 
2.2 Secondary Objectives (or Aim) 
The secondary objectives are to: 
• To examine implementation outcomes of the adapted STAT-ED intervention 
(acceptability, feasibility, fidelity) for Black youth and caregivers compared to the 
control condition (enhanced Treatment as Usual). 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
The study utilizes a mixed methods design which involves a qualitative phase and 
randomized trial phase. The qualitative phase consists of two steps: 1) interviews with 15 
youth and 15 caregivers and 2) field testing of the intervention with 5 youth and 5 
caregivers. The qualitative phase and field testing will occur prior to the randomized trial. 
The randomized trial is a prospective design comparing adapted STAT-ED with comparison 
condition. We will test the adapted patient navigation intervention in a small RCT with 50 
Black youth presenting in the ED with suicidal ideation or behaviors and their caregivers. 
The RCT will be conducted after an amendment to the study is approved by the IRB.  
Medical and mental health information will be collected from medical records.  
 
Caregiver and youth interviews will be conducted separately and virtually either over the 
telephone or through a CHOP approved virtual meeting platform, either Blue Jeans or 
Microsoft Teams. Interviews will be recorded. We will incorporate feedback from the youth 
and caregiver qualitative interviews as well as elicit feedback on which intervention 
components will be adapted and the types of cultural adaptations needed from the study 
Advisory Group (caregivers, youth, and clinicians) and a consultant. 
 
During the field testing, we will conduct as rapid-cycling prototyping and testing to gather 
information  on intervention content, materials, and delivery. This will involve conducting 
the intervention, examining recruitment strategies and gaining more information about 
mental health referral strategies. 
 
3.1.1 Screening Phase 
For  the qualitative interviews, the field testing, and the RCT, potential participants will be 
identified through three avenues in the ED: 1) clinicians; 2) a behavioral health screening 
conducted in the ED; and 3) diagnostic codes in the electronic health record (EHR). Co-I 
Esposito, ED attending physician and ED Behavioral Health Program Director and his team 

 
 
 
 
 
 
4 
will identify and recruit potential participants via three avenues: (1) all ED patients aged >12 
years complete the Behavioral Health Screen (BHS), which includes a suicidal ideation 
item; the BHS is on a web-based platform, automatically scored, integrated with patients’ 
EHR, generating automated notification to the ED clinician when the patient reports suicidal 
ideation. (2) We will peruse the EHR for an extensive list of diagnostic codes related to 
suicidal ideation, suicide attempt, and self-harm to identify potential participants. (3) ED 
clinicians can refer patients with suicidal ideation or attempt. Academic Associates, CHOP 
ED staff whose primary role is to approach potential participants for clinical research, and 
study staff will screen potential participants using protocol inclusion and exclusion criteria. 
Academic Associates and study staff will be available in the ED to meet with youth and 
caregivers, discuss study procedures, enroll participants and gather consent/assent. For 
participants who meet the study eligibility criteria, we will either gather consent/assent from 
caregivers and youth in the ED or at a later time by study staff depending on what is 
convenient for family. If teen and/or caregiver are undecided or do not have time in ED to 
discuss study, a study flyer will be given by Academic Associates and study staff. Signed 
consent/assent forms and caregiver and/or youth contact information will be transferred 
from Academic Associates to study team in a secure manner. Study staff will contact 
enrolled participants to initiate study procedures for the field testing and RCT and within a 
week for the interviews.  
3.1.2 Study Treatment Phase (start of the study intervention) 
Cargiver and Youth Interviews: We developed an interview guide to identify barriers and 
facilitators to mental health treatment.. We  used prompts from our conceptual model to 
query about issues such as barriers to care that STAT-ED may address, the extent to which 
STAT-ED components address stigma, and the cultural relevance and appropriateness of 
STAT-ED components. Interviews were conducted and the audio was recorded by research 
staff separately for youth and caregivers. All audio files were stored on a secure CHOP 
server for the study. All audio files were sent to ADA Transcription services for 
transcription with deletion of any identifying information. The de-identified transcripts were 
returned and maintained on CHOP’s secure research server accessed only by members of the 
study team. The ADA Transcription services is a CHOP approved vendor that have been 
used before for other research studies at CHOP and will continue to be used in the future. 
Initial codes weredeveloped inductively through consensus of the investigative team. 
Themes pertaining to child and family factors and benefits and barriers to MH service use in 
a virtual environment were identified. We used EHOST, an open source software program, 
to facilitate coding of transcripts and identification of themes. The results were used to adapt 
STAT-ED content and materials in preparation for the RCT.  The recruitment for and 
analyses of the interviews have been completed.   
 
Field testing: We used rapid-cycle prototyping and testing as our field testing. This  involved 
the study staff conducting the intervention and documenting its delivery. This  also included 
examining mental health referral pathwaysand the study’s ability to recruit appropriate 
patients for the RCT.  The study staff provided feedback and observations about the 
intervention delivery and referral pathways by written notes. We examined screening 
strategies to identify patients and determine if we are capturing all appropriate patients. The 
field testing finished recruitment and is complete.   

