Problem Behavior
Conditions
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.
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.
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
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
\- Youths with a documented history of mental retardation and/or organic dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sexual Risk Behaviors as Assess by the Comprehensive Adolescent Severity Inventory (CASI) | 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) |
| Number of Participants Who Reported Sustained Abstinence in Substance Use | 12 months | Participants reported sustained abstinence and assessment was done through drug test. |
| Change in Family Functioning Assessed by the Family Environment Scale (FES) | 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 | 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) |
| Number of Participants That Completes the Intervention: | 12 months | Number of participants that complete the modules constitutes the outcome measure |
| Number of Participants With Sustained Abstinence in Substance Use | 12 months | Number of participants reporting sustained abstinence in substance use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Peer Gang Involvement | 12 months | Number of participants recorded involved in peer gangs. |
| Change in Family Communication by Parenting Style Questionnaire (PSQ) | baseline, 12 months | PSQ Responses rage from 1 (never) to 6 (always) |
| Number of Participants With Recidivism in Delinquency | 12 months | Number of participants that have no report of arrests from the Juvenile Services Department |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 15 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Re-arrest | 0 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | CIFFTA | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 15 years | 15 years | 15 years |
| Race/Ethnicity, Customized Black or African Americans | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 15 |
| other Total, other adverse events | 0 / 20 | 0 / 15 |
| serious Total, serious adverse events | 0 / 20 | 0 / 15 |
Outcome results
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)
Time frame: baseline, 12 months
Population: The measure has 113 items and the total score ranges from 0 to 226 with higher numbers indicating more problems.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CIFFTA | Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists | Baseline | 131 score on a scale | Standard Deviation 18.48 |
| CIFFTA | Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists | 12 Months | 121 score on a scale | Standard Deviation 10.3 |
| Standard of Care | Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists | Baseline | 128 score on a scale | Standard Deviation 19.19 |
| Standard of Care | Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists | 12 Months | 124 score on a scale | Standard Deviation 11.13 |
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
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CIFFTA | Change in Family Functioning Assessed by the Family Environment Scale (FES) | Baseline | 9 score on a scale | Standard Deviation 1.69 |
| CIFFTA | Change in Family Functioning Assessed by the Family Environment Scale (FES) | 12 months | 9 score on a scale | Standard Deviation 1.37 |
| Standard of Care | Change in Family Functioning Assessed by the Family Environment Scale (FES) | Baseline | 10 score on a scale | Standard Deviation 1.54 |
| Standard of Care | Change in Family Functioning Assessed by the Family Environment Scale (FES) | 12 months | 9 score on a scale | Standard Deviation 1.96 |
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)
Time frame: baseline, 12 months
Population: 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.
Primary
Number of Participants That Completes the Intervention:
Number of participants that complete the modules constitutes the outcome measure
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CIFFTA | Number of Participants That Completes the Intervention: | 17 Participants |
| Standard of Care | Number of Participants That Completes the Intervention: | 8 Participants |
Primary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CIFFTA | Number of Participants Who Reported Sustained Abstinence in Substance Use | 17 Participants |
| Standard of Care | Number of Participants Who Reported Sustained Abstinence in Substance Use | 8 Participants |
Primary
Number of Participants With Sustained Abstinence in Substance Use
Number of participants reporting sustained abstinence in substance use
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CIFFTA | Number of Participants With Sustained Abstinence in Substance Use | 17 Participants |
| Standard of Care | Number of Participants With Sustained Abstinence in Substance Use | 8 Participants |
Secondary
Change in Family Communication by Parenting Style Questionnaire (PSQ)
PSQ Responses rage from 1 (never) to 6 (always)
Time frame: baseline, 12 months
Population: 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.
Secondary
Number of Participants With Peer Gang Involvement
Number of participants recorded involved in peer gangs.
Time frame: 12 months
Population: 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.
Secondary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CIFFTA | Number of Participants With Recidivism in Delinquency | 17 Participants |
| Standard of Care | Number of Participants With Recidivism in Delinquency | 8 Participants |