Computer Assisted Family Intervention to Treat Self- Harm Disparities in Latinas and Sexual/Gender Minority Youth (CA CIFFTA)
Phase: NA
Conditions: Self Harm, Depression, Emotion Dysregulation, Suicidal Ideation, Family Relations
Sponsor: University of Miami

NCT03709472
Computer Assisted Family Intervention to Treat Self-Harm 
Disparities in Latinas and Sexual/Gender Minority Youth
Study Protocol date: 2/3/2022

1) Protocol Title
Computer Assisted Family Intervention to Treat Self-Harm Disparities in 
Latinas and Sexual/Gender Minority Youth (CA CIFFTA)
2) IRB Review History*
IRB for NIH “Just in Time” was approved on 9/1/2017. 
3) Objectives*
The study described in the protocol is a randomized trial at UM. The study 
will enroll 100 11-18 year old youth with a self-reported act of self-harm 
in the past 6 months and their families. This study is designed to refine 
and test the efficacy of a computer assisted culturally informed and 
flexible/adaptive intervention for Latino adolescents for whom self-harm 
behaviors are a health disparity—specifically, Latinas and sexual/gender 
minority youth. The specific aims of this study are: 
1) To build on the Computer Assisted CIFFTA intervention by creating a
web-site and web-based delivery system and by adding content that is
relevant for the factors that maintain self-harm in Latina adolescents
(e.g., depression, family conflict, substance use, and emotion
dysregulation) and for unique stressors often linked to sexual/gender
minority youth and those exposed to trauma.
2) To investigate the preliminary efficacy of the Computer Assisted
CIFFTA in reducing self-harm and in modifying the factors that place
youth at risk for self-harm (e.g., depression, family conflict, substance
use, and emotion dysregulation) when compared to controls (Treatment-
As-Usual).
3) To investigate the linkages between co-existing problem areas (e.g., self-
harm, risky sexual behavior, substance use) to see if there is evidence of a
syndemic.
4) To investigate the relationship of culture-related variables (e.g.,
acculturation, familism, and Hispanic Stress) to the key factors
hypothesized to contribute to self-harm behavior (i.e., depression, family
conflict, substance use, and emotion dysregulation).
4) Background*
Significance and Rationale 
Suicide is the second leading cause of death in youth ages 10-24, and self-harm—
which includes nonfatal suicide attempts (SA) and non-suicidal self-injury (NSSI)—is 
prevalent and is a risk factor for future suicide attempts and suicide completion. Self-
harm does not typically emerge in a vacuum; it is commonly found to occur with other 
mental health (e.g., depression and emotion dysregulation) and behavioral (e.g., alcohol 
and drug use, risky sexual behavior, and externalizing behavior) symptoms. Evidence 
suggests that these behaviors occur in clusters as described by Syndemic theory and, if 
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untreated, lead to severe adverse substance abuse, violence, and HIV/AIDS (SAVA) 
disparities in youth and other vulnerable populations. A cross-sectional investigation of 
high school youth found that engagement in risky sex, self-harm/cutting, and 
externalizing behaviors tended to co-occur among youth who reported using illicit 
substances. In a study with adolescents participating in an intensive psychiatric treatment 
program, risky sexual behaviors, including inconsistent condom use, were found to be 
associated with self-harm behaviors. In the treatment of these youth, research has 
suggested that (a) several stressors are likely to arise with non-suicidal self-injury and 
suicide-related injuries and (b) any program seeking to treat existing risk factors and 
prevent repeated self-injury and suicide should be prepared to address these stressors. 
Among these stressors are the marginalization experienced by sexual and gender minority 
youth, traumatic experiences, chronic family conflict, and alcohol use. In addition, 
culture-related variables may place Latinas at even higher risk due to breakdowns in 
family protective factors.
Hispanic/Latino adolescents, self-harm, mental health, and risky sexual behaviors
A set of health disparities often linked together in Hispanic/Latino youth are self-
harm behaviors, rates of depressive symptoms, and HIV rates. According to the 2015 
Youth Risk Behavior Surveillance System (YRBSS) survey of high school students, 
Hispanic youth reported feeling sad or hopeless at higher rates than non-Hispanic White 
youth, 35.3% versus 28.6%. Among all high school students who completed the survey, 
17.7% of youth reported having seriously considered attempting suicide in the previous 
year and Hispanic rates were higher than non-Hispanic youth.  Hispanic/Latino females 
appear to be at particularly high risk—reporting the highest prevalence of having felt sad 
or hopeless (46.7%), of having seriously considered attempting suicide (25.6%), of 
having made a suicide plan (20.7%), and of having attempted suicide (15%) in the past 
12 months. Another health disparity area also found in Hispanic/Latino females— and 
possibly linked to self-harm and depression profiles—involves risky sexual behavior and 
HIV risk. Hispanic/Latino youth have an earlier age of onset for sexual intercourse than 
non-Hispanic White youth and are less likely to use condoms consistently, which may 
place them at increased risk for pregnancy, STIs, and HIV. According to the 2015 
YRBSS, the high school prevalence of having ever had sexual intercourse was highest 
among Hispanic/Latino females at 39.8%. In 2014, Hispanic teen birth rates were more 
than two times higher than the rate for non-Hispanic White teens. In 2013, of new 
diagnoses in the United States among youth 24 and younger 20% were Hispanic/Latino 
youth compared to 17% of non-Hispanic White youth. Among male adolescents ages 13-
24 living with a diagnosis of HIV infection at the end of 2012 in the US, 20% were 
Hispanic/Latino compared to 15% non-Hispanic White. Of the new infections in 2015, 
Hispanic/Latino gay and bisexual adolescent males were infected at the second highest 
rate. Among females in the age group who were diagnosed, 18% were Hispanic/Latina 
compared to 13% non-Hispanic White female adolescents.
There are individual, familial, acculturation and immigration-related factors, and 
trauma-related factors that have been hypothesized to contribute to this self-harm 
disparity in Latinas. Zayas (2011) postulates that this set of factors can have a debilitating 
effect on mental health, negatively impacting an individual’s ability to cope and 
increasing the risk for self-harm behaviors. Traumatic immigration experiences and 
prolonged immigration-related separation between caregivers and youth can also cause 
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high stress and family disruptions resulting in increased risk for self-harm behaviors. A 
recent study of Hispanic/Latino youth found that the female adolescents with exposure to 
a traumatic event and who reported low family cohesion reported more symptoms of 
anxiety and depression. These findings are consistent with literature pointing to the 
negative effects of poor family cohesion on symptoms of depression and highlights the 
importance of identifying and addressing these experiences in treatment to avoid 
worsening symptom and self-harm. Hispanic/Latino youth may experience family 
conflict and a loss of family cohesion as they acculturate to the US culture. Studies have 
suggested that Hispanic/Latino girls and boys have different acculturation experiences 
and that Hispanic/Latino girls may acculturate faster than boys when they are attracted to 
less traditional gender roles in the United States. Due to gender role expectations in 
Hispanic/Latino families, adolescent females report greater responsibilities at home, less 
freedom to socialize outside of the home, and greater supervision than males. Research 
has also suggested that females place more importance on interpersonal connections and 
closeness than males and that Hispanic/Latino females are more negatively affected by 
family conflict than their male counterparts. Thus, girls may experience more family 
conflict and less family cohesion when parents and other relatives impose rules on them 
and when they rebel against these gendered restrictions. As a result of the family 
disruptions, parenting quality and other protective family factors can decline and the 
adolescent girl may be exposed to high levels of negative emotion from parents or other 
family members. These factors may negatively impact her ability to cope and regulate 
emotions, and impact internalizing and externalizing behaviors leading to self-harm 
behaviors.
LGBT and Sexual and Gender Minority Youth and Self-Harm
Lesbian, gay, bisexual and transgender youth are a minority group that are at 
increased risk for self-harm. In the year preceding the YRBSS 2015 survey, 60.4% of 
gay, lesbian, and bisexual students reported feeling so sad or helpless that they stopped 
doing some usual activities, 42.8% had seriously considered attempting suicide, and 
29.4% had attempted suicide one or more times. LGBT youth are at increased risk of 
negative health outcomes such as increased rates of STIs/HIV, increased use of alcohol 
and drugs, and issues related to weight. LGBT youth engage in high risk sexual behaviors 
such as early age of first sexual intercourse, more lifetime and recent sex partners, and 
drinking alcohol or being high during last sexual intercourse, and are less likely to use a 
condom during intercourse than heterosexual peers. They are also five times more likely 
to use alcohol and drugs than their heterosexual peers. Meta-analyses show that 
adolescents and young adult MSM show high rates of several serious symptoms 
including substance use, risky sexual behaviors that can lead to HIV, and self-harm 