 
 
 
 
 
 
5 
 
Intervention adaptation: We developed an intervention draft that will balance core elements 
of the STAT-ED intervention with information gathered from the qualitative interviews and 
field testing (Wingood et al., 2008).  The intervention adaption was informed by the 
caregiver and youth interviews, and the current literature. We also elicited feedback on 
which intervention components will be adapted and the types of cultural adaptations needed 
from the Advisory Group and consultants. This involved using relevant components, as well 
as writing adaptations to current components and  new content.  The intervention will 
include patient navigator instructions, such as motivational interviewing questions, 
procedures for assisting with mental health appointments, and tips for problem solving 
barriers, and content for youth and caregivers.. The intervention manual discusses potential 
intervention delivery strategies such as by telephone, in-person, and by texting.  A written 
manualhas been developed.     
 
RCT: Study staff will contact enrolled participants, complete baseline assessments, and 
randomize to the adapted STAT-ED or control condition (enhanced Treatment as Usual). 
The adapted STAT-ED will involve the following strategies: psychoeducation, motivational 
interviewing, problem solving logistical barriers, and assistance with making and following 
up with mental health appointments. This could involve identifying additional mental health 
resources and providers based on insurance type. One social worker has beenhired and 
trained to implement the adapted STAT-ED and the control condition (enhanced Treatment 
as Usual) for study.  Patient navigator will communicate with the family in person, by 
telephone, and/or by text messaging via family’s preference. The control condition 
(enhanced Treatment as Usual) will receive telephone contacts to check in and remind 
families about mental health care initiation. Telephone contacts are consistent with current 
ED practice in which social work team members follow up by telephone with patients and 
their caregivers about referrals given at ED discharge. The proposed study is a small pilot to 
adapt a patient navigator intervention for suicidal Black youth and test the preliminary 
effectiveness of the intervention in preparation for a fully-powered RCT. We will perform 
initial analyses (chi-square and t-tests) to compare the intervention and control groups on 
proportion to initiate mental health treatment, mean number of days to treatment initiation, 
and mean number of treatment sessions at both 2 months and 6 months follow-up. A Cox 
proportional hazards model will examine group differences in mental health utilization, time 
to treatment initiation, suicidal ideation, and mental health motivation (Cox, 1972). 
Assessments may be conducted in-person, via telephone, or electronically/online. At the end 
of the study, we will also solicit and review feedback from the patient navigator who is 
research staff member about feasibility and acceptability. The patient navigator will also 
complete fidelity measure after first session of the adapted STAT-ED. 
Participants may be recontacted to update information or to see if they are interested in 
participating in other research. 
3.2 Allocation to Treatment Groups and Blinding.  
In the RCT, subjects will be randomized to either the adapted STAT-ED or to enhanced 
treatment as usual.  Randomization will be accomplished in advance using computer-

 
 
 
 
 
 
6 
generated random numbers. Allocation concealment (blinding of the treatment assignment) 
will be implemented using sealed, opaque envelopes. 
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Subject Study Participation 
For the qualitative phase, the study duration will last one day. For the field testing, the study 
duration per subject will be up to 3 months.  For the RCT, the study duration per subject will 
be up to 8 months, with up to 1 month screening, up to 6 months for baseline assessments 
and intervention delivery, and 2 months for study visits completion. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at approximately 1 investigative site at CHOP in the United 
States. 
Recruitment for RCT will stop when approximately 100 participants (50 youth-caregiver 
dyads) are enrolled. It is expected that approximately 100 subjects will be enrolled to 
produce 85 evaluable subjects. Recruitment for interviews will stop when approximately 30 
participants (15 youth-caregiver dyads) are enrolled and recruitment for field testing will 
stop when approximately 10 (5youth-caregiver dyads) are enrolled. 
 
3.4 Study Population 
3.4.1 Inclusion Criteria  
 
3.4.1.1 Youth Inclusion Criteria for qualitative interviews  
1) Identify as Black 
2) are between ages of 10-18 years 
3) endorse suicidal ideation and/or behaviors within the last year at an ED visit 
 
4) live within Philadelphia County or nearby Pennsylvania suburb 
 
5) Must be able to read and understand English 
 
 
3.4.1.2 Youth Inclusion Criteria for field testing and RCT  
1) Identify as Black 
2) Are between ages of 10-18 years 
3) Endorse suicidal ideation and/or behaviors within the last year at an ED visit 
4) Live within Philadelphia County or nearby Pennsylvania suburb 

 
 
 
 
 
 
7 
5) Must be able to read and understand English 
 
3.4.1.3 Caregiver Inclusion Criteria for interviews, field testing, and RCT 
1) Parent or legal guardian of eligible youth 
  
2) Must be able to read and understand English 
 
3.4.1.4   Patient Navigator Inclusion Criteria for RCT 
 
1)   Employed by study to implement adapted STAT-ED 
 
  
3.4.2 Exclusion Criteria  
1) Does not identify Black as one of their races 
 
2) Under 10 or over 18 years old 
 
3) Does not speak English 
 
4) No history of suicidal ideation or behavior 
 
3.4.2.1 Youth Exclusion Criteria for interviews  
1) Exclusion criteria listed in section 3.4.2 
 
2) Requires acute or intensive inpatient treatment for safety or medical reasons 
 
 
 
