The Rural African American's Health Project (RAAFHP)

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.

Study Overview

• Status: Completed
• Conditions: SAAF-T; FUEL for Families
• Intervention / Treatment: Behavioral: SAAF-T; Behavioral: Fuel for Families

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.

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAAF-T; Participants received a 5 session, 10-hour family centered prevention program designed to prevent substance use, conduct problems, and risky sexual behavior	Behavioral: 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.; Other Names: Strong AFrican American Families-Teen Program
Placebo Comparator: Fuel for Families; Participants received a 5 session, 10 hour family centered program that focused on healthy nutrition and exercise.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance Use	Index of alcohol, cigarette, and marijuana use in the past 3 months	Follow up period baseline to 22 months post-baseline
Risky Sexual Behavior	Count of unprotected intercourse	Follow up period baseline to 22 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptomology- CES-D Scale	Symptoms of depression, 20 items	Symptoms in past week assessed, follow up period includes baseline to 22 months post baseline
Conduct Problems	Using 14 questions from the National Youth Survey,adolescents indicated the frequency during the past 6 months with which they had fought, stolen, been truant from school, or been suspended from school. Adolescents' responses were summed, and the sum constituted the conduct problems score.13	Follow up period baseline to 22 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discussion Quality Scale	The DQS assessed communication frequency and quality for discussions of difficult issues.	Follow up period -baseline to 6 month posttest
Family Support Inventory	The FSI measured provision of emotional support, involvement, and quality of caregiver-youth communication	Follow up period -baseline to 6 month posttest

Collaborators and Investigators

• Sponsor: University of Georgia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2005
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2006-10685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No