Culturally Modified Family Based Therapy for Haitian Youth in South Florida
Phase: NA
Conditions: Problem Behavior
Sponsor: University of Miami

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
Page 1 of 21 
Revised: July 19, 2018 
 
Study Title 
Culturally Modified Family Based Therapy for Haitian Youth in South Florida 
(CIFFTA).  
 
 
NCT number: 03876171 
 
Date: July 19, 2018 
 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
Page 2 of 21 
Revised: July 19, 2018 
 
INSTRUCTIONS: 
 
1) Protocol Title 
Culturally Modified Family Based Therapy for Haitian Youth in South Florida 
(CIFFTA).  
 
2) IRB Review History* 
None 
3) Objectives* 
The study will pursue the following Specific Aims: 
Aim 1. To adapt CIFFTA and the assessment instruments necessary to test its efficacy to 
the unique Haitian sociocultural contexts. This process of adaptation has the 
purpose of optimizing CIFFTA’s acceptability and cultural appropriateness.  It will 
rely on ethnographic methods (participant observations, focus groups, and 
interviews) to guide the adaptation process. 
Aim 2. Determine, via a pilot efficacy trial, the impact of CIFFTA compared with 
standard-of-care for reduction of drug use, risky sexual behaviors, and delinquency 
risk among Haitian adolescents ages 13 to 17 in Miami-Dade County. The 
ethnographic component of the study will monitor the delivery of the intervention, 
collecting process data, and affording the investigators needed perspective on the 
intervention’s impact. 
Aim 3. To generate preliminary data on the usefulness of assessment tools and CIFFTA’s 
efficacy among the population. These data will help evaluate the effect of the 
intervention and its best form of implementation. They will also provide 
preliminary evidence to justify a full clinical trial of CIFFTA in a population of at-
risk Haitian youth.   
 
Primary study outcomes include: intervention attendance and completion; sustained 
abstinence in substance use through biochemical verification and self-report; family 
functioning; sexual risk behavior; and conduct disorder. Secondary outcomes include: 
recidivism in delinquency, improvement in family communication, and peer/gang 
involvement. Outcomes will be assessed through follow-up instruments at three points: 3, 
6 and 12 months.  
 
4) Background* 
 
Despite preventive efforts made over the last three decades, it is clear that some 
populations have not benefited from attempts to deter them from risky behaviors. Haitian 
youth constitute an important but understudied population who may be particularly 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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difficult to “reach” via the usual preventive and intervention strategies due to 
circumstances of immigration, poverty, and marginalization.  
 
This study will develop and implement a culturally specific, family-based individual, 
drug use, sexual risk and delinquency risk reduction program for Haitian adolescents 
aged 13-17 in Miami-Dade County. First, instruments for the intervention will be 
pretested with 10 Haitian youth and their families and then refined based on cultural 
acceptability interviews and focus group data. Second, we will conduct a pilot 
randomized trial with 88 at-risk Haitian youth and their families. We will test the 
CIFFTA model against the Standard of Care currently being offered by the Miami-
Dade’s Juvenile Service Department (JSD) to Haitian adolescents in their diversionary 
program. The goal of the pilot study is to obtain preliminary data on CIFFTA’s 
feasibility, cultural acceptability and efficacy.   
 
Research activities will include recruitment of Haitian families whose youths are in the 
JSD program in Miami-Dade Juvenile Justice System; participant observation in 
households of recruited families in Miami, Homestead, and Florida City; modification of 
CIFFTA for use in Haitian families; implementation of a pilot intervention in a limited 
number of youth and their families; process and outcome evaluation of those 
interventions; analysis of data resulting from these activities; and design of an 
intervention to be applied on a larger scale after completion of the present project.  
 
5) Inclusion and Exclusion Criteria* 
Eighty-eight (88) adolescents aged 13 to17 and their families will be recruited into the 
study to obtain 80 after attrition. Age, place of residence (Miami-Dade), and Haitian 
ancestry will constitute the main criteria for selection. Other criteria of inclusion are:  
adolescents that are NOT incarcerated and with no prior mental health care or history of 
psychoactive medication, to increase the homogeneity of the sample in terms of a naive 
population; adolescents in families who have lived in the US for 3 years, to avoid 
confounding initial culture shock with other conventional aspects of maladjustment; 
families with a range of organizational structures (nuclear and non-nuclear), to achieve 
variability and observe differences in family dynamics with regard to response to the 
intervention. Youths with a documented history of mental retardation and/or organic 
dysfunction will be excluded; the youths in question will be referred to appropriate 
agencies. 
6) Number of Subjects* 
Eighty-eight (88) participants will be recruited into the study. Instruments for the 
intervention will be pretested with 10 Haitian youth. 
7) Study-Wide Recruitment Methods* 
This project’s recruitment approach will consist of the following steps: (a) after 
initial referral by the JSD, potential participants will be approached by the 
ethnographer who will describe the scope of the study and ask the participant if 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
Page 4 of 21 
Revised: July 19, 2018 
she or he wants to be enrolled.  If the participant agrees, his/her family will be 
contacted. Once a family is contacted, the ethnographer will schedule the first 
home visit with the parent(s)/caretaker(s) of the potential participant. S/he will 
explain (a) the objectives of the study, (b) the possible recruitment of the youth 
under his/her care as well as their own participation, (c) the possible risks that this 
participation could involve, and (d) the content of the parental consent form. If the 
parent(s) of the potential participant express(es) interest in the study, the 
ethnographer will explain the study to the potential participant. The procedure for 
introducing the study to potential participants and their caretakers will be written 
in English, French and Haitian Creole. After obtaining the verbal agreement of the 
parent/caretaker and the verbal assent of the participant, ethnographer will recruit 
the participant and his/her parent(s) or caretaker(s). S/he will explain in detail the 
adolescent assent form and obtain the participant’s signature (as well as the parent 
consent form) prior to any further activity related to the study. The ethnographer 
and each participant will then schedule a time and a place for the baseline 
interview. The baseline questionnaire that addresses questions of demographics, 
family structure, immigration, neighborhood context and risky behaviors will be 
administered to participants at baseline at the participant’s home. The 
ethnographer, who will have received specialized training in the conduct of 
structured interviews, will conduct the baseline interviews. Each interview is 
expected to take 1-2 hours; participants will be offered $25 for their time.  At this 
point, the interventionist will contact the participant and her/his parent/caretaker 
to schedule the first intervention session. Subsequent contact between the 
interventionist and the participant will be once a week on a pre-scheduled 
appointment basis. 
8) Study Timelines* 
This is a multi-wave study, with approximately all the participants recruited by the 
end of Year 02 and the remainder in the beginning of Year 03. At baseline, we will 
conduct comprehensive assessments of all study constructs and repeat all other 
assessments annually. Activities during the first three months will consist of the 
following: Staffing, Instrument        Calibration, Ethnographic Update. Each wave 
will be composed of 22 participants to be randomized into two groups (11 each). 
Each undergo assessment at intake (T1) and outtake (T2), a booster session 3 
months after outtake and a final assessment at 12 months. Data analysis process will 
be initiated at the third month and continue throughout the study implementation. 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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Publications are expected to start from month 20. The table below details the 
activity processes. 
 