behaviors. Further, these researchers hypothesize that the strong linkages between the 
rates of these behaviors point to a possible syndemic in which contextual conditions (e.g., 
marginalization and victimization) may significantly contribute to the co-occurrence of 
these symptoms. 
Minority Stress Theory suggests that sexual minorities experience unique, 
recurring stressors that lead to unhealthy behaviors. LGBT youth experience 
homelessness at a higher rate than their non-LGBT counterparts and experience stressors 
such as discrimination, rejection, violence, abuse, lack of support, and trauma.  Previous 
research has linked PTSD symptoms and self-harm behaviors. A 2016 CDC report 
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comparing LGB youth to heterosexual youth in high school showed that LGB youth were 
more likely to be physically forced to have sex (18% LGB vs. 5% heterosexual), to 
experience sexual dating violence (23% LGB vs. 9% heterosexual), to experience 
physical dating violence (18% LGB vs. 8% heterosexual), and to be bullied at school or 
online (at school: 34% LGB vs. 19% heterosexual; online: 28% LGB vs. 14% 
heterosexual). LGB students were more likely to miss school in the recent past due to 
feeling unsafe at school. In combination or individually, these risk factors greatly 
increase the risk for self-harm and/or suicide in LGBT youth. Parental rejection following 
their child’s disclosure has also been associated with various negative outcomes, 
including depression, substance abuse, academic and conduct problems, and troubled 
interpersonal relationships. 
Hispanic/Latino LGBT youth possess unique cultural factors that place them at 
additional risk for self-harm behaviors and being both an ethnic minority and a sexual 
minority results in a compounding of adverse outcomes. A large national study showed 
that compared with White LGBT youth, Latino LGBT youth were more likely to attempt 
suicide. Latina LGBT youth had significantly higher rates of suicide attempts in the 
previous year than any other racial/ethnic group in the study. Latino LGBT boys reported 
twice the amount of feeling sad in the last year than boys of other racial categories. Fewer 
than half of LGBT Latino youth have an adult in their family they can turn to if worried 
or sad, compared to 80% of their non-LGBT Latino peers; and among LGBT youth ages 
13-17 who disclosed to their parents, about one-third lacked family acceptance.
Additionally, LGBT Latino youth are more likely to face harassment and violence 
in the community than their non-LGBT Latino peers. Results of an online survey of 
approximately 2,000 LGBT Hispanic youth suggest that they may experience differences 
in the process of coming out, parental and family support, and the extent to which they 
feel a sense of belonging in their community when compared to non-Hispanic White 
LGBT youth. Hispanics are among the most religiously observant populations in the 
country and while faith can be a protective factor, it can conflict with an LGBT identity.
Issues in the treatment of self-harm risk and its underlying conditions
Research investigating ways to reduce the risk of future self-harm behavior and 
co-occurring behaviors (e.g., HIV and STIs) should consider factors that help to maintain 
these conditions and that can be modified through treatment. The literature suggests that 
depression, emotion dysregulation, family conflict, and substance use can each create the 
conditions that increase risk for repeated acts of self-harm. For example, studies support 
the link between non-suicidal self-injury and emotion dysregulation such that 
engagement in NSSI results in negative affect reduction and emotion regulation. When 
adolescents report more than one of these conditions, they may be at particular risk for 
self-harm. Treatment of these conditions can substantially change the course of the 
syndemic and development long term.
Family based interventions have been among the most efficacious treatments 
across a wide variety of adolescent disorders including ADHD, Depression, and 
Disruptive Behaviors and have been recommended for use with the LGBT population. 
Family interventions are also the preferred mode of treatment for ethnic minority 
adolescents. The utilization of a treatment that works well for Hispanics is important 
given the evidence that Hispanics receive less treatment, poorer quality treatment, and 
treatment that is not culturally competent. Statistics show that Hispanics utilize mental 
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health services at half the rate of non-Hispanic Whites despite reporting more mentally 
unhealthy days.
Despite the efficacy of family-based interventions, there have also been major 
implementation challenges that require continued treatment innovation. One set of 
implementation challenges includes: sustainability of a multicomponent treatment that 
requires considerable staff time to deliver, difficulties related to scheduling and reaching 
underserved populations, and transportations. The logistics of frequent office visits may 
be one of the problems contributing to the underutilization of services by minority 
adolescents and families. The significance of the proposed Research Project is that it has 
the potential to deliver services effectively and efficiently—because some of the key 
interventions are packaged and delivered through a web-based platform that is easy to 
use, requiring fewer office based visits, and allowing families to access resources at times 
that are more convenient to families with multiple jobs. The technology can be made 
more attractive to adolescents, relevant to their concerns, and consistent with their 
lifestyles. Interventions with prominent technology components may keep adolescents 
continually engaged in therapeutic activities that would otherwise be confined to 
scheduled sessions.31,52 The benefits of technology are described further in the Innovation 
section below. 
A second set of challenges is the difficulty in creating a “one-size-fits-all” 
treatment. Adolescents and families display great diversity in terms of cultural 
background, life stressors, strengths and needs, and clinical symptoms.  In the proposed 
treatment, we aim to reduce the risk of repeated incidents of self-harm and suicide related 
behavior and we understand that to accomplish this goal, our treatment must have 
interventions that focus on those factors that we hypothesize to maintain the risk. In other 
words, our treatment must seek to decrease depression, emotion dysregulation, family 
conflict, and substance use.  In order to increase the ecological validity of the treatment 
sessions, the manualized intervention must also be designed to address the day to day 
stressors that emerge in the lives of Latina and LGBT youth and that contribute to 
depression, emotion dysregulation, family conflict and substance use. Content that 
includes discussion of marginalization, traumatic events, culture-related factors at the 
individual and family levels must all be clearly articulated in the treatment manual if it is 
to have a high degree of ecological validity.6 A major challenge for many manual-guided 
interventions is that they must adapt considerably to address these unique culture-related 
(e.g., facing stressors due to acculturation, immigration, discrimination due to race, 
ethnicity), unique life stressors (e.g., rejection due to being LGBTQ, exposure to trauma, 
discrimination and rejection), and clinical profiles (e.g., family risk factors, co-occurring 
psychiatric disorders). When manualized interventions do not clearly articulate the 
treatment adjustments needed to address these complexities, clinicians are required to 
make adjustments in an idiosyncratic fashion. These adjustments become challenges to 
fidelity and become more difficult to replicate. A second area of significance of the 
proposed work is that it will utilize a culturally informed intervention delivered in an 
adaptive framework that includes modular material that can be selected to address many 
of these commonly found stressors (e.g., emotion dysregulation, minority and 
acculturation stress) and the explicit decision rules that facilitate replication. In the 
Innovation section below, we describe the adaptive framework of the Culturally Informed 
and Flexible Family-Based Treatment for Adolescents (CIFFTA).   
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The proposed study: (a) enhances the content of the original Computer Assisted 
Culturally Informed and Flexible Family-Based Treatment for Adolescents (CA 
CIFFTA) to directly address the new key targets (e.g., depression, emotion dysregulation, 
LGBT and trauma-related stressors), (b) refines the technological aspects of CA CIFFTA 
for web-based delivery and use feedback and data from our first small trial, and (c) tests 
the preliminary efficacy of the new intervention and its delivery system in a randomized 
trial of 100 adolescents and their parents. We seek to reduce risk for repeated self-harm 
and risky sexual behavior by showing treatment effects on depression, emotion 
regulation, substance use, and family functioning.  With the large numbers of adolescents 
that go without services due to service utilization obstacles and stigma, technology-
related innovations that can enhance treatment effects and/or reduce barriers should be 
considered an urgent need.
5) Inclusion and Exclusion Criteria*
Inclusion Criteria: To be included in the study, the adolescent must: (a) be 11 to 
18 years old; (b) self-report an act of self-harm in the past 6 months, (c) meet cut-off 
criteria on two of the four maintaining factors (depression, emotion dysregulation, family 
conflict, substance use), and (d) live with at least one parent-figure who agrees to 
participate in assessments and treatment. Participants should be willing and able to 
