- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876171
Culturally Modified Family Based Therapy for Haitian Youth in South Florida
April 18, 2024 updated by: Louis Herns Marcelin, University of Miami
The CIFFTA study is a unique intervention that will develop and implement a culturally-specific, family-based individual, drug use, sexual risk and delinquency risk reduction program for Haitian youth ages 13-17 in Miami-Dade County, Florida.
Study Overview
Status
Completed
Conditions
Detailed Description
Haitian youth in Miami-Dade County who become part of the juvenile justice system have not received culturally appropriate remediating or rehabilitative attention by that system.
This study will modify a specific variety of intervention, the Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA) for appropriateness in Miami's Haitian cultural contexts.
This study will develop and implement a culturally specific, family-based adolescent therapy, drug use, sexual risk and delinquency risk reduction program for Haitian adolescents aged 13-17 in Miami-Dade County, Florida.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33124
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria :
- Adolescents aged 13 to 17
- Place of residence is Miami-Dade
- Has Haitian ancestry
- Adolescents not incarcerated
- No prior mental health care or history of psychoactive medication
- Adolescents who have lived in the US for 3 years
Exclusion Criteria:
- Youths with a documented history of mental retardation and/or organic dysfunction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard of Care
The Diversion Programs used by the Juvenile Services Department in Miami-Dade.
|
Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.
|
|
Experimental: CIFFTA
Family-Based Adolescent Therapy, Individual Therapy, and Psycho-educational Modules
|
Weekly one and one psychoeducational module will be delivered to the youth.
A weekly group therapy with the youth in presence of a parent or caretaker in the family.
Weekly psychoeducational module will be delivered to the adolescent to the youth in the presence of a family.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants That Completes the Intervention:
Time Frame: 12 months
|
Number of participants that complete the modules constitutes the outcome measure
|
12 months
|
|
Number of Participants With Sustained Abstinence in Substance Use
Time Frame: 12 months
|
Number of participants reporting sustained abstinence in substance use
|
12 months
|
|
Number of Participants Who Reported Sustained Abstinence in Substance Use
Time Frame: 12 months
|
Participants reported sustained abstinence and assessment was done through drug test.
|
12 months
|
|
Change in Family Functioning Assessed by the Family Environment Scale (FES)
Time Frame: Baseline, 12 months
|
Improved connectivity and communication within the family system will be assess via a composite score using the FES questionnaire with scales ranging from 0-26 with the highest score indicating that no further intervention is needed
|
Baseline, 12 months
|
|
Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists
Time Frame: baseline, 12 months
|
Improvement in conduct disorder as assess in Revised Behavior Problem Checklists (RBPC) evaluating the severity of disorderly behavior with scales ranging from 0 to 2 (0=no problem; 1=mild problem; 2=severe problems)
|
baseline, 12 months
|
|
Change in Sexual Risk Behaviors as Assess by the Comprehensive Adolescent Severity Inventory (CASI)
Time Frame: baseline, 12 months
|
Reduction in risky sexual activities as assess by CASI using normative data-severity scores range from 0 (never) to 3 (very often)
|
baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Recidivism in Delinquency
Time Frame: 12 months
|
Number of participants that have no report of arrests from the Juvenile Services Department
|
12 months
|
|
Number of Participants With Peer Gang Involvement
Time Frame: 12 months
|
Number of participants recorded involved in peer gangs.
|
12 months
|
|
Change in Family Communication by Parenting Style Questionnaire (PSQ)
Time Frame: baseline, 12 months
|
PSQ Responses rage from 1 (never) to 6 (always)
|
baseline, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Louis H Marcelin, Ph.D., University of Miami
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Marcelin LH, Cela T, Dembo R, Jean-Gilles M, Page B, Demezier D, Clement R, Waldman R. Remote delivery of a therapeutic intervention to court-mandated youths of Haitian descent during COVID-19. J Community Psychol. 2021 Sep;49(7):2938-2958. doi: 10.1002/jcop.22559. Epub 2021 Mar 18.
- Cela T, Marcelin LH, Waldman R, Dembo R, Demezier D, Clement R, Arcayos A, Santisteban D, Jean-Gilles M, Hogue A. Haitian and Haitian American experiences of racism and socioethnic discrimination in Miami-Dade county: At-risk and court-involved youth. Fam Process. 2023 Mar;62(1):216-229. doi: 10.1111/famp.12764. Epub 2022 Mar 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 15, 2019
Study Record Updates
Last Update Posted (Actual)
May 14, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180597
- 1R34DA043784-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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