3.4.2.2 Youth Exclusion criteria for field testing  
1) Exclusion criteria listed in section 3.4.2 
2) Requires acute or intensive inpatient treatment for safety or medical reasons 
3) Currently engaged in mental health treatment 
 
3.4.2.3 Youth Exclusion criteria for RCT 
1) Exclusion criteria listed in section 3.4.2 
2) Currently engaged in mental health treatment 

 
 
 
 
 
 
8 
3.4.2.4 Patient Navigator Exclusion Criteria 
1) Does not consent to be a secondary research participant 
Subjects with limited English proficiency will be excluded from this study because the 
interview materials and measures are not available in multiple languages.  In addition, the 
adaptation and implementation of the intervention in multiple languages is not feasible for 
this pilot study. If this study shows efficacy, we will hope to be able to engage Black 
families who speak languages other than English in the next study.   
 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.   
 
4 
STUDY PROCEDURES 
4.1 Screening Visit  
Qualitative Interviews, Field Testing, and RCT 
• Informed Consent/assent/HIPAA authorization 
• Medical Record Review  
• Review of Inclusion/Exclusion Criteria 
• Collection of demographics including contact information 
 
 
4.2 Study Treatment Phase 
This will include the qualitative interviews, field testing, and RCT.  Medical Health Record 
Review will not access protected mental health records. 
4.2.1 Visit 1 
Qualitative interviews 
• Informed Consent/Assent 
• Medical  Record Review  
• Review of Inclusion/Exclusion Criteria 
• Recorded semi-structured interview 
• Demographics questionnaire 
 
      Field Testing 
• Review of Inclusion/Exclusion Criteria 
• Informed consent/assent 
• Demographics questionnaire 
• Field testing procedures 
 

 
 
 
 
 
 
9 
 
       RCT 
• Medical records review  
• Review of inclusion/exclusion criteria 
• Youth and caregiver report measures (MYTS, SIQ-Jr, PANAS, demographics 
questionnaire) 
• Randomization 
• Intervention 
 
 
4.2.2 Visit 2 
RCT 
• Youth and caregiver report measures (MYTS, SIQ-Jr,  ED STARS, AIM) 
• Assess possible adverse events  
• Medical Health Record Review  
 
4.2.3 Visit 6: End of Study 
The end of the study visit for randomized trial is at 6 months after baseline assessment.  
Youth and caregiver report measures are administered (MYTS, SIQ-Jr, ED STARS, 
intervention acceptability survey). Adverse events will be assessed.  
 
4.3 Unscheduled Visits 
If a family needs additional intervention support to navigate mental health initiation, then 
this will be performed by the patient navigators.   
 
4.4 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to the study visit schedule or any AEs.  The Investigator may also withdraw 
subjects who violate the study plan, or to protect the subject for reasons of safety or for 
administrative reasons. It will be documented whether or not each subject completes the 
study. If the Investigator becomes aware of any serious, related adverse events after the 
subject completes or withdraws from the study, they will be recorded in the source 
documents and on the CRF. 
 
4.4.1 Early Termination Study Visit 
If early termination occurs, reasons for early termination will be documented.   

 
 
 
 
 
 
10 
Subjects who withdraw from the study or were withdrawn from study before or during the 
intervention will be asked to complete the post-intervention assessments. Subjects who 
withdraw prior to the baseline assessment will be considered lost and not be evaluable.   
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review 
Medical record number 
Date of birth 
Demographics including county of residence 
Race 
Columbia Suicide Severity Rating Scale 
Behavioral Health Screen 
Problem list  
ICD codes 
Contact information 
Languages spoken/read 
Results of tests and procedures 
Chart review for mental health treatment or hospitalizations (this will be gathered from 
medical records and will not access protected mental health records) 
Medical insurance information 
5.1.2 Other Evaluations, Measures 
Qualitiative Interviews  
• Qualitative interview guide will be developed. Questions concerning perceptions 
and preferences of mental health treatment and barriers and facilitators to 
accessing mental health services will be asked of participants.  
• Demographics survey will gather information such as age, biological sex, 
gender, race/ethnicity, sexual orientation, and family income. 
 
 
Field Testing 
• Demographics survey will gather information such as age, biological sex, 
gender, race/ethnicity, sexual orientation, and family income. 
• Patient navigation notes 
 
RCT 
 
 

 
 
 
 
 
 
11 
• ED STARS mental health service use is a 8-item interview that measures mental 
health services children receive and actions taken by family to obtain services. 
This measure was used with over 6000 adolescents from the Pediatric 
Emergency Care Applied Research Network (PECARN) that spanned diverse 
geographic regions of the US (King et al., 2020). Cargeivers will complete this 
interview unless youth is participating without a parent.   
 
