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Culturally Modified Family Based Therapy for Haitian Youth in South Florida

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ClinicalTrials.gov Identifier: NCT03876171
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Louis Herns Marcelin, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Problem Behavior Behavioral: Haitian youth and family intervention study: family functioning Behavioral: Haitian youth intervention study: youth psychoeducational Behavioral: Haitian family intervention study: family psychoeducational Behavioral: Diversion Programs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Culturally Modified Family Based Therapy for Haitian Youth in South Florida
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

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.




Primary Outcome Measures :
  1. Number of participants that completes the intervention [ Time Frame: 12 months ]
    All the participants that complete the modules and the baseline instruments

  2. 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.

  3. 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

  4. 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

  5. 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)

  6. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Number of participants with peer gang involvement [ Time Frame: 12 months ]
    Number of participants with peer gang involvement self-reported



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876171


Contacts
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Contact: Louis H Marcelin, Ph.D. 305-284-8493 lmarcel2@miami.edu

Locations
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United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33124
Contact: Louis H Marcelin, Ph.D.         
Principal Investigator: Louis H Marcelin, Ph.D.         
Sponsors and Collaborators
University of Miami
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Louis H Marcelin, Ph.D. University of Miami

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Responsible Party: Louis Herns Marcelin, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03876171     History of Changes
Other Study ID Numbers: 20180597
1R34DA043784-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms