Culturally Modified Family Based Therapy for Haitian Youth in South Florida

March 29, 2023 updated by: Louis Herns Marcelin, University of Miami
The Culturally Modified Family Based Therapy for Haitian Youth and Their Families in South Florida study is a unique intervention that will develop and implement a culturally-specific, integrated family and individual-based, 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

Intervention / Treatment

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, integrated family and individual-based, 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)

44

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 Contact

Study Locations

  • United States
    • 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

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Adolescents aged 13 to 17 and their families
  • Place of residence is Miami-Dade
  • Has Haitian ancestry
  • Adolescents not incarcerated
  • No prior mental health care or history of psychoactive medication
  • Adolescents in families who have lived in the US for 3 years
  • Families with a range of organizational structure (nuclear and non-nuclear)

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
Experimental: CIFFTA
Family Therapy, Individual Therapy, and Psycho-educational Modules
Behavioral: Haitian youth and family intervention study: family functioning
A weekly group therapy with the youth, the parents and other members of the family.
Behavioral: Haitian youth intervention study: youth psychoeducational
Weekly one and one psychoeducational module will be delivered to the youth.
Behavioral: Haitian family intervention study: family psychoeducational
Weekly psychoeducational module will be delivered to the family.
Active Comparator: Standard of Care
The Diversion Programs used by the Juvenile Services Department in Miami-Dade.
Behavioral: Diversion Programs
Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.

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
All the participants that complete the modules and the baseline instruments
12 months
Number of participants with sustained abstinence in substance use as assessed by biochemical verification
Time Frame: 12 months
Participants maintain a sustained abstinence measured through biochemical verification via urine drug test.
12 months
Number of participants with sustained abstinence in substance use as assessed by self-reporting
Time Frame: 12 months
Participants maintain a sustained abstinence measured through self-reporting
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 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
Change in family communication as assessed by Parenting Style Questionnaire (PSQ)
Time Frame: baseline, 12 months
Change in family communication as assessed by Parenting Style Questionnaire (PSQ) with scoring ranges from 1 to 7 where 7 indicates optimum communication.
baseline, 12 months
Number of participants with peer gang involvement
Time Frame: 12 months
Number of participants with peer gang involvement self-reported
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

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

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)

December 31, 2022

Study Completion (Actual)

December 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)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

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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