• Motivation for Youth’s Treatment Scale (MYTS) is an 8-item measure of 
intrinsic treatment motivation that has both youth and parent reports (Breda et 
al., 2012).  It has two subscales:  recognition that the youth has a problem and 
readiness to participate in the youth’s treatment. It has good internal consistency 
and validity with support for the factors. MYTS has a 5-point Likert scale with 
higher scores representing higher motivation. MTYS will be completed by youth 
and caregivers. 
• Suicide Ideation Questionnaire-Junior (SIQ-Jr) is a youth report measure of 
frequency of suicidal thoughts over the last month (Reynolds, 1988). SIQ-Jr has 
high internal consistency, test-retest reliability, predictive validity for suicidal 
behavior, and is sensitive to change (Reynolds & Mazza, 1998).    
• Acceptability of Intervention Measure (AIM), a 4-item, psychometrically-
validated measure that indexes the extent to which stakeholders believe an 
intervention is acceptable.  Both youth and a caregiver will rate the intervention 
helpfulness and satisfaction. Additionally, the patient navigator will complete 
the AIM after the trial is completed. 
• Positive and Negative Affect Scale (PANAS) is a widely used and validated 
measure (Watson et al., 1988).  It has been used for adolescent samples with 
evidence of potentially three factors: Positive Affect, Negative affect with two 
factors of Distress and Fear (Villodas et al., 2011; Allan et al., 2015). The 
Positive Affect factor will be administered to youth.   
• Demographics survey will gather information such as age, biological sex, 
gender, race/ethnicity, sexual orientation, family income, religion, and insurance 
type. Same demographic survey will be used for interviews and field testing.  
Another demographic survey will be used for RCT. 
• Feasibility of Intervention Measure (FIM), a 4-item, psychometrically-validated 
measure that indexes the extent to which stakeholders believe an intervention is 
feasible.  The patient navigator will complete the FIM after the trial is 
completed.   
A fidelity checklist has been developed to assess self-reported task completion by the patient 
navigators (0- not completed, 1- partially completed, 2- fully completed). This will be 
completed after the  interview.  
5.2 Efficacy Evaluations 
In the RCT, these are the measures that will be used to assess efficacy (mental health 
utilization)- ED STARS.  The three primary efficacy outcomes are 1) whether the patient 
initiated mental health treatment (yes/no), 2) time to treatment initiation, and 3) number of 

 
 
 
 
 
 
12 
treatment sessions attended. Other outcomes are suicidal ideation and behavior measured by 
SIQ-Jr.  
5.2.1 Diagnostic Tests, Scales, Measures, etc. 
In the qualitative interviews, the research staff will conduct semi-structured interviews with 
questions concerning perceptions and preferences of mental health treatment and barriers 
and facilitators to accessing mental health services with youth and caregiver participants. In 
the field testing,participants will not complete any measures or scales. . In the RCT, ED 
STARS is an interview and will be administered by research staff to caregivers at 2 (Study 
visit 2) and 6 months (final visit) after baseline assessment.  SIQ-Jr is a self-report measure 
that will be administered to youth at baseline and 2 and 6 months after baseline assessments.   
5.3 Safety Evaluation 
In the RCT, participant safety will be monitored by adverse events and the SIQ-Jr.  It will 
also include responses on the intervention satisfaction. 
 
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
Primary endpoint for qualitative phase (interviews and field testing):  themes of caregiver 
and youth mental health attitudes and engagement and an adapted STAT-ED manual 
Primary endpoint for randomized trial: mental health treatment initiation. The three primary 
efficacy outcomes are: a) whether the patient initiated mental health treatment (yes/no), b) 
time to treatment initiation, and c) number of treatment sessions attended. 
 
6.2 Secondary Endpoints 
At the end of the RCT, we will also solicit and review feedback from the patient navigators 
about feasibility and acceptability and evaluate fidelity by calculating an overall adherence 
to intervention tasks score for each patient navigator by aggregating navigator ratings on the 
fidelity checklist. Both youth and caregiver will complete AIM.   
 
6.3 Statistical Methods 
6.3.1 Baseline Data  
For qualitative interviews, caregiver and youth interviews will be analyzed using EHOST 
open source  analysis software. Initial codes will be developed inductively through 
investigative team consensus. Themes pertaining to child, family, clinician and systemic 
barriers and facilitators, motivation for treatment, receipt and perceptions of mental health 
services will be identified. After initial exploration, a comprehensive coding scheme will be 
developed and applied to all data to produce a fine-grained descriptive analysis. 

 
 
 
 
 
 
13 
For the RCT, descriptive statistics for demographic and behavioral characteristics measured 
at baseline will be examined across the two treatment groups to assess the success of the 
randomization. 
 
6.3.2 Efficacy Analysis 
These are the measures that will be used to assess efficacy (mental health utilization), ED 
STARS.  The three primary efficacy outcomes are 1) whether the patient initiated mental 
health treatment (yes/no), 2) time to treatment initiation, and 3) number of treatment 
sessions attended. Other outcomes are suicidal ideation and behavior which will be 
examined by changes in total score over time from baseline to Visit 2 and final Visit. 
6.3.3 Safety Analysis 
In the RCT, Participant safety will be monitored by adverse events reporting. Participant 
safety will be monitored by adverse events and the SIQ-Jr.  It will also include responses on 
the intervention satisfaction. 
 
6.4 Sample Size and Power 
For the RCT, we followed established rules of thumb for pilot trial size estimation for two-
armed studies to determine our total sample size of 100 (Whitehead et al., 2016). Even 
accounting for greater than 15% attrition, power analyses (Faul et al., 2009) indicate that this 
sample size will produce 80% power to detect a large effect for group differences between 
conditions over time (f = .72). This pilot trial is not intended to detect statistically significant 
differences in outcomes; rather, the primary aim of this pilot is to establish the feasibility of 
research procedures in preparation for a fully-powered RCT. The effect sizes obtained in 
this pilot study will be used to estimate parameters for a subsequent R01 to inform sample 
size considerations. 
 