9) Study Endpoints* 
Primary outcomes are: intervention attendance and completion; sustained 
abstinence in substance use through biochemical verification and self-report; 
family functioning; sexual risk behavior; and conduct disorder. 
Secondary outcomes include recidivism in delinquency, improvement in family 
communication, and peer/gang involvement.  
10) 
Procedures Involved* 
 
RCT procedures 
CIFFTA has three major components – Family-Based Therapy, Individual 
Therapy, and Psycho-educational Modules – delivered over 16 weeks in a 
six sessions (60 minutes each) per month format.  In this study, the 
therapy will be delivered in the home to reduce missed sessions and 
premature termination. Special training will focus on how to structure the 
home environment to reduce distractions. Three sessions per month will 
typically be a session which may include Family-based Therapy or 
Psycho-educational modules with the family or parents alone (e.g., parent 
training). The other three sessions are typically with the adolescent alone 
and include Motivational Interviewing or Psycho-educational modules 
designed for the adolescent. 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
Page 6 of 21 
Revised: July 19, 2018 
In the early stages of treatment with the family (weeks 1-3) the therapist 
uses motivational interviewing to enhance the family’s motivation to 
change their behaviors and specialized engagement strategies to make sure 
all family members are active in treatment of the adolescent.  The therapist 
helps families understand the urgency of changing key behaviors but also 
instills hope that change is possible. The therapists helps identify the many 
stressors impinging on the adolescent and family.   
 In the early stages of treatment with the adolescent (weeks 1-3) the 
therapist uses motivational interviewing to develop discrepancies between 
current behaviors and desired outcomes and to acknowledge the stressors 
she/he confronts each day.  
In the middle stages of treatment (weeks 4-13) family sessions focus on 
teaching parenting practices, increasing family cohesion and support, and 
reducing parenting disengagement or conflict. Psycho-educational 
modules are used to teach concepts (e.g., parenting, immigration and 
acculturation related stressors) that increase readiness for successful 
family therapy to improve the family’s supportive interactions. Parents are 
helped to understand the adolescents’ co-occurring disorders and 
vulnerabilities that underlie the behavior problems and they learn to 
validate the adolescent’s struggles.  
In the middle stages of treatment (weeks 4-13) adolescent sessions focus 
on setting goals for their lives, becoming more active in changing 
behaviors that are risky, and learning life skills that can be helpful in their 
day-to-day lives.  Psycho-educational modules are used to teach concepts 
(e.g., risky drug use and sexual behavior, interpersonal effectiveness, 
emotion regulation) that can be generalized to everyday life. 
In the later stages of treatment (weeks 14-16), both individual and family 
sessions focus on relapse prevention and successful termination from 
treatment.     
CIFFTA uses a flexible manual that allows for tailoring of the intervention 
through the selection of psycho-educational modules that address specific 
family and adolescent clinical and cultural issues that are central to that 
lives of that family.  Individual and family level targets of change must be 
specifically able to address the ecological factors as well.  For example, 
parenting practices may be improved to better monitor the adolescent’s 
peers; parental leadership and guidance may focus on taking a more active 
role in advocacy in schools and in teaching adolescents how to handle 
racism and discrimination; and adolescent skills may become important in 
better addressing peer pressure in the peer context.   
Overall intervention process.  