participate fully in the protocol (e.g., to accept assignment to either condition, to provide 
sufficient locator information for follow-up, to allow their treatment sessions to be 
recorded for fidelity/process assessment and supervision). All family members in the 
household are invited to participate in treatment. Our success at engaging family 
members is evident in that an average of three family members per household 
participated in family intervention studies.
Exclusion Criteria: Exclusion criteria include: (a) history of DSM V 
Developmental Disorders, Elective Mutism, Organic Mental Disorders, Schizophrenia, 
Delusional Disorder, Psychotic Disorder, and Bipolar Affective Disorder. We will 
exclude youth who are actively in crisis and reporting current ideation with a specific 
plan and with means to complete the plan. If a youth is referred in this state, it will be a 
priority to utilize a warm-handoff procedure to connect them to a more intensive 
treatment program.
Eligibility Screening: Staff at the referral sites will be trained to identify 
youth appropriate, namely a self-harm event, for the study. When a youth/family 
is identified as potentially appropriate the referral site will ask the family to sign a 
release of information so that study personnel can contact them to schedule a 
formal screening. If the form is signed, the referral site will contact the designated 
study personnel (assessor) and provide the contact information for the family. The 
study personnel will contact the family and schedule an appointment to conduct 
the screening. When the family attends the appointment, the screening measures 
(Self-harm, family conflict, emotion dysregulation, depression and substance 
abuse) will be administered to determine eligibility. (see sections below) 
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6) Number of Subjects*
A total of 100 11-18 year-olds with a self-reported act of self-harm in the past 6 
months and their families will be involved in the proposed study. 
7) Study-Wide Recruitment Methods*
NA. This is not a multicenter study. Subjects will be recruited by methods under 
the control of the local site. See recruitment procedures in section 24) 
Recruitment Methods.
8) Study Timelines*
Both conditions will be tested as 16-week interventions. There will be an 
additional 8-week period of continuing care, then 6 months of no contact, 
followed by a final assessment. The final assessment will occur 12 months after 
baseline. The duration of an individual subject’s participation in the study will be 
1 year (including all follow-up assessments).  
16-week 
intervention
8-week period of 
continuing care
6-month period of 
no contact
Final assessment - 
12 months post 
baseline
The duration anticipated to enroll all study subjects is 35 months. Recruitment 
will begin in month 8 of the study and end in month 43. 
The estimated date for the investigators to complete this study (including primary 
analyses) is 60 months. 
9) Study Endpoints*
1. Primary
a.
Self-harm
2. Secondary:
a.
Depression
b. Family functioning
c.
Alcohol/substance use
d. Emotional dysregulation
e.
Risky sexual behaviors
There are no safety endpoints in this study.  
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10)
Procedures Involved*   
Procedures for Phase I:  During the first months, we will identify existing video taped 
segments from previous pilot work that can be utilized in this new study, videos that need 
to be created, and written text from the original scripts can be used as templates. 
Likewise, scripts that had been previously created for different themes will be modified 
for this new population and updated. Videos to be delivered on our website will be brief 
10-15 minute videos.  We will also focus on integrating Motivational Incentives and 
Motivational Interviewing components, and aftercare interventions into computer 
supported activities. The development and programming of all applications will take 
place in this phase. We will organize multiple events so that parents and adolescents can 
experiment with the use of the technology and give our team feedback on what works 
well and what can be improved. Feedback will focus on both content and technical 
aspects of the intervention. The assessment battery will be finalized and lead to the 
creation of the REDCap battery, which will be for entry of data directly during the 
interview and for measures of more sensitive issues (e.g., risky sexual behavior). The 
REDCap system has been utilized successfully in prior research. This phase will also 
include therapist and assessor selection and training. 
Therapist Training. Therapists should have at least a master’s degree in counseling, 
psychology, or a related field. The PI will train the assessor and the therapist who will be 
bilingual, fluent in English and Spanish, and must have experience working with 
adolescents and families. Should we need to recruit a therapist less experienced with 
family therapy, we will utilize the therapist training model we have used in large clinical 
trials and which consists of a 3-day training workshop that includes the use of didactic 
material, treatment manuals, and the presentation of videotaped sessions from our pilot 
work. 
Procedures for Phase II: The Randomized Clinical Trial  
One hundred adolescents (11-18 years of age) with a self-reported act of self-
harm in the past 6 months will be recruited into the study. Following screening, consent 
and baseline assessment, the adolescents and their families will be randomly assigned to 
either the (1) Technology assisted -CIFFTA or 2) Treatment As Usual.  The comparison 
condition was selected to test our intervention against a standard of care in the 
community which is usually delivered in the traditional face-to-face method with no 
technology. CIFFTA treatment services will be delivered at the Institute for Individual 
and Family Counseling (IIFC), which is a training clinic for graduate students in the 
School of Education and Human Development at the University of Miami or virtually via 
HIPAA compliant Zoom. The IIFC provides affordable counseling services to the local 
community and serving as a center for counseling research. Families randomized to TAU 
will be referred to services in the community which will be delivered in person or 
virtually via HIPAA compliant Zoom. Randomization will be stratified by gender, type of 
self-harm, trauma exposure and LGBT status.  During the treatment phase, the two 
conditions will be tested as 16 week interventions.  We will not try to match face to face 
intervention hours but we will try to match overall contact hours (in the experimental 
condition some of these hours will be with technology).  During the “continuing care” 
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phase the CIFFTA families will have the opportunity to interact with the therapist via the 
website for a period of 8 additional weeks and can access all website resources.  To 
match dosage time during aftercare, TAU will receive telephone calls in which the 
therapist asks how things are going and reiterates some of the main messages of 
treatment. The participation of adolescents and families in clinical services and final 
assessments will end around month 54 of the study. Months 55-60 will focus on data 
cleaning and logic checks, data base locks, and the analysis, interpretation and reporting 
of findings. Assessments will be conducted at baseline, 16 weeks post baseline/treatment 
termination, and at T3: 6 months post completion of continuing care. Assessments will be 
collected in person or virtually via HIPAA compliant Zoom. Data from self-reported 
satisfaction with the intervention, youth outcomes, and service utilization outside of the 
program will be collected throughout the course of therapy. 
Participant Recruitment Plan. The research team has considerable experience in running 
trials with this population. Nicklaus Children’s Hospital Inpatient Psychiatry Department 
will provide referrals to the UM CIFFTA project. They have extensive experience 
treating the population, which is the focus of this project. This collaboration will allow 
the teams to work hand in hand through the referral and assessment process. Nicklaus 
Children’s Hospital will not be releasing any information to the UM CIFFTA program. 
Banyan Health Systems Mobile Crisis Unit (See letter of support) has been operating a 
24-hour mobile crisis response team (MCT) for the past decade. The MCT responds to an 
average of 80 calls per month where approximately 20% are for teens and the vast 
majority is Hispanic. The unit functions as an outreach service, which provides 
evaluation and crisis intervention. Following an in-depth evaluation in which current 
mental health and/or substance abuse issues are assessed, the MCT assists in determining 
which community services are most appropriate based on need, location and family 
preference. Additional referral sources are needed, long-time UM partners such as the 
Mailman Center Adolescent Clinic at University of Miami Medical Campus, 
ConnectFamilias, the YES Institute, Regis House, Larkin Hospital, the Institute for 
Individual and Family Counseling within our School of Education and Human 
Development, and the Miami-Dade County Public School System which has special 
programs for LGBT youth will be utilized. 
Screening and Assessment Procedures. Interested participants will have the study 
explained to them by UM study personal and will be asked to sign an informed 
consent/assent and begin the screening of inclusion/exclusion criteria. Paper consent 
forms will be used for face-to-face interactions. Youth and families participating via 
HIPAA compliant Zoom will read and review the consent and assent forms virtually 
through the Zoom screen share option. The consent and assent forms will be sent via 
email to the family before the online meeting so that the family also has the consent and 
