Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA043784-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIFFTA | Experimental | Family-Based Adolescent Therapy, Individual Therapy, and Psycho-educational Modules |
|
| Standard of Care | Active Comparator | The Diversion Programs used by the Juvenile Services Department in Miami-Dade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haitian youth family-based intervention study: family functioning | Behavioral | A weekly group therapy with the youth in presence of a parent or caretaker in the family. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recidivism in Delinquency | Number of participants that have no report of arrests from the Juvenile Services Department | 12 months |
| Number of Participants With Peer Gang Involvement |
Not provided
Inclusion Criteria :
Exclusion Criteria:
- Youths with a documented history of mental retardation and/or organic dysfunction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louis H Marcelin, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35272392 | Derived | 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. | |
| 33734451 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Excluded:
Participants with prior mental health care or history of psychoactive medication Participants that are incarcerated. Participants with a documented history of mental retardation and/or organic dysfunction
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CIFFTA | Family-Based Therapy, Individual Therapy, and Psycho-educational Modules Haitian youth and family-based intervention study: family functioning: A weekly group therapy with the youth, the parents and other members of the family. Haitian youth intervention study: youth psychoeducational: Weekly one and one psychoeducational module will be delivered to the youth. Haitian family intervention study: family-based psychoeducational: Weekly psychoeducational module will be delivered. Participants will receive the CIFFTA intervention for up to 3 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2018 | Jan 23, 2024 |
Not provided
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.
Not provided
Not provided
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.
| Haitian youth intervention study: youth psychoeducational | Behavioral | Weekly one and one psychoeducational module will be delivered to the youth. |
|
| Haitian family-based intervention study: psychoeducational | Behavioral | Weekly psychoeducational module will be delivered to the adolescent to the youth in the presence of a family. |
|
| Diversion Programs | Behavioral | Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program. |
|
Number of participants recorded involved in peer gangs.
| 12 months |
| Change in Family Communication by Parenting Style Questionnaire (PSQ) | PSQ Responses rage from 1 (never) to 6 (always) | baseline, 12 months |
| FG001 | Standard of Care | The Diversion Programs used by the Juvenile Services Department in Miami-Dade. Diversion Programs: Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program. Participants in this group will receive the standard of care for up to 3 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline data was not collected for parents/caregivers.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CIFFTA | Family-Based Therapy, Individual Therapy, and Psycho-educational Modules Haitian youth and family-based intervention study: family functioning: A weekly group therapy with the youth, the parents and other members of the family. Haitian youth intervention study: youth psychoeducational: Weekly one and one psychoeducational module will be delivered to the youth. Haitian family intervention study: family-based psychoeducational: Weekly psychoeducational module will be delivered. Participants will receive the CIFFTA intervention for up to 3 months. |
| BG001 | Standard of Care | The Diversion Programs used by the Juvenile Services Department in Miami-Dade. Diversion Programs: Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program. Participants in this group will receive the standard of care for up to 3 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Completes the Intervention: | Number of participants that complete the modules constitutes the outcome measure | Participants dropped out because of COVID-19 during the grant period, we could not perform some of the analyses initially proposed in the grant application. This limitation was particularly true for proposed growth curve analyses, which require larger sample sizes than the sample we ultimately recruited. | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Sustained Abstinence in Substance Use | Number of participants reporting sustained abstinence in substance use | Participants dropped out because of COVID-19 during the grant period, we could not perform some of the analyses initially proposed in the grant application. This limitation was particularly true for proposed growth curve analyses, which require larger sample sizes than the sample we ultimately recruited. | Posted | Count of Participants | Participants | 12 months |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Reported Sustained Abstinence in Substance Use | Participants reported sustained abstinence and assessment was done through drug test. | Participants dropped out because of COVID-19 during the grant period, we could not perform some of the analyses initially proposed in the grant application. This limitation was particularly true for proposed growth curve analyses, which require larger sample sizes than the sample we ultimately recruited. | Posted | Count of Participants | Participants | 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 | Participants dropped out because of COVID-19 during the grant period, we could not perform some of the analyses initially proposed in the grant application. This limitation was particularly true for proposed growth curve analyses, which require larger sample sizes than the sample we ultimately recruited. | Posted | Mean | Standard Deviation | score on a scale | 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) | The measure has 113 items and the total score ranges from 0 to 226 with higher numbers indicating more problems. | Posted | Mean | Standard Deviation | score on a scale | 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) | Data on risky sexual behaviors was not collected from the questionnaires. There were no participants who responded to questions relevant to this measure at both the baseline and month 12 time points, therefore change data could not be calculated. | Posted | 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 | Participants dropped out because of COVID-19 during the grant period, we could not perform some of the analyses initially proposed in the grant application. This limitation was particularly true for proposed growth curve analyses, which require larger sample sizes than the sample we ultimately recruited. | Posted | Count of Participants | Participants | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Peer Gang Involvement | Number of participants recorded involved in peer gangs. | We made the strategic decision to not collect data on gang involvement because of negative sociocultural norms that prevail in the community. It was an oversight that we did not amend the protocol to reflect this decision. | Posted | 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Family Communication by Parenting Style Questionnaire (PSQ) | PSQ Responses rage from 1 (never) to 6 (always) | Data on family communication was not collected from the questionnaires. There were no participants who responded to questions relevant to this measure at both the baseline and month 12 time points, therefore change data could not be calculated. | Posted | baseline, 12 months |
|
3 years
Adverse events were not monitored for parents/caregivers.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CIFFTA | Family-Based Therapy, Individual Therapy, and Psycho-educational Modules Haitian youth and family-based intervention study: family functioning: A weekly group therapy with the youth, the parents and other members of the family. Haitian youth intervention study: youth psychoeducational: Weekly one and one psychoeducational module will be delivered to the youth. Haitian family intervention study: family-based psychoeducational: Weekly psychoeducational module will be delivered. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Standard of Care | The Diversion Programs used by the Juvenile Services Department in Miami-Dade. Diversion Programs: Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis Herns Marcelin, Ph.D. | University of Miami | 3052848493 | lmarcel2@miami.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2018 | Nov 2, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2018 | Nov 3, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000066553 | Problem Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|