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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Pretest. CIFFTA instruments only will be pretested with a subsample of 5 
Haitian youths and their families. Youths and families will be selected 
purposefully and will NOT be included in the study sample. Because the 
whole trial is consist of testing the applicability of CIFFTA within this 
population, the study will not be tested prior implementation. The 
instruments will be tested for fidelity of translation. 
Study Process. Randomization will be done after baseline data are logged 
and will be carried out via computer-generated sequential assignment; in 
that sense, interventionists do not control randomization and interviewees 
will be blind to condition. At baseline, we will conduct comprehensive 
assessments of all study constructs and repeat all other assessments (see 
timeline). Outcomes anticipated will include lowered risk for re-offending 
(i.e. YLS scores), rates of recidivism (i.e. re-arrest), drug/alcohol use, and 
improved psychological adjustment and family functioning of those 
youths in the intervention group relative to those in the comparison group. 
Similarly, we expect parents/caregivers of these youths to see 
improvement in their child’s behavior (i.e. less conduct disorder reported) 
and improved family functioning overall. 
 
Ethnography.  
Ethnographic methods will be employed including: in-depth interviews; 
focus group discussions; and observation of participating families in daily 
life. The ethnographers will conduct observations as the study begins and 
during follow-up data collection. With regard to Aims 1 & 3, the 
ethnographic observations and interviews help the research team to 
monitor the fidelity of the intervention. Ethnographic data will also help to 
define the processes by which change takes place. To summarize: the 
ethnographic data will: a) guide the development and implementation of 
the intervention (see also timeline); b) enable us better to understand 
barriers and facilitators to change that will inform further modification of 
family-based interventions of this kind; and c) facilitate interpretation of 
the outcome analysis results. 
In order to give the study a chance of determining the intervention’s 
impact in preventing drug use, we intend to collect urine samples at 
baseline and all follow-up time points.  The urine tests will not be the only 
measures of drug use employed during the follow-up period, but in an 
institutional setting like the JAC, they are likely to be the most accurate. 
Field observations. Ethnographers will be trained to capture processes and 
describe events, communications, behaviors, activities and cultural 
materials that make up the particular contexts in which Haitian live. They 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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will make regular visits to pre-selected, highly frequented locales, 
gendered or not, where Haitian youths "hang out."  
In-depth Interviews. In-depth interviews will begin after field observations 
have been initiated, and therefore should benefit from findings of 
observations in progress.  The Interview Guide serves as a preliminary 
template to be used by interviewers. It will generate information on topics 
such as (a) life experiences, (b) drug use, (c) identity, (d) lifestyle, (e) 
personal experiences, such as forms of sociability and beliefs associated 
with youth behaviors and the juvenile justice.   
Focus Group. Focus groups will be guided by the following criteria: (a) 
they will be homogeneous with regard to age (parents or adolescents 
only); (b) they will follow a relatively structured interview guide with high 
involvement of the ethnographer as moderator; and (c) they will have six 
to ten participants each. Topical areas for the focus group will include the 
following: impact of the interventions; behavior changes of adolescents of 
parents; changes in the family. 
Instrumentation.  
The primary constructs for the youth participants will include: risk for re-
offending, criminal history, patterns of drug/alcohol use, psychological 
adjustment, evidence of conduct disorder, family functioning, and 
acculturation. Constructs for the caregiver(s) will include their assessment 
of their child’s conduct, family functioning, and their own level of 
acculturation. At baseline, information will also be gathered on 
participants demographic status. The instrument will be administered at 
participants’ homes. Along with the demographic data, the baseline 
questionnaire will incorporate measures from the instruments described 
below, culminating in a unified tool taking no more than one hour to 
administer.  
Behavioral, emotional, and academic functioning. We will administer 
standardized measures of youths’ emotional and behavior disorders. 
Parent and youth reports on the Achenbach System of Empirically Based 
Assessment will assess youth’s behavioral, emotional, and academic 
functioning. Parents will complete the Child Behavior Checklist 
(Achenbach 1983); and youth also will complete the parallel Youth Report 
Form (YRF). These measures yield scores for internalizing and 
externalizing problems and academic competence, and have DSM-5 scales 
for multiple problem areas: depression, anxiety, somatic, attention deficit/ 
hyperactivity, oppositional, and conduct problems.  
Risk for re-offending. Level of risk will be assessed with the Youth Level 
of Service/Case Management Inventory (YLS/CMI) developed by Hoge 
and Andrews (51) that screens for risk in eight domains (conduct disorder, 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
Page 9 of 21 
Revised: July 19, 2018 
school, criminal friends, alcohol/drug use, leisure/recreation, 
personality/behavior, family circumstances, and attitudes/orientation) 
yielding overall risk scores ranging from (0-8). The YLS/CMI is 
administered to all juveniles processed in the JSD. The same instruments 
will be used to assess youth from the GRP. 
Drug use and psychological adjustment will be assessed with the 
Comprehensive Adolescent Severity Inventory developed by Myers and 
colleagues (52). The CASI covers a broad range of psychosocial and risk 
behaviors including information on substance abuse (e.g. age of first use, 
current patterns of use, friends’ use), criminal activity, mental health, peer 
relationships, family/household relationships, education, and sexual 
behavior. Among other things, the instrument gathers information 
concerning youth use of a range of substances and will be adapted to 
assess ATOD use at baseline and post-intervention. In this way, we will be 
able to determine participants’ historical and recent use (i.e. past 30 days, 
past 3, 6, and 12 months), if any, of drugs and alcohol. Similar 
assessments are made of sexual risk behavior and a global assessment of 
psychological adjustment is included that yields a continuous measure of 
global functioning. Adequate levels of internal consistency, test-retest 
reliability and validity coefficients are reported. 
Conduct Disorder. Youth problem behaviors will be measured using the 
Conduct Disorder instrument from a Revised Behavior Problem Checklist 
(53) utilized previously by BSFT staff (54). The RBPC is an empirically 
derived measure consisting of 89 problem behaviors. We will adapt the 
instrument to include behaviors that are particularly salient among Haitian 
youths and exclude others that are deemed less salient. For each youth, the 
primary caregivers will rate the severity of each behavior on a 3 point 
scale (0 = no problem, 1 = mild problem, 2 = severe problem). The 
Conduct Disorder Subscale as used for this study consists of 22 items (α = 
.92) measuring the youth's disruptive behavior at home (e.g., “disobedient; 
difficult to control”). The Conduct Disorder Subscale will be administered 
at intake and again at termination. 
Family Functioning. Family functioning will be assessed by the Cohesion 
and Conflict Subscales from the Family Environment Scale [FES] (55). 
Family cohesion and conflict are specifically targeted because they have 
been found to be among the strongest predictors of youth problem 
behavior and these two scales have been found to capture much of the 
variability attributed to the FES (56). In prior work, the FES has 
demonstrated good internal consistency reliability (α = .93 for adults and 
.94 for children) (55). We will also modify this instrument for adaptability 
to the Haitian immigrant context. As with the other instruments, 
reliabilities of the modified Family Functioning instrument will be 
ascertained for additional internal consistency and test-retest reliability as 

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
Page 10 of 21 
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necessary. Parents’ involvement in the day-to-day lives of their youth 
children will be further assessed with a 5-item paternal-child centeredness 
scale developed by Schaefer (57) that typically yields reliability 
coefficients in excess of .80.  
The Bicultural Involvement Questionnaire, designed by Szapocznick (24) 
and adapted for use in Haitian populations by Jean-Gilles (58) measures 
the degree of comfort and enjoyment respondents receive from engaging 
in behaviors representative of the culture of origin (e.g. speaking the 
native language, consuming native food, listening to ethnic music) as well 
as behaviors representative of the host (U.S.) culture. Scores deriving from 
this measure include one for monoculturalism with respect to the native 
(Haitian) culture, and another for adaptation to the host (U.S.) culture. 
Szapocznick & Kurtines (24) report internal consistency coefficients of 
.93 and .89 for these scales on samples of 12 to 16 year old Hispanic 
youths. The internal consistency coefficients for the Creole version of the 
BIQ subscales were .72 for monoculturalism and .87 for Americanism, 
respectively. 
Youth Urine Toxicology. As part of our research component, we plan to 
collect voluntary urine specimens for analysis at the times of the youths’ 
initial and follow- up interviews in order to validate self-report. We will 
follow procedures informed by NIDA’s CJDATS workgroup guidelines. 
Urine specimens will not be collected on youths incarcerated for more 
than two days. The use of four substances will be probed using the Onsite 
CupKit® urine screen procedure (positive threshold levels are noted in 
parentheses): (1) methamphetamines (500 nanograms per milliliter [ng/ml] 
of urine), (2) opiates (300 ng/ml of urine), (3) cocaine (300ng/ml of urine), 
and (4) marijuana (THC) (50 ng/ml of urine). The surveillance window for 
the four drugs is as follows: methamphetamines and opiates = 48 hours; 
cocaine = 72 hours; marijuana: moderate users = 5 days; heavy users = 10 
days; chronic users = 20 days. Although we considered hair analysis, urine 
screens were selected because of they are the most widely used and 
accepted method for supervision monitoring (Lipsey & Wilson, 1998), 
they are minimally invasive, can be collected in the community during 
follow-up assessments and carry fewer taboos on collection (Meyers et al., 
2002). Urine screen results will be kept confidential, and will be collected 
in containers marked with pre-printed labels without personal identifying 
information. To assure integrity of the sample, the Onsite CupKit® 
automatically checks for temperature, and the interviewer will ensure that 
there is no one else in the restroom. 
Overview of Assessment Procedures and Attrition 
The 3-month follow-up assessment will be measured from the end of the 
intervention, as will be the 6-month and the 12-month follow-up 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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interviews. All participants entered into the study will be tracked for the 
follow-up assessments, even if the individual drops out of treatment early. 
Whereas this is not expected to be a significant problem given the few 
number of treatment sessions, our design calls for an intent-to-treat 
assessment and data analytic plan. If the youth or parent cannot be located, 
records of official agencies (e.g., law enforcement, department of juvenile 
justice, local jails, department of corrections, state attorney, department of 
motor vehicles) will be searched. Our tracking efforts will be informed by 
the successful strategies used by Stouthamer-Loeber et al. (1992), 
Farrington et al. (1990), and in the Family Empowerment Intervention 
project (Dembo & Schmeidler, 2002) to minimize attrition.  One of the 
greatest advantages in using family–based approach is that it creates 
conditions to build relationship over time within the communities studied 
and with the families. Based on our experiences conducting family-based 
studies, we will use procedures proven instrumental in obtaining high 
retention rates. 
11) 
Data and Specimen Banking* 
As part of our research component, we plan to collect voluntary urine 
specimens for analysis at the times of the youths’ initial and follow- up 
interviews in order to validate self-report. We will follow procedures 
informed by NIDA’s CJDATS workgroup guidelines. Urine specimens 
will not be collected on recruited youths for more than two days. 
The use of four substances will be probed using the Onsite CupKit® urine 
screen procedure (positive threshold levels are noted in parentheses): (1) 
methamphetamines (500 nanograms per milliliter [ng/ml] of urine), (2) 
opiates (300 ng/ml of urine), (3) cocaine (300 ng/ml of urine), and (4) 
marijuana (THC) (50 ng/ml of urine). The surveillance window for the 
four drugs is as follows: methamphetamines and opiates = 48 hours; 
cocaine = 72 hours; marijuana: moderate users = 5 days; heavy users = 10 
days; chronic users = 20 days. 
Although we considered hair analysis, urine screens were selected because 
of they are the most widely used and accepted method for supervision 
monitoring (Lipsey 
& Wilson, 1998), they are minimally invasive, can be collected in the 
community during follow-up assessments and carry fewer taboos on 
collection (Meyers et al., 2002). Urine screen results will be kept 
confidential in containers marked with pre- printed labels without personal 
identifying information. To assure integrity of the sample, the Onsite 
CupKit® automatically checks for temperature, and the interviewer will 
ensure that there is no one else in the restroom. 