7 
SAFETY MANAGEMENT 
7.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that do not meet prompt reporting requirements will be summarized in narrative or 
other format and submitted to the IRB at the time of continuing review (if continuing 
reviews are required), or will be tracked and documented internally by the study team but 
not submitted to the IRB (if continuing reviews are not required).  

 
 
 
 
 
 
14 
8 
STUDY ADMINISTRATION 
8.1 Treatment Assignment Methods 
8.1.1 Randomization 
Randomization will be accomplished in advance using computer-generated random 
numbers. Allocation concealment (blinding of the treatment assignment) will be 
implemented using sealed, opaque envelopes. 
 
8.1.2 Blinding 
Allocation concealment (blinding of the treatment assignment) will be implemented using 
sealed, opaque envelopes to prevent staff and participants from manipulating the 
randomization.     
 
8.2 Data Collection and Management 
All records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. All data for these study procedures will 
be maintained on CHOP/Penn/NIH secure servers, and all analyses will be performed on de-
identified data only. All collected study measures will be entered directly into a REDCap 
database maintained and protected on this secure research server. Any paper copies of 
research instruments will be kept in locked file cabinets at CHOP. Recordings of interviews 
will be stored on a password protected secured servers at CHOP/Penn to be coded and 
analyzed. All audio files will be sent to ADA Transcription services for transcription with 
deletion of any identifying information. The de-identified transcripts will be returned and 
maintained on CHOP’s secure research server with regular backup. The ADA Transcription 
services is a CHOP approved vendor that have been used before for other research studies at 
CHOP and will continue to be used in the future. A master list, linking the study data with 
subject PHI will be stored separately  from the data in a password-protected file on a secure 
CHOP drive accessible only to the study team.  Participants’ information will be stored in 
the REDCap database and configured to export data without PHI. The coded data may be 
shared with the study sponsor, University of Pennsylvania, other other research staff at 
CHOP/Penn for current or future research purposes. Every 6 months, the study sponsor 
NIMH requires a data transfer to the NIMH Data Archive (NDA). During the course of the 
study and after its completion, the research team will send coded data to the NDA repository 
where it will be stored and managed. Additionally, any necessary study data will be 
transmitted accordingly to Clinicaltrials.gov. Identifiable and non-identifiable information 
may be stored for future research purposes indefinitely. 
8.3 Confidentiality 
All data and records generated during this study will be kept confidential and in accordance 
with institutional policies and HIPAA on subject privacy. Participation in all aspects of the 
proposed study is completely voluntary. The research team will institute strict procedures to 
maintain confidentiality. Subjects will be assigned a unique identification code that will be 

 
 
 
 
 
 
15 
used as the sole identifier whenever possible. Any results obtained cannot be related to the 
original source, so no results would be provided to the patient, healthcare provider, or 
insurance provider. Per standard NIH guidelines, a Certificate of Confidentiality will be 
automatically generated for this NIH-funded study. No identifiable data will be used for 
future study without first obtaining IRB approval or determination of exemption. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers before sharing a limited dataset.  
 
8.4 Regulatory and Ethical Considerations 
8.4.1 Data and Safety Monitoring Plan 
The CHOP PI will monitor and review the study progress, subject safety, and the accuracy 
and security of the emerging data. In accordance with the NIH requirements, we will adopt a 
Data and Safety Monitoring Plan. All SAEs will be reported to the IRBs in accordance with 
CHOP and Penn IRB policies. AEs that are not serious will be summarized in narrative or 
other format and submitted to the CHOP and Penn IRBs the University of Pennsylvania, to 
the OHRP and to the NIMH Project Officer at the time of continuing review. We will use 
the centralized Data Safety Monitoring Board (DSMB) that was developed for the Center. 
The DSMB will meet regularly to review the study progress, review modifications, and 
monitor compliance with IRB rules, human subjects’ procedures, OHRP regulations, and 
plan for rules for stopping clinical trial. This project will be under the Penn Inspire DSMB. 
Its members and their credentials will be submitted to the University of Pennsylvania IRB 
and to NIMH prior to any Project accruing human research participants. The DSMB will 
comprise at least four members with expertise in clinical psychiatry, mental health services 
research, biostatistics, and bioethics. The DSMB will hold scheduled annual meetings in 
person or virtually to review any INSPIRE Project or Pilot Study involving a clinical trial by 
NIH criteria. These will be supplemented by ad hoc interim meetings on a particular 
project(s) during the year, as needed. The DSMB will review and approve the research 
protocol and examine progress annually. 
 