assent forms readily available. Consent and assent forms will be signed via DocuSign.  
Screening and assessments will take place either in person or virtually via HIPAA 
compliant Zoom. Participants that do not meet criteria for the study will receive a referral 
using warm handoff procedures. Participants that meet inclusion criteria will sign 
informed consent/assent for the RCT, complete the baseline assessment will be 
randomized upon completion of baseline and will be given the name of the therapist who 
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will be contacting them within 48 hours. These activities are conducted by study 
personnel (UM researchers) at the UM site, the IIFC or virtually via HIPAA compliant 
Zoom. If a participant is randomized to the control condition, a warm hand-off process 
will be used to connect the family to an agency staff member for the treatment. If a 
referral is identified by the Nicklaus Children’s Hospital Inpatient Psychiatry Department 
staff, they will contact the youth’s caregivers directly to explain the study. If the family is 
interested in participating in the study, the Nicklaus staff will obtain a release of 
information so that the UM staff can contact the youth and caregiver to sign consent, 
screen and assess the family. If the family is not randomized to the CIFFTA program, the 
UM staff and the Nicklaus staff will work together to place the youth in an outpatient 
program in the community. Nicklaus Children’s Hospital will not be releasing any 
information to the UM CIFFTA program.  All participants will be assessed again 16 
weeks post baseline/treatment termination, and at T3: 6 months post completion of 
continuing care (12 months after baseline). Bachelor’s/Master’s level research assistants 
who are bilingual in English and Spanish will be available to administer all assessments. 
Each assessment interview lasts approximately 2 hours and consists of two parts, an 
interview (adolescents and parents separately) and responding to questions on the 
REDCap.  The assessor interviews parents while the adolescent completes the REDCap 
battery and then they switch. The Measures appendix provides an overview of the 
measures, the time-points and the target of data collection. To increase participation 
families will be paid $75 for T2 and$100 for T3 completed assessments. They will 
receive the money either in person or cash deposits via Zelle. The fees may be slightly 
higher than studies that work with only one participant.  The fee is meant to compensate 
2-3 participants (typically adolescent and two caregivers) for 2 hours of assessment time. 
Interview data are entered directly into the REDCap system.  In addition to the baseline 
assessment that all families receive at the start of the study, families will be asked to 
participate in an additional semi-structured interview right after the baseline (1 hour 
semi-structured interview for the child and 1 hour for the parent/caregiver). This 
interview is voluntary and asks additional qualitative questions about family functioning 
and self-harm to gather  details on these concepts (these types of questions are asked in 
the baseline and follow-up assessments). To compensate for each family’s time 
participating in these interviews, each youth will be offered a $15 gift card to either 
Target or Amazon and each parent/caregiver will also be offered a $15 gift card to either 
Target or Amazon.
Therapist Supervision and Adherence Monitoring. Weekly clinical 
supervision/consultation meetings will be held for the CA-CIFFTA, led by Dr. Mena. 
Recorded therapy sessions will be reviewed and good manual implementation will be 
emphasized. In the CA-CIFFTA condition, reports generated weekly showing usage (in 
minutes) of the web-based components will be reviewed. An independent adherence rater 
trained to rate therapy sessions will randomly select 20% of the CA CIFFTA sessions at 
different phases (early, mid, and late) of treatment. Ratings that fall below adequacy on 
any dimension/component will trigger increased supervision focus for that dimension and 
if necessary, re-training. The condition supervisor will be the gold-standard for inter-rater 
reliability on adherence ratings and raters will be trained to achieve an intra-class 
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correlation coefficient of .70 or higher, and at least 80% agreement across items. Inter-
rater reliability will be checked regularly to avoid drift.
Prevention of Dropouts from the study. To ensure sample retention procedures include: 1) 
conducting assessments at convenient locations when necessary(e.g., homes), 2) paying 
families for their participation in assessments, 3) conducting service utilization phone 
interviews between the T2 and T3 assessments and updating all contact information at 
regular intervals, 5) obtaining the names of three contact persons who may be contacted 
by the Assessment Specialist when the family is unreachable (included in the consent 
form), and 6) sending out birthday and holiday cards to all participants. In our 
experience, the utilization of such procedures for tracking and contacting participants 
dramatically increase retention rates in the study. In our previous large NIDA randomized 
trial with high–risk Hispanic youth with Substance Abuse Disorder, we were successful 
at obtaining approximately 75% of the caregiver and 70% of the adolescent scheduled 
assessments 16 months after baseline.
Control/Comparison Condition: Treatment As Usual 
Once a participant is engaged, assessed, and randomized to TAU, the crisis team will 
refer to their usual treatment agencies in the community and complete the warm handoff 
of the participant and share the assessment data we have collected. We will coordinate 
carefully with the TAU agencies so that we can minimize the overlap of data collected. 
Banyan will often provide the service needed by the TAU participants but will refer out 
to other services when those agencies and their locations are more convenient. Our long-
standing collaboration with Banyan will facilitate the coordination of assessment 
measures and ensure a successful warm-handoff of clients. Services will be delivered in 
person or remotely via Telehealth. Considerations in selecting the comparison condition. 
A great deal of thought has gone into the selection of the Treatment as Usual condition.  
We wanted to compare CA CIFFTA’s ability to retain and bring about change in 
participants compared to what is typically done in the community. Although running an 
in-house comparison condition gives us more control of the delivery of services and 
tracking of clients, it would be difficult to know how that compared to the services that 
are typically provided in the community. Service utilization interviews will allow us to 
track the precise services that are received in the TAU condition.   
Treatment Condition: Computer Assisted Culturally Informed and Flexible Family-Based 
Treatment for Adolescents (CA CIFFTA).CA CIFFTA will consist of a hybrid 
intervention utilizing some Office Based CIFFTA sessions and some technology-
delivered material (e.g., psycho-educational modules and the collect of information on 
risk patterns and situations). CIFFTA will be delivered in person or virtually via HIPAA 
compliant Zoom. During the treatment phase CIFFTA participants will be offered 1. 5 
hours of contact per week that includes 45 minutes of face-to-face time per week plus 
approximately 45 minutes of intervention time delivered via the web over 16 weeks. 
During the 8 week continuing care phase participants will continue to access the website 
and its resources and will receive targeted messages focused on how to handle the 
conditions found in T2 that might be expected to fuel relapse (family or interpersonal 
conflicts and continuing depression). CA CIFFTA will: 1) deliver psycho-educational 
modules (e.g., depression, risky sexual behavior information, emotion regulation and 
distress tolerance, handling marginalization, coping strategies for traumatic experiences) 
via multimedia formats that include text, audio, video and graphics,2) facilitate contact 
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with the counselor via computer-based messaging, 3) collect diary-card type information 
(e.g., affective struggles, high risk environmental cues) to be used in treatment, 4) 
document usage of all website components, and 5) facilitate continuing care (post-
treatment) checkups to prevent relapse. Many of the videos originally created for the 
original CA-CIFFTA (e.g., psycho-educational material on adolescent depression, 
substance use risk, risky sexual behavior, and others offered in both English and Spanish) 
will be updated/enhanced. As in the pilot, parents and adolescents will watch videos and 
click the symptoms of concern to them. This information will be automatically 
transmitted to therapists and used in the next session.  
The modules proposed are presented in the table below 
CA CIFFTA will facilitate the tailoring of the intervention making the intervention 
strategies and the timing of health messages unique to individual high risk youth. The 
initial assessment identifies the high risk areas reported by adolescents and parents (e.g., 
emotion dysregulation, low distress tolerance, depression, substance use, family conflict, 
acculturation-related conflicts) and these data are used to create a “tailoring profile”. 
When an adolescent is high on any of the indicators shown above, the treatment is 
tailored to include the corresponding modules on emotion regulation, distress tolerance, 
working through acculturation-related conflicts, and substance abuse and risky sexual 
behavior information for both parents and youth. Participants can access content on the 
website specifically selected for them. Mobile assessments may be able to identify the 