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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12) 
Data Management* 
Qualitative data:  
Research staff will be monitored during every step of data collection by 
appropriate investigators. Instruments will be reviewed periodically to insure 
validity and reliability. Data will be entered by our personnel into a database 
under the supervision of PI. Control measures will be instituted to ensure 
accuracy of data entry procedures prior to analysis. Also, all data will be analyzed 
at our data processing center, under guidelines of our data safety and monitoring 
plan. All written and tape-recorded materials in this study will be transcribed 
using Microsoft Word on a daily basis and stored in locked the PI files cabinet. 
They will be coded and analyzed using procedures described in Schensul et. al.  
The PI, with the assistance of the project’s co-Is and Post-Doctoral Associate, will 
analyze the data using SPSS®, STATA®, the R statistical package or relate 
statistical software. Outcome measures will include drug use, delinquency/crime, 
family functioning, educational performance, and emotional/ psychological 
functioning. Predictor and outcome data will be analyzed using confirmatory 
factor analysis, generalized linear mixed effects modeling, latent growth 
modeling, structural equation modeling, analysis of variance, logistic regression, 
and stepwise multiple regression. The significance levels will be adjusted to 
control for multiple outcome measures. For the primary hypotheses, power is 
anticipated to be .80.  
To ensure the consistency and integrity of the independent variables, project 
research assistants will record on a regular basis all random assignments, other 
contacts, and assessments. These records will be audited regularly by the PI and 
Co-Is. To ensure high quality data, all research staff will be closely trained in 
proper data collection and entry. All data will be checked promptly after 
collection for completeness, quality, and accuracy. This will include screenings 
for out-of-range values and missing data. Apparent anomalies will be immediately 
brought to the attention of the interviewer for clarification and any indicated 
follow-up. We will monitor three key outcome measures on a bimonthly basis. 
For urine tests:  
Urine specimens will be collected using the Onsite CupKit®, which produces test 
results within 3 to 5 minutes. As such, no biological specimens will be kept for 
storage. 
Urine specimens will be collected, but not stored. 
Because youths tend to underreport the use of such socially disapproved drugs as 
cocaine (Dembo & Schmeidler, 2002), urine testing is a valuable component of 
our data collection plan. Based on previous experience conducting research on 
delinquent youth (e.g., Dembo & Schmeidler, 2002), and because the urine test 
data will be treated as confidential, we anticipate a low rate of refusal to provide a 

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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specimen at each time point. If preliminary analyses at each data collection point 
indicates a low concordance rate (kappa < .80) between self-reported use and 
urine toxicology results for a given drug (e.g., marijuana) both self-report and 
urine      test results will be used to construct drug use measures for our analyses 
(e.g., self- reported use or a positive urine test = use; no self-reported use and a 
negative urine test = no use). If a high concordance rate is found (kappa > .80), 
the self- reported use data for that drug will be used. 
13) 
Provisions to Monitor the Data to Ensure the Safety of Subjects* 
All data collection protocols include Informed Consent Forms. They also include 
Confidentiality Safeguards, Mandatory Reporting Safeguards, Staff Training 
Safeguards, Data Safeguards, Discomfort with Assessment Procedures or 
Disclosure Safeguards, and Dissatisfaction Safeguards. In addition, the PI will 
constitute an external Data safety and Monitoring Board (DSMB). 
Confidentiality safeguards. The Data Safety and Monitoring Plan guidelines 
require that the degree of monitoring be commensurate with the degree of risk to 
study participants. The primary risk to study participants is loss of confidentiality. 
In order to ensure protection of study participants’ confidentiality, participant 
locator information, including names of family, will be encrypted and stored in 
password protected files accessible to the PI. Participant identifier will be 
destroyed at the end of the study. Study participants' names will not be used in 
computer files; only each participant’s unique code number will be linked to the 
data.  
Mandatory reporting safeguards. The PI will report any participant safety issues to 
the IRB within three working days. Reportable issues include: 1) serious adverse 
events associated with study procedures, 2) any problems or complaints related to 
conduct of research personnel, and 3) any incidents or problems related to 
recruitment and consent. The PI will also provide, on an annual basis, a full report 
to the IRB detailing any problems encountered during the years in which the 
research project is in contact with human participants. 
Discomfort with Assessment Procedures or Disclosure Safeguards. Some people 
may experience mild fatigue or concerns when responding to the interview 
schedule. Others may experience psychological distress when questioned about 
sexual behaviors and forms of sociability. Some of the participants that are 
involved in disruptive behaviors may be taking risks by enrolling in this study 
because of the information related to delinquency, drug use, and other risky 
behaviors collected from them. We may even have to report to the appropriate 
authorities sexual abuse and crimes resulting in injury or death. We will adhere to 
the following procedures for responding to adverse events associated with 
subjects’ participation in the study. 
Data Safeguards. Fieldworkers will be monitored at every step during the data 
collection process and questionnaires will be reviewed to insure validity and 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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reliability. Data will be entered by our data entry personnel into a database under 
the supervision of the PI. Control measures will be instituted to ensure the 
accuracy of data entry procedures prior to conducting the analysis. Upon 
collection from the field interviewers or other investigators, the Post-Doc will 
place in their respective locations in the file cabinets all transcripts, field notes, 
USB keys, and completed interview schedules. The PI will develop a readily 
usable filing system. Data and study related materials will be secured in a locked 
file cabinet at the PI’s office. Only staff directly involved in the assessment of 
each participant will have access to documents that contain identifying 
information. This list includes the study’s principal investigator (PI), co-Principal 
Investigators, the Post-Doctoral Research Associate/Field Manager and the 
Therapists. 
A single password-protected file with identifying information will be kept for 
tracking purposes only. As mentioned above, only the study’s principal 
investigator (PI), co-Principal Investigators, the Post-Doctoral Research 
Associate/Field Manager and the Therapists. 
Staff Training. Research staff will be extensively trained regarding the importance 
of confidentiality and procedures for maintaining sensitive information. The PI 
will strictly monitor procedures relating to protection of data and confidentiality 
and staff’s adherence to same.  Research staff will complete NIH requested 
human subjects research training. 
Data Safety and Monitoring Board (DSMB). The PI will constitute a DSMB 
composed of a University of Miami experienced faculty, a member from the 
Community Advisory Board for the Miami-Dade County Juvenile Delinquency 
Alternative program (J-DAP), and a member of the Institute for Child and Family 
Health, and a member from a Haitian community center. 
The University of Miami's IRB will oversee and monitor the involvement of 
participants in the study to ensure their safety. We will submit a yearly report to 
the Office of Human Subject Protection reporting on the conduct of the research, 
the safety of the participants, any adverse event that may affect a participant and 
the study’s compliance with federal, state, and University regulations. Under the 
University of Miami's IRB policy, the IRB may request an audit by the Office of 
Research Compliance of any study it has approved to ensure the validity and 
integrity of the data. Unexpected adverse events will be directly reported to the 
University's IRB for immediate decision. 
Data review may indicate a need for early termination of the study, amendment to 
the protocol or other changes to the data collection plan or study forms (for 
example translation). We will obtain permission from the Program Official prior 
to effectuating the suggested changes and implementing them. The University of 
Miami IRB will be notified of any planned changes and all amendments to study 
procedures will be approved by the IRB prior to implementation.   

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
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The PI acknowledges the requirement to report DSMB activities to the Program 
Official at NIDA on an annual basis as part of the non-competing progress report. 
Clinical trial information for this study is posted at ClinicalTrials.gov in 
accordance with NIH guidance. 
14) 
Withdrawal of Subjects* 
Potential Adverse Events (AEs) and Serious Adverse Events (SAEs)  
In this study, SAEs will be defined according to NIH criteria. We will carefully 
and continually monitor all participant data on a monthly basis for potential SAEs 
induced by any of the experimental interventions or by other circumstances. Any 
SAE, whether or not related to the study interventions, will be reported 
immediately to the study's IRB at the University of Miami and to NIDA Program 
Official within 24 hours and follow up report within 2 hours. The initial SAE 
Report will be followed by submission of a completed SAE Report to both 
institutions. In the event that a participant withdraws from the study or the PI 
decides to discontinue a participant due to an SAE, the individual will be 
monitored by the investigator via on-going status assessments until 1) a resolution 
is reached; i.e., the problem requiring intervention has resolved or stabilized with 
no further changes expected; 2) the SAE is determined to be clearly unrelated to 
the study intervention; or 3) the SAE results in death. Outcomes of SAEs will be 
periodically reported to NIDA. A summary of the SAEs that occurred during the 
previous year will be included in the annual progress report to NIDA. 
Procedures for Research Team Management of AEs, SAEs and other 
Study Risks.  
Project staff will be trained to recognize symptoms of psychological distress and 
to make appropriate referrals with follow-up. Psychological support through 
licensed practitioners at the J-DAP go-to counselor staff at the Miami-Dade 
Juvenile Justice Services and the Juvenile Assessment Center. In addition, 
licensed practitioners at the Center for Haitian Studies (University of Miami) will 
be available for participants who experience discomfort with disclosure and/or 
psychological distress. When appropriate, community resources such as Haitian 
churches, informal networks, and Haitian CBOs can also be mobilized to help 
minimize potential adverse effects. In the event that a participant informs research 
staff about potential harm to self or others (e.g., child abuse, crimes resulting in 
injury or death, suicidal actions, or ideation), the PI must be informed and the 
incident reported to the appropriate authorities. We will comply with these 
guidelines. The project Post-Doc will also produce a safety report for the PI, 
describing any adverse events within two days of their occurrence. This will 
ensure that an appropriate response is made and any negative trends are identified.  
 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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Revised: July 19, 2018 
15) 
Risks to Subjects* 
This study involves minimal risks with no prospect of benefit. We do not 
anticipate any adverse effects. Nevertheless, if a serious adverse event occurs, it 
will be reported to the Institutional Review Board (IRB). Risks related to study 
procedures will be monitored closely, and any changes to increase safety will be 
addressed. Risks identified as possible outcomes for all of our study subjects 
participating in the assessment:  
1) 
possible violation of confidentiality,  
2) 
possible discomfort due to assessment procedures, 
3) 
possible psychological stress associated with discussing issues related 
to stigma and disclosing sensitive personal information, 
4) 
possible disclosure of information about health status or abuse that 
would need to be reported to families and/or the appropriate agencies 
and ensuing investigation of the allegation(s) and further action, as 
indicated, 
5) 
possible dissatisfaction with the assessment procedures, and  
6) 
possible dissatisfaction with the intervention activities. 
In addition, sensitive information about the participants may constitute a serious 
risk, as the information in essence will consist on records of delinquency, drug 
possession or serious first offense. 
16) 
Potential Benefits to Subjects* 
Potential Risks and Benefits There are several risks associated with this study. 
Potential breach of confidentiality, feelings of discomfort about sensitive 
information shared during interviews, focus group discussions and during 
therapeutic interventions. Some participants may experience psychological 
distress when questioned about risky behaviors associated with drug use and 
sexual activity, among others. 
This research will develop and implement a culturally specific, family-based 
individual-based, sexual risk and delinquency risk reduction program for Haitian 
adolescents ages 13-17 in Miami-Dade County, Florida. As there are no 
documented interventions that have been specifically modified or created for this 
distinct cultural group, this preventive/intervention program could eventually 
allow clinicians to offer family-based interventions that integrate individually-
oriented approaches to therapy and are better suited to the Haitian American 
sociocultural context. 
 

Study Protocol  
IRB ID: 20180597 (CR00012479) 
Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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17) 
Vulnerable Populations* 
. The youths to be recruited are minors aged 13-17. 
18) 
Multi-Site Research* 
This is not a Multi-Site Research. 
19) 
Community-Based Participatory Research* 
This study is not a Community-Based Participatory Research 
20) 
Sharing of Results with Subjects* 
Not Applicable. 
21) 
Setting 
When a youth is arrested in Miami-Dade, he or she is brought by the arresting 
officer to the JSD. At the JSD the child goes through an initial arrest process, 
including fingerprinting, mug shots and other typical intake and assessment 
procedures. During the intake the youths are asked to self-identify as to their 
ethnicity. The child is given an assessment which includes a determination of 
whether or not the appropriate criterion is met for entering a diversion program. 
Criteria for the various diversionary programs include prior criminal history and 
the nature of the current arrest. If the child is eligible for a diversionary program 
then the range and type of programs and services which might be suitable are 
considered. Programs are offered for substance abuse, educational needs, 
psychotherapy, family-based interventions, anger management, community 
service and so forth. If the parents and the youth both agree, then a diversion 
program is assigned.  
Once assignment to a diversion program has been made, participation by the 
youth, and in many cases also by a parent, becomes a mandatory condition of the 
program. A case manager is assigned to monitor program compliance. If either 
fails to participate the program will not be completed and the youth may then be 
referred to the court system and may face prosecution and further sanctions. 
When parents/guardians picking up a project eligible youth meet or when project 
staff meet eligible youth at the community diversion program, only then will they 
be informed about their eligibility of the proposed project. Parents/guardians and 
youths who are interested in participating in the project will then be informed that 
project services are provided in-home, confidential, and that participation is 
voluntary. Project’s procedures will be performed at the home of the participants 
in the Haitian neighborhood in Miami-Dade. 
22) 
Resources Available 
The PI and Co-Investigators have each at least more than 30 years of large-scale 
experiences in the field of public health. They have over 3 decades of community-

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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based research in the Haitian community in Miami-Dade. All research clinical 
staffs have been performing CIFFTA in diverse ethnic contexts in Miami-Dade 
for over two decades. They are well-trained in human subject protection and 
research implementation.  They are well-informed of their tasks and duties and 
they will be trained for this study to be implemented in the Haitian community. 
The 88 at-risk youth (ages 13-16) of Haitian descent will be recruited in Miami-
Dade County with the intention to analyze 80 participants because of attrition. 
Sample sizes are derived from power calculations based on data from published 
work. 
Two therapists will deliver the CIFFTA intervention. Therapist will have 
experience in working with adolescents with behavior problems and with Haitian 
families. The first phase of therapist CIFFTA training will consist of a 3-day 
training workshop that includes the use of didactic material, the intervention 
manual, and the presentation of videotaped sessions from our previous CIFFTA 
work. This workshop will also include presentations by the PI and Dr. Page on 
what is known about Haitian families in our community. The second phase will 
include intervention implementation with 1 pilot case. A therapist is required to 
work with a pilot case over at least a one-month period and work with that pilot 
cases will be supervised directly by the study PI, the CIFFTA Developer, and the 
CIFFTA supervisor. Because the implementation of the psycho-educational 
modules is fairly straightforward, training and certification efforts will focus 
primarily on the individual and family-based therapy components. Any rating 
below “adequacy” will require retraining on that specific component. 
Interventions will be delivered over a briefer period than is typical of the actual 
intervention in the trial but will be sufficient to ensure comfort and competence in 
the key intervention components. There will be a 2 day workshop following the 
pilot phase to solidify any issues that remain and to incorporate any manual 
clarification that will assist in achieving high levels of competence and 
fidelity/adherence. This training format has been utilized successfully in our 
family training institute. SOC therapists will already be experienced in delivering 
the community standard and will not require additional training.     
Intervention Integrity/Fidelity Checks: Weekly clinical meetings will be held to 
supervise the team. Each therapist will receive formal supervision in these 
meetings, in addition to consults as needed. Recorded therapy sessions will be 
reviewed, the clinical complexity of cases will be discussed, and good manual 
implementation will be emphasized. An independent adherence rater will 
randomly select 20% of the sessions at different intervention phases (early, mid, 
and late) for adherence ratings to document the adequacy of intervention delivery. 
Ratings that fall below adequacy on any dimension/component will trigger 
increased supervision focus for that dimension and if necessary, re-training. 
Adherence raters will be trained using the established CIFFTA adherence 
checklist. The condition supervisor will be held as the gold-standard for inter-rater 
reliability on adherence ratings and raters will be trained to achieve an intra-class 

