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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03876171
Other study ID # 20180597
Secondary ID 1R34DA043784-01A
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date May 31, 2022

Study information

Verified date April 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 31, 2022
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Haitian youth family-based intervention study: family functioning
A weekly group therapy with the youth in presence of a parent or caretaker in the family.
Haitian youth intervention study: youth psychoeducational
Weekly one and one psychoeducational module will be delivered to the youth.
Haitian family-based intervention study: psychoeducational
Weekly psychoeducational module will be delivered to the adolescent to the youth in the presence of a family.
Diversion Programs
Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants That Completes the Intervention: Number of participants that complete the modules constitutes the outcome measure 12 months
Primary Number of Participants With Sustained Abstinence in Substance Use Number of participants reporting sustained abstinence in substance use 12 months
Primary Number of Participants Who Reported Sustained Abstinence in Substance Use Participants reported sustained abstinence and assessment was done through drug test. 12 months
Primary Change in Family Functioning Assessed by the Family Environment Scale (FES) 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
Primary Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists 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
Primary Change in Sexual Risk Behaviors as Assess by the Comprehensive Adolescent Severity Inventory (CASI) 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 Number of Participants With Recidivism in Delinquency Number of participants that have no report of arrests from the Juvenile Services Department 12 months
Secondary Number of Participants With Peer Gang Involvement Number of participants recorded involved in peer gangs. 12 months
Secondary Change in Family Communication by Parenting Style Questionnaire (PSQ) PSQ Responses rage from 1 (never) to 6 (always) baseline, 12 months
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