high-risk times of the day, places, interpersonal (e.g., conflicts with family or peers) and 
intrapersonal (e.g., feeling bad due to boredom, frustration) processes that constitute risk 
for that individual. This method is similar to diary card methodology developed by the 
Linehan/DBT research group to identify high risk situations, emotions, people and times. 
During the continuing care period, messages that have been found helpful to the 
adolescent and related to their risk process will be delivered periodically. The Center for 
Research and Education on Aging and Technology Enhancement team has experience 
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delivering interventions through a variety of telephone technologies (e.g., screen and 
video phones)26,27 and they have partnered with the PI in the pilot work that is the 
precursor to this more advanced effort.   
The technology system will collect usage data that will be securely housed on the 
project servers. Data will be collected without requiring that the participant actively send 
them. Interaction and usage information is automatically delivered to the counselor’s 
cellular phones via an existing secure server housed at the University Data Center. Data 
collected in real-time do not contain names or identifying information, only case 
numbers.  In addition, the system will require a password to see messages sent to the 
participant. Physical access to servers at the Data Center are controlled by security 
systems, intruder alarms, and monitored by the Department of Security video 
surveillance/recording systems. The Data Center provides appropriate environmental 
control via HVAC systems, uninterruptible Power Supply and emergency generators to 
maintain power without interruption, and FM200 and Inergen fire suppression systems to 
extinguish fires without damaging equipment or backup tape systems. The Data Center 
also provides secure backup for all data systems. Real-time information sent to 
counselors was successful in guiding the counselors’ work in our preliminary study.  For 
development purposes, we will set-up a desktop development environment with Android 
SDK and an alternate development environment for development in iOS. We will also 
subscribe to Apple’s iOS developer program.
Adaptations for youth who report being LGBTQ and/or exposed to trauma, and families. 
CIFFTA’s design lends itself to adaption to diverse populations. Its logic and emphasis 
on tailoring facilitates the treatment’s extension to new populations with unique stressors. 
During the development phase of this study (first 7 months) we will build on existing 
modules.  Some of the expected adaptations will focus on modules for kids on how they 
can cope with stressors related to LGBT-related rejection and alienation, emotion 
regulation and distress tolerance for ameliorating self-harm behaviors, using evidence-
based coping strategies for risk factors result from exposure to traumatic events (see 
Seeking Safety strategies). A module for parents who are having a hard time accepting 
their son’s/daughters being a gender/sexual minority youth will help them to understand 
the normative stages some parents must go through, allow parents to express their 
concerns, distress, and fears, so that they are more ready to have a productive family 
therapy session with their sons and daughters. A parallel module may be offered to youth 
to increase their readiness to have a family session in which a loving and caring 
relationship can be created. 
Measures: Measures have been selected for: 1) Screening; 2) Ultimate Adolescent 
Outcomes, e.g., Self-harm; 3) Immediate Outcomes, e.g., depression, emotion regulation, 
family conflict, and substance use; 4) Cultural Factors; and 5) Additional Measures, e.g., 
trauma, minority stress. Measures will be administered at Screening, Baseline (T1) 4 
months after baseline (Termination or T2), and 12 months after baseline (T3). Spanish 
versions of the measures are available. Every effort has been made to reduce participant 
burden. The total battery is expected to take 90 minutes to administer to youth and 40 
minutes to parents. These will be administered in person or via HIPAA compliant Zoom. 
Measures are attached.
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11)
Data and Specimen Banking*
NA. 
12)
Data Management*
Data will be collected using the REDCap web-based system. The REDCap 
data will be collected on secured laptops and the data will be stored on the 
University of Miami secure data network. REDCap is a web-based data 
management system that is backed-up and supported on site at the 
University of Miami. REDCap acts as a central database for facilitating 
processes related to study and patient management, including 
scheduling/calendaring, data collection via electronic CRF, data and safety 
monitoring, study reporting, and milestone tracking.  Access to the system 
is limited to authorized users. Each user has his/her own individual 
username and password managed by the University single sign-on system. 
Only authorized members of a study team have the ability to identify a 
patient associated with their study. Key personnel and their roles on IRB 
approved protocols are used by the UM REDCap support team when 
establishing access rights. Changes to study or patient information require 
a user e-signature for validation as an extra precaution. 
Patients associated with this study will have their ongoing study-related 
status tracked using this system. All study measures will be programmed 
electronically in REDCap and will be used to collect the data. The 
assessor will interview the parent using the REDCap system where 
responses to questionnaires will be entered directly into the web-based 
system. At the same time, the adolescent will also be completing 
questionnaires on the REDCap system. Upon entry into the study, 
participants will be assigned a study ID and will only be identified with 
the study’s ID code for the participant on all measures. The codes that link 
the name of the participant and the study ID will be kept confidential in a 
secured cabinet. All documents collected which contain the names of 
participants will be kept confidential in a locked cabinet, in a locked room 
at the UM School of Education and Human Development. The study 
statistician will analyze the data. 
Procedures for the proposed study will follow quality assurance (QA) 
procedures established by CLaRO for data management and safety, to 
ensure quality and consistency in the implementation of the protocol and 
data quality, to adhere to regulatory requirements and, most importantly, 
to protect the safety of study participants. All CLaRO studies will have a 
QA review prior to initiation which must be passed before commencing 
study enrollment, upon conducting baseline procedures with the first five 
study participants, and then every 4 months for interim reviews. For the 
initiation review the Study Monitoring team reviews protocol procedures 
and their manualization, documentation of staff training, evaluates that the 
study site is prepared to conduct the study, and ensures that the Regulatory 
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Binder is complete. Interim monitoring visits verify that study screening, 
consent, and data storage procedures are being conducted as stated in 
protocol, review 100% of informed consent and assent forms, and review 
a random selection of 10% of case files (all of the first five cases are 
reviewed in the first interim QA visit) on the following parameters: 
eligibility criteria and documentation, randomization documentation, lab 
records, data reports, study milestones, progress notes, intervention 
documentation, participant remuneration receipts, and verifying that time 
points are completed according to protocol. After each QA visit the Study 
Monitoring team prepares a written report that is sent to the study PI and 
to the corresponding CLaRO PI. These reports include deficiencies noted 
and plans for corrective action. The Study Monitoring team follows up 
with the study team to ensure that the corrective plan and any required 
reports to the IRB are filed in a timely manner.  Protocol violations that 
are recurrent or serious will be brought to the attention of the CLaRO 
Executive Committee for determinations regarding corrective action.
13)
Provisions to Monitor the Data to Ensure the Safety of Subjects 
DATA SAFETY MONITORING BOARD AND PLAN
Composition of DSMB
This proposed study will have a Data Safety Monitoring Board (DSMB) consisting of 
three individuals: Dr. Guillermo Prado, Dr. Brian McCabe, and Dr. Soyeon Ahn. The 
Chair of the Committee will be elected during the first meeting.  
Guillermo Prado, Ph.D.  is Dean of the Graduate School, Leonard M. Miller Professor of 
Public Health Sciences, Director of the Division of Prevention Science and Community 
Health at the University of Miami. He has a doctoral in epidemiology and a master’s in 
statistics. His research broadly focuses on the development and evaluation of parenting 
interventions for Hispanic youth and their families. Dr. Prado’s research has been funded 
by over $15 million dollars of continuous NIH funding as PI since the first year of his 
doctoral program and by over an additional $80 million as Co-I or mentor. As Dean of 
the University of Miami’s Graduate School, Dr. Prado has developed programming 
around responsible conduct for research, professional development, and grantsmanship 
for all graduate students at the University of Miami.  Dr. Prado has also had key roles in 
training components on NIH funded centers of excellence. He was the co-chair of 
NIDA’s Center for Prevention Implementation Methodology as well as Director of 
Training for an NCI funded U54. Dr. Prado is currently the Director of the Investigator 
Development Core of the NIMHD funded Center for Latino Health Research 
Opportunities.  Finally, Dr. Prado is President-Elect of the Society for Prevention 
Research and a Board Member of Research!America, the country’s largest not-for-profit 
public education and advocacy alliance committed to making research to improve 
health a higher national priority.
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Brian McCabe, Ph.D. is an Assistant Professor in the Department of Special Education, 
Rehabilitation, and Counseling at Auburn University. He earned his PhD in Counseling 
Psychology at the University of Miami. Dr. McCabe researches prevention and 
intervention strategies using an eco-developmental approach. This work examines the 
interactions between risk and protective processes, specifically connections between 
mental health, substance use, sexual behavior, and social relationships for people in 
varied life stages. Recent projects have been with Hispanic/Latinx immigrants and 
college students.
Soyeon Ahn, Ph.D. is a Professor at the University of Miami School of Education and 
Human Development. Currently, Dr. Ahn is the director of the Statistical Supporting Unit 
at the School of Education and Human Development Dunspaugh-Dalton Community and 
Educational Well-Being (CEW) Research Center and is the Associate Dean for Research. 
Dr. Ahn’s research focuses on the application of the existing data analytic techniques in 
resolving the complicated data issues in meta-analysis (research synthesis). She has 
published numerous methods papers and several peer-reviewed articles on the application 
of meta-analytic methods in educational and behavioral science have appeared in 
substantive journals such as Scientific Studies of Reading, Journal of Pediatric 
Psychology, Journal of Counseling Psychology, and Research Quarterly for Exercise and 
Sport (RQES). She has served as an ad-hoc reviewer for journals including JEBS, RER, 
BRM, Research Synthesis Methods, Psychological Reviewer, Educational Reviewer, and 
RQES. Dr. Ahn is a member of: (1) Society for Research Synthesis Methodology 
(Elected in 2013), (2) Campbell Collaboration (C2) Methodology Group, and (3) 
American Educational Research Association (Division D: Measurement and Research 
Methodology). She has served on the grant review panels for several programs in the 
National Science Foundation since 2011. Dr. Ahn has been involved in doctoral research 
methodology training and statistical support for educational and behavioral science 
research occurring within and outside the University. She also teaches several higher-
level statistical courses. 
Charge of the Board DSMB
The purpose of the DSMB will be to provide oversight on the human subject issues 
described in the protocol, including review (overall and by condition) of the number and 
type of adverse and serious adverse events. The trial is focusing exclusively on two high 
risk groups, Hispanic females and Hispanic LGBT youth with a history of self-harm. 
Adverse events that will be monitored include, but are not limited to psychiatric 
hospitalizations, suicidal attempts, arrests and child abuse, including sexual abuse. The 
DSMB will be blinded to condition but will review the number of adverse and serious 
adverse events by condition in group format.  If it becomes apparent that there may be an 
imbalance by condition, the DSMB will offer its recommendation to the PI regarding the 
conduct of the trial. Any action that results in the temporary or permanent suspension of 
the trial will be undertaken with consultation with the study’s NIMHD project officer and 
University of Miami’s IRB. The DSMB will provide a copy of the meeting’s minutes to 
the PI. 
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The University of Miami IRB will provide general study oversight for all grant activities. 
The Principal Investigator will report DSMB activity to NIMHD as part of the Annual 
Progress Report. 
Statement of No Conflicts of Interest
None of the DSMB members have any conflicts of interest to report, other than they are 
faculty at the University of Miami. 
Frequency of Meetings
Drs. Prado, McCabe, and Ahn will convene as a DSMB three times a year (i.e., every 
four months).  
PI Acknowledgment of Requirement to Report DSMB Activity 
Daniel Santisteban, Ph.D, the Principal Investigator, understands that he is required to 
report DSMB activity in the Annual Progress Report to NIMHD.  
The DSM and DSMB reports will include the participants’ sociodemographic 
characteristics, treatment retention rates, any quality assurance or regulatory issues that 
occurred during the previous year, a summary of AEs and SAEs (Adverse Events and 
Serious Adverse Events), and any actions or changes with respect to the protocol. The 
DSM report to NIMHD will also include, when available, the results of any efficacy data 
analyses conducted. The PI will also: 1) determine if an AE or SAE was study related and 
to what degree, 2) determine whether an AE or SAE that are study related are listed in the 
Informed Consent Form or should be listed, 3) ensure that when the AE or SAE was 
discovered, if it was related and/or possibly related to the study procedures that there was 
timely and complete reporting to IRB. 
AEs and SAEs are sometimes more difficult to identify in behavioral research with 
adolescents. Based on our experience working with high-risk youth, we have identified 
common AEs and SAEs that occur in this population, that will be used in training staff to 
identify AEs and SAEs, and that will be reported during protocol implementation.
Adverse Events
Serious Adverse Events
1. Arrest
6. Physical/Sexual Abuse 
2. Runaway                                              
7. Suicidal Behavior
3. Kicked out of Home
8. Homicidal Behavior
4. School Suspension/Expulsion
9. Hospitalization (psychiatric, drug 
related)
5. Violence (Victim/Exposure)
10. Death
                                                                       11. Other (indicate if serious)
Adverse events for this study may be identified during regularly scheduled intervals or 
may be reported at any other times during the study.  For adolescents and their 
parent/caregivers that are participating in assessments, the ten adverse events listed above 
will be queried specifically at T2 and T3 time points. An “other” category has been 
included to capture unexpected adverse events reported by participants, which do not fall 
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within the scope of any of the ten defined AEs/SAEs for this study. All assessments 
conducted by the study assessor are opportunities for identifying adverse events if 
reported by the participant and/or a family member. The assessor will be trained to 
identify AEs and SAEs at each of the time points. Additionally, anytime during the study, 
a participant or his/her family member may report an AE/SAE to their therapist. These 
events will be identified, classified as serious or not, and will be handled in the same 
manner as AEs/SAEs during the formal assessments. 
Therapists will be trained to identify adverse events, and categorize serious adverse 
events, based on direct reporting during sessions. Upon identification of an adverse event, 
the assessor or therapist should categorize the event for seriousness to guarantee that 
appropriate care and reporting occur within approximately 24 hours. As soon as an 
adverse event is identified either by querying or direct report, the event will be recorded 
in the AE log. In addition, the PI and Clinical Supervisor at the site will be notified of any 
and all AEs. In both treatment conditions, action may be taken by the therapist to respond 
to non-serious events (e.g., booster sessions, or increase in the frequency of sessions). If a 
therapist is the one to identify the event, after notifying the PI and Clinical Supervisor, 
they are to notify and inform the assessor, who is then responsible for conducting further 
evaluations and completion of the AE log.  All non-serious adverse events require no 
further reporting. Adverse events will be reviewed by the Principal Investigator (PI) 
weekly to evaluate relatedness to the intervention and whether resolution occurred. 
Ser“serious and non-serious events that are 
SAE’s include 1) Physical/Sexual Abuse 2), Suicidal Behavior, 3) Homicidal Behavior, 
4) Hospitalization (psychiatric or drug related), and 5) Death. All of these problems may 
involve imminent danger to self or other. In cases of current suicidal, homicidal, and 
abusive behaviors, participants in both conditions will be immediately referred to the 
clinical supervisor to ensure that appropriate crisis intervention services are provided. 
Serious adverse events listed in this study will also be reported for any family participant. 
The reporting procedures for SAEs experienced by any participant in the study will be in 
accordance with the University of Miami IRB reporting policy and determining whether 
they are unexpected and probably related or expected and non-related will guide 
reporting. When an SAE occurs, the Clinical Supervisor and the PI must be notified when 
possible within 2 hours of identification. The Clinical Supervisor will be responsible for 
ensuring appropriate and timely care of participants. The PI will be responsible for 
assessing relatedness to the intervention and forwarding the report to the UM IRB and 
study sponsor. In the event that a participant either withdraws from the study or the PI 
decides to discontinue a participant due to an SAE, the participant will be monitored by 
the PI via ongoing status assessment until 1) a resolution is reached or 2) the SAE is 
determined to be clearly unrelated to the study intervention. Outcomes of the SAE will be 
reported to the sponsor on a quarterly basis. A summary of the SAEs that occurred during 
the previous year will be included in the annual progress report to the sponsor. 
 