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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Revised: July 19, 2018 
correlation coefficient of .70 or higher, and at least 80% agreement across items. 
Inter-rater reliability will be checked regularly to avoid drift.     
23) 
Prior Approvals 
There was no prior approval. 
24) 
Recruitment Methods 
This project’s approach will consist of the following steps: (a) after initial referral 
by the JSD, potential participants will be approached by the ethnographer who 
will describe the scope of the study and ask the participant if she or he wants to be 
enrolled.  If the participant agrees, his/her family will be contacted. Once a family 
is contacted, the ethnographer will schedule the first home visit with the 
parent(s)/caretaker(s) of the potential participant. S/he will explain (a) the 
objectives of the study, (b) the possible recruitment of the youth under his/her 
care as well as their own participation, (c) the possible risks that this participation 
could involve (see Human Subjects), and (d) the content of the parental consent 
form. If the parent(s) of the potential participant express(es) interest in the study, 
the ethnographer will explain the study to the potential participant. The procedure 
for introducing the study to potential participants and their caretakers will be 
written in English and Haitian Creole. After obtaining the verbal agreement of the 
parent/caretaker and the verbal assent of the participant, ethnographer will recruit 
the participant and his/her parent(s) or caretaker(s). S/he will explain in detail the 
adolescent assent form and obtain the participant’s signature (as well as the parent 
consent form) prior to any further activity related to the study. The ethnographer 
and each participant will then schedule a time and a place for the baseline 
interview. The baseline questionnaire that addresses questions of demographics, 
family structure, immigration, neighborhood context and risky behaviors will be 
administered to participants at baseline at the participant’s home. The 
ethnographer, who will have received specialized training in the conduct of 
structured interviews, will conduct the baseline interviews. Each interview is 
expected to take 1-2 hours; participants will be offered $50 for their time.  At this 
point, the interventionist will contact the participant and her/his parent/caretaker 
to schedule the first intervention session. Subsequent contact between the 
interventionist and the participant will be once a week on a pre-scheduled 
appointment basis. 
25) 
Local Number of Subjects 
88 
26) 
Confidentiality 
Participants’ contact information will be entered into the confidential password-
protected tracking system. Their study information, however, will be de-identified 
in a separate file. If at the time of assent, consent or if it has been determined later 

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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that a participant is no longer eligible, the participant will be discontinued from 
the study and told that the study inclusion criteria are no longer met. All 
information regarding that participant will be destroyed. Every precaution will be 
taken to prevent any violations of confidentiality. Confidentiality of subject 
records is assured by assigning the participants research numbers and storing 
computer files without identifying information. A single password-protected file 
with identifying information will be kept for tracking purposes only. Only Dr. 
Marcelin, Dr. Santisteban and the Postdoc will have access to the password 
protected files. All personal information and data contained in computer systems 
will be password-protected and stored in locked facilities. Paper records are kept 
in locked file drawers in a locked room. 
This study will have an extended NIDA Certificate of Confidentiality to protect 
the subjects’ confidentiality. 
27) 
Provisions to Protect the Privacy Interests of Subjects 
Parents/guardians and youths who are interested in participating in the project will 
be informed that project services are provided in-home, confidential, and that 
participation is voluntary. Interviews will be done at a comfortable place chosen 
by the study participant where there is no intrusion from a third party and where 
participant feel safe providing response to questions, examinations, and 
procedures.  
Trained research staff will ensure participants of the study that all information 
regarding that participant will be destroyed and that every precaution will be 
taken to prevent any violations of confidentiality. Confidentiality of subject 
records is assured by assigning the participants research numbers and storing 
computer files without identifying information. 
28) 
Compensation for Research-Related Injury 
Not applicable. 
29) 
Economic Burden to Subjects 
There is no cost to participate in this study. 
Consent Process  
We will obtain signed assent from children participating in this research study as it is 
appropriate for the age, maturity and psychological state of the child. The consent/assent 
process will occur in the youths’ homes by appointment, after they and their 
parents/guardians have left the Juvenile Services Department/Juvenile Assessment 
Center. Parents/guardians and youths will be informed that participation in the study is 
completely voluntary.  
Non-English Speaking Subjects 

Study Protocol  
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Study Number: 1 R34 DA043784-01A1 
Date: July 19, 2018 
 
 
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Although Haitian youths in this study are bilingual, their parents are most likely to 
be Creole speakers. The consent and assent forms will be translated in Haitian 
Creole and the process will be done in the language parents or youth is most 
comfortable with. 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
We will not apply for waiver in this study. 
Cognitively Impaired Adults 
No cognitively impaired individuals will be enrolled in this study. 
Adults Unable to Consent 
Not applicable. 
30) 
Process to Document Consent in Writing 
Informed consent attached.