The Rural African American's Health Project

NCT ID: NCT04501471

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2010-09-30

Brief Summary

This is an attention controlled randomized clinical trial testing the efficacy of the Strong African American Families-Teen program. The two arm trial tests SAAF-T, a family centered brief intervention against a similarly designed program that targets nutrition and exercise. The outcomes examined include substance use and risky sexual behavior.

Detailed Description

In the past, African American adolescents in rural areas have avoided the high-risk behaviors prevalent among youth in urban areas. Recent epidemiologic data, however, indicate that rural African American youth use substances and engage in high-risk sexual behavior at rates equal to or exceeding those in densely populated inner cities (Kogan, Berkel, Chen, Brody, & Murry, in press; Milhausen et al., 2003). These risk behaviors predict HIV infection, adolescent parenthood, school dropout, involvement with the criminal justice system, and continued substance use during early adulthood (Friedman et al., 1996; Miller, Boyer, & Cotton, 2004; St. Lawrence & Scott, 1996; Tucker, Orlando, & Ellickson, 2003). No developmentally appropriate, culturally sensitive prevention programs have been developed to deter substance use and high-risk sexual behavior among the several million African American adolescents who live in the rural South (Murry & Brody, 2004). To address this public health need, Drs. Brody and Murry from the University of Georgia and Drs. DiClemente and Wingood from Emory University designed a multicomponent, family-centered prevention program, the Strong African American Families-Teen program (SAAF-T). We conducted a randomized prevention trial to test the program's efficacy. The sample included 502 rural African American families with a 10th-grade student, half of whom will be assigned randomly to a prevention group and half to an attention-control group. Pre-intervention, post-intervention, and long-term follow-up assessments of adolescents' substance use and high-risk sexual behavior were gathered from the entire sample. Specific aims were to test hypotheses that rural African American adolescents randomly assigned to participate in SAAF-T, compared to attention-control participants, will demonstrate lower rates of substance use and risky sexual behavior.

Conditions

SAAF-T; FUEL for Families

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

SAAF-T

Participants received a 5 session, 10-hour family centered prevention program designed to prevent substance use, conduct problems, and risky sexual behavior

Group Type: EXPERIMENTAL

SAAF-T

Intervention Type: BEHAVIORAL

Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.

Fuel for Families

Participants received a 5 session, 10 hour family centered program that focused on healthy nutrition and exercise.

Group Type: PLACEBO_COMPARATOR

Fuel for Families

Intervention Type: BEHAVIORAL

Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.

Interventions

SAAF-T

Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.

Intervention Type: BEHAVIORAL

Fuel for Families

Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.

Intervention Type: BEHAVIORAL

Other Intervention Names

Strong AFrican American Families-Teen Program

Eligibility Criteria

Inclusion Criteria

• Self-identified Black or African American
• 10th grade in public school in targeted county

Exclusion Criteria

• Unable to participate in group-based intervention due to mental health

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Gene H. Brody

Regents Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Brody GH, Yu T, Chen E, Miller GE, Barton AW, Kogan SM. Family-Centered Prevention Effects on the Association Between Racial Discrimination and Mental Health in Black Adolescents: Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Mar 1;4(3):e211964. doi: 10.1001/jamanetworkopen.2021.1964.

Reference Type: DERIVED

PMID: 33760092 (View on PubMed)

Other Identifiers

2006-10685

Identifier Type: -

Identifier Source: org_study_id