Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study
Phase: NA
Conditions: Depression, Suicidal Ideation
Sponsor: New York University

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Engaging Black Youth in Depression and Suicide Prevention Treatment within 
Urban Schools: A Preliminary Study 
 
1 R34 MH119290-01 
 
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Summary of the Research 
The overall goal of this study is to examine the effectiveness of the Making Connections 
Intervention, hereafter referred to as the MCI. Based on the Unified Theory of Behavior and 
Stages of Change Theory, the MCI is designed to facilitate adolescents' identification of 
perceptual and actual barriers that influence their mental health treatment acceptability (i.e. 
engagement, perceived relevance, and satisfaction), and equip them with the skills to overcome 
these barriers at the initiation and/or during the course of treatment. As a test of the MCI, our 
target population was urban, Black adolescents screened for depression and referred for 
Interpersonal Psychotherapy for Depressed Adolescents, or IPT-A, for treatment. Prior research 
by the PI indicates that depressed, Black adolescents are likely to have untreated depression 
due to negative family influences, negative perceptions of services and providers, or self-stigma 
associated with experiencing depressive symptoms. This is of public health significance 
because: (1) this group uses less mental health services than any other adolescent group, and 
non-financial factors (e.g. mental illness stigma, negative perception of providers/services) plays 
a significant role in their lower service use; (2) if/when they do enter treatment, low engagement 
and early termination typify their experiences; and (3) suicide, a byproduct of untreated 
depression, has increased among this group, narrowing the gap in suicide rates between White 
and Black adolescents. To date, limited work has been done to improve treatment acceptability 
among urban, Black adolescents with depression, especially those in their middle-school age 
years. This study proposes a small-scale trial in New York City DOE school-based mental 
health clinics throughout the Bronx, where Black youth would be randomized to receive the 
MCI+IPT-A or IPT-A alone. 
Project Information II 
Description of study procedures: 
a. The study will be conducted at six (6) New York City Department of Education (DOE) 
Middle and High School School-Based Mental Health Clinics. 
b. Participants will need to sign consent (caregivers) and assent (youth) forms. Following 
enrollment, youth and caregivers will be given a baseline assessment consisting of a 
series of questionnaires. Both youth and caregivers assigned to the MCI + IPT-A group 
will attend one or two MCI sessions lasting approximately 45 minutes. The youth 
participants will continue to receive IPT-A for 12 sessions and will be given additional 
assessment questionnaires at weeks 4, 8, and 12. Youth in the IPT-A only group will 
begin IPT-A sessions immediately following enrollment and will follow the same 
assessment schedule. Assessments, screenings, and MCI and IPT-A sessions will be 
conducted at the youth's school.  
c. The MCI coupled with the IPT-A will consist of 13-15 intervention sessions. The IPT-A 
alone will consist of 12-15 intervention sessions. The MCI will occur with parents or legal 
guardians and students for one hour (60-75 minutes) over 1-2 sessions (Note: the 
screening and initial assessment will occur prior to the MCI session). The remaining 12-
15 sessions will focus on the delivery of the evidence-based depression treatment, IPT-
A, which will occur in weekly 30-45 minute individual therapy sessions (over 12 weeks, 
additional if a week is skipped) with the students and allowing possible concurrent 
sessions with the parent or legal guardian as needed. Thus, the intervention should last 
for approximately 3-4 months.  

