NCT03876171

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

March 6, 2019

Results QC Date

November 3, 2023

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Number of Participants That Completes the Intervention:

    Number of participants that complete the modules constitutes the outcome measure

    12 months

  • Number of Participants With Sustained Abstinence in Substance Use

    Number of participants reporting sustained abstinence in substance use

    12 months

  • Number of Participants Who Reported Sustained Abstinence in Substance Use

    Participants reported sustained abstinence and assessment was done through drug test.

    12 months

  • 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

  • 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

  • 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 Outcomes (3)

  • Number of Participants With Recidivism in Delinquency

    12 months

  • Number of Participants With Peer Gang Involvement

    12 months

  • Change in Family Communication by Parenting Style Questionnaire (PSQ)

    baseline, 12 months

Study Arms (2)

CIFFTA

EXPERIMENTAL

Family-Based Adolescent Therapy, Individual Therapy, and Psycho-educational Modules

Behavioral: Haitian youth family-based intervention study: family functioningBehavioral: Haitian youth intervention study: youth psychoeducationalBehavioral: Haitian family-based intervention study: psychoeducational

Standard of Care

ACTIVE COMPARATOR

The Diversion Programs used by the Juvenile Services Department in Miami-Dade.

Behavioral: Diversion Programs

Interventions

A weekly group therapy with the youth in presence of a parent or caretaker in the family.

CIFFTA

Weekly one and one psychoeducational module will be delivered to the youth.

CIFFTA

Weekly psychoeducational module will be delivered to the adolescent to the youth in the presence of a family.

CIFFTA

Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.

Standard of Care

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \- Youths with a documented history of mental retardation and/or organic dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33124, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Results Point of Contact

Title
Louis Herns Marcelin, Ph.D.
Organization
University of Miami

Study Officials

  • Louis H Marcelin, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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. The goal of the pilot study is to obtain preliminary data on CIFFTA's feasibility, cultural acceptability and efficacy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 15, 2019

Study Start

April 1, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2022

Last Updated

May 14, 2024

Results First Posted

May 14, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations