Trial Outcomes & Findings for Culturally Modified Family Based Therapy for Haitian Youth in South Florida (NCT NCT03876171)
NCT ID: NCT03876171
Last Updated: 2024-05-14
Results Overview
Number of participants that complete the modules constitutes the outcome measure
COMPLETED
NA
35 participants
12 months
2024-05-14
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).
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
15
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Re-arrest
|
0
|
4
|
Baseline Characteristics
Culturally Modified Family Based Therapy for Haitian Youth in South Florida
Baseline characteristics by cohort
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 years
n=99 Participants
|
15 years
n=107 Participants
|
15 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African Americans
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Number of participants that complete the modules constitutes the outcome measure
Outcome measures
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants That Completes the Intervention:
|
17 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Number of participants reporting sustained abstinence in substance use
Outcome measures
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants With Sustained Abstinence in Substance Use
|
17 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Participants reported sustained abstinence and assessment was done through drug test.
Outcome measures
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants Who Reported Sustained Abstinence in Substance Use
|
17 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
|---|---|---|
|
Change in Family Functioning Assessed by the Family Environment Scale (FES)
Baseline
|
9 score on a scale
Standard Deviation 1.69
|
10 score on a scale
Standard Deviation 1.54
|
|
Change in Family Functioning Assessed by the Family Environment Scale (FES)
12 months
|
9 score on a scale
Standard Deviation 1.37
|
9 score on a scale
Standard Deviation 1.96
|
PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: The measure has 113 items and the total score ranges from 0 to 226 with higher numbers indicating more problems.
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)
Outcome measures
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
|---|---|---|
|
Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists
Baseline
|
131 score on a scale
Standard Deviation 18.48
|
128 score on a scale
Standard Deviation 19.19
|
|
Change in Conduct Disorder as Assess by Revised Behavior Problem Checklists
12 Months
|
121 score on a scale
Standard Deviation 10.30
|
124 score on a scale
Standard Deviation 11.13
|
PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: 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.
Reduction in risky sexual activities as assess by CASI using normative data-severity scores range from 0 (never) to 3 (very often)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Number of participants that have no report of arrests from the Juvenile Services Department
Outcome measures
| Measure |
CIFFTA
n=20 Participants
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.
|
Standard of Care
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants With Recidivism in Delinquency
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Number of participants recorded involved in peer gangs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: 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.
PSQ Responses rage from 1 (never) to 6 (always)
Outcome measures
Outcome data not reported
Adverse Events
CIFFTA
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place