Study assessors will contact participants in the TAU condition one time per month via 
telephone to monitor AEs and SAEs that may have occurred as well as to offer referrals 
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to the youth/family if needed. The procedures to be followed by the assessor are detailed 
below.  
Telephone contact:
The assessor will contact the parent figure and the adolescent and will speak to each one 
separately.
Questions to Ask Parent

How has ____ been doing in the last month?

Has there been a change in the problems that brought _____ to our program?

Questions should be specific to intake assessment e.g. ADHD, Depression, 
Anxiety, Violent or Aggressive Behavior, Drug use, Suicidal thinking, gestures or 
attempts, etc.

If there has been a deterioration in functioning in core area (school, peers, severe 
family conflict) ask for specific behaviors or incidents that occurred in the last 4 
weeks. (Check for occurrence of AEs and SAEs)

Has the youth been attending therapy?

Has the youth been admitted to a crisis or inpatient treatment program?
Questions to ask Adolescent

How have you been doing in the last month?

You were having some problems with (ADHD, Depression, Anxiety, Violent or 
Aggressive Behavior, Drug Use, Suicidal thinking, gestures or attempts, Self 
harm without suicidal intent, etc.) when you first came in, how are you doing 
today?

Have things become worse or better for you?

If there has been a deterioration in functioning in a core area (school, peers, 
severe family conflict) ask for specific behaviors or incidents that occurred in the 
last month. (Check for occurrence of AEs and SAEs)

Have you been attending therapy?

Have you been admitted to a crisis or inpatient treatment program?
Criteria for Referral (**if not currently attending therapy**)

Suicidal thinking, gestures or attempts

Self-Harm without Suicidal Intent

Violent or Aggressive Behavior

Moderate to Severe Depression

Moderate to Severe Anxiety

Significant Deterioration in School Functioning (may be related to ADHD or 
other problems)

Significant Increase in Drug Use

Significant Deterioration in Family Functioning
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Community Referral Sources

Banyan Health Systems

Regis House
14)
Withdrawal of Subjects*
Participants will be told that this study is completely voluntary and that they have 
the right not to participate in any intervention procedure. They can also 
completely withdraw from the study at any time without any negative 
consequences.
Participants will be told that their participation in the study may be stopped at any 
time by the investigator of the sponsor without their permission. Possible reasons 
for removal may include: 1) adolescent is at particular risk for self-harm and more 
intensive services are needed or 2) adolescent is not attending treatment sessions 
and may be at risks for self-harm and/or other risky behaviors. 
15)
Risks to Subjects*
No side effects have been noted in the current literature in association with the 
behavioral questionnaires, interviews, or assessments used in this study, although, 
as with many assessment batteries, some people may experience mild fatigue or 
momentary concern about their ability to do well. There is some risk in this type 
of study because of the higher than average incidence of high risk behaviors, such 
as self-harm that may require that we report some information to outside agencies. 
All of the steps that may be taken to protect the well-being of family members 
deemed to be in danger will be described fully to all participants and we will do 
everything possible to minimize harm to the youth, family or any of its members. 
The Principal Investigator has conducted six treatment development randomized 
trials with high risk adolescent populations, including one with adolescents 
meeting DSM IV criteria for Borderline Personality Disorder, and is highly 
experienced in working with youth and ensuring their protection from any undue 
risks.
16)
Potential Benefits to Subjects*
There may be direct benefits to participating in this study. The most important 
benefit from participation in this study will accrue to adolescents who decrease 
their self-harm behaviors and risky sexual behaviors and improve their 
psychosocial functioning and family functioning. Families will also receive a total 
of $175 if they complete all assessments. 
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17)
Vulnerable Populations*
Children ages 11-18 will participate in this research study, which meets the 
additional regulatory requirements described in the HHS regulations, Subpart D. 
The study protocol, assessments, and consent/assent forms will be submitted to 
the UM IRB for review and approval. All children (11-17) who agree to 
participate in the study will sign IRB approved study assent forms. Youth who are 
18 years old will sign study participant consent forms. Parent/caregivers will be 
required to give permission for their child to participate in the study. 
The purpose of the research is to build on the Computer Assisted CIFFTA 
intervention by creating a web-site and web-based delivery system and by adding 
content that is relevant for the factors that maintain self-harm in Latina 
adolescents (e.g., depression, family conflict, substance use, and emotion 
dysregulation) and for unique stressors often linked to sexual/gender minority 
youth. Selecting youth in middle school and high school (11-18) is justified given 
the nature of the study and specific research questions to be addressed. CIFFTA 
was designed and developed for youth in this age range and their families. 
The Principal Investigator has conducted six NIH funded trials focused on 
developing and testing a treatment intervention for high-risk minority youth and 
their families and has expertise in working with youth. The Project 
Coordinator/Clinical Supervisor has been Co-principal Investigator and 
Investigator on these studies and possesses much experience in working with 
youth and their families.  The entire sample will be comprised of youth and their 
families therefore there will be sufficient youth for meaningful analyses and 
results to be derived from the study. 
18)
Multi-Site Research*
NA. This is not a multi-site research study.  
19)
Community-Based Participatory Research*
NA. This study is not considered community-based participatory research. 
20)
Sharing of Results with Subjects*
NA. Participants’ improved and symptoms will be discussed as part of the clinical 
process; however, we will not be sharing individual-level scores (e.g., test results, 
scores). Overall study results will only be shared with participants who express an 
interest. 
21)
Setting
Study personnel will identify and recruit participants from the main recruitment 
sites, Banyan Health Systems Mobile Crisis Unit, Mailman Center Adolescent 
Clinic at the University of Miami Medical Campus, ConnectFamilias, the YES 
Institute, Regis House, Larkin Hospital, the Institute for Individual and Family 
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Counseling within our School of Education and Human Development, and the 
Miami-Dade County Public School System which has special programs for LGBT 
youth will be utilized. 
For the CIFFTA condition, treatment and assessment will take place at the 
Institute for Individual and Family Counseling or virtually via HIPAA compliant 
Zoom. For the TAU condition, all study assessment procedures will take place at 
the IIFC or virtually via HIPAA compliant Zoom and individuals in this condition 
will receive treatment from treatment agencies in the community either in person 
or virtually via Telehealth. 
22)
Resources Available
Research Team Qualifications

Dr. Daniel Santisteban
Daniel A. Santisteban, Ph.D., the Program Director is the developer of the 
CIFFTA intervention that is on the NREPP list of evidence based practices 
and that is listed on the Children’s Trust RFP. He has supervised 
adolescents and family-based prevention and treatment services in Miami-
Dade County for over 25 years. Dr. Santisteban has extensive experience 
in ensuring high quality training, tailoring of interventions to 
adolescent/family needs, cultural competence, and creating tools to 
achieve high levels of fidelity to the evidence based practice. 

Dr. Maite Mena 
Maite P. Mena, Psy.D. has been a leader in the development and testing of 
the CIFFTA treatment for over a dozen years and has contributed to all 
aspects of the CIFFTA program. Dr. Mena has extensive experience in 
establishing good working relationships with referral sources and other 
community partners. She has been a key player in the development of 
teams and procedures that ensure high quality implementation of CIFFTA 
services. Dr. Mena will co-supervise all study therapist during the CA 
CIFFTA delivery. 

Dr. Karina Gattamorta
Karina Gattamorta, Ph.D. is a Research Associate Professor at the School 
of Nursing and Health Studies at the University of Miami. In 2013, she 
was awarded a Diversity Supplement under the supervision of Dr. Daniel 
Santisteban that allowed her to pursue interests in health disparities 
research focusing on Hispanic adolescents. She has conducted preliminary 
research examining the role of families and the coming out experiences of 
Hispanic sexual minorities. Her research aims to understand and 
ultimately help reduce health disparities in mental health, substance abuse, 
and HIV risk among sexual minorities. 

Therapist(s)
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Therapist(s) will be Masters-level counselors that have experience with 
adolescents and families and that have expertise in working with diverse 
families. The therapist will be a Spanish speaker able to provide the 
intervention in Spanish. The therapist will be trained in CIFFTA and will 
be capable of providing all interventions within a tailored framework. The 
therapist(s) will be supervised by Dr. Muir. 
Other Resources: 

Banyan Health Systems Mobile Crisis Unit
Banyan has been operating a 24-hour mobile crisis response team (MCT) for the 
past decade. The MCT responds to an average of 80 calls per month where 
approximately 20% are for teens and the vast majority is Hispanic. The 
unit functions as an outreach service which provides evaluation and crisis 
intervention. Following an in-depth evaluation in which current mental health 
and/or substance abuse issues are assessed, the MCT assists in determining which 
community services are most appropriate based on need, location and family 
preference. If additional referrals are needed, long-time UM partners such as the 
Mailman Center Adolescent Clinic at University of Miami Medical Campus, 
ConnectFamilias, the YES Institute, Regis House, the Institute for Individual and 
Family Counseling within our School of Education and Human Development, and 
the Miami-Dade County Public School System which has special programs for 
LGBT youth will be utilized. 

