Problem BehaviorNCT03876171
Culturally Modified Family Based Therapy for Haitian Youth in South Florida
A study testing Haitian youth family-based intervention study: family functioning, Haitian youth intervention study: youth psychoeducational and Haitian family-based intervention study: psychoeducational in people with Problem Behavior, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Problem Behavior
- What is being tested?
- Haitian youth family-based intervention study: family functioning, Haitian youth intervention study: youth psychoeducational and Haitian family-based intervention study: psychoeducational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Youths with a documented history of mental retardation and/or organic dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Problem Behavior
- Being tested
- Haitian youth family-based intervention study: family functioning, Haitian youth intervention study: youth psychoeducational, Haitian family-based intervention study: psychoeducational, Diversion Programs
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haitian youth family-based intervention study: family functioningBehavioural
A weekly group therapy with the youth in presence of a parent or caretaker in the family.
Haitian youth intervention study: youth psychoeducationalBehavioural
Weekly one and one psychoeducational module will be delivered to the youth.
Haitian family-based intervention study: psychoeducationalBehavioural
Weekly psychoeducational module will be delivered to the adolescent to the youth in the presence of a family.
Diversion ProgramsBehavioural
Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.
| Study group | Role | What they receive |
|---|---|---|
| CIFFTA | Experimental | Family-Based Adolescent Therapy, Individual Therapy, and Psycho-educational Modules Receives: Behavioral: Haitian youth family-based intervention study: family functioning; Behavioral: Haitian youth intervention study: youth psychoeducational; Behavioral: Haitian family-based intervention study: psychoeducational |
| Standard of Care | Active comparator | The Diversion Programs used by the Juvenile Services Department in Miami-Dade. Receives: Behavioral: Diversion Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Completes the Intervention:
Number of participants that complete the modules constitutes the outcome measure
Measured: 12 months
Number of Participants With Sustained Abstinence in Substance Use
Number of participants reporting sustained abstinence in substance use
Measured: 12 months
Number of Participants Who Reported Sustained Abstinence in Substance Use
Participants reported sustained abstinence and assessment was done through drug test.
Measured: 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
Measured: 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)
Measured: 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)
Measured: baseline, 12 months
Secondary outcomes (3)
Number of Participants With Recidivism in Delinquency
Number of participants that have no report of arrests from the Juvenile Services Department
Measured: 12 months
Number of Participants With Peer Gang Involvement
Number of participants recorded involved in peer gangs.
Measured: 12 months
Change in Family Communication by Parenting Style Questionnaire (PSQ)
PSQ Responses rage from 1 (never) to 6 (always)
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Apr 2019
- Primary completion31 May 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Louis Herns Marcelin, University of Miami
- Investigators
- Louis H Marcelin, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876171
- Sponsor's protocol ID
- 20180597
- Other IDs
- 1R34DA043784-01A1
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2019
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35272392Marcelin 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 at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Modified Family Based Therapy for Haitian Youth in South Florida
- ClinicalTrials.gov ID
- NCT03876171
- Acronym / sponsor ID
- 20180597
- Conditions
- Problem Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CIFFTA | Experimental | Behavioral: Haitian youth family-based intervention study: family functioning, Behavioral: Haitian youth intervention study: youth psychoeducational, Behavioral: Haitian family-based intervention study: psychoeducationalFamily-Based Adolescent Therapy, Individual Therapy, and Psycho-educational Modules |
| Standard of Care | Active comparator | Behavioral: Diversion ProgramsThe Diversion Programs used by the Juvenile Services Department in Miami-Dade. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Youths with a documented history of mental retardation and/or organic dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haitian youth family-based intervention study: family functioningA weekly group therapy with the youth in presence of a parent or caretaker in the family. | Behavioural | CIFFTA |
| Haitian youth intervention study: youth psychoeducationalWeekly one and one psychoeducational module will be delivered to the youth. | Behavioural | CIFFTA |
| Haitian family-based intervention study: psychoeducationalWeekly psychoeducational module will be delivered to the adolescent to the youth in the presence of a family. | Behavioural | CIFFTA |
| Diversion ProgramsYouth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program. | Behavioural | Standard of Care |
Primary outcome
Number of Participants That Completes the Intervention:
Time frame: 12 months
Number of participants that complete the modules constitutes the outcome measure
Number of Participants With Sustained Abstinence in Substance Use
Time frame: 12 months
Number of participants reporting sustained abstinence in substance use
Number of Participants Who Reported Sustained Abstinence in Substance Use
Time frame: 12 months
Participants reported sustained abstinence and assessment was done through drug test.
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 a composite score using the FES questionnaire with scales ranging from 0-26 with the highest score indicating that no further intervention is needed
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)
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)
3 secondary outcomes
Number of Participants With Recidivism in Delinquency
Time frame: 12 months
Number of Participants With Peer Gang Involvement
Time frame: 12 months
Change in Family Communication by Parenting Style Questionnaire (PSQ)
Time frame: baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35272392Cela 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.
- Derived from this study: PubMed 33734451Marcelin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis H Marcelin, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haitian youth family-based intervention study: family functioning, Haitian youth intervention study: youth psychoeducational and Haitian family-based intervention study: psychoeducational in people with Problem Behavior, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Completes the Intervention: (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876171, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.