The Rural African American's Health Project (RAAFHP)

University of Georgia (UGA)

Status and phase: Completed; Phase 2

Conditions: FUEL for Families; SAAF-T

Treatments: Behavioral: SAAF-T; Behavioral: Fuel for Families

Study type: Interventional

Funder types: Other

Identifiers

NCT04501471

2006-10685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 15 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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502 participants in 2 patient groups, including a placebo group

SAAF-T

Experimental group

Description:

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

Treatment:

Behavioral: SAAF-T

Fuel for Families

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Fuel for Families