8.4.2 Risk Assessment 
The study procedure risks are not greater than minimal.  The research involves the collection 
of sensitive and protected health information from participants. The risk of participation is 
considered minimal. There is a potential risk of breach of confidentiality of information and 
study results about individuals. This risk is minimized by measures taken by the study team 
to ensure confidentiality: use of secure files, storing data on secure computers, using unique 
study identifiers, using only coded data for analysis, and obtaining a Certificate of 
Confidentiality through NIH. A second risk is that participants may become uncomfortable 
in completing study measures. The risks to participants of the measures and intervention are 
similar to those associated with receiving care coordinating services for mental health 
treatment referral. The discussion of personal and sensitive material (e.g., mental health) 
may make participants uncomfortable. The participants’ right to refuse to answer questions 
or discontinue a procedure will be communicated to them and respected and considered to 
be an essential component of maintaining a positive study experience for the participant. 

 
 
 
 
 
 
16 
Some further potential risks to participants include disclosing child abuse/neglect, suicidal 
ideation and behaviors, and homicidal ideation. Additionally, the family’s routine activities 
may be disrupted slightly because of participation in the study. Participants will not be 
deceived in any way about the nature of the study or reimbursement. Suicidal ideation and 
behavior are risk factors for suicide attempt or death. Therefore, there is increased risk of 
suicide among the participants regardless of their participation in the study. 
 
Should suicidal ideation or behaviors or functioning worsen, we will implement a suicide 
prevention plan to assess immediate risk for harm. Participant will be assessed for suicidal 
risk and determine next steps, such as contacting provider, revising safety plan and/or 
referral to Emergency Department at a nearby hospital for evaluation for psychiatric 
hospitalization. Should child maltreatment be suspected, study staff will comply with all 
mandated reporting laws. 
 
8.4.3 Potential Benefits of Trial Participation 
There are direct benefits to the individuals for study participation for the field testing and 
randomized trial but not for the interviews. All field testing participants will receive the 
intervention.  For RCT, youth assigned to the intervention arm will receive patient 
navigation services to potentially reduce barriers to receiving mental health treatment. 
Additionally, the youth in the control condition (enhanced Treatment as Usual) will receive 
telephone contacts which may benefit their receipt of mental health treatment. There are 
benefits to society for increasing the understanding of motivation for obtaining mental 
health treatment and providing more culturally informed care, which may help to increase 
service utilization among the underserved population of Black youth at risk for suicide.   
 
8.4.4 Risk-Benefit Assessment 
The potential risks associated with study procedures are minimal.  Results gathered from 
this study will provide preliminary information on the effects of the patient navigation 
intervention on use of mental health services and suicidal ideation and behavior. This 
information can be used in subsequent studies to test the effectiveness and implementation 
of this intervention. Given the minimal risk nature of the study, the risks are considered 
reasonable in relation to the generalizable knowledge to be gained. 
 
8.5 Recruitment Strategy 
For qualitative interviews, potential participants identified through any of the three avenues 
by clinicians, behavioral health screening and by diagnostic codes in CHOP ED. Academic 
Associates who work in the CHOP ED and study staff will confirm eligibility for the study, 
describe the study procedures, and enroll interested participants. Academic Associates will 
notify study staff of the enrollment. Study staff will contact participants and schedule 
interviews. 
 

 
 
 
 
 
 
17 
 
For field testing and RCT, potential participants will be identified through any of the three 
avenues by clinicians, behavioral health screening and by diagnostic codes in CHOP ED. 
Academic Associates who work in the CHOP ED and study staff will confirm eligibility for 
the study, describe the study procedures, and enroll interested participants. Academic 
associates will notify study staff of the enrollment. Study staff will contact participants and 
schedule study visit 1 (intervention session for field testing and baseline assessment for 
RCT). For the RCT, a study flyer will be given to families who are undecided about the 
study or do not have time to be enrolled in the ED 
All recruitment materials will be IRB approved. 
8.6 Informed Consent/Assent and HIPAA Authorization 
Parent/legal guardian consent and child assent will be obtained for study participation. 
Consent will may be collected in-person or remotely and may be documented on paper or 
electronically. A waiver of screening consent is being requested to screen medical records 
for inclusion/exclusion. For the qualitative interviews, for youth age 18 years, consent will 
be attained. If a youth turns 18 during the course of the study, consent will be gathered by 
the currently approved consent form for continued participation at the next study visit or 
contact after the youth reaches the age of majority.  For youth between 10-17 years of age, 
youth assent and parental/ legal guardian consent will be attained. For the field testing and 
RCT, for youth ages 14 years or older, consent will be attained. If a youth turns 14 during 
the course of the study, consent will be gathered by the currently approved consent form for 
continued participation at the next study visit or contact after the youth reaches the age of 
majority.  For youth between 10-13 years of age, youth assent and parental/ legal guardian 
consent will be attained. Participation in the study will be completely voluntary, and 
participants will have the study rationale and goals explained to them, as well as the 
requirements for participation, the risks and benefits of participation, and alternatives to 
participation. This is done by reviewing verbally and participants will be allowed to ask 
questions and state concerns. Should any participant become intolerant of any aspect of the 
study or an exclusionary condition be identified, their participation will be discontinued. If 
potential participants want additional time to consider study participation, they can be 
contacted at a later time by study staff to consent. There is no time limit for consent and 
participation as long as that phase of the study is still active. Parent consent and child assent 
also will be gathered for the qualitative interview consent form for their willingness to 
participate in the field testing study procedures. If consent is gathered in person, research 
staff will be given a hard copy of the signed consent form.  In the event that the participants 
are not seen in person, an alternative method of obtaining informed consent will be used. 
Eligible participants will be sent the informed consent document electronically through 
REDCap. The study team will then go over the document in detail with the eligible 
parents/legal guardians and youth. The e-consent function in REDCap will be used to obtain 
the parent/legal guardian’s signature. The signed e-consent will then be stored within 
REDCap, and a copy of the form will be available to download and emailed securely to the 
family. 
 

