The Rural African American's Health Project

Study Overview
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Brief Summary
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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
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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
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SAAF-T, FUEL for Families

Intervention / Treatment
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* Behavioral: SAAF-T
* Behavioral: Fuel for Families


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAAF-T<br>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<br>* Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.<br>* Other names: Strong AFrican American Families-Teen Program;|
| Placebo Comparator: Fuel for Families<br>Participants received a 5 session, 10 hour family centered program that focused on healthy nutrition and exercise. | Behavioral: Fuel for Families<br>* Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.<br>|

What is the study measuring?
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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 |