NCT03876171

Culturally Modified Family Based Therapy for Haitian Youth in South Florida

Completed NA Results posted Last updated 14 May 2024

What this trial tests

NA trial testing Haitian youth family-based intervention study: family functioning in Problem Behavior in 35 participants. Completed in 31 May 2022.

Timeline

1 April 2019

Primary endpoint
31 May 2021

31 May 2022

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	35
Start date	1 April 2019
Primary completion	31 May 2021
Estimated completion	31 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Haitian youth family-based intervention study: family functioning
• Haitian youth intervention study: youth psychoeducational
• Haitian family-based intervention study: psychoeducational
• Diversion Programs

Conditions studied

• Problem Behavior — all drugs for Problem Behavior →

Sponsor

University of Miami

Who can join

Adults 13 to 17, any sex, with Problem Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants That Completes the Intervention: Primary · 12 months

Number of participants that complete the modules constitutes the outcome measure

Group	Value	95% CI
CIFFTA	17
Standard of Care	8

Number of Participants With Sustained Abstinence in Substance Use Primary · 12 months

Number of participants reporting sustained abstinence in substance use

Group	Value	95% CI
CIFFTA	17
Standard of Care	8

Number of Participants Who Reported Sustained Abstinence in Substance Use Primary · 12 months

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

Group	Value	95% CI
CIFFTA	17
Standard of Care	8

Change in Family Functioning Assessed by the Family Environment Scale (FES) Primary · 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

Group	Value	95% CI
CIFFTA	9	± 1.69
Standard of Care	10	± 1.54

12 months

Group	Value	95% CI
CIFFTA	9	± 1.37
Standard of Care	9	± 1.96

Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists Primary · 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

Group	Value	95% CI
CIFFTA	131	± 18.48
Standard of Care	128	± 19.19

12 Months

Group	Value	95% CI
CIFFTA	121	± 10.30
Standard of Care	124	± 11.13

Number of Participants With Recidivism in Delinquency Secondary · 12 months

Number of participants that have no report of arrests from the Juvenile Services Department

Group	Value	95% CI
CIFFTA	17
Standard of Care	8

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remote delivery of a therapeutic intervention to court-mandated youths of Haitian descent during COVID-19.
   Marcelin LH, Cela T, Dembo R, Jean-Gilles M, et al · · 2021 · cited 5× · PMID 33734451 · DOI 10.1002/jcop.22559
2. Haitian and Haitian American experiences of racism and socioethnic discrimination in Miami-Dade county: At-risk and court-involved youth.
   Cela T, Marcelin LH, Waldman R, Dembo R, et al · · 2023 · cited 4× · PMID 35272392 · DOI 10.1111/famp.12764
3. Juvenile justice-involved Haitian families' experiences of structural racism and socioethnic discrimination.
   Cela T, Demezier D, Waldman R, Clement R, et al · · 2022 · cited 2× · PMID 36817967 · DOI 10.1111/fare.12788