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d. A member of the research staff will conduct interviews and assessments. SMH clinicians 
will deliver the MCI and IPT-A interventions. This study will feature a 2-group 
randomized design. Eligible students will be randomized to receive the MCI and IPT-A 
enhanced intervention, or to receive IPT-A only. Astor Services for Children & Families is 
a community based, non-profit organization that provides children’s mental health 
services, child welfare services, and early childhood development programs. Astor 
serves children and families in the Bronx through school-based mental health clinics. 
These on-site mental health clinics, which are all licensed mental health clinics in New 
York State, offer individual, group, and family treatment, as well as crisis intervention on 
school campuses. Six to eight clinicians employed by Astor will deliver both the MCI and 
IPT-A interventions, or the IPT-A alone. Therefore, Astor Services for Children & 
Families will be responsible for administering individual psychotherapy at their 6 selected 
school-based sites in the Bronx, but will not be involved in the design, oversight and/or 
management of the study. 
e. Screening tools will be distributed to students in a take-home packet, completed along 
with a consent form, and collected by research staff or SMH clinicians. Assessment 
questionnaires will be given by a member of the research staff and delivered to the 
research coordinator when completed.  
Incentives 
Incentives will be provided to both youth and caregiver participants in the form of gift cards. If 
participants withdraw prior to study completion, they may keep any gift cards they received but 
will not receive additional gift cards that would have been distributed at a later point in the study. 
Participating caregivers receive a $20 gift card at baseline, $15 gift card following the post-MCI 
assessment, and then a $15 gift card following the assessments at week 4, week 8 and week 
12. Youth receive a $15 gift card at baseline, $10 gift card following the post-MCI assessment, 
$10 gift card following the week 4 assessment, $10 gift card following the week 8 assessment, 
and then a $10 gift card following the week 12 assessment. The total gift card amount for 
caregivers completing the study is $80 in gift cards; the total for youth participants completing 
the study is $55 in gift cards. 
Participant Identification, Recruitment, & Selection 
We based our sample projections on the demographic data from our partnering NYC DOE 
schools. The schools we are partnering with have approximately similar percentages of male 
and female students, of whom over 20% are African American. The students who attend these 
schools are generally from low-income families (live below the poverty line, receive Medicaid). 
We will enroll a total of 60 subject and randomly assign them to the MCI + IPT-A or IPT-A only 
in a 1:1 ratio. Based on screening rates in our previous R21, we anticipate recruiting 60 
adolescents (10 per school-based site). In our R21 study, we were able to recruit 24 
adolescent/parent pairs from our partnering schools using similar screening processes. 
At each school, students with elevated depression will be identified through a school-wide 
screening process. We will work in concert with NYC DOE school mental health (SMH) staff to 
screen participants as per usual care procedures. We will identify participants through the 
following procedures. First, a screening (PHQ-9) and consent form (caregivers provide 
permission for their child to be seen in SMH services) are sent home with all students at the 
beginning of the academic year. We have requested (per IRB approval) to also send home a 

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permission to be contacted form, along with a letter describing our study. If caregivers agree to 
be contacted, the SMH staff will share with the research staff the contact information of students 
who scoring above the clinical cutoff of 11 (range 0 to 27). Astor Services for Children & 
Families used the school-wide screening method with the Strengths and Difficulties 
Questionnaire in 2015 and had an approximately 50% return rate on the screenings/consent 
forms. Research staff will not receive names of students whose parents do not provide a 
permission to be contacted from. Of the received forms, the research staff will contact the family 
to set up a time to consent/assent for the study and screen the adolescent using our standard 
screening procedure, which is to administer the Center for Epidemiologic Studies Depression 
Scale (CES-D). Second way we also will recruit participants is that using another standard of 
care in SMH service delivery, which is to recruit through the school-based clinics among those 
students presenting to services for mental health needs. That is, SMH staff at the participating 
schools currently receive referrals from NYC DOE social workers, guidance counselors, 
administrators, teachers, other school-based providers, family members, and self-referrals. All 
referrals are screened using the PHQ-9. Upon receipt of referrals, the SMH staff person will 
share a brochure of the study and a letter to be shared with the family, along with a permission 
to be contacted form. Following assessment, Dr. Lindsey and Tracy Grogan will review 
assessment, establish eligibility, and follow random assignment procedures. Randomization lists 
will be prepared by Dr. Jaccard who will have no contact with participants, clinicians, or study 
staff members. We will randomize within schools and provide clinicians information per each 
case about whether the participant will receive the MCI + IPT-A or IPT-A only. Clinicians will 
complete fidelity assessments, and we will randomly listen to audiotapes of sessions to 
document the extent of contamination or the potential of it. We will also make sure to discuss 
instances of contamination (or the potential of it) during weekly supervision with the clinicians.  
Note: We will keep track of the % of families who return the permission to be contacted forms. 
Research staff will follow-up on all returned forms and schedule a time to consent/assent for the 
study and screen the adolescent using our standard screening procedure 
Participant Population 
Inclusion Criteria:  
1. 
Must identify as Black and/or African American 
2. 
Must be enrolled in grades 6-12 (except 12th graders in their last semester)  
3. 
Must be able to speak English 
4. 
Must have received caregiver consent and have assented to participate 
5. 
Must meet depression and global functioning levels indicated by a CES-D score ≥16, a 
Hamilton Rating Scale of Depression (HRSD) Score ≥ 10, and a Global Assessment 
Scale for Children (C-GAS) score ≤ 65 at baseline  
6. 
Students who are currently on a stable dose of anti-depressant medication, but still meet 
inclusion criteria, can be enrolled in the study.  
Exclusion Criteria: 
1. 
Actively suicidal with intent or plan 

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2. 
Intellectually disabled 
3. 
Have a life threatening medical illness 
4. 
Have a current primary substance abuse diagnosis in the moderate to severe range, 
schizophrenia, bipolar disorder, any evidence of psychosis, a primary diagnosis of 
anorexia 
5. 
Currently in active treatment for depression (excluding medication) at baseline 
assessment 
Note: Adult caregivers included in the study must be the adolescent’s legal guardian. 
Otherwise, exclusion criteria similar to what is applied to the adolescents will be applied to the 
legal guardians.  
Informed Consent 
All student participants will require parental consent and student assent to participate in the 
study. At each school, students will be recruited through a school-wide screening process. Prior 
to screening, the research team will hold an informational meeting for parents, adolescents, and 
teachers regarding adolescent depression, rationale for screening for elevated depression, and 
treatment options including the current study. Parents will then be sent a PHQ-9 and a consent 
form for their child’s participation in the screening (students will take home in a packet) as part 
of usual care procedures at the participating NYC DOE schools. Upon receipt of a willingness to 
be contacted form, the research team will contact families about their interest in participating in 
the study. Upon an expressed interested, a research team member will meet the family to 
explain the study and cover the informed consent procedures (and child assent). The research 
team member will explain the study to the family, including the randomization procedure. They 
will understand that they are participating in a research study and that participation is voluntary. 
The consents also give information regarding what the study entails, incentives, and 
requirements of participants. Students and parents or legal guardians will also be given a copy 
of all consents/assents signed for their records and are welcome to contact any member of the 
research staff or the school mental health clinicians regarding questions or concerns they may 
have. Participants may choose not to participate. Consents will be written at the 7th grade 
reading level for parents or legal guardians and at the 5th grade level for student assents. The 
research team member will be sure that the participants understand all aspects of the consent 
process. Note: For those families who do not wish to participate in the study, usual care 
treatment will be offered. With informed consent and child assent obtained, the research team 
member will administer the CES-D screen. If the student scores above the clinical cutoff on the 
CES-D (i.e., 16 or higher), and the Hamilton (i.e., 10 or higher), and meet other 
inclusion/exclusion criteria, the student will be enrolled. We anticipate these procedures will be 
completed at the participating schools.  
 
Participation Consideration 
Study participants are allowed to enroll or withdraw from the study at any time. The recruitment, 
active treatment phases, and data collection will take place over 3 years. 
Privacy of Participants 

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Information will be obtained in a school-based setting during the normal school day. Loss of 
privacy and confidentiality are possible risks of participation in the study. For example, there is 
potential for being stigmatized by peers for participating in a study on depression, particularly if 
peers of the participant discover this information. For example, peers may notice that a 
participant is absent from class or may pass them in a hallway while a participant is on his/her 
way to a private setting. To protect privacy during the data collection phase, (1) research staff 
will have direct contact with the caregiver(s) of the participants during afterschool hours; (2) any 
referees will be informed that the names of participating students must be kept confidential; and 
(3) copies of study assessments are kept in locked files at schools (not containing identifying 
information).  
Private Information Sources 
Mental health assessments and audio taped sessions 
Regulatory Risk/Benefit Determination Applicable to Children 
Federal regulations (45 CFR 46, subpart D) define risk/benefit categories as they apply to 
children.  
(404) Minimal Risk research, where the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological 
examinations or tests. For research with children, adequate provisions must also be 
made for soliciting the assent of the children and the permission of their parents or 
guardians, as set forth in 46.408. 
Participants are subject to minimal levels of risk - not greater than that of a typical therapy 
session with a counselor. 
Data Confidentiality and Risks & Benefits 
During data collection, a participant number will be assigned to each participant and indicated 
on research forms, so that it is the only link on assessment instruments. Access to consent 
forms, assent forms, demographic information, audio tapes, and assessment materials will be 
limited to the research staff at the NYU in password-protected files; the school mental health 
clinicians have access to copies of student assessments. The document containing students' 
identification number assignment will be sent to school mental health clinicians via NYU’s 
secure file transfer system. The document is password protected, and the password is provided 
in a separate email. Only research personnel listed in this application have access to the hard 
copies of any data.  
a. Research data and digital recordings of therapy sessions are stored on a password-protected 
network at the School of Social Work, which is on a secure server in the school and accessed 
only by investigators who are from NYU Silver School of Social Work. Data stored on the School 
of Social Work servers are protected by Windows New Technology File System (NTFS) Access 
Control Lists (ACL) tied to users Active Directory domain accounts. Users have access to a 
private folder accessible only to them and group folders accessible by select groups of people. 
Logging will be established on group folders and files to monitor access to individual folders and 
files. Access will be established and tracked by the user’s New York University NetID. The only 