Nicklaus Children’s Hospital Inpatient Psychiatry Department-Dr. Janet 
Rosen.
23)
Prior Approvals
This study was approved by the IRB on 09/01/2017 for an NIH “Just in 
Time” request.  
24)
Recruitment Methods
The research team has considerable experience in running trials with high risk-
youth who are Hispanic. The main recruitment sites will be Nicklaus Children’s 
Hospital and Banyan Health Systems Mobile Crisis Unit. If additional referrals 
are needed, community agencies with a long-time research partnership with the 
applicant such as, the Mailman Center Adolescent Clinic at University of Miami 
Medical Campus, ConnectFamilias, the YES Institute, Regis House, the Institute 
for Individual and Family Counseling within our School of Education and Human 
Development, and the Miami-Dade County Public School System which has 
special programs for LGBT youth will be utilized. 
Staff at the referral sites will be trained to identify youth appropriate with this 
study and in line with the inclusion criteria stated above. They will explain the 
study to any adolescent and family interested in hearing about it. Staff will then 
ask families that are interested to sign a release of information to be contacted by 
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Study #: 20170791        Effective Date: 2/3/2022

the research study assessor or the family and Crisis Unit staff may contract our 
staff together. The assessor will be Bachelor’s/Master’s level research assistant 
who is bilingual in English and Spanish and will administer all informed consents, 
assents, and assessments. The assessor will contact the family’s that gave 
permission and explain the study in more detail to them. If the family is interested 
in participating an appointment for the adolescent and family to come in and hear 
more about the study will be set up. If they continue to be interested, they will 
sign an informed consent and assent, in their preferred language that allows the 
screening of inclusion/exclusion criteria to be made. After the screening has been 
conducted, the families that do not meet inclusion/exclusion criteria for the study 
will receive a referral to an appropriate treatment program via warm-handoff 
procedure. 
Materials used for the recruitment of participants (e.g., flyer) have been uploaded 
for review. 
25)
Local Number of Subjects
A total of 100 youth will be accrued locally. The participants’ families will also 
be included in the study.
26)
Confidentiality
The issues surrounding confidentiality are of supreme importance and sensitivity 
because highly personal clinical information will be obtained from the adolescent 
and their family members. Participants will sign a statement attesting to their 
understanding that the information they provide will be held as personal and 
confidential to the extent permitted by law. Consent and assent forms (described 
above) will clearly state the right to refuse participation at any time. Further, the 
refusal to participate will not influence any of the services the adolescent or 
his/her family may receive. In addition to the confidentiality assurances, the 
participants in the study are protected by a Certificate of Confidentiality under 
section 301(d) of the Public Health Service Act (42 U.S.C. 241(d), authority 
delegated to the National Institutes of Health (NIH).
Regarding data/records confidentiality, the UM School of Education and Human 
Development has an established set of procedures designed to ensure the 
protection of confidentiality. All project staff will be specifically trained on issues 
of confidentiality. Due to the use of the web-based REDCap system there will not 
be any hard copies of the assessment data of the participants. Passwords are used 
to restrict entry into the REDCap database. There will be very few documents 
with identifying information (consent forms) and all documents with identifying 
information will be stored at the UM School of Education and Human 
Development in locked file cabinets within a locked office. Videotapes, which 
represent very sensitive clinical material, will also be stored in Box, a secure, 
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Study #: 20170791        Effective Date: 2/3/2022

HIPAA compliant data storage system maintained by the University of Miami. 
Use of the videotapes is restricted to the UM School of Education and Human 
Development and IRB and PI approved research study staff. It should be noted 
that in our years of clinical research (over 35 years), not a single incident of 
violation of confidentiality has occurred.  
The technology system that will be used in the study will collect usage data that 
will be securely housed on the project servers. Data will be collected without 
requiring that the participant actively send them. Interaction and usage 
information is automatically delivered to the counselor’s cellular phones via an 
existing secure server housed at the University Data Center. Data collected in 
real-time do not contain names or identifying information, only case numbers. In 
addition, the system will require a password to see messages sent to the 
participant. Physical access to servers at the Data Center are controlled by 
security systems, intruder alarms, and monitored by the Department of Security 
video surveillance/recording systems. The Data Center provides appropriate 
environmental control via HVAC systems, uninterruptible Power Supply and 
emergency generators to maintain power without interruption, and FM200 and 
Inergen fire suppression systems to extinguish fires without damaging equipment 
or backup tape systems. The Data Center also provides secure backup for all data 
systems.
27)
Provisions to Protect the Privacy Interests of Subjects
During the recruitment and consent/assent process, and prior to any data 
collection, participants will be assured that their information is 
confidential, and will only be accessed by study staff members. As 
described above, participants will sign a statement attesting to their 
understanding that their information will be kept private and confidential 
to the extent permitted by law. Participants know that they will be 
assigned unique case numbers (and that their names will not be used) to 
protect their identity. Participants will be encouraged to ask questions 
throughout the consent/assent processes and will be provided contact 
information for both the Principal Investigator (Dr. Daniel Santisteban) 
and the University of Miami’s Human Subjects Research Office. 
28)
Compensation for Research-Related Injury
NA.  
29)
Economic Burden to Subjects
NA. Participants may incur costs associated with transportation to and from 
intervention sessions.
30)
Consent Process
For those families that meet the inclusion/exclusion criteria and are interested in 
participating in the research study, the study assessor will obtain a second assent 
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Study #: 20170791        Effective Date: 2/3/2022

from the adolescent and informed consent from her/his primary caregiver to 
participate in the randomized trial. The assessor will provide the adolescent and 
family members with a copy of the consent and assent forms in person or via 
Zoom with the screen share option, and, because subjects may have a low level of 
literacy, will then read the consent and assent forms out loud. Consent and assent 
forms will also be emailed to the family. The study assessor will explain to the 
adolescent and her/his family the purpose and procedures of the study. All of their 
family members will be asked if they are willing to participate in this study. 
Adolescents and caregivers will be asked if they are willing to be randomly 
assigned into one of two treatment conditions: CA CIFFTA or TAU. The assessor 
will explain that they have no way of predicting which family will receive which 
kind of treatment because this is established by chance (as if by the flip of a coin). 
If the family decides to participate, they will get paid $75 at T2 and $100 at T3. 
The nature of the confidentiality that surrounds research studies will be discussed 
with the adolescent and family members, explaining that confidentiality is assured 
to the extent allowed by law. Specifically, that the information they provide is 
strictly confidential, except for the case of potential abuse of a child, or danger to 
their own lives or that of others. The adolescent and family members will be 
informed that information collected from the research instruments will be used 
only for research purposes and reported in aggregate form and composite case 
studies (a strategy for creating case studies in which several cases are integrated 
into a single case study and all identifiers are removed, to protect confidentiality). 
They will also be informed that therapy sessions will be videotaped, and they will 
be asked to provide permission for videotaping sessions for supervision, research, 
and training. Consent and assent forms clearly specify that any family member 
has the right to request that their videotapes, and corresponding transcripts be 
erased/destroyed in part, or in whole at any time during the course of the study or 
thereafter. In addition, informed consent and assent will be obtained allowing 
research study staff to call three persons who are close to the adolescent and 
family members for the purpose of contacting families that may be unreachable at 
any of the assessment time points.
Once the entire consent and assent form has been read and explained, the assessor 
will give the adolescent and family members a chance to ask any additional 
questions. If the family agrees to participate, they will be asked to sign the 
informed consent and assent forms and will be given copies of each signed form. 
Youth and families engaging in the consent process via HIPAA compliant Zoom 
will sign the consent and assent forms with DocuSign. If they do not want to 
participate, the referral procedure listed above for screen failures will be followed. 
After the adolescent and family sign the consent and assent forms the assessor 
will establish a convenient date and time for conducting the baseline assessment 
(T1). Although most assessments will be completed at the office, some may be 
done in the participant’s home to facilitate data collection. The entire consent and 
assent process, will be documented by the assessor in the form of a study contact 
note. 
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Study #: 20170791        Effective Date: 2/3/2022

The consent and assent forms for participation in the study and for videotaping 
family therapy sessions are submitted within this protocol for approval to the 
University of Miami Institutional Review Board (IRB) Behavioral Subcommittee 
for the Protection of Human Subjects.
Non-English speaking participants will be provided with consent and assent 
in Spanish. Consent forms have been translated and back-translated by study 
personnel.  
Waiver or Alteration of Consent Process – NA.
Subjects who are not yet adults, which include adolescents ages 11-18 in the 
current study will go through a similar process for as their parents/family 
(explained above). After the parent or guardian has consented, study personnel 
will provide the assent form to the adolescent. 
Cognitively Impaired Adults – NA.
Adults Unable to Consent – NA. 
31)
Process to Document Consent in Writing
We will be following the “SOP: Written Document of Consent (HRP-
091).” Consent and assent forms have been uploaded for review. 
32)
Drugs or Devices
NA.
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Study #: 20170791        Effective Date: 2/3/2022