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Culturally Modified Family Based Therapy for Haitian Youth in South Florida

Primary Purpose

Problem Behavior

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Haitian youth and family intervention study: family functioning

Haitian youth intervention study: youth psychoeducational

Haitian family intervention study: family psychoeducational

Diversion Programs

About this trial

This is an interventional treatment trial for Problem Behavior

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

Adolescents aged 13 to 17 and their families
Place of residence is Miami-Dade
Has Haitian ancestry
Adolescents not incarcerated
No prior mental health care or history of psychoactive medication
Adolescents in families who have lived in the US for 3 years
Families with a range of organizational structure (nuclear and non-nuclear)

Exclusion Criteria:

- Youths with a documented history of mental retardation and/or organic dysfunction.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIFFTA

Standard of Care

Arm Description

Family Therapy, Individual Therapy, and Psycho-educational Modules

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

Outcomes

Primary Outcome Measures

Number of participants that completes the intervention

All the participants that complete the modules and the baseline instruments

Number of participants with sustained abstinence in substance use as assessed by biochemical verification

Participants maintain a sustained abstinence measured through biochemical verification via urine drug test.

Number of participants with sustained abstinence in substance use as assessed by self-reporting

Participants maintain a sustained abstinence measured through self-reporting

Change in family functioning assessed by the family environment scale (FES)

Improved connectivity and communication within the family system will be assess via 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

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)

Reduction in risky sexual activities as assess by CASI using normative data-severity scores range from 0 (never) to 3 (very often)

Secondary Outcome Measures

Number of participants with recidivism in delinquency

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

Change in family communication as assessed by Parenting Style Questionnaire (PSQ)

Change in family communication as assessed by Parenting Style Questionnaire (PSQ) with scoring ranges from 1 to 7 where 7 indicates optimum communication.

Number of participants with peer gang involvement

Number of participants with peer gang involvement self-reported

Full Information

NCT ID

NCT03876171

First Posted

March 6, 2019

Last Updated

March 29, 2023

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03876171

Brief Title

Culturally Modified Family Based Therapy for Haitian Youth in South Florida

Official Title

Culturally Modified Family Based Therapy for Haitian Youth in South Florida

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Culturally Modified Family Based Therapy for Haitian Youth and Their Families in South Florida study is a unique intervention that will develop and implement a culturally-specific, integrated family and individual-based, 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, integrated family and individual-based, drug use, sexual risk and delinquency risk reduction program for Haitian adolescents aged 13-17 in Miami-Dade County, Florida.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Problem Behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CIFFTA

Arm Type

Experimental

Arm Description

Family Therapy, Individual Therapy, and Psycho-educational Modules

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Haitian youth and family intervention study: family functioning

Intervention Description

A weekly group therapy with the youth, the parents and other members of the family.

Intervention Type

Behavioral

Intervention Name(s)

Haitian youth intervention study: youth psychoeducational

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Haitian family intervention study: family psychoeducational

Intervention Description

Weekly psychoeducational module will be delivered to the family.

Intervention Type

Behavioral

Intervention Name(s)

Diversion Programs

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants that completes the intervention

Description

All the participants that complete the modules and the baseline instruments

Time Frame

12 months

Title

Number of participants with sustained abstinence in substance use as assessed by biochemical verification

Description

Participants maintain a sustained abstinence measured through biochemical verification via urine drug test.

Time Frame

12 months

Title

Number of participants with sustained abstinence in substance use as assessed by self-reporting

Description

Participants maintain a sustained abstinence measured through self-reporting

Time Frame

12 months

Title

Change in family functioning assessed by the family environment scale (FES)

Description

Time Frame

baseline, 12 months

Title

Change in conduct disorder as assess by Revised Behavior Problem Checklists

Description

Time Frame

baseline, 12 months

Title

Change in sexual risk behaviors as assess by the Comprehensive Adolescent Severity Inventory (CASI)

Description

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 Outcome Measure Information:

Title

Number of participants with recidivism in delinquency

Description

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

Time Frame

12 months

Title

Change in family communication as assessed by Parenting Style Questionnaire (PSQ)

Description

Change in family communication as assessed by Parenting Style Questionnaire (PSQ) with scoring ranges from 1 to 7 where 7 indicates optimum communication.

Time Frame

baseline, 12 months

Title

Number of participants with peer gang involvement

Description

Number of participants with peer gang involvement self-reported

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Adolescents aged 13 to 17 and their families Place of residence is Miami-Dade Has Haitian ancestry Adolescents not incarcerated No prior mental health care or history of psychoactive medication Adolescents in families who have lived in the US for 3 years Families with a range of organizational structure (nuclear and non-nuclear) Exclusion Criteria: - Youths with a documented history of mental retardation and/or organic dysfunction.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis H Marcelin, Ph.D.

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33124

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35272392

Citation

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.

Results Reference

derived

PubMed Identifier

33734451

Citation

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.

Results Reference

derived

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Culturally Modified Family Based Therapy for Haitian Youth in South Florida

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