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account(s) on the system with access to all files is the main administrator account (which is not 
named administrator and has a 15 random character password, and the system internal account 
for tape backup. The School’s main file server uses a Storage Area Network (SAN), which 
distributes the data over multiple redundant hard drives for reliability. In addition, Shadow copies 
are created at multiple times throughout the day and servers are backed up nightly to tape. 
Servers, network access devices and tape backups are housed in locked limited access rooms. 
b. Research data and digital recordings of therapy sessions are stored on the password-
protected network at the School of Social Work. Only the PI, research coordinator, and research 
assistants will have access to the data and digital recordings. Co- Principal Investigator, Dr. 
Laura Mufson of Columbia University, will have access to de-identified data and de-identified 
digital recordings of therapy sessions to review for IPT-A fidelity. SMH clinicians have access to 
copies of assessments. 
c. Research data will be kept for 3 years post the conclusion of the study. At the 3-year point, 
the data will be destroyed. 
d. Research data has been kept in locked cabinets in the research coordinator's office at NYU. 
The office is locked by key whenever the research coordinator is not in the office. When the time 
arrives for the data to be destroyed, it will be done so by shredding the documents. 
e. Additionally, we have also provided a data safety and monitoring plan. 
Risks of the Study  
Participants are subject to minimal levels of risk - not greater than that of a typical therapy 
session with a counselor. (Note: In instances where youth are on medications related to their 
mental health symptoms, those youth will not be asked to stop taking medication. If appropriate, 
they will be referred for medical or psychiatric treatment.) 
During the assessment and/or treatment sessions, students are asked questions that may 
cause some discomfort. Participants may experience some anxiety and/or increased sadness 
related to discussing personal information with the SMH clinician; however, students are not 
pressured to respond to any questions that they did not want to answer. Additionally, the SMH 
clinician as well as the PI are available to provide debriefing opportunities and discuss any 
issues related to this study. 
Loss of privacy and confidentiality are possible risks of participation in the study. For example, 
there is a potential for being stigmatized by peers for participating in a study on depression, 
particularly if peers of the participant discover this information. We will make sure, to the extent 
possible, to protect the participation of students from other students. For example: (1) only 
research staff will have direct contact with the caregiver(s) of the participants during afterschool 
hours; (2) referees will be informed that the names of participating students must be kept 
confidential; and (3) copies of study assessments are kept in locked files at schools and do not 
contain identifying information. It is possible that participants may themselves inform peers 
about participating in the study or receiving treatment.  
Due to working with students showing symptoms of depression, there was a risk that their 
depression could worsen while engaging in mental health treatment. The PI and research team 
will make every available effort to safely and sensitively handle significant worsening of 

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depressive symptoms. For example, as a standard of practice in the IPT-A treatment, SMH 
clinicians assess current symptom levels at the beginning of each session. Further, SMH 
clinicians complete the Children's Global Assessment Scale (C-GAS) to assess for global 
impairment associated with mood disorder. Additionally, the Hamilton Rating Scale for 
Depression (HRSD) and Center for Epidemiological Studies-Depression Scale (CES-D) are 
administered at baseline, post-MCI session, and at weeks 4, 8 and 12. If at any time the 
symptoms, as indicated by the HRSD and CES-D, reach a clinically severe level (HRSD score 
of 28 or greater; CES-D score of 31 or greater), the PI and SMH clinicians immediate ask follow-
up questions to determine whether the youth is expressing suicidal ideation; if suicidal ideation 
was indicated, the PI and SMH clinicians further assess whether the youth has a plan, whether 
there is access and means to follow through with a plan, the level of suicidal intent and the 
presence of current suicidal gestures. We also contact the caregiver and provided information 
about emergency psychiatric services for determination of whether hospitalization is necessary. 
If there was a pattern of worsening depressive symptoms or de-compensation in the absence of 
suicidal intent during the course of the study (as measured by the Clinical Global Impressions 
(CGI), which was given weekly by the SMH clinician and indicated by a 6 or 7 on the CGI for 2 
consecutive weeks), the PI in consultation with the SMH clinicians will make a determination of 
whether the youth is: (1) appropriate for the study; or (2) in need of more emergent psychiatric 
care such as hospitalization. Referral may have also be made back to a primary care physician 
or to community-based mental health services in instances where participants might worsen 
during the course of the study. Again, guidance on this determination is informed on a session-
by-session basis (e.g. symptom query is a standard practice of the IPT-A treatment) and via the 
standardized assessments of depression (e.g. HRSD and CES-D). If hospitalization was 
necessary, information on psychiatric services (e.g. hospitalization) will be provided to the 
caregiver. 
Benefits of the Study 
Participants experience minimal risks and receive high quality mental health services from 
master’s level SMH clinicians in an effort to help reduce presenting issues. Participants may 
gain knowledge of the therapy process and learn problem solving skills to reduce hesitancy to 
engage in treatment. Participants may experience a reduction in depression as an outcome of 
completing the full depression intervention. 
However, participants may not receive any direct benefit from participating in the study. 
Results of this study will inform the preparation of a future federal grant application proposal 
(e.g. NIH R01) to address the effectiveness of the intervention approach outlined here in a 
larger scale trial. In particular, a future randomized controlled trial will be conducted to further 
test or refine the MCI intervention for SMH/community-based services. An intervention that will 
help reduce barriers to care and improve engagement in therapy would benefit the community 
greatly, particularly for those groups who experience many challenges in obtaining mental 
health services such as Black adolescents in an urban setting.