 
 
 
 
 
 
18 
Verbal Consent from patient navigators 
Informed Consent of patient navigators will be obtained verbally. The aforementioned 
patient navigators are employed at CHOP and will not be paid for their participation as a 
secondary research participant. A waiver of documentation of consent is being requested for 
these participants. Verbal consent will be documented internally by the study team using a 
Consent Affirmation Note. Informed consent will be conducted by a study team member 
(other than a principal investigator) so that the patient navigators does not feel pressure to be 
a secondary research participant. The provider will have no direct reporting relationship to 
the study team member that obtains informed consent from them. Those noted are research 
study team members as well as secondary research subjects. They will be provided with a 
verbal consent form outlining what their participation as a research subject will entail. 
Participation will include the completion of surveys of feasibility and acceptability of the 
intervention and the completion of fidelity checklists.  Completion of fidelity checklists is a 
widely accepted, standard practice in the delivery of a behavioral intervention to monitor 
adherence to an intervention manual and part of routine practice at CHOP. These checklists 
will be used in the clinical supervision of the patient navigator and for research purposes. 
However, participants can choose to not have their fidelity checklist data used beyond 
clinical supervision purposes (i.e., for research purposes).   Participants will be given time to 
ask questions and make an informed decision regarding their completion of the feasibility 
and satisfaction surveys and use of the “data” from the fidelity checklists for research 
purposes. No HIPAA related information will be gathered from the patient navigators.   
 
 
8.7 Payment to Subjects/Families 
8.7.1 Reimbursement for travel, parking and meals 
We will provide transportation services for each family to complete study visits if conducted 
in person.   
8.7.2 Payments to subject for time, effort and inconvenience (i.e. compensation) 
For qualitative interviews, $30 for each participant which includes both youth and cargiver. 
For field testing, $25 for each subject. For randomized trial: $25 for baseline, $25 for 2 
month follow up and $50 for 6-month follow up for each subject. 
 
9 
PUBLICATION 
The study protocol for this application will be registered with Clinicaltrials.gov. Results will 
be submitted to Clinicaltrials.gov after completion and analysis of data. Informed consent 
documents will include a specific statement regarding the dissemination of aggregate study 
results in Clinicaltrials.gov, peer-reviewed publications, and other policy-relevant 
summaries. The study team plans to work closely with the Penn INSPIRE center to 
disseminate and implement the findings of the research study into accessible and usable 
formats in research, clinical, and community-based settings. Using social media, policy 
briefs, mass emails and newsletters, we will target findings to city, state and national 

 
 
 
 
 
 
19 
policymakers, county behavioral health departments across the state of Pennsylvania, and 
pediatric emergency departments. We will also work with PolicyLab at CHOP to develop 
dissemination plans. PolicyLab has extensive experience distilling research findings into 
policy-relevant summaries and disseminating research findings to end-users. We will also 
utilize traditional approaches such as peer-reviewed publications and presentations at 
national meetings to disseminate findings to other researchers. 
 
10 REFERENCES 
 
Ali-Faisal SF, Colella TJ, Medina-Jaudes N, Scott LB. The effectiveness of patient 
navigation to improve healthcare utilization outcomes: A meta-analysis of randomized 
controlled trials. Patient Education and Counseling. 2017;100(3):436-448. 
 
Allan NP, Lonigan CJ, Phillips BM. Examining the factor structure and structural 
invariance of the PANAS across children, adolescents, and young adults. Journal of 
Personality Assessment. 2015;97(6):616-25. 
 
Breda CS, Riemer M. Motivation for Youth’s Treatment Scale (MYTS): A new tool for 
measuring motivation among youths and their caregivers. Administration and Policy in 
Mental Health and Mental Health Services Research. 2012;39(1-2):118-132. 
 
Bridge JA, Asti L, Horowitz LM, et al. Suicide trends among elementary school–aged 
children in the United States from 1993 to 2012. JAMA Pediatrics. 2015;169(7):673-677. 
Bridge JA, Horowitz LM, Fontanella CA, et al. Age-Related Racial Disparity in Suicide 
Rates Among US Youths From 2001 Through 2015. JAMA Pediatrics. 2018;172(7):697-
699. 
 
Congressional Black Caucus. Ring the Alarm: The Crisis of Black Youth Suicide in 
America.; 2019. https://watsoncoleman.house.gov/uploadedfiles/full_taskforce_report.pdf 
 
Cox D. Regression Models and Life-Tables. Journal of the Royal Statistical Society 
Series B (Methodological). 1972;34(2):87-22. 
 
Curtin SC, Heron M. Death Rates Due to Suicide and Homicide among Persons Aged 
10–24: United States, 2000–2017. National Center for Health Statistics; 2019. Accessed 
October 26, 2020. https://www.cdc.gov/nchs/data/databriefs/db352-h.pdf 
 
Faul F, Erdfelder E, Buchner A, Lang A-G. Statistical power analyses using G*Power 
3.1: Tests for correlation and regression analyses. Behavior Research Methods. 
2009;41(4):1149-1160. 
 
Freedenthal S. Racial disparities in mental health service use by adolescents who 
thought about or attempted suicide. Suicide and Life-Threatening Behavior. 2007;37(1):22-
34. 
 
Godoy L, Hodgkinson S, Robertson HA, et al. Increasing Mental Health Engagement 
from Primary Care: the potential role of family navigation. Pediatrics. 2019;143(4). 
 
Grupp-Phelan J, Stevens J, Boyd S, et al. Effect of a Motivational Interviewing–Based 
Intervention on Initiation of Mental Health Treatment and Mental Health After an 
Emergency Department Visit Among Suicidal Adolescents: A Randomized Clinical Trial. 
JAMA Network Open. 2019;2(12):e1917941-e1917941. 
 
Horwitz SM, Hoagwood K, Stiffman AR, et al. Reliability of the services assessment 
for children and adolescents. Psychiatric Services. 2001;52(8):1088-1094. 

 
 
 
 
 
 
20 
 
Ivey-Stephenson AZ, Demissie Z, Crosby AE, et al. Suicidal Ideation and Behaviors 
Among High School Students - Youth Risk Behavior Survey, United States, 2019. MMWR 
Suppl. 2020;69(1):47-55. 
 
King CA, Brent D, Grupp-Phelan J, Shenoi R, Page K, Mahabee-Gittens EM, Chernick 
LS, Melzer-Lange M, Rea M, McGuire TC, Littlefield A. Five profiles of adolescents at 
elevated risk for suicide attempts: Differences in mental health service use. Journal of the 
American Academy of Child & Adolescent Psychiatry. 2020 Sep 1;59(9):1058-68. 
 
Lee-Tauler SY, Eun J, Corbett D, Collins PY. A systematic review of interventions to 
improve initiation of mental health care among racial-ethnic minority groups. Psychiatric 
services. 2018;69(6):628-647. 
 
Lindsey MA, Sheftall AH, Xiao Y, Joe S. Trends of Suicidal Behaviors Among High 
School Students in the United States: 1991–2017. Pediatrics. 2019;144(5):e20191187. 
 
Marrast L, Himmelstein DU, Woolhandler S. Racial and ethnic disparities in mental 
health care for children and young adults: A national study. International Journal of Health 
Services. 2016;46(4):810-824. 
 
Moore KL. Mental health service engagement among underserved minority adolescents 
and young adults: a systematic review. Journal of racial and ethnic health disparities. 
2018;5(5):1063-1076. 
 
Pina AA, Polo AJ, Huey SJ. Evidence-based psychosocial interventions for ethnic 
minority youth: the 10-year update. Journal of Clinical Child & Adolescent Psychology. 
2019;48(2):179-202. 
 
Planey AM, Smith SM, Moore S, Walker TD. Barriers and facilitators to mental health 
help-seeking among African American youth and their families: A systematic review study. 
Children and Youth Services Review. 2019;101:190-200. 
 
Reynolds WM. SIQ, Suicidal Ideation Questionnaire: Professional Manual. 
Psychological Assessment Resources; 1988. 
 
Reynolds WM, Mazza JJ. Reliability and validity of the Reynolds Adolescent 
Depression Scale with young adolescents. Journal of School Psychology. 1998;36(3):295-
312. 
Sheftall AH, Asti L, Horowitz LM, et al. Suicide in elementary school-aged children and 
early adolescents. Pediatrics. 2016;138(4):e20160436. 
 
Stiffman AR, Horwitz SM, Hoagwood K, et al. The Service Assessment for Children 
and Adolescents (SACA): Adult and Child Reports. Journal of the American Academy of 
Child & Adolescent Psychiatry. 2000;39(8):1032-1039. 
Sullivan PS, Stephenson R, Grazter B, et al. Adaptation of the African couples HIV testing 
and counseling model for men who have sex with men in the United States: an application 
of the ADAPT-ITT framework. SpringerPlus. 2014;3(1):249. 
 
Villodas F, Villodas MT, Roesch S. Examining the factor structure of the positive and 
negative affect schedule (PANAS) in a multiethnic sample of adolescents. Measurement and 
Evaluation in Counseling and Development. 2011;44(4):193-203. 
 
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of 
positive and negative affect: the PANAS scales. Journal of Personality and Social 
Psychology. 1988;54(6):1063-70. 

 
 
 
 
 
 
21 
 
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a 
pilot randomised trial to minimise the overall trial sample size for the external pilot and 
main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25(3):1057-1073. 
 
Wingood GM, DiClemente RJ. The ADAPT-ITT Model: A Novel Method of Adapting 
Evidence-Based HIV Interventions. JAIDS Journal of Acquired Immune Deficiency 
Syndromes. 2008;47. 
https://journals.lww.com/jaids/Fulltext/2008/03011/The_ADAPT_ITT_Model__A_Novel_
Method_of_Adapting.8.aspx 
 
 
 
 
 

 
 
 
 
 
 
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APPENDIX 
See attached.