CClinicalTrials.gg
CompletedNCT03876171Updated May 14, 2024Results posted

Culturally Modified Family Based Therapy for Haitian Youth in South Florida

An interventional study of Haitian youth family-based intervention study: family functioning and Haitian youth intervention study: youth psychoeducational in Problem Behavior, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

Read the 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, family-based adolescent therapy, drug use, sexual risk and delinquency risk reduction program for Haitian adolescents aged 13-17 in Miami-Dade County, Florida.

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Conditions studied

  • Problem Behavior

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03

In context

Problem Behavior

517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.

This study's enrollment of 35 is below the median of 90 across 391 interventional studies indexed under Problem Behavior.

Browse Problem Behavior studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Youths with a documented history of mental retardation and/or organic dysfunction.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    CIFFTA

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

    Behavioral: Haitian youth family-based intervention study: family functioning · Behavioral: Haitian youth intervention study: youth psychoeducational · Behavioral: Haitian family-based intervention study: psychoeducational

  • Active comparator
    Standard of Care

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

    Behavioral: Diversion Programs

Interventions

  • BehavioralHaitian youth family-based intervention study: family functioning

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

  • BehavioralHaitian youth intervention study: youth psychoeducational

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

  • BehavioralHaitian family-based intervention study: psychoeducational

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

  • BehavioralDiversion Programs

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

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What researchers measure

Primary outcomes

  1. Number of Participants That Completes the Intervention:

    Number of participants that complete the modules constitutes the outcome measure

    Time frame: 12 months

  2. Number of Participants With Sustained Abstinence in Substance Use

    Number of participants reporting sustained abstinence in substance use

    Time frame: 12 months

  3. Number of Participants Who Reported Sustained Abstinence in Substance Use

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

    Time frame: 12 months

  4. 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

    Time frame: Baseline, 12 months

  5. 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)

    Time frame: baseline, 12 months

  6. 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)

    Time frame: baseline, 12 months

Secondary outcomes

  1. Number of Participants With Recidivism in Delinquency

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

    Time frame: 12 months

  2. Number of Participants With Peer Gang Involvement

    Number of participants recorded involved in peer gangs.

    Time frame: 12 months

  3. Change in Family Communication by Parenting Style Questionnaire (PSQ)

    PSQ Responses rage from 1 (never) to 6 (always)

    Time frame: baseline, 12 months

07

Results

Posted May 14, 2024

Participant flow

Recruitment steps was as follow: JSD Referral=\> Initial Contact (w/in 3 days of referral)=\>Consent Process (w/in 7 days of referral) =\> Randomization (assigned condition w/in 24 hrs of consent) =\> Conditions 1 or 2 =\> Baseline Assessments (w/in 7 days of Consent). Condition 1: referred to Modified (at home) CIFFTA intervention group. Condition 2: referred to Standard of Care (SOC).

Participant flow — Overall Study
MilestoneCIFFTAStandard of Care
Started2015
Completed178
Not completed37
Withdrew: Withdrawal by subject33
Withdrew: Re-arrest04

Outcome measures

PrimaryNumber of Participants That Completes the Intervention:

Number of participants that complete the modules constitutes the outcome measure

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants That Completes the Intervention:
ParticipantsCIFFTAStandard of Care
Number of Participants That Completes the Intervention:178
PrimaryNumber of Participants With Sustained Abstinence in Substance Use

Number of participants reporting sustained abstinence in substance use

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Sustained Abstinence in Substance Use
ParticipantsCIFFTAStandard of Care
Number of Participants With Sustained Abstinence in Substance Use178
PrimaryNumber of Participants Who Reported Sustained Abstinence in Substance Use

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants Who Reported Sustained Abstinence in Substance Use
ParticipantsCIFFTAStandard of Care
Number of Participants Who Reported Sustained Abstinence in Substance Use178
PrimaryChange 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

Time frame:
Baseline, 12 months
Reported as:
Mean · score on a scale
Change in Family Functioning Assessed by the Family Environment Scale (FES)
score on a scaleCIFFTAStandard of Care
Baseline9 ± 1.6910 ± 1.54
12 months9 ± 1.379 ± 1.96
PrimaryChange 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)

Time frame:
baseline, 12 months
Reported as:
Mean · score on a scale
Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists
score on a scaleCIFFTAStandard of Care
Baseline131 ± 18.48128 ± 19.19
12 Months121 ± 10.30124 ± 11.13
PrimaryChange 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)

Time frame:
baseline, 12 months

No measurements were reported for this outcome.

SecondaryNumber of Participants With Recidivism in Delinquency

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Recidivism in Delinquency
ParticipantsCIFFTAStandard of Care
Number of Participants With Recidivism in Delinquency178
SecondaryNumber of Participants With Peer Gang Involvement

Number of participants recorded involved in peer gangs.

Time frame:
12 months

No measurements were reported for this outcome.

SecondaryChange in Family Communication by Parenting Style Questionnaire (PSQ)

PSQ Responses rage from 1 (never) to 6 (always)

Time frame:
baseline, 12 months

No measurements were reported for this outcome.

Adverse events

Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CIFFTA0/20 (0%)0/20 (0%)0/20 (0%)
Standard of Care0/15 (0%)0/15 (0%)0/15 (0%)

Baseline characteristics

Baseline data was not collected for parents/caregivers.

Age, Continuous
Age, Continuous(years)CIFFTAStandard of CareTotal
Median15 (13 to 17)15 (13 to 17)15 (13 to 17)
Sex: Female, Male
Sex: Female, Male(Participants)CIFFTAStandard of CareTotal
Female7714
Male13821
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CIFFTAStandard of CareTotal
Black or African Americans201535
08

Study locations

1 site
  • University of Miami
    Miami, Florida 33124, United States
09

References and documents

Publications

  • 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. PubMed 35272392 ↗
  • 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. PubMed 33734451 ↗

Study documents

  • Study protocol · Jul 19, 2018
  • Statistical analysis plan · Jul 19, 2018
  • Informed consent form · Jul 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03876171
Lead sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Louis Herns Marcelin (Professor, University of Miami) — Principal investigator
First posted
Mar 15, 2019
Start date
Apr 1, 2019
Primary completion
May 31, 2021
Completion
May 31, 2022
Results posted
May 14, 2024
Last update
May 14, 2024

Study contacts

Louis H Marcelin, Ph.D.
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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